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Radiological Protection of
Patients in Diagnostic and

Interventional Radiology,
Nuclear Medicine and
Radiotherapy
Proceedings of an international conference held in Málaga,

Spain, 26–30 March 2001, organized by the
International Atomic Energy Agency
and co-sponsored by the European Commission,
the Pan American Health Organization
and the World Health Organization
RADIOLOGICAL PROTECTION
OF PATIENTS IN DIAGNOSTIC AND
INTERVENTIONAL RADIOLOGY,
NUCLEAR MEDICINE
AND RADIOTHERAPY
a
PROCEEDINGS SERIES
OF PATIENTS IN DIAGNOSTIC AND
INTERVENTIONAL RADIOLOGY,
NUCLEAR MEDICINE
AND RADIOTHERAPY
PROCEEDINGS OF AN INTERNATIONAL CONFERENCE HELD

IN MÁLAGA, SPAIN, 26–30 MARCH 2001, ORGANIZED BY
THE INTERNATIONAL ATOMIC ENERGY AGENCY
AND CO-SPONSORED BY THE EUROPEAN COMMISSION,
THE PAN AMERICAN HEALTH ORGANIZATION
AND THE WORLD HEALTH ORGANIZATION
INTERNATIONAL ATOMIC ENERGY AGENCY

VIENNA, 2001
c
Permission to reproduce or translate the information contained in this publica-
tion may be obtained by writing to the International Atomic Energy Agency,
Wagramer Strasse 5, P.O. Box 100, A-1400 Vienna, Austria.
© IAEA, 2001
VIC Library Cataloguing in Publication Data

International Conference on Radiological Protection of Patients in Diagnostic
and Interventional Radiology, Nuclear Medicine and Radiotherapy (2001 :
Malaga, Spain)
Radiological protection of patients in diagnostic and interventional radiol-
ogy, nuclear medicine and radiotherapy : proceedings of an international con-
ference held in Malaga, Spain, 26–30 March 2001 / organized by the
International Atomic Energy Agency...[et al.]. — Vienna : The Agency, 2001.
p. ; 24 cm. — (Proceedings series, ISSN 0074–1884)
STI/PUB/1113
ISBN 92–0–101401–5
Includes bibliographical references.
1. Diagnosis, Radioscopic—Safety measures—Congresses. 2. Interventional
radiology—Safety measures—Congresses. 3. Nuclear medicine—Safety
measures—Congresses. 4. Radiotherapy—Safety measures—Congresses.
I. International Atomic Energy Agency. II. Series.
VICL 01–00268
Printed by the IAEA in Austria

September 2001
STI/PUB/1113
d
FOREWORD
Medical applications of ionizing radiation (or ‘radiation’ for short) are accept-
ed worldwide as essential tools for protecting and improving human health. However,
they also represent by far the largest human-made source of radiation exposure. The
United Nations Scientific Committee on the Effects of Atomic Radiation estimates
that diagnostic medical applications of radiation account for about 95% of the expo-
sure to radiation from human-made sources and about 12% of total exposure.
Furthermore, there is certain to be a continuing increase in the prevalence of medical
applications of radiation, including high dose procedures, as in the following cases:
— Radiological interventional procedures, which are increasingly being used to

replace surgery, can lead to very high radiation doses, both to patients and to
medical staff, in some cases exceeding thresholds for deterministic effects.
— The use of helical computed tomography (CT) has improved the diagnostic
quality of CT examinations, and the procedures are faster and more flexible
than with non-helical equipment. However, the increased number of procedures
and the increased number of scans per procedure may lead to a significant
increase in radiation exposure to patients.
In diagnosis, the radiological protection objective is to keep doses as low as

reasonably achievable while obtaining the necessary diagnostic information.
According to the International Commission on Radiological Protection, doses from
similar radiological investigations can differ by as much as two orders of magnitude.
There is therefore considerable scope for dose reduction in diagnostic and interven-
tional radiology and also in nuclear medicine. In therapy, the objective is to ensure
that the target tissue is given the prescribed dose while minimizing the dose to sur-
rounding healthy tissue. If the dose, dose distribution or dose fractionation is signif-
icantly different from that prescribed, serious consequences can arise, as in recent
incidents involving the accidental exposure of radiotherapy patients. The application
of well designed quality assurance programmes is necessary in order to ensure the
protection of patients.
In October 1999 the IAEA General Conference issued resolution GC(43)/RES/12
requesting the Secretariat of the IAEA “to organize as soon as feasible, in close collab-
oration with the World Health Organization and within the Agency’s current budgetary
resources, an international meeting on the radiological protection of patients for the pur-
pose of an exchange of information and the development of recommendations, as
appropriate, regarding the radiological protection of patients”.
In response to that request, the IAEA organized the International Conference on
the Radiological Protection of Patients in Diagnostic and Interventional Radiology,
Nuclear Medicine and Radiotherapy, which was co-sponsored by the European
e
Commission, the Pan American Health Organization and the World Health
Organization, and which was hosted by the Government of Spain. The conference
took take place in Torremolinos (Málaga), Spain, from 26 to 30 March 200l.
Other international organizations and professional societies co-operated in the
conference, namely the United Nations Scientific Committee on the Effects of
Atomic Radiation (UNSCEAR), the International Commission on Radiological
Protection (ICRP), the International Organization of Medical Physics (IOMP), the
International Radiation Protection Association (IRPA), the International Society of
Radiation Oncology (ISRO), the International Society of Radiographers and
Radiological Technologists (ISRRT), the International Society of Radiology (ISR)
and the World Federation of Nuclear Medicine and Biology (WFNMB).
The conference was the first of its kind specifically focused on the radiological
protection of patients. Apart from the opening and closing sessions, the conference pro-
gramme comprised background sessions with papers by representatives of the co-spon-
soring organizations and the professional societies, a briefing session with five papers
to introduce the subject of the conference, 13 topical sessions and six round tables.
The proceedings contain all the presentations and the summaries of all discus-
sions, and also include the opening addresses and the conclusions and recommenda-
tions. The contributed papers are provided on a CD-ROM which accompanies these
proceedings.
The IAEA gratefully acknowledges the support and generous hospitality
extended to the conference participants by the Spanish authorities.
EDITORIAL NOTE
The Proceedings have been edited by the editorial staff of the IAEA to the extent
considered necessary for the reader’s assistance. The views expressed remain, however, the
responsibility of the named authors or participants. In addition, the views are not necessarily
those of the governments of the nominating Member States or of the nominating organizations.
Although great care has been taken to maintain the accuracy of information contained
in this publication, neither the IAEA nor its Member States assume any responsibility for
consequences which may arise from its use.
The use of particular designations of countries or territories does not imply any judge-
ment by the publisher, the IAEA, as to the legal status of such countries or territories, of their
authorities and institutions or of the delimitation of their boundaries.
The mention of names of specific companies or products (whether or not indicated as
registered) does not imply any intention to infringe proprietary rights, nor should it be
construed as an endorsement or recommendation on the part of the IAEA.
The authors are responsible for having obtained the necessary permission for the IAEA
to reproduce, translate or use material from sources already protected by copyrights.
Material prepared by authors who are in contractual relation with governments is
copyrighted by the IAEA, as publisher, only to the extent permitted by the appropriate national
regulations.
f
CONTENTS
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
OPENING SESSION
Opening Address
C. Villalobos Talero . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Opening Address
J.Á. Azuara . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Opening Address
A. Díez de los Ríos Delgado . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Opening Address
R. Ruiz Cruces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Opening Address
F.A. Mettler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Opening Address
A.J. González . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Opening Address
K. Schnuer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Opening Address
C. Borrás . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Opening Address
H. Ostensen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
GLOBAL VIEW ON THE RADIOLOGICAL PROTECTION OF

PATIENTS (Background Session)
Role of the IAEA in the radiological protection of patients

P. Ortiz López, A.D. Wrixon, A. Meghzifene, J. Izewska . . . . . . . . . . . . . . . 35
EU laws and guidance reinforce the radiological protection of patients
M. Sarró Vaquero, D. Teunen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Global view on the radiological protection of patients: PAHO position paper
C. Borrás . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Global view on the radiological protection of patients: The World Health
Organization position
H. Ostensen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
The role of the United Nations Scientific Committee on the Effects of
Atomic Radiation in relation to medical radiation exposures
P.C. Shrimpton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
g
International Commission on Radiological Protection
F.A. Mettler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Role and responsibilities of medical physicists in radiological protection
of patients
A. Niroomand-Rad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
The activities of the International Radiation Protection Association in relation
to the radiological protection of patients
G.A.M. Webb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
International Society of Radiology and Radiation Protection
C.G. Standertskjöld-Nordenstam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Global view on the radiological protection of patients: Position paper by the
International Society for Radiation Oncology
H. Svensson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
International Society of Radiographers and Radiological Technologists and
radiation protection
A. Yule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
World Federation of Nuclear Medicine and Biology
H. Amaral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
BRIEFING SESSION
The current uses of radiation in medicine

P.C. Shrimpton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Radiological risks associated with the various uses of radiation in medicine
within the context of their associated benefits
F.A. Mettler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Current level of radiation dose to patients
A. Servomaa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Lessons learned in radiology
D.J. Goodenough . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
The international regulatory climate
J.-F. Lacronique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
TOPICAL SESSIONS
RADIOLOGICAL PROTECTION OF PATIENTS IN GENERAL

DIAGNOSTIC RADIOLOGY (Topical Session 1)
Protection of patients in general radiography

M.M. Rehani . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
h
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
RADIOLOGICAL PROTECTION ISSUES IN SPECIFIC USES OF

Radiological protection issues in mammography and computed tomography

J.E. Gray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
RADIOLOGICAL PROTECTION IN INTERVENTIONAL

RADIOLOGY (Topical Session 3)
Radiological protection in interventional radiology

R. Padovani . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
RADIOLOGICAL PROTECTION OF PATIENTS IN NUCLEAR

MEDICINE (Topical Session 4)
Radiological protection of patients in nuclear medicine

L.K. Harding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234
DEVELOPING AND USING GUIDANCE (REFERENCE) LEVELS IN

RADIOLOGY AND NUCLEAR MEDICINE EXAMINATIONS
(Topical Session 5)
Diagnostic reference levels in medical imaging

M. Rosenstein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
RADIOLOGICAL PROTECTION OF THE EMBRYO AND FOETUS

IN PREGNANT PATIENTS (Topical Session 6)
Effects after prenatal radiation exposures

C. Streffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275
RADIOLOGICAL PROTECTION OF PAEDIATRIC PATIENTS

(Topical Session 7)
i
Radiological protection of paediatric patients: An overview
H.G. Ringertz, S. Bremmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285
RADIOLOGICAL PROTECTION OF PATIENTS IN

RADIOTHERAPY (Topical Session 8)
Radiation protection in patients treated with radiation therapy

C.A. Pérez, H. Svensson, J.A. Purdy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291
Radiotherapy dosimetry audit: A European programme to improve quality
and safety in radiation treatments
I.H. Ferreira, A. Dutreix, A. Bridier, D. Marre, J. Chavaudra, H. Svensson 309
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325
RADIOLOGICAL PROTECTION OF PATIENTS IN BIOMEDICAL

RESEARCH (Topical Session 9)
Radiation protection of patients in biomedical research

J. Liniecki . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 343
INFLUENCE OF STANDARDIZATION IN THE DESIGN AND

DEVELOPMENT OF MEDICAL RADIOLOGICAL EQUIPMENT
(Topical Session 10)
Influence of standardization in the design and development of medical

radiological equipment for the radiological protection of patients
S.C. Lillicrap, P. Paras, H. Duschka . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 347
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 357
EDUCATION, TRAINING AND CONTINUOUS PROFESSIONAL

DEVELOPMENT IN THE RADIOLOGICAL PROTECTION OF
PATIENTS (Topical Session 11)
Education, training and continuous professional development in the

radiological protection of patients
L.K. Wagner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 361
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 375
TOPICS FOR RESEARCH AND DEVELOPMENT IN THE

RADIOLOGICAL PROTECTION OF PATIENTS (Topical Session 12)
j
Topics for research and development in the radiological protection of patients
K. Faulkner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 379
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 386
IMPLEMENTATION OF REGULATIONS FOR THE RADIOLOGICAL

PROTECTION OF PATIENTS (Topical Session 13)
Implementation of regulations for the radiological protection of patients

J. Cassar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 391
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 398
ROUND TABLES
Round Table 1: Expectations of patients’ advocates . . . . . . . . . . . . . . . . . . . . 403

Round Table 2: What should be done about radiation sensitive groups? . . . . . 415
Round Table 3: Establishing priorities in radiological protection . . . . . . . . . . 425
Round Table 4: Risks and benefits: Can they be assessed? How? . . . . . . . . . . 435
Round Table 5: Regulations: Too much or not enough? . . . . . . . . . . . . . . . . . 445
Round Table 6: What is the acceptable (non-occupational) exposure of
caregivers? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 455
Chairpersons of Sessions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 461

President of the Conference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 461
Vice-Presidents of the Conference (Spain) . . . . . . . . . . . . . . . . . . . . . . . . . . . 461
Scientific Conference Programme Committee . . . . . . . . . . . . . . . . . . . . . . . . 462
Spanish Conference Organizing Committee . . . . . . . . . . . . . . . . . . . . . . . . . . 462
Spanish Scientific Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 463
Host Government Liaison . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 463
Secretariat of the Conference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 464
List of Participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 465
Author Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 587
k
EXECUTIVE SUMMARY
The International Conference on the Radiological Protection of Patients in

Diagnostic and Interventional Radiology, Nuclear Medicine and Radiotherapy took
place in Torremolinos, Málaga, Spain, from 26 to 30 March 200l. It was hosted by the
Government of Spain. Nearly 800 senior officers and scientists from 88 Member
States, four co-sponsoring organizations, two co-operating organizations and six
international professional bodies participated in the conference. The conference was
co-sponsored by the European Commission, the Pan American Health Organization
and the World Health Organization. The following international organizations and
professional bodies co-operated in the organization of the conference: the United
Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), the
International Commission on Radiological Protection (ICRP), the International
Organization of Medical Physics (IOMP), the International Radiation Protection
Association (IRPA), the International Society of Radiation Oncology (ISRO), the
International Society of Radiographers and Radiological Technologists (ISRRT), the
International Society of Radiology (ISR) and the World Federation of Nuclear
Medicine and Biology (WFNMB).
The officers of the conference were as follows:
President: Celia Villalobos Talero, Minister of Health and Consumer Affairs,

Spain.
Vice-Presidents: Juan M. Kindelán Gómez de Bonilla, President of the Nuclear

Safety Council, Spain; Francisco Vallejo Serrano, Health Counsellor of the Regional
Government of Andalucía; and Antonio Díez de los Ríos Delgado, Rector of the
University of Málaga, Spain.
Chairperson of the Progamme Committee: F. Mettler, School of Medicine of

the University of New Mexico, United States of America.
Chairperson of the Organizing Committee: R. Ruiz Cruces, University of

Málaga, Spain.
Chairperson of the Spanish Scientific Committee: J. Hernández Armas,

University of La Laguna, Canary Islands, Spain.
Membership of the Programme Committee: C.E. de Almeida, Universidad do

Estado de Rio de Janeiro, Brazil; J. Cosset, Institut Curie, France; M. Magnusson,
Icelandic Radiation Protection Institute, Iceland; Y. Sasaki, National Institute of
i
ii EXECUTIVE SUMMARY
Radiological Sciences, Japan; E. Vañó (Vice-Chairperson), Universidad Complutense

de Madrid, Spain; L. Wagner, University of Texas Medical School, United States of
America; P. Ortiz López, International Atomic Energy Agency; A.J. González,
International Atomic Energy Agency; S. Groth, International Atomic Energy
Agency; A. Meghzifene, International Atomic Energy Agency; H. Ostensen, World
Health Organization (WHO); C. Borrás, Pan American Health Organization
(PAHO); K. Schnuer, European Commission.
Chairpersons of Technical Sessions and Round Tables: C.G. Standertskjöld-

Nordenstam, Helsinki University Hospital, Finland; G. Klempfner, St. Frances
Cabrini Hospital, Australia; V. Sinitsyn, Cardiology Research Center, Moscow
Medical Academy, Russian Federation; J. Konishi, Kyoto University School of
Medicine and Hospital, Japan; E. Vañó, Universidad Complutense de Madrid, Spain;
W. Leitz, Swedish Radiation Protection Institute, Sweden; P. Corr, Faculty of
Medicine, University of Natal, South Africa; C. Pérez, Washington University School
of Medicine, United States of America; H. Amaral, Medicina Nuclear, Clínica
Alemana, Chile; C. Lavoie, Radiation Protection Bureau, Canada; S. Nazarenko,
Tallin Central Hospital, Estonia; G. Drexler, Universidad do Estado do Rio de
Janeiro, Brazil; F. Vargas Marcos, Ministerio de Sanidad y Consumo, Spain;
B. Balaban, United States of America; J. Hendry, Christie Hospital NHS Trust, United
Kingdom; J.P. Oliva González, Instituto Nacional de Oncología y Radiobiología,
Cuba; M. Verdejo Silva, Dirección General de Salud Ambiental, Mexico;
Commissioner N.J. Díaz, US Nuclear Regulatory Commission, United States of
America; A. Hefner, Austrian Research Centre, Austria, and the Holy See.
The topics covered in the conference were:
Briefing sessions
• Current uses of radiation in medicine

• Current levels of radiation dose to patients
• History of the use of radiation in medicine and lessons learned from past
experience
• Benefits and radiological risks from medical exposure
• International regulatory climate
Topical sessions
• Radiological protection of patients in general diagnostic radiology

• Radiological protection issues in specific uses of diagnostic radiology, such as
mammography and computed tomography (with special consideration of the
EXECUTIVE SUMMARY iii
impact of digital techniques)

• Radiological protection in interventional radiology, including fluoroscopy not
carried out by radiologists (this topic covered the radiological protection both
of patients and of staff carrying out interventional radiology)
• Radiological protection of patients in nuclear medicine
• Developing and using guidance (reference) levels in radiology and nuclear
medicine examinations
• Radiological protection of the embryo and foetus in pregnant patients
• Radiological protection of paediatric patients
• Radiological protection of patients in radiotherapy (including the prevention of
exposures differing from prescription)
• Radiological protection of patients in biomedical research
• Influence of standardization in the design and development of medical radio-
logical equipment on the radiological protection of patients
• Education, training and continuous professional development in the radiologi-
cal protection of patients
• Topics for research and development in the radiological protection of patients
• Implementation of regulations on the radiological protection of patients
Round tables
• Expectations of patients’ advocates

• What should be done about radiation sensitive groups?
• Establishing priorities for the radiological protection of patients
• Risks and benefits: Can they be assessed? How?
• Regulations: Too much or not enough?
• What is the acceptable (non-occupational) exposure for caregivers?
iv EXECUTIVE SUMMARY
FINDINGS, CONCLUSIONS AND RECOMMENDATIONS
General
1. Medical practice involving the use of ionizing radiation (hereinafter referred

to as radiation) is by far the largest contributor to human exposure from
human-made sources of radiation; it accounts worldwide for about 95% of the
total dose from such sources. Worldwide, about 2 billion diagnostic X ray
examinations, 32 million nuclear medicine procedures and 5.5 million radia-
tion therapy treatments are currently being carried out annually, and the trend
is upwards.
2. There are enormous health benefits to be derived from medical uses of radia-
tion, and there is no doubt about the need to increase the availability of radio-
logical equipment and services in many countries. The radiological risks asso-
ciated with diagnostic procedures are typically low (there are some notable
exceptions which are discussed below), but it is important to manage the expo-
sure of patients so that it is no higher than is needed to obtain the required diag-
nostic information. The consequences of accidental exposures in radiotherapy1,
however, can be very serious and therefore exposures must be managed in such
a way that they are sufficiently high to produce the desired therapeutic results
in the target area, but are as low as reasonably achievable to other organs and
tissues.
3. The conference confirmed that there is scope for reducing the radiological risks
involved in both diagnostic and therapeutic uses of radiation without reducing
the medical benefits. It recognized that everyone in the health care community
has a role to play in this. Education and training of staff and appropriate qual-
ity assurance arrangements were regarded as essential for this purpose and were
underlying themes throughout the conference, and therefore will be reiterated
in the detailed findings of the topical sessions discussed below only when par-
ticular emphasis needs to be given to them.
1 Accidental exposure is referred to in the International Basic Safety Standards for

Protection against Ionizing Radiation and for the Safety of Radiation Sources as including “any
therapeutic treatment delivered to either the wrong patient or the wrong tissue, or using the
wrong pharmaceutical, or with a dose or dose fractionation differing substantially from the val-
ues prescribed by the medical practitioner or which may lead to undue acute or secondary
effects.”
EXECUTIVE SUMMARY v
Findings of the topical sessions
Radiological protection of patients in general diagnostic radiology
4. The conference identified a number of important means of reducing doses to

patients. These include ensuring that:
• appropriate quality control is exercised over the processing of films;

• radiation beams are appropriately collimated, to avoid the exposure of other tis-
sues than those of interest, and filtered, to limit the exposure to low energy radi-
ation which has no diagnostic value;
• fluoroscopy is not used without image intensifiers;
• the X ray tube potential (kVp) used is appropriate for the particular examina-
tion being performed; and
• fluoroscopy protocols are regularly reviewed and updated in the light of the
technique and the equipment type being used, with special emphasis on fluo-
roscopy time.
It was noted that the replacement of fluoroscopy units which do not currently
use image intensifiers entails a significant investment and requires planning.
Radiological protection issues in specific uses of diagnostic radiology, such

as mammography and computed tomography (with special consideration of
the impact of digital techniques)
5. The conference noted that mammography is the procedure in diagnostic radiol-

ogy for which most specific guidance and regulations have been developed,
particularly in industrialized countries. Training and quality assurance are
important, especially for screening mammography, where large numbers of
asymptomatic women are exposed. Quality assurance needs to be required by
regulations, but the protocols need to be allowed to evolve readily with chang-
ing technology.
6. Special attention also needs to be given to digital mammography. The fact that
digital images are relatively easy to obtain and delete may encourage less care
to be taken over the positioning of patients, which may, in turn, lead to an
increased potential for repeating the exposures. In addition, because digital
mammography uses an image receptor with a much broader dynamic range
than film, the exposure to the patient is not restricted by the characteristics of
the receptor, with the consequence that a higher dose than is necessary to obtain
the information needed for diagnosis may be used. It is possible to record a dig-
ital mammographic image with much higher doses than would be used in
vi EXECUTIVE SUMMARY
screen-film mammography, e.g. 2 to 4 times higher or more. In fact, these

higher doses result in even better image quality, as the appearance of quantum
mottle, or noise, is reduced (this is true for all digital radiological images, but
may be especially critical for mammography).
7. Computed tomography (CT) has considerable benefits in the diagnosis of dis-
ease, but, unlike most general diagnostic radiology, involves relatively high
doses. Newer techniques such as multislice CT and CT fluoroscopy can result
in even higher doses. It is important that these potentially very high doses be
kept to a minimum through careful assessment of protocols, strict referral cri-
teria for patients, use of automatic exposure controls and choice of scan
techniques.
Radiological protection in interventional radiology, including fluoroscopy

not carried out by radiologists (this topic covered the radiological protection
both of patients and of staff carrying out interventional radiology)
8. Interventional radiology (IR) is a technique with significant benefits for patient

care, and its use is increasing rapidly. It involves, however, relatively high doses
and, in a number of cases, deterministic effects are reported to have been pro-
duced in patients as a result of radiation exposure. In addition to the protection
of patients, the protection of staff is an important issue requiring a comprehen-
sive approach and standardized methods of exposure monitoring. Areas of the
body of particular concern in this respect are the skin (of patients), and the lens
of the eye and hands (of the interventionists). There is also concern about non-
radiologists (cardiologists, surgeons, urologists, etc.) conducting the interven-
tions, who may cause higher doses to patients and to themselves. Thus, educa-
tion and training programmes should also address these professionals.
9. To improve the radiological protection of patients, there is a need:
• to develop standardized methods for determining the doses, especially to the

patient’s skin, during IR;
• to explore the possibility of establishing guidance (reference) levels2;
• to develop image quality criteria;
2 The expression ‘diagnostic reference levels’ is used in European Union directives and
ICRP documents and has the same meaning as the expression ‘guidance levels for medical
exposure’, which is used in the International Basic Safety Standards for Protection against
Ionizing Radiation and for the Safety of Radiation Sources (BSS). The definition in the BSS is
“a level of a specified quantity above which actions should be considered. In some circum-
stances, actions may need to be considered when the specified quantity is substantially below
the guidance level.”
EXECUTIVE SUMMARY vii
• to develop guidance on beam projection and dynamic features of IR such as the

frame frequency;
• to develop material for education and training in radiation protection for radi-
ologists and the other specialists involved in IR;
• to establish quality assurance programmes that include simple constancy tests;
• to ensure closer collaboration between radiologists, radiographers and medical
physicists and non-radiologists performing IR; and
• to ensure that IR is performed with specialized equipment and not with general-
purpose equipment.
10. The conference noted that the uses to which IR is put are evolving very rapidly,
and the approaches to radiation safety and the training of personnel will need
to keep pace with developments.
11. Nuclear medicine, which involves the administration of radioactive materials to

patients, is a widely used technique for obtaining diagnostic information as well
as for therapeutic purposes using radiopharmaceuticals. New techniques, such
as positron emission tomography (PET), which provides new diagnostic infor-
mation, are being increasingly used. The doses from such techniques are often,
however, higher than those from more conventional techniques using, for exam-
ple, technetium-99m. The conference concluded that:
• as a tool in the optimization of protection, diagnostic guidance (reference) lev-

els of administered activity for nuclear medicine should be developed on a
national or local basis, but used in a way that takes account of the size of the
patient, with particular allowance being made for children, on the one hand, and
overweight patients, on the other;
• before nuclear medicine techniques are used, particular care should be taken to
find out whether female patients are pregnant or breastfeeding and adapt the
technique or advise the patient accordingly;
• following the administration of radiopharmaceuticals, women should be
advised to delay pregnancy so as to limit the dose to the foetus;
• consideration should be given to the appropriate ways of informing patients
regarding the two previous points;
• in the event of accidental exposure, especially of therapeutic doses, measures
should be taken to increase excretion; and
• because of the increased exposure from PET studies, specific consideration
should be given to the optimization of protection.
viii EXECUTIVE SUMMARY
Developing and using guidance (reference) levels for medical exposures in

radiology and nuclear medicine examinations
12. The objective of guidance (reference) levels is to assist in the management of

the exposure of patients in such a way that the radiation doses resulting from
the conduct of a medical imaging task are commensurate with the clinical pur-
pose. They are advisory and should be used flexibly. In essence, they should act
as investigation levels and, as such, should be a part of any quality assurance
arrangements. Exceeding them should stimulate questions regarding the equip-
ment or the procedures used3. The view was expressed that they can be applied
in a number of ways: (a) in a triage of patient dose distributions for general clin-
ical tasks in order to reduce the number of unjustified high or low values in the
distribution; (b) in promoting good practice for a specific clinical application;
and (c) in promoting the optimum use of medical radiation exposure for a
specific clinical protocol, with more precisely defined clinical and technical
conditions.
13. The conference agreed that the guidance (reference) levels should be developed
through co-operation between health and radiation protection authorities and
the appropriate professional groups and should be derived from the distribu-
tions of doses observed in practice in the relevant region or country. The focus
so far has been on establishing upper levels, but the conference felt that lower
levels also need to be specified so as to indicate when the relevant diagnostic
information would not be obtained.
14. In complex procedures such as interventional radiology, guidance (reference)
levels could assist in the management of the stochastic effects, but, with regard
to the deterministic effects of radiation exposure, doses should be monitored
continuously to determine whether the threshold doses are being approached.
Radiological protection of the embryo and foetus in pregnant patients
15. The conference discussed the specific issues surrounding the protection of the
embryo and foetus. The discussion covered the effects of radiation exposure,
the doses received from medical practice, the administrative measures neces-
sary to avoid unintended exposures, the management of medical examinations
involving pregnant patients and the possible need for counselling after radiation
exposure. It was noted that the risk factors for stochastic effects, such as car-
cinogenesis, are assumed to be similar to those in early childhood. Additional
3 The BSS also require that “corrective actions be taken if doses or activities fall sub-
stantially below the guidance level and the exposures do not provide useful diagnostic
information…”.
EXECUTIVE SUMMARY ix
health effects, however, are associated with prenatal exposure — for example,
malformation and growth retardation — although these are largely restricted to
a particular period of prenatal development and only occur above a threshold of
100 mGy or more. In cases of genetic predisposition, which are rare, malfor-
mations can also be induced in the pre-implantation phase.
16. Doses to the embryo and foetus from diagnostic examinations do not normally
exceed the threshold dose of about 100 mGy. However, there might be some
exceptions to this, for example in some extended CT examinations of the
abdomen.
Radiological protection of paediatric patients
17. Special attention should be given to infants and children: first, because the risks
of stochastic effects are higher than for adults; second, because of the wide
range of their weight, which makes standardization of procedure more compli-
cated; and third, because of the number of paediatric diagnostic procedures
conducted annually — currently above 250 million throughout the world. There
are issues relating to both justification of a procedure and optimization of the
protection associated with the procedure. Particular problems that were noted
include poor beam collimation, inadequate devices for immobilization, lack of
adequate quality control and the need for age-specific exposure factors based
on appropriate anatomical parameters, especially with CT examinations. It was
estimated that, with appropriate care, doses to paediatric patients could be
reduced by 35–75% without affecting image quality.
18. To achieve better patient care in this area, the conference recommended that:
• protocols with referral (justification) criteria based on clear clinical indications

should be developed for paediatric patients;
• techniques and procedures should be specifically tailored for paediatric
patients, necessitating improvement in both equipment and staff training; and
• patient preparation guidelines, exposure factors, diagnostic guidance (refer-
ence) levels and image quality criteria should be developed.
Radiological protection of patients in radiotherapy (including the

prevention of exposures differing from prescription)
19. Radiotherapy is an extremely important tool in the treatment of cancer.

However, it is essential to limit the exposures of tissues other than the target and
the risk of accidental exposure. Quality assurance is essential for patient pro-
tection to ensure safe and effective treatment, including the prevention of acci-
dental medical exposure. New techniques, such as intensity modulation,
x EXECUTIVE SUMMARY
dynamic therapy, computer controlled accelerator therapy and tomotherapy, are

being introduced and these require their own well developed quality assurance,
which in turn requires an adequate commitment of resources. Also, endovascu-
lar brachytherapy poses new radiation protection problems. The session on this
subject also highlighted the need to pay attention to the protection of staff and
the public.
Radiological protection of patients in biomedical research
20. Biomedical research involving the radiation exposure of persons, not as part of
any diagnosis or treatment, carries with it important ethical considerations and
should only be undertaken in accordance with the relevant standards established
by the World Medical Assembly, the ICRP, WHO, the IAEA and the European
Commission. The basic principles are:
• voluntary participation;
• justification of the exposure;
• optimization of protection; and
• prior approval by an ethics committee.
21. It was noted, however, that these basic principles are not always fully met. The
following are particularly important:
• the informed consent of the person concerned;

• the approval by an ethics committee which includes members appropriately
qualified in radiation protection and capable of arriving at an informed judge-
ment;
• monitoring by the ethics committee to ensure observance of the conditions of
approval; and
• the avoidance of financial incentives for volunteers, which can create an ethi-
cally unclear situation.

radiological equipment on the radiological protection of patients
22. Equipment standards relate to the manufacture, maintenance and quality con-
trol of equipment, whereas the use of equipment in obtaining images of the
quality required for diagnosis is the responsibility of the medical practitioner.
The standards for medical radiological equipment should reflect the state of
the art and should be reviewed from time to time in the light of changes in
technology and practices. Standardization should not, however, be allowed to
EXECUTIVE SUMMARY xi
impede the development of medical radiological equipment. There is a particu-

lar need to improve the standardization of digital radiological systems for con-
nectivity among components of a system and among different systems and
imaging modalities, i.e. standardization in relation to connectivity in picture
archiving and communication systems (PACS) and radiological information
systems (RIS). This standardization should include dose data to be incorpo-
rated into equipment design. The conference also noted that standardization
related to radiation safety and effectiveness of the equipment is not a matter
for developed countries alone, but should be applicable and verifiable in all
countries.

23. Education, training and continuous professional development were seen as key
to the effective radiological protection of patients and should be incorporated
into the overall quality management system in radiology, nuclear medicine and
radiation oncology. Programmes should be comprehensive and specifically
targeted at their particular audiences, taking account of their specialities —
medical practitioners (including general practitioners), technologists, nurses,
medical physicists, equipment designers, equipment maintenance engineers,
administrators and regulators. This requires the development of a systematic
approach to education and training in which the needs of the recipients and the
means of meeting those needs are clearly identified, with the overall objective
of discriminating against bad practice. An individual’s training should be doc-
umented, but particularly in the case of continuous professional development it
was felt that care should be taken to ensure that the programmes are effective
and that documentation does not become an end in itself. Education and train-
ing programmes should also encourage the adoption of a balanced approach to
the benefits and risks of medical radiology. Furthermore, the potential for using
information technology and distance learning should be thoroughly examined.
24. Education, training and continuous professional development should be rein-
forced by legislative and administrative requirements and receive the neces-
sary financial and moral support at the local, regional and national level.
25. It was strongly recommended that the organizers of the conference should
work towards the establishment of a harmonized approach to education, train-
ing and continuous professional development in the radiological protection of
patients. On an associated topic, it was also recommended that relevant infor-
mation concerning radiological protection should be developed and provided
to patients in order to facilitate obtaining their informed consent before the use
of any particular procedure involving radiation exposure.
xii EXECUTIVE SUMMARY
Topics for research and development in the radiological protection of

patients
26. It was noted that the use of radiation in medicine is growing rapidly and that
research has failed to keep pace with the technological developments. Further
research was therefore regarded as essential, the following areas being identified:
• quantification of the risks and benefits of medical exposure;

• the applicability of current methods of assessment of radiological risk in med-
icine;
• the dosimetric infrastructure and biological dosimetry methods;
• the interrelationship between the various dose quantities used;
• the development of criteria for image quality;
• the development of dosimetric techniques for the purposes of optimization of
protection;
• the evaluation of dose reduction techniques, such as the use of increased tube
filtration, pulsed flouroscopy, beam profile filters, road mapping and other dig-
ital image processing;
• the development of guidance (reference) levels to include complex procedures;
• the assessment of methods of evaluating equipment performance, particularly
in relation to new technologies in digital radiology, with emphasis on research
on the trade-off between patient dose and image quality (noise);
• recording and retrieval of data related to patient doses to be incorporated into
equipment design;
• standardization in relation to connectivity in picture archiving and communica-
tion systems (PACS) and radiological information systems (RIS);
• research to address radiation protection issues posed by intravascular
brachytherapy;
• recommendations to address difficulties in evaluating equipment performance
in countries with various levels of development.
Implementation of regulations on the radiological protection of patients
27. Justification and optimization are the fundamental principles underlying radia-
tion protection regulations, and they need to be reflected in regulatory require-
ments. However, in order to implement these requirements effectively, close
liaison between regulators and medical and paramedical professionals needs to
be fostered and a safety culture should be encouraged as part of the implemen-
tation of radiation protection regulations. Regulations should require quality
assurance programmes to be established, but the programmes and protocols
EXECUTIVE SUMMARY xiii
should not be part of the regulatory text, in order to allow for developments in
technology.
Findings from the round tables
Expectations of patients’ advocates
28. Patients expect, before giving their consent to a procedure involving radiation
exposure, to be adequately informed about the nature of the proposed proce-
dure, about the benefits and risks, about the alternatives and about the duties of
the medical staff. Many patients dislike being transferred from one physician to
another and being isolated from the medical staff during diagnostic and thera-
peutic procedures. Patients should be partners in treatment decisions and be
represented on committees and other groups dealing with health policy issues.
What should be done about radiation sensitive groups?
29. Some 0.1–1% of people are highly radiation sensitive. The main problems due
to high radiosensitivity occur in radiotherapy, and will possibly emerge in high
dose diagnostic radiology procedures involving prolonged fluoroscopy. The
currently available laboratory techniques for screening for such sensitivity are
not sufficiently accurate and specific to provide a reliable predictive test.
However, radiotherapy patients who are observed after treatment to be
radiosensitive should be examined frequently (once a week at least) in order
that any serious complications due to the radiation exposure can be mitigated.
Cancer patients with certain types of tumour and a family history of cancer may
be genetically predisposed to both cancer and radiosensitivity. Genetic coun-
selling and testing for radiosensitivity are particularly important for these
patients, with consideration being given to alternative treatments or modified
radiotherapy, if necessary.
Establishing priorities for the radiological protection of patients
30. There should be one system of radiation protection for all countries, even if dif-
ferent levels of implementation exist. Regulations should emphasize the need
for and specify the elements of quality assurance programmes. Familiarity with
diagnostic guidance (reference) levels and how they are used is important.
Radiation protection should not be compromised by market pressures.
xiv EXECUTIVE SUMMARY
Risks and benefits: Can they be assessed? How?
31. The benefits and risks associated with medical uses of radiation vary substan-
tially from one individual to another and each use should be judged on its own
merits. The benefits and risks for a particular individual are difficult to quantify,
and justification decisions must therefore be taken on the basis of the physi-
cian’s training and experience and of knowledge regarding the individual
patient’s medical history.
Regulations: Too much or not enough?
32. Regulations should be such as to result in a benefit. Risk-informed regulations

can positively affect the benefit/risk ratio. However, it is not the regulators’ role
to scrutinize the benefits of medical uses of radiation; rather, it is their role to
enforce good practice. It was felt that there was a possible danger associated
with too much regulation in this area. The motto in such circumstances should
be “fewer but better regulations”, the particular point being that regulations are
necessary but not sufficient alone to achieve the necessary safety standard. The
development and implementation of regulations was seen as a corporate exer-
cise involving all the key stakeholders — regulators, physicians, physicists,
paramedical staff and representatives of professional associations.
What is the acceptable (non-occupational) exposure for caregivers?
33. The risk to ‘comforters’ (caregivers) is mainly from gamma emitters used in
brachytherapy and nuclear medicine, especially radiopharmaceuticals used in
therapy. The exposure of comforters should be voluntary and risk-informed.
Recommendations relating to international co-operation
34. The relevant international organizations should promote the distribution and
appropriate use of basic radiographic equipment. Consideration should be
given to promoting the use of high kVp rather than low kVp techniques for
chest radiography. Fluoroscopy units without image intensifiers should be
replaced and the use of photofluorography for screening should be reduced.
35. Education and training should be promoted, with programmes specifically
addressing the management of medical radiation exposures. Future training,
possibly provided through CD-ROM-based courses, should include training
in the use of information available on the Internet. Preference should be
given to the use of existing material, rather than to the development of new
material.
EXECUTIVE SUMMARY xv
36. Quality assurance programmes should be promoted, with a strong emphasis on

image quality, as dose assessment needs to be associated with evaluation of the
diagnostic information provided by the images.
37. The relevant international organizations should tailor their programmes, rec-
ommendations and standards to each country’s resources and priorities, in order
to avoid resource misallocation. A coherent philosophy should be developed
regarding flexibility in the application of regulations, for example in the use of
guidance (reference) levels.
38. Guidelines should be developed regarding intercountry transfers of second-
hand equipment.
39. The relevant international organizations should encourage countries to develop
their own guidance (reference) levels.
Overall recommendation of the Málaga Conference
40. The relevant international organizations should convene a group of experts,

including experts from professional societies and regulatory bodies, to formu-
late an action plan based on the findings of the conference for future work relat-
ing to the radiological protection of patients.
OPENING SESSION
OPENING ADDRESS
C. Villalobos Talero
Ministra de Sanidad y Consumo,
Madrid, Spain
I would like to welcome the Health Adviser of the Andalusian Regional

Government and the Rector of the University of Málaga, and representatives of the
IAEA, the World Health Organization, the Pan American Health Organization and the
European Union.
First of all let me extend a very warm welcome to you all and express my most
sincere appreciation of your participation in this conference. It is a pleasure for me to
be with you here today at this important meeting, which, without doubt, will help
increase our knowledge of the radiological protection of patients.
I would like to congratulate the IAEA on its excellent organization of this first
International Conference on the Radiological Protection of Patients in Diagnostic and
Interventional Radiology, Nuclear Medicine and Radiotherapy. At the same time, I
should like to express my gratitude to the co-sponsors — the European Commission,
the Pan American Health Organization and the World Health Organization. Allow me
also to mention the contribution made by the authorities of the Andalusian Regional
Government, and the generous participation of the University of Málaga and the
Radiological Protection Research Group of the University of Málaga.
I cannot but mention the co-operation provided by the following scientific and
technical organizations: the International Commission on Radiological Protection,
the United Nations Scientific Committee on the Effects of Atomic Radiation, the
International Organization for Medical Physics, the International Radiation
Protection Association, the World Federation of Nuclear Medicine and Biology, the
International Society of Radiology, the International Society for Radiation Oncology,
and the International Society of Radiographers and Radiological Technologists. It is
an honour for me, as the Minister of Health and Consumer Affairs, to host this con-
ference in a city with which I have strong personal ties.
The radiological protection of patients is a priority activity for the Ministry of
Health and Consumer Affairs as part of the work carried out by the General
Directorate for Public Health and Consumer Affairs pursuant to our General Health
Act.
One of the things that we have done in recent years is to develop legislation on
the radiological protection of patients subjected to medical exposures. As you know,
the public want safe and quick high quality services that enable disorders to be diag-
nosed and treated without any health risk. It is our obligation to provide health care
3
4 VILLALOBOS TALERO
services that guarantee the fair and effective use of ionizing radiation. More than 30
years have passed since the radiologist Richard H. Chamberlain highlighted the fact
that two thirds of the human race do not have access to the most basic radiological
techniques; the situation is similar for radiotherapy and, of course, nuclear medicine.
I hope that the holding of this conference will help us make significant progress
towards reducing the disparities that exist in the access of people throughout the
world to radiological treatment and diagnostic services, irrespective of where they
live. The use of new information technologies should facilitate the acquisition, analy-
sis and transmission of images from anywhere on the planet.
In the European arena, the 1984 patient protection directive recognized that,
apart from exposure to natural sources of radiation, which is to a large extent
inevitable, medical exposure is the most significant source of exposure to ionizing
radiation for citizens of the European Union.
This directive established basic measures to improve the radiological protection
of patients, without jeopardizing the benefits to be obtained from radiation as regards
early detection, diagnosis and treatment. These measures seek to prevent inadequate
or excessive exposure to radiation, and to improve the quality and effectiveness of
medical radiological procedures.
In 1990 the European Community legislation was incorporated into the Spanish
legal system by means of a Royal Decree establishing basic measures for the radio-
logical protection of persons undergoing medical examinations and treatments.
One of the basic principles inspiring this directive was the need to avoid the
unnecessary proliferation of radiological installations. With this in mind, the Ministry
of Health and Consumer Affairs, in close co-ordination with the autonomous com-
munities, has compiled a national inventory of installations that provide radiodiagno-
sis, radiotherapy and nuclear medicine services.
With a view to implementing this standard, the Ministry of Health and
Consumer Affairs has published four Royal Decrees, three of which deal with qual-
ity criteria in radiodiagnosis, including interventional radiology, radiotherapy and
nuclear medicine, respectively. These Royal Decrees contain provisions on quality
assurance programmes, the protection of persons exposed voluntarily in the course of
medical research, the evaluation of doses to patients, etc. A fourth Royal Decree reg-
ulates the granting of the official titles of specialists in hospital radiophysics.
We believe that the inclusion of hospital radiophysics as one of the specializa-
tion fields in the health sector was an important step. These specialists are trained for
three years in the hospital system. To date, four groups have been trained and a fifth
will finish in May of this year.
The work that is being done to provide training in radiological protection for
those responsible for using ionizing radiation equipment in medicine is also impor-
tant. The medical specialization fields directly related to the use of ionizing radiation,
such as radiodiagnosis, radiotherapeutic oncology and nuclear medicine, have now
OPENING ADDRESS 5
incorporated radiological protection into their teaching programmes, and it is planned

to include the subject in the teaching programmes of other specialist fields, such as
cardiology, traumatology and orthopaedic surgery, that also employ diagnosis and
therapy techniques based on the use of ionizing radiation.
Furthermore, the study programmes for specialized technicians in the diagnos-
tic and radiotherapeutic imaging field already cover radiological protection.
A Royal Decree will be published very shortly on justification of the use of ion-
izing radiation in medicine, as provided for in the European Community standard.
The draft covers the need for medical specialists, dentists and chiropodists, and refer-
ring physicians, to justify radiological practices. The possibility of including radio-
logical protection in the training programme of faculties of medicine and dentistry
and in university schools of chiropody is also addressed.
Despite the problems and difficulties that the implementation of all these regu-
lations might entail, it is worth making the necessary effort to set up quality assurance
programmes in radiological installations with a view to optimizing the radiological
We should not forget the special precautions for the treatment of children, preg-
nant or breastfeeding women, and practices involving high exposure levels and health
screening programmes.
The health authorities and the professionals involved in medical radiological
procedures should all be involved in this effort.
I hope that this meeting, where experts from 100 countries have gathered
together, will be an excellent forum for exchanging experience and opinions, helping
further to improve the radiological protection of patients.
The conclusions of this conference will clearly benefit all authorities, radiolog-
ical protection experts, medical specialists and referring physicians, and other health
professionals, and all representatives of international organizations and societies in
the radiological protection field.
Finally, I should like to thank all the members of the Programme Committee,
the Conference Secretariat, the Spanish Organizing Committee and the Spanish
Scientific Committee for their superb work.
I wish you a pleasant stay in the wonderful city of Málaga.
OPENING ADDRESS
J.Á. Azuara
Consejo de Seguridad Nuclear,
Madrid, Spain
As the representative of the Nuclear Safety Council (NSC) at this meeting I

wish, first of all, to pass on to you the greetings of its President, who cannot be here
today as he had wished owing to unavoidable commitments. I should also like to
express our appreciation to the organizers and sponsors of this conference for their
invitation to take part in this opening ceremony. In particular, the NSC would like to
express its gratitude to the IAEA for having accepted the invitation from the
Government of Spain to hold this event in this country.
I will take this opportunity to share with you some general thoughts on the sys-
tem for regulating radiological protection, with particular reference, of course, to the
medical related aspects and, especially, protection of the patient.
First of all, I should like to emphasize that regulation of radiological protection
is based not only on the scientific knowledge of harmful effects, but also on ethical
values and principles. These ethical values should be in keeping with the values pre-
vailing in other areas of social and political life if these principles are to be univer-
sally accepted.
The evolution of radiological protection during the twentieth century can be
explained with reference to ethical and scientific arguments, and three stages can be
distinguished. Until the 1950s, when the scientific community discovered the possi-
ble carcinogenic and hereditary effects of radiation, the basic protection principle was
to protect individuals from the appearance of lesions of a deterministic nature, keep-
ing exposures below specific thresholds. No social considerations were taken into
account, as low doses of radiation were considered to be beneficial.
From the 1950s, and in particular at the end of the 1970s, when non-determin-
istic effects began to be taken into account, the protection system started to work on
the principle that if society was adequately protected so was the individual, bringing
into play the principles of justification and optimization. In maximizing the benefit
for the community an eminently social ethical principle was being applied. These
principles, though they do apply to patient protection, were implemented in a more
discretionary manner in the field of medical practice.
The current recommendations of the International Commission on Radiological
Protection (ICRP) apply restrictions to optimization in order to prevent excessive dis-
parities in the exposure of individuals. Since the beginning of the 1990s there has
been an increasing interest in the protection of individuals and of their rights, which
7
8 AZUARA
is reflected both in the legal sphere and science (e.g. the genetic susceptibility of indi-
viduals). The ICRP is now considering revising these recommendations, taking into
account the ethical dimensions of radiological protection in the present day social
context, and establishing a new regulatory framework based on the principle of equal-
ity in which all individuals have the right to a certain level of protection. Patient pro-
tection would seem to fit in better in this new framework.
I should now like to highlight one of the characteristics of and, in turn, one of
the real values of, regulation in this field, namely the high level of harmonization
internationally both with regard to the basic principles and the specifics of the vari-
ous fields of applications.
Advances in our understanding of the effects of ionizing radiation are the objec-
tive of many studies carried out at research centres all over the world; the results of
those studies have traditionally been compiled and systematized by a number of
national and international organizations, including the United Nations Scientific
Committee on the Effects of Atomic Radiation [1] and the Committee on the
Biological Effects of Ionizing Radiation [2] of the United States Academy of
Sciences. The work carried out by these bodies forms the basis on which the ICRP
develops its recommendations, which usually serve as the effective point of departure
for a revision of the standards.
Although there is no consensus on what model depicts accurately the relation-
ship between exposure to ionizing radiation and its effects at low doses, the majority
of scientific and regulatory bodies accept that a linear, non-threshold relationship is
the most prudent hypothesis to take when establishing the basis for the regulation of
radiological protection. We may recall the conclusions of the International
Conference on Low Doses of Ionizing Radiation, held in Sevilla in 1997 [3], which
was sponsored by the IAEA and the World Health Organization and co-ordinated by
the Nuclear Safety Council, and which reaffirmed that this scenario was adequate for
regulatory purposes.
The established procedure in the international community for elaborating regu-
lations in this field is a great help in preventing a disparate and contradictory
approach. As I have mentioned already, the ICRP recommendations played a crucial
role in the establishment of universal benchmarks for the development of these regu-
lations. Their acceptance by the IAEA and Euratom at the end of the 1950s helped
consolidate appropriate mechanisms for the promotion of an international consensus
on these efforts.
In Spain, as in the other States of the European Union, radiological protection
standards are developed and updated by incorporating European Community direc-
tives into our legal system. Thus Directive 84/466/Euratom, which has now been
replaced by Directive 97/43/Euratom, lays down the basic measures for the radiolog-
ical protection of patients and facilitates improvements of the quality and effective-
ness of medical radiological procedures, avoiding unnecessary or excessive exposures
OPENING ADDRESS 9
without hampering the use of ionizing radiation for the early detection, diagnosis or
treatment of disease.
The incorporation into national law of the second of these directives on protec-
tion against the health risks of ionizing radiation exposure in medicine has given rise
to three Royal Decrees establishing quality criteria for radiodiagnosis, nuclear medi-
cine and radiotherapy, and to the Royal Decree on justification of the use of ionizing
radiation in medicine, which is in the final stages of approval.
With the making of these Royal Decrees, Spain is in a similar position in this
field to other countries. However, we should not forget that radiological protection,
and, in particular, the optimization of protection as regards both medical exposures
and other types of exposure, requires more than regulation and quality assurance pro-
grammes for equipment. To a large extent it is a matter of attitude, goodwill and com-
mitment of the professionals involved.
Finally, I am confident that this conference will promote discussion and shar-
ing of experience, both being so necessary to improve even further the harmonization
of regulations based on ethical principles and in-depth scientific knowledge; it should
also help disseminate state of the art knowledge and good practice in this field
throughout the world. This will not only meet effectively the objectives of the regu-
lations, it will also be a great help in transmitting a message of confidence to society.
REFERENCES
[1] UNITED NATIONS, Sources, Effects and Risk of Ionizing Radiation (Report to the
General Assembly), Scientific Committee on the Effects of Atomic Radiation
(UNSCEAR), UN, New York (1988).
[2] NATIONAL RESEARCH COUNCIL COMMITEE ON THE BIOLOGICAL EFFECTS
OF IONIZING RADIATION, Health Effects of Exposure to Low Levels of Ionizing
Radiation (BEIR V), National Academy Press, Washington, DC (1990).
[3] Low Doses of Ionizing Radiation: Biological Effects and Regulatory Control (Proc. Int.
Conf. Seville, 1997), IAEA, Vienna (1998).
OPENING ADDRESS
A. Díez de los Ríos Delgado

Rector of the University of Málaga, Spain
I welcome you not only in my capacity of Rector of the University of Málaga

but also as a research worker who is concerned with questions of radiological pro-
tection and who is a member of a research group that participated in the organization
of this conference.
I hope that this conference will be productive, helping to ensure that radiologi-
cal protection becomes more and more effective in the face of the fresh challenges
constantly being posed by medical practice.
I wish to express my gratitude to the IAEA, and especially Mr. Abel González,
for having chosen the University of Málaga as one of its partners in organizing this
conference, following a very successful course on the radiological protection of
patients that we held three or four years ago. They say that one has to sow a lot in
order to harvest a little, but I am sure that that will not be so in the case of this con-
ference.
In thanking the other participants and organizers, I should like to say how
pleased I am that Her Excellency the Minister of Health found time in her very busy
schedule to be with us here today.
11
OPENING ADDRESS
R. Ruiz Cruces
President of the Organizing Committee,
PRUMA, University of Málaga,
Torremolinos, Spain
Welcome to the International Conference on the Radiological Protection of

Patients in Diagnostic and Interventional Radiology, Nuclear Medicine and
Radiotherapy. Welcome to Málaga. We are all very happy to see our city serve as a
meeting point for scientists from all over the world. For one week we will have the
opportunity to exchange experience, discuss, work and pool criteria in order to verify
and optimize protection, and to reduce excessive or unnecessary radiation doses; in
short, we are here for the benefit of patients, who are our raison d’être as profession-
als in the field of ionizing radiation.
As organizers we wish to express our gratitude to all those bodies, both public
and private, that have contributed to making this meeting possible. As scientists we
are expecting a great deal from this week’s work. We are in no doubt as to the high
standards of the working sessions, and the excellence of the physical and human envi-
ronment in which they are going to be held.
Welcome to this conference. Welcome to Málaga, the place that is to be your
home for the next few days.
13
OPENING ADDRESS
F.A. Mettler
University of New Mexico Health Sciences Center,
Albuquerque, New Mexico, United States of America
Medical radiation exposure is rapidly increasing around the globe, and cur-
rently benefits hundreds of millions of people each year. However, as with any med-
ical treatment, there is a social, moral and ethical responsibility to manage exposure
appropriately.
We have ambitious goals for this week, and we are going to be concentrating
particularly on protecting patients without unduly compromising the benefits to those
patients. There are two purposes of this conference: first, to foster information
exchange in the area of patient protection; second, to formulate recommendations and
findings regarding further international co-operation in this area.
The input will come from the 197 accepted papers, the Round Tables, the
Topical Sessions and, more importantly, you, the audience from 80 different coun-
tries. There will be chances for audience participation during each Round Table and
Topical Session.
I should like to thank the conference organizers, the IAEA, and the co-spon-
soring organizations, the World Health Organization, the Pan American Health
Organization and the European Commission. Finally, I thank the Government of
Spain and the authorities of Andalucía and Málaga for the hospitality accorded to us,
and the organizing committee for all its hard work.
15
OPENING ADDRESS
A.J. González
Director of the Division of Radiation and Waste Safety,
International Atomic Energy Agency,
Vienna
I wish to convey to you all a warm welcome from the Director General of the
IAEA, Dr. Mohamed ElBaradei, who, owing to unexpected commitments, cannot be
with us today.
We welcome you to this friendly Spanish city of Torremolinos, in the
Andalusian Province of Málaga, and to this first international gathering aimed at fos-
tering information exchange on the pressing issue of protecting patients against expo-
sure to ionizing radiation incurred as a result of diagnostic or therapeutic medical pro-
cedures.
My initial remark is to express my gratitude, which I am sure is shared by the
intergovernmental organizations co-sponsoring this conference together with the
IAEA — namely the European Commission (EC), the World Health Organization
(WHO) and its regional office for the Americas, the Pan American Health
Organization (PAHO) — our gratitude to you all for making this magnificent event
possible.
With the discovery of X rays by Roentgen a century ago, ionizing radiation
began to be used in revealing the parts of the human body that previously could not
be seen, thereby improving the diagnostic techniques available to the medical profes-
sion. Not much later ionizing radiation began to be used also in the treatment of var-
ious ailments, and today it is an essential tool in procedures for treating and curing
cancer.
However, the properties that make radiation so effective for diagnostic and ther-
apeutic purposes, namely its ability to penetrate tissue and to kill and transform tis-
sue cells, can also make it hazardous to health. Employing radiation in medicine,
therefore, presents a dilemma: on one hand the use of radiation should be encouraged
in order to enhance human health and welfare, on the other hand the overall radiation
exposure of people in medical practices should be kept as low as reasonably achiev-
able, in order to minimize its deleterious effects. According to the United Nations,
radiation exposure in medical practices accounts for most of the exposure of people
to human-made sources of radiation.
This dilemma, namely using radiation in medicine as much as feasible while
keeping exposures as low as possible, is the fundamental reason for the discipline
termed the radiological protection of patients. The dilemma permeates the radiation
17
18 GONZÁLEZ
related activities of international organizations such as the IAEA and of the other
organizations co-sponsoring this conference.
The IAEA, for instance, has a statutory responsibility to establish standards for
the protection of people against exposure to ionizing radiation and to provide for the
worldwide application of those standards; this responsibility is unique within the
United Nations system, and it is the reason why the IAEA’s Division of Radiation and
Waste Safety, which is under my supervision, was entrusted with the task of organiz-
ing this conference.
The IAEA’s Statute also requires, however, the IAEA to seek to accelerate and
expand the contribution of ionizing radiation to health. So, like the WHO the IAEA
has a health mandate, a mandate to promote nuclear applications for health in nuclear
medicine, for radiodiagnostic, radiotherapeutic and other procedures. This pro-
gramme is executed by, inter alia, transferring relevant technologies to its Member
States, while at the same time fostering a culture of quality assurance (QA). These
QA activities include a thermoluminescent dosimetry audit service, which the IAEA
has been running jointly with the WHO and the PAHO since 1969. QA and the radi-
ological protection of patients are two disciplines that are inherently integrated. That
is why my colleague, Dr. Steffen Groth, Director of the IAEA’s Division of Human
Health, which has this particular responsibility within the IAEA, is also present at this
conference.
The conflict between promoting and restricting radiation exposure has contin-
ued throughout the history of radiology. Its resolution has been so elusive that the
radiological protection of patients remained for years a pragmatic discipline based on
the case by case consideration of individual situations. It should not be surprising,
therefore, that for many years there was an absence of universally accepted criteria
and generic approaches, and no internationally accepted standards for the radiologi-
cal protection of patients were established. As astonishing as it might seem, apart
from a certain amount of general national guidance, the radiological protection of
patients was effectively excluded from international standards until as recently 1996,
when the IAEA, together with the other relevant organizations of the United Nations
system, including the WHO and the PAHO, established the current international radi-
ation safety standards, the so-called Basic Safety Standards [1], which contain several
requirements relating to the protection of patients. Thus the need for general stan-
dards became evident and many international organizations are following up with
detailed guidance, notably the EC, which has issued specific directives, and
Committee 3 of the International Commission on Radiological Protection (ICRP),
which, under the chairmanship of Professor Fred Mettler, has sped up the issuing of
detailed recommendations for the medical community.
The establishment of standards, however important and even essential it is, rep-
resents only one element of ensuring the protection of patients. The second element
is the application of such standards in practice. As I mentioned before, the IAEA has
OPENING ADDRESS 19
a statutory responsibility to provide for the application of such standards and employs
a variety of mechanisms for this purpose. One important mechanism is the fostering
of information exchange. This conference is a good example of how we employ this
mechanism in discharging that statutory responsibility.
The IAEA has organized this conference in the manner in which it usually orga-
nizes its major meetings on radiation safety. Following a decision of the IAEA
General Conference calling for this conference, we sought a host government and the
co-operation and collaboration of relevant international organizations. As to the for-
mer, we once again gratefully received an offer of hospitality from the Government
of Spain. As to the latter, the EC, WHO and PAHO immediately took on the challenge
of co-sponsoring this conference with us. We subsequently convened a programme
committee of high level experts from all over the world, chaired by Professor Fred
Mettler, to decide on the main issues to be covered by this conference. These issues
are:
— The radiological protection of patients in diagnostic radiology, including such

specific procedures as mammography and computed tomography, in interven-
tional radiology, including fluoroscopy not carried out by radiologists, and in
nuclear medicine;
— The use of guidance or reference levels in radiology and nuclear medicine
examinations;
— The radiological protection of the embryo and foetus in pregnant patients;
— The radiological protection of paediatric patients, including those undergoing
radiotherapy;
— The radiological protection of patients in biomedical research;
— The influence that standardizing medical radiological equipment has on radio-
logical protection;
— Education and training, research and development, and the implementation of
regulations.
Contributed papers were requested on all these issues. They have been repro-
duced in a substantial book, which you should have received when registering for this
conference. We have also arranged for the preparation of papers by keynote speakers
and on overviews by the Rapporteurs introducing the issues, which will also cover the
subsequent discussions among you.
In addition, six Round Tables have been organized. They will provide an oppor-
tunity to discuss a number of controversial questions not included among the main
issues before this conference. They include such questions as:
— What are the expectations of patients from the use of ionizing radiation?
— How does one deal with patients belonging to radiation sensitive groups?
20 GONZÁLEZ
— What should the priorities be in the radiological protection of patients? This is

one of the dilemmas faced by developing countries.
— How should a medical doctor quantify risks and benefits in order to justify pre-
scribing radiological procedures and in order to optimize patient protection?
— Are there too many regulations or not enough? (Radiologists and radiothera-
pists seem to regard regulatory standards as an obstacle; conversely, regulators
seem to feel that the regulation of radiodiagnosis and radiotherapy is inade-
quate.)
— How should caregivers be protected? Is it acceptable that so many caregivers,
for example family members and those who dedicate their lives to caring vol-
untarily for the sick, should receive high exposures?
Let me share with you the IAEA’s ambitious expectations for this conference.
Firstly, we would like you to engage in a candid discussion on all the issues and
questions that I have mentioned, with the aim of finding solutions to the problems
presented. Following each session and Round Table the Chairpersons, with the sup-
port of the Rapporteurs and the Secretariat, will, we hope, summarize the findings.
The President of the Conference, with the help of the President of the Programme
Committee, will try to amalgamate all the findings into a short, simple document,
aimed mainly at political decision makers. If that objective is achieved, the Secretariat
of the IAEA will, as is customary after IAEA radiation safety conferences, submit the
findings to the policy making organs of the IAEA with the view to their approving an
international action plan to strengthen the radiological protection of patients. The
IAEA will then implement the action plan in co-operation with other relevant inter-
national organizations. These are our expectations, and I urge you to help in ensuring
that they are realized.
The keynote papers to be presented during this week, and an edited English ver-
sion of the discussions, will form the proceedings of this conference, which will be
issued by the IAEA in its usual matter. The contributed papers, which you have
received in draft form, will be made available on compact disk in addition to the pro-
ceedings.
Let me now take a few minutes of your time in order to speak about the mag-
nificent organization of this event. It is obvious that convening such an enormous
gathering as this, with so many reputed scientists from a wide range of disciplines,
requires tremendous efforts on the part of many people. We are indebted to all those
who have made this event possible. It would take me the remainder of the morning to
pay tribute to each one of them, so I apologize to all those silent workers for not ful-
filling what should perhaps be my main obligation in this opening speech.
I will try, however, to express our gratitude to so many by speaking briefly
about just a few. Firstly, we are extremely grateful for the generous hospitality
extended once again by the Governments of Spain and Andalucía. Andalucía, this
OPENING ADDRESS 21
land of hospitality, has hosted three major IAEA conferences in the past few years.
Sevilla, Córdoba and now Málaga have become part of the history of radiation safety
by hosting important events that foster the exchange of information among experts in
this discipline.
Spain is represented here today by its Ministry of Health and Consumer Affairs,
headed by Her Excellency Dr. Celia Villalobos Talero, who is also the President of the
Conference. Through her I would like to convey to the Government of Spain the
IAEA’s recognition of its unremitting support for the IAEA’s activities. His
Excellency Dr. José Ángel Azuara represents Spain’s Nuclear Safety Council, which
is the regulatory authority in Spain with responsibility for radiation protection (and I
apologize to Dr. Azuara for an unforgivable printing error: the Nuclear Safety Council
is not mentioned in the programme leaflet that has been distributed; a corrigendum
has, however, been issued). Andalucía is represented here by His Excellency Dr. José
Luis Marcos of the Andalusian Ministry of Health, whom I would ask to convey to
the authorities of Andalucía our thanks for the hospitality that has been extended to
so many gatherings organized by the IAEA in this beautiful part of Spain. Our host
city is represented by its highest authority, His Excellency the Mayor of
Torremolinos, Mr. Pedro Fernández Montes, to whom I should like to say, on behalf,
I am sure, of the thousand or more people in this room, how greatly we appreciate the
superb facilities, including this magnificent Palace of Congresses, made available for
our conference, and the kindness and hospitality of the people of Torremolinos.
This event would certainly not have been possible without the enthusiasm and
professionalism of the University of Málaga and its research group PRUMA, repre-
sented here by His Excellency Dr. Antonio Díez de los Ríos Delgado, to whom I offer
my heartfelt thanks, with a request that he convey our gratitude to the university staff
and undergraduates who worked so hard in preparing for this event.
I also wish to express the gratitude of the IAEA to the sister organizations co-
sponsoring this conference, namely the EC, PAHO and WHO, and to the ICRP, the
United Nations Scientific Committee on the Effects of Atomic Radiation and the
many professional societies that have co-operated in the organization of this event:
the International Organization of Medical Physicists, the International Radiation
Protection Association, the International Society of Radiology, the International
Society of Radiation Oncology, the International Society of Radiographers and
Radiological Technologists, the World Federation of Nuclear Medicine and Biology
and the United States Conference on Radiation Control Program Directors.
However, the major organizational task fell on the shoulders of the three main
committees of this conference: firstly, the Programme Committee, chaired by
Professor Fred Mettler from the United States of America (thank you Fred for your
unremitting efforts on behalf of this conference, and kindly convey our thanks to all
the other members of the committee); secondly, the Spanish Scientific Committee,
chaired by Dr. J. Hernández Armas of the University of La Laguna, Canary Islands
22 GONZÁLEZ
(thank you Pepe, and my thanks also to your colleagues); and, thirdly, above all, the
Spanish Organizing Committee, chaired by Dr. Rafael Ruiz Cruces, Vice Dean of the
Faculty of Medicine of the University of Málaga (Rafael, you have been the real guid-
ing spirit during the preparations for this conference, and we are greatly indebted to
you).
In addition to the Spanish Nuclear Safety Council, many other regulatory orga-
nizations are represented here. I will mention just one of them, the Nuclear
Regulatory Commission of the United States, which is represented here by its
Commissioner Nils Díaz.
The IAEA wishes all of you who have travelled from afar an enjoyable stay in
Torremolinos, in this most hospitable part of Spain, Andalucía. The IAEA is very
grateful to you all, to the institutions to which you belong and to the Member States
from which you come for the unstinting support accorded to our activities in the field
of the radiological protection of patients.
The success of this conference lies in your expert hands.
REFERENCE
[1] FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS,
INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR
ORGANISATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN
HEALTH ORGANIZATION, WORLD HEALTH ORGANIZATION, International
Basic Safety Standards for Protection against Ionizing Radiation and the Safety of
Radiation Sources, Safety Series No. 115, IAEA, Vienna (1996).
OPENING ADDRESS
K. Schnuer
European Commission,
Luxembourg
I am delighted to have the opportunity to welcome you to this important

International Conference on the Radiological Protection of Patients in Diagnostic and
Interventional Radiology, Nuclear Medicine and Radiotherapy here in Torremolinos.
It would be negligent of me if I did not first express my thanks to the Government of
Spain and the University of Málaga for inviting us to the Costa del Sol and its beau-
tiful capital, Málaga. I should also like to thank the IAEA for its initiative, and the
World Health Organization and the Pan American Health Organization for their sup-
port.
This conference provides a timely opportunity to initiate a new debate on the
future direction of radiological protection in the medical sector. It will help to focus
attention on the role that national regulators, medical services, doctors and medical
staff will play in implementing the most recent international and national provisions
on the radiological protection of persons undergoing medical investigations involving
ionizing radiation.
The European Commission has defined the responsibilities for radiation pro-
tection within the European Union and therefore has a keen interest in the proceed-
ings of this conference. As you know, the European Union places heavy emphasis on
nuclear safety and radiological protection. In particular, the most recent multiannual
work programme of the European Commission recognizes the importance of the use
of radiation in relation to medical diagnosis and treatment, as well as the necessary
protection requirements.
The European Commission has actively sought to strengthen international
health and safety regulations to enhance radiation protection in general and in the
medical sector in particular.
The importance of appropriate and effective radiation protection policies can-
not be overemphasized. Exposure to ionizing radiation can lead to detrimental health
effects in humans, and there is an obligation on each government to ensure that the
highest standards of safety and radiological protection are employed.
The subjects that will be discussed over the course of the next few days con-
cerning the exposure of patients to ionizing radiation are the result of a number of
years of careful and detailed deliberations by scientists and medical and radiation pro-
tection experts. The provisions of the most recent international and European recom-
mendations and regulations will profoundly influence radiological protection world-
23
24 SCHNUER
wide for a considerable time and will represent a significant step forward in the radi-
ological protection of patients.
All of you here this morning will be aware of the major contribution that the
European Commission has made to advance discussions in this field, including those
that will take place at this conference. I am pleased to see that the IAEA, in initiating
this conference, is committed to continuing its support to the international medical
community as it prepares to implement and to transpose the most recent scientific
information into operational practice.
The additional radiation protection requirements for the protection of patients
will undoubtedly have financial consequences. A critical concern will be to ensure the
optimum benefit and welfare of the patients and the minimum adverse impact on
financially stressed national health care budgets.
It is a major task for politicians to create the legal basis and the conditions
required for the protection of persons in general against all sorts of dangers affecting
their health and welfare. As recent epidemics and disasters have shown, there is a
need for such political efforts based on sound and comprehensive scientific informa-
tion.
The protection of patients against the dangers arising from ionizing radiation is
not an isolated subject in health politics. It should be part of a package of regulatory
measures and actions taken in the social and health policy sector.
The European Commission is aware of the fact that an unequal administrative
or financial burden on national health services may create an unwanted economic
misbalance. However, assurance should be provided that it is not used to justify inci-
sive social change.
The subject of radiation protection in medical practice is a multidisciplinary ini-
tiative involving different interest groups and specialized services. It is a subject that
will continue to be of importance in the twentyfirst century.
I invite the responsible representatives in this field to contribute to a construc-
tive exchange of information and experience and to put all their efforts into the devel-
opment of practical solutions that are acceptable to all involved in the medical health
sector.
I firmly believe that, through a process of negotiation and discussion, such as
that provided at this conference, we will gain a deeper insight and a better apprecia-
tion of the many issues involved in the operational implementation of international
and national medical radiation protection requirements and the more efficient use of
diagnostic and nuclear medicine techniques.
The European Commission will do its best to make this conference a success-
ful step forward to achieve this goal.
To conclude, I would like to wish all participants every success in their delib-
erations. Regardless of the weather conditions, I hope that you all will have an oppor-
tunity to sample some of the splendours and hospitality of Málaga and Torremolinos
OPENING ADDRESS 25
over the next few days. To those visiting from abroad, I hope you will have a pleas-
ant stay and return again soon.
OPENING ADDRESS
C. Borrás
Pan American Health Organization,
Washington, D.C.
On behalf of the Director of the Pan American Health Organization (PAHO),

Dr. Sir George Alleyne, welcome. It is a great pleasure for the PAHO to co-sponsor a
conference on a subject, that of patient care, that we consider to be entirely related to
public health.
As many of you are aware, next year PAHO will complete 100 years of unin-
terrupted work in the field of public health. Its history is interesting; perhaps we can
review it a little.
Public health co-operation in the Americas began at the end of the nineteenth
century. In 1890 the First International Conference of American States took place, at
which the International Union of American Republics, now the Organization of
American States (OAS), was set up. In 1901 the Second International Conference of
American States recommended that regular regional conferences of health represen-
tatives should be held to draw up health agreements and regulations. The union pro-
posed that a permanent executive body should be set up in the form of the
International Sanitary Bureau. Its mandate was finalized in 1902, in Washington, DC,
during the First International Sanitary Convention of the American Republics. This
gave rise to what we now know as the Pan American Health Organization and had
seven members and a budget of US $5000.
Between 1902 and 1920 there were six international conferences on health in
the Americas, at which the International Sanitary Bureau was responsible for gather-
ing and disseminating sanitary information. In 1924 the Pan American Sanitary Code
was signed, and is still in force today.
After the Second World War in 1945 the need arose to establish the United
Nations and the specialized agencies that have a global reach. In 1946 the World
Health Organization (WHO) was founded, and it began its activities in 1948. Several
months after the WHO signed its constitution the body now known as the Pan
American Sanitary Organization (PASO) ratified its own constitution and, in 1949,
both organizations signed an agreement through which the latter agreed to operate as
the WHO Regional Office for the Americas. In 1950 the PASO formalized its rela-
tions with the Organization of American States, which continues to recognize it as a
specialized agency of the inter-American system. In 1958 PASO became the Pan
American Health Organization.
27
28 BORRÁS
PAHO currently has 38 Member States and one associate member, Puerto Rico.
The United Kingdom, France and the Netherlands, which have territories in the west-
ern hemisphere, are Member States. Spain and Portugal, which do not have territories
there, are observers.
Concern for patients subjected to radiodiagnostic procedures, radiotherapy or
nuclear medicine dates back to the 1950s, when PAHO began to promote radiologi-
cal protection as an essential public health function and provided grants for training
in the use of radiation in medical practice. In 1960 a regional radioprotection unit was
set up, the aim of which was to encourage the sanitary authorities to develop radio-
logical safety procedures and regulations.
In April 1968 in Caracas, Venezuela, the PAHO, WHO and IAEA sponsored a
symposium on dosimetry needs in radiotherapy centres. This event produced recom-
mendations of great importance, including the establishment of the network of sec-
ondary standard dosimetry laboratories — Argentina and Mexico were among the
first countries to have such laboratories. The main aim of these laboratories was to
verify the calibration of cobalt therapy units with FLi thermoluminescent dosimeters,
an activity that is still being carried out today with the current Dosimetry and Medical
Radiation Physics Section of the IAEA’s Division of Human Health.
In 1991 we began collaborating with the Division of Radiation and Waste
Safety, when the PAHO became part of the Inter-Agency Committee on Radiation
Safety, comprising the Food and Agriculture Organization, the IAEA, the
International Labour Organization, the Nuclear Energy Agency of the Organisation
for Economic Co-operation and Development, the WHO, the PAHO, the European
Commission and the United Nations Scientific Committee on the Effects of Atomic
Radiation. The primary objective of this committee was to draw up the International
Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of
Radiation Sources [1], or the BSS as they are affectionately known in English. The
PAHO played an important role in the part on medical exposure. Following their
adoption by our governing bodies, the PAHO has contributed to additional publica-
tions, the majority with the IAEA and the WHO’s headquarters, and to introducing
them through training courses, especially in the countries that are members of the
PAHO but not of the IAEA.
We consider that this conference will be a landmark in the control of medical
exposure. We are grateful to the organizers for the opportunity they have given us to
put forward our point of view. Within the overall public sector reform in the countries
of Latin America and the Caribbean, the role of the PAHO is to strengthen the lead-
ership of the sanitary authorities in the health sector. Irrespective of whether the pro-
vision of health services is public or private and of whether a ministry of health acts
as the radioprotection regulatory authority, it is the responsibility of the sanitary
authorities to control medical exposure by establishing standards and guidelines so
that medical procedures involving the use of ionizing radiation are safe, effective and
OPENING ADDRESS 29
of a high quality. We await with interest the conclusions of this conference so that we
are able to specify the function and responsibilities of each of the public and private
organizations involved in dealing with medical exposures.
REFERENCE
OPENING ADDRESS
H. Ostensen
World Health Organization,
Geneva
On behalf of the World Health Organization (WHO) I would like to welcome

all participants to this very important International Conference on the Radiological
Protection of Patients in Diagnostic and Interventional Radiology, Nuclear Medicine
and Radiotherapy.
The safe and appropriate use of ionizing radiation in hospitals and medical
practices is of major concern to the WHO, and the seriousness of the matter is under-
lined by an alarming number of reports from all over the world of injuries caused by
the incorrect use of radiation for diagnostic or therapeutic purposes. Rapid develop-
ment and the introduction of new equipment and procedures may be responsible for
some of these problems. However, education and training on how to apply interna-
tional and national laws practically and regulations on radiation protection are of high
importance both in highly developed and in less developed countries.
Laws and regulations are important and necessary, but they are of little use
when not followed properly at all levels. National authorities should be encouraged
to implement and strengthen regulations and controls on the use of ionizing radiation
for medical purposes. Equally important, however, is to ensure that the necessary and
adequate knowledge is conveyed properly to the medical staff involved, be they in a
small, remote clinic with limited resources, or in a highly specialized hospital with
most types of equipment and staff. As an increasing number of diagnostic and thera-
peutic procedures involving ionizing radiation are performed by staff not primarily
trained in radiation protection issues, it is of great importance to include such groups
when discussing radiation safety or planning educational programmes.
At the WHO we see the necessity for an extended dialogue between interna-
tional organizations and national authorities on one side and end-users on the other,
and see it to be of major importance for practically improving radiation safety both
for the patients and medical staff involved. This conference is one important step in
that direction, and we believe that the scientific programme planned will contribute
significantly to a better understanding of the necessity of not only developing regula-
tions and recommendations but also implementing them in practical daily work.
As the WHO is a co-sponsor of this conference, I should like to wish you all
some scientifically successful days here in Torremolinos, and I believe that the out-
come of the conference will contribute significantly to our common goal, which is
health for all.
31
GLOBAL VIEW ON THE RADIOLOGICAL
PROTECTION OF PATIENTS
(Background Session)
Chairpersons
F. METTLER
United States of America
J. HERNÁNDEZ ARMAS
Spain
ROLE OF THE IAEA IN THE
RADIOLOGICAL PROTECTION OF PATIENTS
P. ORTIZ LÓPEZ, A.D. WRIXON

Division of Radiation and Waste Safety
A. MEGHZIFENE, J. IZEWSKA
Division of Human Health

Vienna
E-mail: P.Ortiz-Lopez@iaea.org
Abstract
The paper discusses the role of the IAEA in relation to the radiological protection of
patients. Within the IAEA there are two major programmes which have an impact on the
protection of the patient. Firstly, patient protection is part of the programme on radiation safety;
secondly, the human health programme contains a number of activities related to quality
assurance (QA), and these also contribute to the protection of patients. A function of the IAEA,
as stipulated in its Statute, is “to establish or adopt, in consultation and, where appropriate, in
collaboration with the competent organs of the United Nations and with the specialized
agencies concerned, standards of safety for protection of health and minimization of danger to
life and property…and to provide for the application of these standards …”. There are three
different levels of the IAEA Safety Standards: Safety Fundamentals, Safety Requirements and
Safety Guides. The Standards are supported by other documents such as Safety Reports. There
are five means used by the IAEA in providing for the application of the Standards: co-
ordinating research, promoting education and training, providing assistance, fostering
information exchange and rendering services to its Member States. All these means are used in
the programme on radiological protection of patients as described in the paper. The IAEA is
assisting its Member Sates in the development and implementation of QA programmes. These
activities help disseminate not only the technical knowledge but also the basic ingredients of
the QA culture. The IAEA assistance is directed at: (1) national regulatory bodies for the
establishment of a regulatory framework which complies with the International Basic Safety
Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources;
(2) standards laboratories for metrological traceability; and (3) end users at medical institutions
for the development and implementation of QA programmes. Traceability of radiation
measurements for radiotherapy, radiodiagnostic and radiation protection level dosimetry, and
quality audit services, such as the IAEA/World Health Organization postal service for the
verification of the clinical beam calibration using thermoluminescent dosimeters, are also
offered to Member States. Other QA related activities are the development and dissemination
of dosimetry techniques and Codes of Practice, and the training of medical radiation physicists
35
36 ORTIZ LÓPEZ et al.
in QA. Close co-operation with international organizations and professional bodies is

maintained by the IAEA to co-ordinate these activities on QA.
1. BACKGROUND
Over the last decade or more there has been a growing awareness throughout
the world of the need to give greater emphasis to the protection of patients undergo-
ing radiation exposure for medical purposes. This has been driven by the realization
that medical exposure is responsible for by far the largest component of exposure
from human activities, that there is scope for reduction of exposures in particular
examinations, and that serious accidents can result from inadequate control, particu-
larly in radiotherapy. It was this growing awareness that in 1999 led the General
Conference of the IAEA to request the Secretariat to organize “an international
meeting on the radiological protection of patients for the purpose of an exchange of
information and the development of recommendations, as appropriate, regarding the
radiological protection of patients”. The present international conference, which is
co-sponsored by the European Commission, the Pan America Health Organization
(PAHO) and the World Health Organization (WHO), was organized in response to
this request.
While the protection of patients undergoing radiation exposure for medical
purposes requires special consideration involving the full application of the princi-
ples of radiation protection, it must be recognized that activities associated with
the development of medical uses necessarily include the promotion of quality
assurance (QA) to ensure the most effective diagnosis or treatment (mainly through
traceability of dose measurements and documented quality control (QC) proce-
dures). To provide an independent quality audit of the dose delivered by radiotherapy
treatment machines, the IAEA in 1969 launched a programme in collaboration
with WHO.
2. ESTABLISHING AND PROVIDING FOR THE APPLICATION OF

STANDARDS
The IAEA’s safety functions consist essentially of two elements: establishing

standards of safety and providing for their application. These are considered
separately in the following sections.
ROLE OF THE IAEA 37
2.1. Establishing standards of safety
The statutory function regarding the establishment of standards of safety and

providing for their application has been given strong emphasis by the IAEA since its
inception. The Board of Governors first approved radiation protection and safety
measures in March 1960 and the first ‘basic safety standards’ in June 1962. Revisions
of these standards were published in 1967, 1982 and, most recently, in 1996 [1]. Such
standards provide the basic requirements that must be satisfied to ensure safety for
particular activities or application areas.
There is now a well developed structure related to the IAEA’s Safety Standards
publications, namely:
(1) Safety Fundamentals. These present basic objectives, concepts and principles
of safety and protection in the development and application of nuclear energy
for peaceful purposes.
(2) Safety Requirements. These establish the requirements that must be met to
ensure safety. These requirements, which are expressed as ‘shall’ statements,
are governed by the objectives and principles presented in the Safety
Fundamentals.
(3) Safety Guides. These recommend actions, conditions or procedures for meeting
safety requirements. Recommendations in Safety Guides are expressed as
‘should’ statements, with the implication that it is necessary to take the
measures recommended or equivalent alternative measures to comply with the
requirements.
These Safety Standards publications are supported by various technical

documents and reports.
The IAEA’s Safety Standards have a clearly defined pedigree. The United
Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), a
body set up by the United Nations in 1955, compiles, assesses and disseminates
information on the health effects of radiation and on levels of radiation exposure due
to different sources. This information is taken into account in developing the
standards. In addition, account is taken of the recommendations of the International
Commission on Radiological Protection (ICRP), which also take account of the
scientific information provided by UNSCEAR. At the time that the IAEA’s Board of
Governors first approved radiation protection and safety measures in March 1960, it
was stated that ‘the Agency’s basic safety standards…will be based, to the extent
possible, on the recommendations of the International Commission on Radiological
Protection (ICRP)”.
The current version, the International Basic Safety Standards for Protection
against Ionizing Radiation and for the Safety of Radiation Sources (the BSS), issued
in 1996 [1], is co-sponsored by the Food and Agriculture Organization of the United
Nations, the International Labour Organization, the OECD Nuclear Energy Agency,
WHO and PAHO. The BSS contain the principal requirements covering all practices,
including uses of radiation in medicine, agriculture, industry, research and teaching,
and intervention in the event of an accident and in chronic exposure situations such
as those due to residues from past activities. Detailed requirements are given in six
Appendices, one of which addresses medical exposure. The Appendix on medical
exposure covers the responsibilities of those involved; the justification of medical
exposures; the optimization of protection, including design and operational consider-
ations, calibration, clinical dosimetry and QA; the establishment of guidance levels;
the maximum activity for patients in therapy on discharge from hospital; the investi-
gation of accidental medical exposures; and records.
Recommendations on how to comply with the requirements of the BSS relating to
medical exposures will be provided in the Safety Guide on Radiation Protection and
Safety in Medical Exposure, now in the process of publication. This Safety Guide is
jointly co-sponsored with PAHO and WHO. It describes strategies to involve organiza-
tions outside the regulatory framework, such as professional bodies, whose co-operation
is essential to ensure compliance with the BSS requirements for medical exposures.
Examples of cases where this is necessary include the establishment of guidance levels
for diagnostic medical exposures, acceptance testing processes for radiation equipment,
calibration of radiotherapy units and reporting of accidental medical exposure.
2.2. Providing for the application of the Safety Standards
There are five means used by the IAEA to provide for the application of the
Safety Standards: co-ordinating research, promoting education and training, provid-
ing assistance, fostering information exchange and rendering services to its Member
States. All these means are used in the programme on radiological protection of
patients described below.
Initial steps in IAEA co-ordinated research in developing countries were taken
in recent years by pilot studies on radiation doses in diagnostic radiology focused on
radiographic procedures, the results of which were published in a technical document
[2]. This research was followed by a second programme involving fluoroscopy and
computed tomography (CT) procedures. The results will be published in 2001. A
third programme on radiation dose and image quality in mammography is expected
to be completed by the end of 2001 and the results will be published in 2002.
The most comprehensive programme of assistance is the Model Project on
Upgrading Radiation Protection Infrastructure, which was started in 1996 to assist those
Member States which have inadequate infrastructures and are already receiving IAEA
technical assistance so that they can comply with the BSS. Initially 52 countries were
involved. A number of documents and some software have been developed that provide
ROLE OF THE IAEA 39
support in building the infrastructure. The elements of the infrastructure are expressed
in terms of five milestones: (1) regulatory framework, (2) occupational exposure,
(3) medical exposure, (4) public exposure, and (5) emergency preparedness and response.
In 2000, the implementation of the Model Project was assessed and as a result
two groups of countries were identified: those that had achieved milestones (1) and
(2), and those that had not. The project was then divided to accommodate the two
groups of countries. A number of additional countries decided to join the project, and
a total of more than 70 are currently involved in this endeavour.
The IAEA is in the process of developing a comprehensive approach to pro-
mote national sustainable education and training programmes, by training ‘trainers’
and providing them with standard training materials in order to enable them to train
the different groups of professionals with responsibilities for radiological protection
in the main medical practices using radiation, i.e. diagnostic and interventional
radiology, nuclear medicine and radiotherapy.
Information exchange has been provided through international symposia,
seminars and conferences. So far, the most important event of information exchange
on the radiological protection of patients is this conference, which will undoubtedly
provide a new impetus to the IAEA’s programme in this area. Information exchange
has also been fostered through other means, such as the publication of lessons learned
from accidental medical exposure [3].
3. PROMOTING QUALITY ASSURANCE IN THE MEDICAL USE OF

RADIATION
Any medical use of radiation necessitates the establishment of an appropriate

QA and QC culture to ensure that the technology is used in a reliable fashion. This is
reflected in BSS requirements for “a comprehensive quality assurance programme for
medical exposures with the participation of appropriate qualified experts in the rele-
vant fields…”.
The IAEA assists Member States to establish and implement national QA
programmes through its programmatic activities and Technical Co-operation projects.
IAEA assistance is aimed at establishing an infrastructure that enables end users to
comply with BSS requirements on QA, at providing metrological traceability through
standards laboratories, and at promoting the development and implementation of QA
programmes by end users at medical institutions.
3.1. Traceability and quality audit services to Member States
In the framework of the international measurement system, the IAEA in

collaboration with other international organizations, including the Bureau
International des Poids et Mesures (BIPM), provides the metrological link for the
traceable calibrations needed in radiotherapy, through the IAEA/WHO network of
Secondary Standard Dosimetry Laboratories (SSDLs) [4]. The IAEA’s support is
accomplished through the provision of calibration factors for national measurement
standards linked to the international measurement system, mainly to those countries
who are not members of the Metre Convention and do not have access to a primary
standard. As a second step, dose quality audits and follow-up programmes are
implemented to help Member States ensure that the measurement standards provided
to national calibration laboratories and hospitals are kept within the levels required by
the international measurement system. These programmes include intercomparisons
using ionization chambers and dose quality audits using mailed thermoluminescent
dosimeters (TLDs). Both programmes are essential for ensuring high accuracy in clin-
ical dosimetry. The TLD programme for hospitals aims at ensuring proper calibration
of radiotherapy beams. It checks approximately 400 clinical beams per year and has
checked a total of approximately 4000 radiotherapy beams in more than 1100 centres.
Follow-up actions on poor results have helped the radiotherapy centres to resolve the
discrepancies, thus preventing further errors in treatment of patients. The TLD pro-
gramme is implemented through a close collaboration between the IAEA and WHO
(PAHO, in Latin America). The programme receives the support of the BIPM, Primary
Standard Dosimetry Laboratories (PSDLs) and some advanced radiotherapy centres.
These institutes provide reference irradiations of the TLDs, acting as an external QC
of the service. The results of the TLD programme for radiotherapy hospitals are given
elsewhere [5].
3.2. Developing and disseminating Codes of Practice
The IAEA has maintained an interest in standardization and development of

Codes of Practice for radiotherapy dosimetry going as far back as the 1970s, with
several publications in the field. The IAEA published the first Code of Practice in
1970 [6], followed by Absorbed Dose Determination in Photon and Electron Beams,
Technical Reports Series No. 277, first published in 1987 and updated in 1997 [7].
Following the world trend in radiation dosimetry, the IAEA developed a new Code of
Practice based on absorbed dose to water standards. This Code has been endorsed by
WHO, PAHO, and the European Society of Therapeutic Radiology and Oncology
(ESTRO) and has recently been published by the IAEA as Technical Reports Series
No. 398 [8]. The Codes of Practice developed by the IAEA on absorbed dose deter-
mination in radiotherapy beams are presently used by many physicists involved with
dosimetry in radiation therapy and have been adopted by several countries as their
national dosimetry protocol.
Until recently, most of the effort of the IAEA was concerned with the develop-
ment of Codes of Practice for external beam therapy. To address the different aspects
ROLE OF THE IAEA 41
of QA in brachytherapy, guidelines on standardized procedures for the calibration of

brachytherapy sources at SSDLs and hospitals have also been developed [9].
Currently, a Code of Practice is being developed to aid in the standardization of
various dosimetry techniques in X ray diagnostic radiology.
3.3. Fostering exchange of information on QA in radiotherapy
An important part of the programme of the IAEA to foster exchange of

information includes providing assistance to Member States to improve QA and
safety in the use of ionizing radiation. Experience gained from different centres can
be of use to others using similar equipment. Also, lessons learned from problems and
incidents in one centre can be of benefit to other users having the same or similar
equipment. In this context, it was decided to make available an updated and complete
directory of radiotherapy centres around the world and their therapy sources. Since
1959, the IAEA has maintained a register of radiotherapy hospitals and clinical
institutions having radionuclide and high energy teletherapy machines. The electronic
version of the Directory of Radiotherapy Centres (DIRAC) is continuously updated
on the basis of information provided by Member States. It includes data on tele-
therapy machines, sources and devices used in brachytherapy, and equipment for
dosimetry, patient dose calculation and QA. Data on staff strength at the installations
(numbers of radiation oncologists, medical physicists, technicians, etc.) are also
included.
4. IAEA ACTIVITIES ON THE RADIOLOGICAL PROTECTION OF

PATIENTS IN 2002–2003
The development of the IAEA programme on the radiological protection of

patients is currently under way, and the final programme will be influenced by the
conclusions of this conference. Most of the activities described below are intended to
be carried out in co-ordination with the international organizations with an interest in
patient protection.
4.1. Guidance
The requirements of the BSS are to be fulfilled by the users of sources of

radiation but they may need guidance on how certain regulatory requirements are to
be fulfilled in particular practices. A set of examples or model regulations for the
three main medical practices using radiation — diagnostic and interventional
radiology, nuclear medicine and radiotherapy — will therefore be provided.
Professional societies will be invited to take part.
An essential component of any programme to improve radiological protection

is the promotion of education and training. The programme to promote national
sustainable training, mentioned above, will also cover the radiological protection
of patients in diagnostic and interventional radiology, nuclear medicine and radio-
therapy.
4.2. Assessment of specific problems in the radiological protection of

patients
The UNSCEAR report published in 2000 [10] highlights an important increase

in collective doses caused mainly by CT and interventional radiology. Deterministic
effects from interventional radiology are also an issue of concern. In addition, new
protection problems arise, for example, through the use of radiation sources in
endovascular brachytherapy.
The UNSCEAR report has been used as the basis for elaborating the following
list of research activities, the results of which will be incorporated into IAEA
guidance and training:
— Quantitative assessment of dose reduction techniques (pulsed fluoroscopy,

filters, road mapping, image processing) in complex procedures such as
interventional radiology;
— Optimization of protection in CT, including new technologies such as beam
intensity modulation, multiple slices and CT fluoroscopy;
— Trade-off of radiation dose and image quality in digital radiology;
— Radiation protection problems and possible emergency situations in intravascu-
lar brachytherapy.
4.3. Worldwide surveys of patient doses in radiology
Doses differing by as much as two orders of magnitude for similar radiological

investigations have been reported [11]. There is therefore considerable scope for dose
reduction in diagnostic radiology and also in nuclear medicine. For this reason, and
in order to provide guidance on what is achievable with current good practice, the
BSS require that “guidance levels for medical exposure be determined as specified in
the Standards, revised as technology improves and used as guidance by medical
practitioners” and that “the guidance levels be derived from the data from wide scale
quality surveys”.
These surveys need to be done in each country, and consideration needs to be
given to local variability, for example with respect to existing equipment and the level
of training and experience of a large population of medical and paramedical staff. Not
only the doses but also the associated image quality need to be surveyed, in order to
ROLE OF THE IAEA 43
ensure that images meet the clinical objectives and that changes made in technical
factors do not lead to a loss of needed information.
Surveys are resource consuming, involving governmental authorities,
professional associations, and medical and paramedical staff. A methodology to plan
and carry out these surveys will therefore be developed to assist Member States in
undertaking them as efficiently and effectively as possible. Workshops will be orga-
nized to promote the use of the methodology.
The use of guidance levels as part of a programme of optimization of protec-
tion is already widely accepted for simple examinations, but their use is less obvious
for complex examinations, such as interventional radiology. Co-ordinated research
programmes (CRPs) will be set up to explore how guidance levels for interventional
radiology might be developed.
4.4. Promotion of self-assessment and peer reviews
Self-assessment is necessary initially and during the implementation of a

programme on radiation protection. Peer reviews, or external audits, are also
desirable both at the national level, to assess the effectiveness of national strategies
(as described in the Safety Guide mentioned in Section 2.1), and at the hospital
level, to assess specific programmes. In order that these assessments and reviews
are undertaken systematically, a methodology will be developed and promoted. The
IAEA is establishing a service to provide peer reviews, upon request by Member
States, based on this methodology. The aim of the peer reviews will be to assess
how requirements of the BSS are addressed and whether internationally harmonized
protocols for QA are adopted to meet those requirements. They will also address
activities which require national strategies, such as the development of guidance
levels for diagnostic radiology, and nuclear medicine and education, as well as sus-
tainable education and training programmes related to the radiological protection of
patients.
4.5. Feedback from experience
Within the context of self-assessment, an area needing feedback from

experience into the practice is the therapeutic use of radiation, in which the poten-
tial consequences of errors and equipment faults can be detrimental. The IAEA has
compiled and published lessons from more than 90 events, some of them involving
severe accidental exposure and even fatalities. In addition, it has set up an
international reporting system of unusual radiation events (RADEV) [12], which
includes incidents involving exposure of patients. Retrospective review and feed-
back of this experience into the formulation of guidance are essential. Prospective
methods such as probabilistic safety assessment [12], at present being evaluated
under a CRP, will be applied for the protection of patients in the therapeutic use of
sources.
4.6. Promoting traceability and standardization of measurements to ensure

consistency in radiation dosimetry
In the coming years, the IAEA will continue to strengthen its support services
to Member States, including provision of traceability and quality audit services to
SSDLs and end users in hospitals. The IAEA will further promote international
standardization in dosimetry and consolidate its traceability links to the international
measurement system in the framework of the Mutual Recognition Arrangement
(MRA) [13]. The MRA aims at enhancing the worldwide mutual recognition of
national measurement standards and of calibration and measurement certificates.
A new CRP will support the development of techniques at the SSDLs for the
dissemination of the new standards based on absorbed dose to water for radiotherapy
dosimetry. This will make possible the implementation in Member States of the new
radiotherapy Code of Practice based on absorbed dose to water [8].
The IAEA dosimetry laboratory has expanded its measurement capabilities to
include conventional diagnostic radiology and mammography beam qualities to
support calibration services to its Member States.
For brachytherapy, the service is, at present, limited to calibrations at 137Cs
radiation quality for low dose rate. The development of calibration procedures at
SSDLs for 192Ir high dose rate will be considered. The IAEA will develop procedures
and guidelines for standardization of measurements and traceability in nuclear
medicine. The long term plan is also to develop measurement standards for radio-
isotopes and to assist Member States in the establishment of traceability of measure-
ments in nuclear medicine.
4.7. Developing and promoting the use of internationally accepted Codes of

Practice in radiotherapy and diagnostic radiology
Continued emphasis is also being given to international harmonization of

radiation dosimetry through the development and dissemination of standards of
radiation measurements and Codes of Practice for dosimetry techniques among
Member States.
Standardized procedures for dosimetry in diagnostic radiology will continue to
be developed within the framework of a CRP.
The new Code of Practice for radiotherapy dosimetry based on the standards of
absorbed dose to water is being tested by SSDLs and end users at hospitals in the
framework of a CRP. The goal is to assist SSDLs and users in hospitals in developing
ROLE OF THE IAEA 45
the systematization needed to implement the new Code of Practice, which is very dif-
ferent from the previous air kerma standards.
4.8. Quality assurance and dose audits
A key element in QA is the quality audit of radiation dose delivered to patients.

The IAEA will continue to provide an independent verification of beam calibration in
radiotherapy centres using TLDs and to assist end users in achieving the required
levels of accuracy in radiotherapy.
Support to the establishment of national QA programmes in Member States to
provide external and independent peer review of practices in radiotherapy, such as
the External Audit Groups (EAGs), established in the framework of a CRP, will
continue. The EAGs aim to establish a TLD audit to check the beam calibration
(i.e. reference conditions) in a first phase and to extend their scope of work to
include checks in non-reference conditions (per cent depth doses, output factors, etc.)
in a second phase.
4.9. IAEA Co-operative Centres for Quality Assurance in Radiotherapy and

Nuclear Medicine
A new activity planned by the IAEA will be the assignment of IAEA Co-
operative Centres for Quality Assurance (IAEA-CCQA). Each centre will agree with
the IAEA to develop and verify QA and QC procedures pertaining to a specific
technology. Collectively the information thus created will effectively further
contribute to the establishment of a close-knit worldwide culture of QA and QC.
These centres will also be used to promote good practice, as recommended in
the BSS.
5. CONCLUSIONS
This paper has described the two programmes of the IAEA which have an
impact on the radiological protection of patients, that within the overall programme
of radiation safety and that which is an integral part of the programme of human
health. These programmes are complementary and emphasize the importance of
appropriate co-ordination between medical practitioners, qualified experts in medical
physics (radiotherapy, diagnostic imaging) and radiation protection experts. The
IAEA will continue strengthening its two programmes and it regards this conference
as seminal in that it believes that the results of the conference will have a major
influence on its work in the years to come.
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[2] INTERNATIONAL ATOMIC ENERGY AGENCY, Radiation Doses in Diagnostic
Radiology and Methods for Dose Reduction, IAEA-TECDOC-796, Vienna (1995).
[3] INTERNATIONAL ATOMIC ENERGY AGENCY, Lessons Learned from Accidental
Exposures in Radiotherapy, Safety Reports Series No. 17, IAEA, Vienna (2000).
[4] INTERNATIONAL ATOMIC ENERGY AGENCY, The SSDL Network Charter, IAEA,
Vienna (1999).
[5] IZEWSKA, J., ANDREO, P., The IAEA/WHO TLD postal programme for radiotherapy
hospitals, Radiother. Oncol. 34 (2000) 65–72.
[6] INTERNATIONAL ATOMIC ENERGY AGENCY, Manual of Dosimetry in
Radiotherapy, Technical Reports Series No. 110, IAEA, Vienna (1970).
[7] INTERNATIONAL ATOMIC ENERGY AGENCY, Absorbed Dose Determination in
Photon and Electron Beams: An International Code of Practice for Dosimetry, 2nd edn,
Technical Reports Series No. 277, IAEA, Vienna (1997).
External Beam Radiotherapy: An International Code of Practice for Dosimetry Based on
Standards of Absorbed Dose to Water, Technical Reports Series No. 398, IAEA, Vienna
(2000).
[9] INTERNATIONAL ATOMIC ENERGY AGENCY, Calibration of Brachytherapy
Sources: Guidelines on Standardized Procedures for the Calibration of Brachytherapy
Sources at Secondary Standard Dosimetry Laboratories (SSDLs) and Hospitals, IAEA-
TECDOC-1079, Vienna (1999).
[10] UNITED NATIONS SCIENTIFIC COMMITTEE ON THE EFFECTS OF ATOMIC
RADIATION, UNSCEAR 2000 Report to the General Assembly, with Scientific
Annexes, UN, New York (2000).
[11] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, 1990
Recommendations of the International Commission on Radiological Protection,
Publication 60, Pergamon Press, Oxford and New York (1991).
[12] INTERNATIONAL ATOMIC ENERGY AGENCY, The Agency’s Programme and
Budget for 2001, IAEA, Vienna (2000).
[13] BUREAU INTERNATIONAL DES POIDS ET MESURES, Mutual Recognition of
National Measurement Standards and of Calibration and Measurement Certificates
Issued by National Metrology Institutes, BIPM, Paris (1999).
EU LAWS AND GUIDANCE REINFORCE THE
M. SARRÓ VAQUERO
Directorate-General Environment,
Luxembourg
E-mail: Mercedes.Sarro-vaquero@cec.eu.int
D. TEUNEN
Directorate-General Research,
Brussels
E-mail: Diederik.Teunen@cec.eu.int
Abstract
European legislation developed under the Euratom Treaty has set uniform safety
standards to protect the health of the public and workers from the dangers of ionizing radiation.
Council Directive 97/43/Euratom, supplementing Council Directive 96/29/Euratom, covers
patients and individuals in relation to medical exposures. It sets requirements for radiological
protection in diagnosis and treatment, stressing training for staff, clinical audits, quality
assurance programmes, patient dose assessments and the protection of pregnant women and
children. The directives had to be transposed into national legislation by 13 May 2000. The
Radiation Protection Unit of the Directorate-General Environment of the European
Commission monitors and controls the implementation of European Community radiation
protection legislation by Member States. The European Commission’s Communication on the
Sixth Environment Action Programme includes the environment and health as priority areas.
Research performed under European Research Framework Programmes in the medical area
aims to obtain suitable tools to optimize radiological diagnostic procedures. It focuses on
exposures associated with high individual risks and/or high individual doses. The main
outcomes have been guidelines on quality criteria for radiological procedures, including
paediatric exposures, computed tomography, interventional radiology and digital mamography.
Dosimetry aspects and quality of imaging are also addressed. The Sixth European Research
Programme will emphasize the development of the European Research Area.
1. INTRODUCTION
Medical diagnosis and treatment is the largest human-made source of radiation

exposure in Europe. The medical use of ionizing radiation continues to expand and,
more importantly, tends towards more complex examinations entailing higher
47
48 SARRÓ VAQUERO and TEUNEN
exposures. However, at the same time, the use of ionizing radiation has allowed for
great progress to be made in diagnostic and therapeutic medical procedures.
Council Directive 97/43/Euratom [1] on the health protection of individuals
against the dangers of ionizing radiation in relation to medical exposures recognizes
these facts and, therefore, requires careful justification and optimization of radiolog-
ical procedures. The latter means that the requested diagnostic information is
obtained at the lowest possible dose. Practical implementation of this principle is only
possible when suitable tools, such as diagnostic reference levels for radiological
diagnostic examinations, are available.
This conference, organized by the IAEA and cosponsored by the Pan America
Health Organization (PAHO), the World Health Organization (WHO) and the
European Commission, aims to promote the exchange of information and the devel-
opment of recommendations in relation to the radiological protection of patients.
There is evidence of the value of debate and co-operation between stakeholders to get
better outcomes and ensure public trust and political support. Hence, we are sure that
this conference will be a success and will benefit patients and citizens.
2. EUROPEAN UNION ROLE IN SETTING STANDARDS
European legislation for radiation protection, developed under the Euratom

Treaty signed in 1957, applies to the control of exposure to ionizing radiation from
human-made sources and, in some cases, from natural sources. It now covers the con-
trol of exposure in the medical use of ionizing radiation.
The Euratom Treaty stipulates that the European Community shall establish
uniform safety standards to protect the health of workers and the general public, and
ensure that they are applied (Article 2.b and Chapter III, Health and Safety). Article
30 defines the concept of ‘basic standards’: (a) maximum permissible doses
compatible with adequate safety, (b) maximum permissible levels of exposure and
contamination and (c) the fundamental principles governing the health surveillance of
workers.
Under the legal framework provided by Chapter III of the Euratom Treaty,
European Community initiatives and actions in the field of radiation protection have
ensured high standards of protection and added value at the European level, while
achieving a fair degree of harmonization throughout the European Union (EU).
3. WORK OF THE EUROPEAN COMMISSION
Further to its work, the European Commission pursues three constant objec-
tives: to identify the European interest, to consult as widely as necessary and to
EU LAWS AND GUIDANCE 49
respect the principle of subsidiarity. Its functions include the legislative initiative, the
control and monitoring of the correct application of EU legislation by Member States,
and executive and negotiation responsibilities.
Subsequent to a recent restructuring of European Commission services, the
Radiation Protection Unit in charge of the implementation, anticipation and follow-
up of European Community legislation for radiation protection has been placed
within the Directorate of Environment and Health in the Directorate-General
Environment. Hence coherence with general environment and health policy has
become essential.
However, the European Commission does not set out to undertake all actions
itself within the field of radiological protection, but instead works with the national
authorities to achieve this aim.
4. LEGAL INSTRUMENTS AND PROCEDURES FOR SETTING SAFETY

STANDARDS
Article 161 of the Euratom Treaty defines the different legal instruments avail-
able to the European Community to accomplish its mission. The main instruments are
European Council directives, regulations and decisions. European Council directives
are binding on Member States within the framework of national legislation.
Regulations are binding in their entirety and directly applicable. Decisions are bind-
ing on these to whom they are addressed.
The procedure for setting standards is also laid down in the Euratom Treaty.
Firstly, the European Commission receives guidance from a group of experts set up
under Article 31 of the Treaty, which then gives rise to a European Commission proposal.
This proposal is submitted to the Economic and Social Committee. Then, after
incorporation of all or part of its observations, it is published in the Official Journal
and forwarded to the Council and the European Parliament. The European Parliament
then proposes amendments to the European Commission proposal, which are exam-
ined by the European Commission and taken up as a whole or in part in a revised
European Commission proposal, which is again submitted to the European Council.
Finally, under the terms of the Euratom Treaty, it is the European Council that
decides and eventually adopts the directive by a qualified majority.
5. REVISED BASIC SAFETY STANDARDS DIRECTIVE (COUNCIL

DIRECTIVE 96/29/EURATOM)
The most important European legal instrument in the field of radiation protec-
tion is the Basic Safety Standards (BSS) Directive. It was last revised in 1996 by
Council Directive 96/29/Euratom of 13 May 1996 [2], which lays down basic safety
standards for the health protection of the public and workers against the dangers of
ionizing radiation. It had to be transposed into national legislation by 13 May 2000.
It confirms the general principles underlying radiation protection: justification
of practices, optimization of protection and dose limitation. It covers practices, inter-
ventions and work activities, and strengthens the regulatory requirements.
In addition, it sets more stringent dose limits for the public and workers, includ-
ing the staff of medical radiological installations. The dose limit for workers is now
50 mSv effective dose per year with an average of 100 mSv over a period of five years
or, in practice, 20 mSv/year (Member States may decide on an annual amount). For
the public the dose limit has been reduced to 1 mSv (exceptionally, more than 1 mSv
may occur as long as the average over five years remains less than 1 mSv).
6. REVISED MEDICAL EXPOSURES DIRECTIVE (COUNCIL DIRECTIVE

97/43/EURATOM)
Council Directive 97/43/Euratom [1] of 30 June 1997 on the health protection

of individuals against the dangers of ionizing radiation in relation to medical expo-
sures, the Medical Exposures Directive (MED), supplements the BSS Directive. The
MED ensures a high level of radiation protection in diagnosis and treatment.
Members States had, again, until 13 May 2000 to transpose it into national legisla-
tion.
The MED lays down provisions to achieve a high level of health radiological
protection in diagnosis and therapy. It expands and strengthens the previous directive
on a number of important issues.
Firstly, it applies to the exposure of patients, as part of their diagnosis or treat-
ment, and the exposure of individuals, such as those volunteers participating in med-
ical or biomedical research, those exposed as part of occupational health surveillance,
health screening programmes and medicolegal procedures, and those exposed help-
ing persons undergoing diagnosis or treatment with radiation.
The MED requires the application of the justification and optimization princi-
ples to all medical exposures. The principle of dose limitation does not apply to med-
ical exposure.
According to the MED, all new and existing radiological medical practices
must be justified and each medical exposure has to show a sufficient net benefit
against the individual detriment that it might cause. What is more, all unnecessary
exposures must be avoided. To facilitate the application of the justification principle,
the MED defines the procedures and system for the justification of practices and indi-
vidual exposures, requiring that both the prescriber and the practitioner are involved
in the justification process.
In addition, the MED details the provisions for the optimization process in
relation to medical exposures, distinguishing between radiodiagnostic and radio-
therapeutic procedures. In diagnosis the optimization goal is to keep doses as low as
reasonable achievable while obtaining the necessary diagnostic information; in
therapy the goal is to ensure that the target tissue is given the prescribed dose while
minimizing the dose to non-target volumes and tissues.
It also introduces new requirements and strengthens the existing ones on a
number of important issues, such as the protection of pregnant women and children
In addition, it defines the roles, responsibilities and training for the staff of
medical facilities, both for radiological practices and for radiation protection. It also
lays down provisions on procedural requirements, such as the availability of referral
criteria for medical exposures, the use of diagnostic reference levels as a tool for
optimization and the performance of clinical audit and quality assurance
programmes. Moreover, it sets provisions relating to equipment, including
acceptance testing, performance testing and quality control measures. It deals
with the prevention of potential exposures and accidents, particularly in radio-
therapy, and it requires the assessment and evaluation of patient dose or administered
activities.
To conclude, the MED constitutes a major step forward and offers an excellent
opportunity to reinforce radiation protection applied to medical radiological practices
for the benefit of all European citizens.
7. GUIDANCE
In order to facilitate the correct application of the directives, the European

Commission has sponsored a few workshops on the implementation of the MED and
has organized seminars on relevant topics, such as:
— Genetic susceptibility and new evolutions on genetic risk,

— Thyroid diseases and exposure to ionizing radiation,
— Low dose ionizing radiation and cancer risk.
In addition, it has published several technical guidelines, developed with the

assistance of the group of scientific experts under Article 31 of the Euratom Treaty.
These include:
— Referral guidelines for imaging,

— Guidelines on education and training in radiation protection for medical
exposures,
— Guidance on diagnostic reference levels for medical exposures,
— Guidance for the protection of unborn children and infants irradiated owing to
parental medical exposures,
— Guidance on medical exposures in medical and biomedical research,
— Radiation protection following 131I therapy (exposures owing to out-patients or
discharged in-patients),
— Criteria for the acceptability of radiological (including radiotherapy) and
nuclear medicine installations.
Technical guides are drawn up to facilitate implementation of the MED.

However, they are not binding on Member States. The above documents can
be downloaded from the European Commission web site at http://
www.europa.eu.int/comm/environment/radprot
8. ENVIRONMENT AND HEALTH — FUTURE DEVELOPMENTS
On 24 January 2001 the European Commission adopted a communication to

the European Council, the European Parliament, the Economic and Social
Committee and the Committee of the Regions on the Sixth Environmental Action
Programme of the European Community, ‘Environment 2010: Our Future, Our
Choice’. In addition, it presented a proposal for a Decision of the European
Parliament and of the European Council, laying down the Community Environment
Action Programme 2001–2010, as the legal basis of a European Commission
treaty.
The Sixth Environmental Action Programme (6EAP) is an strategic document
that emphasizes the need for a new approach to policy making based on wide
participation and dialogue with stakeholders in different issues. It deals with
environmental problems and objectives, identifies the driving forces behind those
problems and indicates four priority areas where integration action is required. The
priority areas are: climate change, nature and biodiversity, environment and health,
and natural resources and waste.
Environment and health is a topic of interest and concern for European citizens,
as regularly shown in the Eurobarometer surveys.
The 6EAP basic approach is that society must aim at decoupling prosperity
from environmental impacts. Eco-efficiency and technological development can help
institutions and companies achieve a better environmental performance, while
improving efficiency and competitiveness.
The 6EAP will cover a ten year period, during which most applicant countries
are expected to join the EU. Thus the strategic approach and the priority themes cho-
sen will apply to an enlarged EU. Applicant countries’ full compliance with European
Community law at the time that they join the EU will entail large benefits not only to
the environment and health of their populations, but also to neighbour Member States
and Europe as a whole.
9. EUROPEAN COMMISSION’S RESEARCH PROGRAMME ON THE

MEDICAL USES OF IONIZING RADIATION
The work in this area under the 4th Framework Programme (FP4) (1994–1998)
was complementary to previous work on quality criteria under the European Research
Programme, which was in fact to a great extent at the basis of a number of important
principles present in the European Council directive. It contains optimization
strategies based on the evaluation of the correlation between patient dose, radio-
logical and technical procedures and diagnostic information requested by
practitioners.
FP4 contracts mainly focus on diagnostic examinations associated with a
relatively high individual risk, such as the exposure of children in paediatric radio-
logical procedures and examinations associated with relatively high individual doses
per examination, such as computed tomography (CT). However, the work also envis-
ages improving the scientific basis for the evaluation of diagnostic image quality cri-
teria and their practical implementation.
Interesting achievements are the development and publication of European
guidelines on quality criteria for CT for six frequently performed examinations,
including the setting of diagnostic reference levels using the weighted CT dose
index and the dose–length product, the development of two draft guidelines on
the optimization of paediatric imaging techniques for a number of frequent
examinations, including fluoroscopic examinations and CT examinations, and estab-
lishing a list of quality criteria and dose criteria. An improvement and refinement of
the existing European Commission quality criteria guidelines for adult chest and
lumbar spine radiographs was also developed together with an analysis of dose audit
techniques.
Under the 5th Framework Programme (FP5) (1998–2002) emphasis is put on
interventional radiology, which is a rapidly developing branch of minimally invasive
medicine that has a potential for the optimization of procedures to avoid adverse
effects. Quality criteria will be adapted to further digital imaging procedures, in
particular for digital mammography, and for interventional radiology. Constancy
testing programmes will be established for different digital systems. Good methods
for patient dosimetry will be developed for both digital and interventional equipment,
including the setting of dose reference values. Furthermore, clinical evaluation
projects in interventional radiology and cardiology are scheduled, which aim to
develop image criteria and to set ‘complexity indices’ for both therapeutic and
diagnostic procedures.
Another project aims at establishing methodologies for assessing objectively

the quality of clinical radiographic images, including the detailed characterization
and representation of both normal and abnormal anatomical structures. This would
result in the development of a programme of physical measurements that can be per-
formed on clinical images produced by direct digital X ray image capture systems.
Also the role and function of the human observer in the diagnostic process and his or
her impact on the clinical outcome will be studied. Through modelling procedures the
whole process should lead to modelled image quality descriptors that ultimately can
help to optimize the design of radiographic imaging systems. Practically applicable
physical parameter and measurement protocols for direct digital radiographic
imaging systems should enable practitioners to assess their performance.
Finally, a European survey on the clinical applications of CT with a focus on
the evaluation of CT protocols and the assessment of patient dose should lead to an
update of the quality criteria guidelines for CT, including new emerging modalities
such as fluoroscopic CT and multislice CT, and further the development of dose
reference levels through better methods for dose assessment.
As regards the future of the European Research Programme, emphasis will be
put on the development of the European Research Area. The programme will focus
on areas where European Community action provides the greatest added value
compared with national actions; it will promote networking between the main stake-
holders in Europe and will enhance efficiency by channelling resources to projects of
greater magnitude and longer duration.
Although the medical use of ionizing radiation is recognized by the European
Community as an important area where, through better justification and optimization
of procedures significant dose saving can be achieved without jeopardizing the
patient’s benefit, it is yet too premature to say what the effects of this radical change
in policy will be on the programme in this particular area.
REFERENCES
[1] EUROPEAN UNION, Council Directive 97/43/Euratom of 30 June 1997, Health

Protection of Individuals against the Dangers of Ionizing Radiation in Relation to
Medical Exposure. (Repealing Directive 84/466/Euratom, O.J. No. L 265/1, 5.10.1984),
Official Journal of the European Communities No. L 180/22–27, Luxembourg (1997).
[2] EUROPEAN UNION, Council Directive 96/29/Euratom of 13 May 1996, Basic Safety
Standards for the Protection of the Health of Workers and the General Public against the
Dangers arising from Ionizing Radiation, Official Journal of the European Communities
No. L 159/1–114, Luxembourg (1996).
PROTECTION OF PATIENTS:
PAHO POSITION PAPER
C. BORRÁS
Program of Essential Drugs and Technology,
Division of Health Systems and Services Development,
Pan American Health Organization,
Regional Office for the Americas,
Washington, D.C.
E-mail: borrasca@paho.org
Abstract
The Pan American Health Organization/World Health Organization (PAHO/WHO),

founded in 1902, initiated a radiological health programme in the 1950s. Within this
programme, there are currently three lines of work: (a) radiology services; (b) radiation safety;
and (c) radiological emergencies. Radiology services deals with health services for diagnostic
and interventional imaging, and for radiation therapy. Radiation safety studies the three types
of exposures to both ionizing and non-ionizing radiation: occupational; medical; and public.
Radiological emergencies involve radioactive waste management programmes and emergency
plans. The radiological protection of patients is addressed in each of these areas: (a) when
analysing the infrastructure of radiology services; and (b) when determining medical
exposures; and (c) when investigating overexposures in interventional or therapeutic
procedures or under-doses in radiation therapy.
1. TECHNICAL CO-OPERATION STRATEGIES
At the Pan American Health Organization/World Health Organization

(PAHO/WHO), patient radiological protection is part of the ‘Program of Essential
Drugs and Technology’ within the Division of Health Systems and Services
Development (HSE/RAD). This programme provides consultation upon request
involving a wide range of subjects. Among the most common are: planning radio-
logical services, including shielding design; specification, selection, acceptance test-
ing, maintenance and repair of radiological equipment; review of diagnostic and ther-
apeutic radiological procedures; calibration of radiation beams for diagnosis and
treatment; physical and clinical dosimetry; radioactive waste management in medical
facilities; development and implementation of quality control and quality assurance
55
56 BORRÁS
(QA) programmes; and prevention, preparedness and response in case of a nuclear

accident or a radiological emergency.
HSE/RAD provides technical co-operation in collaboration with the respon-
sible national authorities (e.g. ministries of health, radiation regulatory authorities and
standards laboratories); international organizations (the International Atomic Energy
Agency (IAEA), the International Labor Organization); PAHO/WHO Collaborating
Centers (Center for Diagnostic Imaging in Mammary Pathology (CIM)), Argentina,
Institute of Radioprotection and Dosimetry (IRD), Brazil, the US FDA’s National
Center for Devices and Radiological Health (CDRH), USA, Radiation Emergency
Assistance Center/Training Site, USA); national organizations (American
Association of Physicists in Medicine (AAPM), American College of Radiology
(ACR), US National Council on Radiation Protection and Measurements (NCRP),
UK National Radiological Protection Board (NRPB), Health Physics Society (HPS));
regional organizations (Asociación Latino-Americana de Físicos en Medicina
(ALFIM), Colegio Inter-Americano de Radiología (CIR), Círculo de Radioterapeutas
Ibero-Latino-Americanos (CRILA), Grupo Latino-Americano de Curieterapia–
Radioterapia Oncológica (GLAC–RO)); global bodies (International Commission on
Radiological Protection (ICRP), International Organization for Medical Physics
(IOMP), International Society of Radiology, International Society of Radiographers
and Radiological Technologists); scientific, professional and technical societies and
co-operative groups (Acuerdos Regionales Cooperativos para la Promoción de la
Ciencia y Tecnología Nucleares en América Latina (ARCAL).
2. TECHNICAL CO-OPERATION ACTIVITIES
2.1. Data collection and situation analysis
HSE/RAD staff visits countries mainly for the purpose of assessing national
policies and resources and advising on the role to be played by the health authorities,
especially in view of their steering role within the area of health sector reform. The
number and quality of diagnostic and therapeutic radiology services differ widely in
the Americas, depending on demographic and socioeconomic factors. The number of
diagnostic X ray units and megavoltage high energy radiotherapy machines for can-
cer treatment and associated staff in Latin American and Caribbean countries, as well
as information on QA programmes, are compiled periodically by HSE/RAD and sent
to PAHO’s Health in the Americas [1] and to the United Nations Scientific Committee
on the Effects of Atomic Radiation [2] for publication.
Information on radiation protection legislation and regulations is also collected.
Of the 38 PAHO Member States, only 19 had radiation regulatory authorities, and in
only two of them was the responsibility located in the ministry of health. The others
PAHO POSITION PAPER 57
were in atomic energy commissions, or the regulatory responsibilities were divided

between two (or more) governmental agencies. This situation led PAHO to join the
international efforts to prepare the ‘International Basic Safety Standards for Protection
against Ionizing Radiation and for the Safety of Radiation Sources’ (BSS) [3].
2.2. Development of standards and guidelines
In 1994, the Pan American Sanitary Conference, PAHO’s highest governing

body that meets every four years, endorsed the BSS, the final version of which were
published by the IAEA in 1996 in English and in 1997 in Spanish. Standards on radi-
ology services were presented in ‘Organization, Development, Quality Assurance and
Radiation Protection in Radiology Services: Imaging and Radiation Therapy’ [4].
This publication describes the organizational and technical aspects of radiology ser-
vices, analysed within the context of PAHO’s strategic and programmatic orienta-
tions. It is aimed at politicians, administrators, planners and health professionals, as
well as the ministries of health, to help them allocate resources and determine tech-
nological configurations for the provision of radiology services. It seeks to strike a
balance between basic principles of decentralized health services and the require-
ments that emerge as advances in medical knowledge are incorporated and applied in
various areas of the health services. As a complement to the concepts developed in
the text, the appendices in the book present examples of equipment specifications and
legislation on practices and specialties, and provide information on technical aspects
of QA and radiation protection. The English and Spanish editions were published by
PAHO/WHO in December 1997 and are now being updated.
Other areas in which standards are currently being developed by HSE/RAD
involve health technology assessment, especially regarding digital radiology and con-
formal radiotherapy; QA; education and training and teleradiology.
2.3. Preparation, review and distribution of technical documents

and publications
In addition to preparing and distributing its own publications, HSE/RAD co-

sponsors as many relevant publications as possible, especially with the IAEA, with
whom recently it elaborated a Safety Guide on radiation protection in medical expo-
sures.
HSE/RAD purchases and distributes to its Member States some of the publica-
tions produced by international and national scientific organizations (for example
from AAPM, ACR, ICRP, NCRP and NRPB). It also plays a significant role in
reviewing technical documents prepared by national authorities, other international
organizations and the scientific community at large. After the publication of the BSS,
practically all Latin American and Caribbean radiation protection and health author-
58 BORRÁS
ities have revised their legislation/regulations. Significant examples of the regulations

of health authorities that were reviewed by PAHO were those from Brazil, Costa Rica,
Mexico and ARCAL projects.
2.4. Educational activities
HSE/RAD has been very active in organizing, co-sponsoring and supporting

educational activities, such as courses, seminars, workshops, congresses and confer-
ences at the national, regional and global levels, aimed at physicians, physicists, engi-
neers and technologists. In the last 13 years, it is estimated that more than 1700
people have been trained. Most of the courses have been aimed at PAHO Member
States that are not IAEA members, and have dealt with the implementation of the BSS
in the medical practice. For the latter, a training manual consisting of 1200 slides,
developed by HSE/RAD for IAEA and PAHO/WHO training courses, has been used.
This manual is divided into four sections, with the first covering general aspects
of radiation protection. It is the only area with a review of basic principles, both in
radiation detection and measurements, as well as in biological effects of radiation.
The second, third and fourth modules address the applications of radiation protection
in diagnostic radiology, nuclear medicine and radiation therapy, respectively. Each
one starts with background material on the corresponding radiological application,
followed by: the biological effects specific to that practice; the radiation protection
aspects for the staff and the public; and medical exposures. It ends with investigation
of accidents. Particular emphasis has been placed in the protection of the patient. The
medical exposure section includes a justification of each practice and optimization of
the protection. The optimization starts with design considerations followed by opera-
tional aspects, and ends up with calibration, clinical dosimetry and QA requirements.
2.5. Upgrading of diagnostic radiology services
PAHO/WHO plays a significant role in advising ministries of health on the

development, organization and improvement of radiology services according to lev-
els of health care. It tries to reconcile the goal of universal health care coverage
(WHO’s “Health for All”) with QA and radiation protection requirements. The fun-
damental issues are: the identification of health problems; their frequency, magnitude
and severity; their geographic and demographic distribution; their evolution and
trends; and the resources available. Physical infrastructure needs, equipment and sup-
plies, human resources, preventive and corrective maintenance and quality control
(QC) and QA programmes are addressed.
Within the framework of health sector reform, and given the deteriorating con-
dition of radiology services, the health authorities of Latin America and the Caribbean
are questioning their role in the provision of these services. Should they upgrade the
existing public installations, purchase services from private facilities or enter into
some kind of partnership with them? If the services are offered privately, how is the
ministry of health going to monitor their quality? Most health authorities do not have
mandatory standards for QA programmes. Who has the responsibility to establish
them? The answers are not simple; they have to be tailored to the specific needs of
the country and resources, taking into account technological, radiation safety and
financial aspects. Radiological equipment is among the most expensive in medicine,
and radiology services require multidisciplinary teams to run the services effectively
and safely. What technologies are to be accepted? Do they really improve the long
term care of the patients?
Access to diagnostic radiology and other imaging equipment in most develop-
ing countries is far from being equitable; only approximately two-thirds of the
world’s population has access to such services. Most of the rural and urban poor pop-
ulations have no access at all. The majority of the diagnostic and imaging services can
be found in the larger cities, where the quality and care received may be questionable.
Furthermore, estimates indicate that 30–60% of the imaging equipment that does
exist may not be in working order. To remedy the situation, in the 1970s WHO intro-
duced the Basic Radiological System (WHO–BRS) as a “safe, inexpensive diagnos-
tic imaging system for developing countries”. This system includes a battery powered
generator to overcome problems with undependable electricity supply and a C-arm
type support stand, which permits general-purpose radiography, including chest X
rays. Training manuals for radiographic and darkroom techniques and for radi-
ographic interpretation were published in several UN languages. In the 1990s, WHO
changed the specifications to incorporate computerized X ray controls and diagnostic
software to the same X ray tube. This upgraded version is called the World Health
Imaging System for Radiography (WHIS-RAD) [4].
PAHO purchased 11 of these units and installed them in Haiti in the mid-1990s.
Figure 1 shows a map with their geographical location and photos of the X ray unit
and a typical radiology facility. In spite of the inherent reliability of the equipment,
the services have serious problems because of lack of maintenance, poor X ray tech-
nician training and inadequate radiation protection measures. Efforts continue at the
regional level to seek funds for Haiti to: provide basic training to X ray technicians in
the radiology services; create a university based maintenance training programme; set
up a maintenance contract with the X ray manufacturers; and establish a radiation
protection programme at the national level. It is felt that only under these circum-
stances will any X ray technology function adequately [5].
The greatest problem in radiology services in Latin America and the Caribbean
is film processing. Will the new digital systems be the answer? From a purely eco-
nomic viewpoint, the cost of the digital processor and phosphor plates will equal in a
few years that of the film developer, the processing chemicals and the supplies of
films, screen and grids. But what about maintenance support and training issues? Can
60 BORRÁS
FIG. 1. Location of radiology services with WHIS-RAD equipment, Haiti.
they be secured? For how long? How will the practice impact on patient protection?
Because phosphor plates can be reused, will the repetition rate be greater than with
conventional radiology using film? Because of the large dynamic range of the digital
system, will the exposures be larger? PAHO is currently working on requests from
ministries of health to advise them on upgrading diagnostic radiology services in
Belize, Haiti, St. Kitts and Nevis and Trinidad and Tobago.
2.6. Promotion and development of QA programmes in diagnostic radiology
A regional diagnostic radiology programme aimed at evaluating the quality of

mammography services in Latin America and the Caribbean, which — according to
some current national surveys — is not satisfactory, is being developed at present by
HSE/RAD in collaboration with the Inter-American College of Radiology (CIR), a
non-governmental organization with official relations with PAHO. The purpose of the
study is to document the situation with regard to mammography services in the region
and to develop a comprehensive QA programme tailored to the situation. Initially,
data will be obtained in a representative number of mammography services concern-
ing equipment and supplies, mammographic techniques and the education and train-
ing of personnel, along with measurements using breast simulating phantoms and
thermoluminescent dosimeters (TLDs). The results will be interpreted following the

imaging criteria of the ACR — an adviser to the project — and the guidance dose lev-
els published in the BSS. The work is being conducted with the co-operation of three
PAHO/WHO Collaborating Centers: the Institute of Radiation Protection and
Dosimetry, in Brazil; the Center for Diagnostic Imaging of Mammary Pathology, in
Argentina; and the Center for Devices and Radiological Health of the Food and Drug
Administration in the USA. It is expected that the resulting comprehensive QA pro-
gramme — to be co-ordinated by HSE/RAD — will be made available to all mam-
mographic services in Latin America and the Caribbean, thereby improving their
quality.
2.7. Review and participation in research programmes
HSE/RAD has been stimulating and supporting applied research activities in

diagnostic radiology services mostly in Cuba and Argentina. Some of the results have
been published in the scientific literature. In 1999, HSE/RAD won the research com-
petition convened by PAHO’s Director with the theme: “Quality Assessment of
Radiology Services” and prepared the terms of reference for the submission of pro-
jects. Seven countries applied and five — Argentina, Bolivia, Colombia, Cuba and
Mexico — were awarded a research contract, which involves medical physicists and
radiologists in these countries. While maintaining their own research interests, the
five participants have agreed to perform a common multi-centric study. Its purpose is
to correlate quality indicators of radiology services with the accuracy of the radio-
logical interpretation as determined by a panel of experts. The project, co-ordinated
by HSE/RAD, is achieving two very important goals. First, it is bringing together
investigators from countries at different stages of development who will benefit from
the exchange of information and experience. Perhaps, most importantly, it is promot-
ing the collaboration between diagnostic physicists and radiologists in each country.
This should ultimately improve radiology services in Latin America. A summary of
the results to date have been presented at this Conference.
2.8. Upgrading of radiation therapy services
After cardiovascular diseases, cancer is currently considered to be the most seri-

ous health problem in the industrialized countries. According to WHO [6]. Cancer
affects nine million people and causes five million deaths annually. In developed coun-
tries it is the second most common cause of death, and epidemiological evidence
points to the emergence of a similar trend in developing countries. Radiation therapy,
together with surgery and chemotherapy, is one of the pillars of cancer treatment. It is
estimated that radiation therapy is used in the management of approximately 40–80%
of all cancer patients, either as the sole method of treatment or in conjunction with
62 BORRÁS
surgery, chemotherapy and/or hyperthermia. Yet, in many countries appropriate tech-

nology and the human resources needed to provide accurate dose calculations, treat-
ment planning and good patient care are lacking. This is the case in many Latin
American and Caribbean countries, where the most prevalent cancers are of the cervix
(25 000–30 000 Latin American women die each year due to cervical cancer), breast,
and head and neck, all radiosensitive, and hence, potentially curable with radiation
therapy.
Recognizing the problems associated with the existing teletherapy equipment,
PAHO’s HSE/RAD, in collaboration with WHO Headquarters, the IAEA, and the
United Nations Industrial Development Organization, convened an Advisory Group
meeting in Washington in 1993 to assess the current situation and make recommen-
dations for the development of megavoltage X ray machines that would be simpler to
operate and maintain than the linear accelerators in use at the time [7]. To date, no
new accelerator has emerged. In fact, the situation has worsened, since most features
in today’s linear accelerators are computerized. Recent uses of computers are confor-
mal treatments and three dimensional dose distribution computation and displays. In
external beam therapy, conformal treatments are achieved through dynamic wedges
and/or intensity modulated radiation beams, which may change the dose rate, gantry
angle, couch angle and collimator settings during treatment. Treatment verification
may be done through radiographic or electronic portal imaging. The latter can now be
used for dose computation.
Brachytherapy innovations include low, medium and high dose rate remote-
afterloading devices. Treatment planning systems involve the capability of ‘inverse
planning’, i.e. once the desired dose distribution is decided, the field size, gantry,
collimator and couch angles, etc., are automatically selected. The computer can also
delineate tumour volumes. Recognizing how labour intensive and prone to human
error is the transfer of parameters from one device to another, many manufacturers
offer an electronic ‘linkage’. Diagnostic images acquired for tumour localization are
fed to the simulator — if these two processes are not obtained in the same machine
— from there to the treatment planning system and finally to the accelerator (or vice
versa if inverse planning is not performed). The claim is that this automatic process
yields a more accurate precision radiotherapy. Does it? PAHO’s perception is that this
may be so only if appropriate standards, including clinical protocols and radiation
safety standards, are developed and implemented. A point of concern deals with
imaging standards for radiotherapy, which seem to be lacking. There are no criteria,
for example, for tumour volume delineation by CT or magnetic resonance imaging
(MRI); how well are the tumour borders visualized? What are the minimum contrast
and resolution needed? When tumour volume definition is done by the computer, is it
more accurate than when done by the doctor, especially a relatively untrained one?
Are those the types of accelerators that will replace cobalt units? They will
allow for increased patient throughput, but they require continuous testing by a
qualified radiation therapy physicist. Where are they to be trained? As for brachy-
therapy units, are high dose rate afterloaders the best? Again, the patient throughput
is higher, but so are the costs of the radiation shielding required. Also, if the tele-
therapy 60Co sources — with a five year half-life — are not being replaced on time
(see Fig. 2), how can we ensure that 192Ir sources — which need to be replaced every
three months because of their three month half-life — will be? In general, HSE/RAD
has leaned towards advising low dose rate remote afterloading units. The ministries
of health are looking to PAHO for guidance in these areas.
Recent examples of technical co-operation in this area include the upgrading of
radiotherapy services in Colombia, where a country wide evaluation is being con-
ducted; Honduras, where remote control low dose rate brachytherapy was introduced;
Trinidad and Tobago, where new teletherapy machines and a computerized treatment
planning system are being installed, and Panama, which is considering a comprehen-
sive cancer therapy centre.
2.9. Promotion and development of QA programmes in radiation therapy

services
The implementation of standards at the institutional level is best monitored by

QA programmes. At the regional level, the oldest programme HSE/RAD co-ordinates
is the IAEA/WHO (IAEA/PAHO in Latin America and the Caribbean) Postal
16
14
Units
1992 Mean : 0.69

12 1998 Mean : 0.67
60 Co
10
8
Number of
0
0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 2 2.1
Dose Rate (Gy/min)
FIG. 2. Absorbed dose rate at 5 cm depth for Latin American and Caribbean 60Co units.
64 BORRÁS
Dosimetry Service, dating from the 1960s. The programme verifies the accuracy of
the calibration of high energy radiotherapy units used for cancer treatment by check-
ing the radiation dose delivered to TLDs that are placed by the user in the radiation
beam simulating a tumour under treatment. More than 100 units are evaluated yearly
in Latin American and Caribbean public and private radiotherapy facilities. The pro-
gramme runs efficiently thanks to the co-ordination of HSE/RAD with PAHO’s coun-
try offices in the distribution of the dosimeters to the radiotherapy facilities. The
results of the last 30 years were recently published by the IAEA and are reproduced,
with permission, as Figs 3 and 4 [8]. They show not only that PAHO’s participation
in the programme is the largest among the WHO’s region, but that the accuracy has
been significantly improved in the last ten years.
Had the results of the programme in the San Juan de Dios Hospital in San José,
Costa Rica — showing a continued significant deviation — been taken into account
by the Costa Rican physicians, it would have prevented the serious radiation overex-
posure that affected 115 patients, half of whom died, while others exhibited signifi-
cant conditions such as paralysis.
3. NEED FOR CO-ORDINATION OF STANDARDS
To ensure patient protection, all standards affecting diagnostic and/or therapeu-

tic medical procedures involving ionizing radiation need to be co-ordinated. This
means that the ministries of health, responsible for health care standards, and the radi-
East
Africa Europe
Mediter.
2% 12%
10%
Latin
America
38%
West
Pacific
23%
SE. Asia
15% Years 1969-2000
110044 cc o u n ttrriieess
11001122 hh o s p iittaallss
33667733 aauu d i tss
FIG. 3. IAEA/WHO TLD Postal Dose Quality Audit — regional participation.

percentage of beams checked in each

1400 100
cumulative number of measurements
in hospitals (therapy beams checked)
1300 95
period with results within ± 5%

Latin America and Caribbean Region
1200 90
1333 beams checked / 30 years
1100 85
1000 80
900 75
800 70
700 65
600 60
500 55
93
97
90
91
92
94
95
96
98
99
<90
period or year of measurement
FIG. 4. IAEA/WHO TLD Postal Dose Quality Audit — PAHO participation.
ation safety regulatory authorities, responsible for radiation safety standards, need to
collaborate effectively. Furthermore, regulators are not to implement QA programmes
in the facilities they inspect. Quality assurance must be performed by the medical
facility staff. They are to develop QA procedures to improve the clinical outcome and
ensure safe fulfillment of the medical management. Regarding radiation safety, the
BSS state that the calibration, QA and clinical dosimetry requirements are to be met
by, or be under the supervision or with the advice (in the case of diagnostic radiol-
ogy) of an expert qualified in the relevant discipline, who is in fact is a medical physi-
cist. The regulator has to ensure that this is done properly and with the periodicity
required by the regulations. Only in this manner will the radiological protection of the
patients be assured.
REFERENCES
[1] PAN AMERICAN HEALTH ORGANIZATION, Health in the Americas, Scientific

Publication 569, PAHO, Washington, DC (1998).
[2] UNITED NATIONS, Ionizing Radiation: Sources and Biological Effects, (Report to the
[3] FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS
66 BORRÁS

[4] BORRÁS, C. (Ed.), Organization, Development, Quality Assurance and Radiation
Protection in Radiology Services: Imaging and Radiation Therapy, Pan American Health
Organization, Washington, DC (1997).
[5] DIVISION OF HEALTH SYSTEMS AND SERVICES DEVELOPMENT, Health
Technology Assessment in Latin America and the Caribbean: Collection of Cases, Pan
American Health Organization, Washington, DC (1999).
[6] WORLD HEALTH ORGANIZATION, National Cancer Control Programs: Policies and
Managerial Guidelines, WHO, Geneva (1995).
[7] BORRÁS, C., STOVALL, J. (Eds), Design Requirements for Megavoltage X-Ray
Machines for Cancer Treatment in Developing Countries: Report of an Advisory Group
Consultation, Washington, DC (1993), Technical Report No. LA-UR-95-4528, Los
Alamos National Laboratory, NM (1995).
[8] IZEWSKA, J., BERA, P., ANDREO, P., MEGHZIFENE, A., “Thirty years of the
IAEA/WHO TLD Postal Dose Quality Audits for radiotherapy”, Medical Physics and
Biomedical Engineering (Proc. World Congr. Chicago, 2000).
THE WORLD HEALTH ORGANIZATION POSITION
H. OSTENSEN
Geneva
E-mail: ostensenh@who.ch
Abstract
Following a major restructuring of the World Health Organization (WHO) the work
planned and carried out in the area of radiation medicine as applicable to medical practices now
focuses on diagnostic imaging, including not only radiography but also ultrasonography and
other imaging modalities as appropriate, and with radiation safety issues incorporated as a
natural part of that. The increased focusing on diagnostic imaging has become necessary
because a majority of the world’s population still has no access to the most basic diagnostic
imaging services, and, where it is available, both quality and safety, including radiation
protection measurements, are often to be questioned. Consequently, the most important
challenge for the WHO Team of Diagnostic Imaging and Laboratory Technology in the area of
radiation safety is to advocate for and to assist countries in implementing and following
existing laws and regulations, and to educate and train the staff involved in how to do so.
During the past three years and following a major restructuring of the World
Health Organization (WHO) the work planned and carried out in the area of radiation
medicine as applicable to medical practice has been revitalized and significantly
upgraded. However, priorities are now given to the needs of Member States with lim-
ited resources. Also, and in addition to the area of radiotherapy, special focus is given
to all aspects of diagnostic imaging, including not only radiography but also ultra-
sonography and other imaging modalities as appropriate; radiation safety issues are
incorporated as a natural part of this. Therefore, the former WHO unit of Radiation
Medicine has changed its name, and is today part of the Team of Diagnostic Imaging
and Laboratory Technology.
The increased focus on diagnostic imaging has become necessary through the
simple facts that, firstly, at least one third of all patients requiring medical treatment
also need diagnostic imaging before a correct diagnosis can be established and even-
tual treatment given and, secondly, that a majority of the world’s population has no
access to the most basic diagnostic imaging services, and, where available, both
safety and quality are often to be questioned. Therefore our priority is to try to help
improve such services. It would certainly be inappropriate to focus mainly on
67
68 OSTENSEN
sophisticated radiotherapy in areas where no proper medical diagnosis can be estab-

lished. Similarly, it would be of very little use to allocate major resources primarily
to the area of radiation protection in countries and regions where little, if any, diag-
nostic imaging or therapy equipment is functioning or even installed.
That said, however, we are well aware of our obligations not only towards
countries and regions with limited resources but also towards the rest of the world,
thereby focusing on how ionizing radiation is being used both for diagnostic and
therapeutic purposes.
The rapid development of both equipment and techniques, as well as the
increased use of such equipment and techniques by persons other than those specially
trained for the purpose, are of major concern to all of us. Reports of injuries to both
patients and medical staff using ionizing radiation, especially in interventional and
therapeutic procedures, come from all over the world, and it may be reasonable to
assume that the published reports represent only the most serious incidents and that
there is significant underreporting.
Everybody is aware of the existence of international and national laws, regula-
tions and recommendations on how to ensure the safe and proper medical use of
ionizing radiation. To be effective, however, such laws and regulations have to be
understood, implemented and followed not only by national authorities but also by
each individual involved, be they medical physicist, radiologist, other physician,
radiographer and technician, nurse or hospital administrator.
Consequently, the most important challenge for the WHO Team of Diagnostic
Imaging and Laboratory Technology in the area of radiation safety is to advocate for
and to assist in implementing and following existing laws and regulations, and to
educate and train the staff involved in how to do so. The majority of adverse effects
or serious accidents caused by the medical use of ionizing radiation can be traced
back to human error, be it equipment malfunctioning owing to insufficient mainte-
nance or improper handling, or be it the neglect or lack of knowledge of the staff
involved. Thus educational programmes and training materials now being developed
and implemented encompass the managerial, medical and technical aspects of diag-
nostic imaging, including practical radiation safety measurements adapted to local
needs, in both small, remote hospitals with very basic equipment and a lack of
properly trained staff and larger medical institutions with most types of high technol-
ogy equipment and well educated staff.
Regardless of location and infrastructure, no education, laws or regulations can
prevent accidents and injuries if not every person involved, at all levels from the
ministries of health to the least knowledgeable assistant in a specific hospital, under-
stands and sufficiently acknowledges the potential hazards involved in the use of
ionizing radiation. Someone has said “radiation does not smell”, and therefore its
potential dangers are often not taken seriously enough. Although a physician carrying
out a percutaneous transluminal coronary angioplasty may be insufficiently trained in
WORLD HEALTH ORGANIZATION
69
radiation protection measurements, she or he would most probably know that it could
be dangerous. She or he may also be aware of the existence of laws and regulations
instituted to prevent injuries and adverse events. The seriousness of not following
such laws and regulations, however, needs to be explained over and over again, and
not only to national authorities. Thus an increased awareness of everybody involved
of the necessity for radiation safety measurements, both in planning and in the
practical, medical use of ionizing radiation, is a major obligation for the WHO Team
of Diagnostic Imaging and Laboratory Technology. The work performed is aimed at
bridging the possible gap between existing laws and regulations on one side and their
practical applications on the other.
In our view, this conference represents a unique opportunity for building further
on this bridge between laws and regulations and their practical applications. Both
aspects are important and necessary, but an eventual success, or improvement of the
situation, should be expected only when national and regulatory authorities extend
and improve their communication with the target groups in a clear and understand-
able language. Not everybody working in this area has the knowledge of a medical
physicist. ‘Gray’, ‘sievert’ and ‘effective dose’ are important, and mathematical
formulas for calculating potential risks may also be beneficial; however, the less
scientific aspects of radiation protection, such as a damaged or missing door between
an X ray examination room and a waiting area, may well be of some importance.
Another example could be to promote research for developing safe, practical, cheap
and really usable sterile gloves for the radiological protection of staff performing
interventional procedures. Such activities, together with the necessary education and
training, are aspects of major concern for the WHO Team of Diagnostic Imaging and
Laboratory Technology.
In addition to promoting such rather practical aspects of radiation safety, the
WHO Team of Diagnostic Imaging and Laboratory Technology also has a major
obligation to ensure that the necessary and updated international and national infor-
mation, recommendations and guidelines are prepared and in place. In this context we
acknowledge the very important necessity of a close collaboration between the
various actors in the field, such as other United Nations organizations, the European
Community, governmental and non-governmental organizations, and various
scientific societies. The development of the Basic Safety Standards [1] was one such
task. The ongoing and nearly accomplished project of publishing a new edition of the
Manual on Radiation Protection in Hospitals and General Practice [2] is another.
Further examples are the IAEA/WHO project on the quality control of radiotherapy
installations and, certainly of major importance, this very conference.
When everybody is doing what they are best at, and the closest possible
collaboration is achieved, it is our sincere belief that our common goal, namely to
improve health for everybody regardless of who they are and where they live, may be
accomplished not only more successfully but also without unnecessary delay.
70 OSTENSEN
REFERENCES

[2] INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR
OFFICE, WORLD HEALTH ORGANIZATION, Manual on Radiation Protection in
Hospitals and General Practice, 5 vols, WHO, Geneva (1974–1980).
THE ROLE OF THE UNITED NATIONS
SCIENTIFIC COMMITTEE ON THE EFFECTS OF
ATOMIC RADIATION IN RELATION TO
MEDICAL RADIATION EXPOSURES
P.C. SHRIMPTON
National Radiological Protection Board,
Chilton, Didcot, United Kingdom
E-mail: paul.shrimpton@nrpb.org.uk
1. INTRODUCTION
In 1955, growing global concerns about ionizing radiation led the General
Assembly of the United Nations to establish the United Nations Scientific Committee
on the Effects of Atomic Radiation (UNSCEAR). The mandate of this committee,
which presently includes 21 Member States, is to assess and report on the levels and
effects of exposure to ionizing radiation. Accordingly, UNSCEAR applies scientific
judgement in undertaking comprehensive reviews and evaluations concerning radia-
tion and maintains an independent and neutral position in drawing its conclusions.
These are published in authoritative reports to the UN General Assembly, with there
having been 14 such substantive reports, with technical annexes, since 1958 [1]. The
information provided by UNSCEAR assists the General Assembly in making recom-
mendations in relation, for example, to international collaboration in the field of
health. Governments and organizations all over the world rely on the committee’s
evaluations as the scientific basis for estimating radiation risk, establishing radiation
protection and safety standards, and regulating radiation sources.
2. UNSCEAR 2000 REPORT
The most recent analysis of the sources and effects of ionizing radiation is
published in the UNSCEAR 2000 Report [1]. This comprises two volumes, the first
reviewing the sources of ionizing radiation and the second the effects, each being sup-
ported by five technical annexes, as listed in Table I. The review addresses all sour-
ces of exposure for populations: natural sources, human-made sources such as nuclear
weapons and nuclear power production, the occupational exposure of workers and, in
particular in Annex D of Volume I, exposures due to the extensive use of radiation in
medicine. This comprehensive approach provides a unique balanced analysis of
global exposure to ionizing radiation.
71
72 SHRIMPTON
TABLE I. SCIENTIFIC ANNEXES TO THE UNSCEAR 2000 REPORT [1]
Volume Annex Topic

I — Sources A Dose assessment methodologies
B Exposures from natural radiation sources
C Exposures to the public from human-made sources of radiation
D Medical radiation exposures
E Occupational radiation exposures
II — Effects F DNA repair and mutagenesis
G Biological effects at low radiation doses
H Combined effects of radiation and other agents
I Epidemiological evaluation of radiation induced cancer
J Exposures and effects of the Chernobyl accident
3. WORLDWIDE EXPOSURES FROM MEDICAL RADIATIONS
The assessment of medical radiation exposures focuses primarily on exposures

received by patients from the use of radiation generators or radionuclides as part of
their diagnosis or treatment. Information is given on the frequencies and common
10 9
Level I
Level II
10 8
Medical X ray examinations
Level III
10 7 Level IV
10 6
10 5
10 4
10 3
10 1 10 2 10 3 10 4 10 5 10 6 10 7
Physicians
Fig. 1. Broad correlation between annual number of medical X ray examinations and number of
physicians in different countries as the basis for their classification into four health care levels.
ROLE OF UNSCEAR 73
TABLE II. UNSCEAR POPULATION MODEL FOR THE GLOBAL

ASSESSMENT OF MEDICAL EXPOSURES [1]
Population
Physicians per million population
Millions Per cent of total
Health care level I >1000 1530 26
Health care level II >300–1000 3070 53
Health care level III 100–300 640 11
Health care level IV <100 565 10
World (1996) — 5800 100
patient dose quantities for different radiological procedures, with diagnostic exposu-
res being summarized in terms of effective doses to individuals and populations.
There is also an analysis concerning the exposure of volunteers participating in medi-
cal research and a short discussion of radiation incidents in medicine. In all, Annex D
of the UNSCEAR 2000 Report [1] includes a substantial amount of data on current
medical exposures, both in relation to national and worldwide practices, presented in
some 79 tables.
In compiling data for this review, the committee has relied primarily on syste-
matic information provided by 60 countries in response to a questionnaire on natio-
nal resources and practices in medical radiology for the period of 1991 to 1996. This
information was supplemented by a review of the published literature, identifying
over 1100 scientific references, so that data were finally included in relation to
aspects of practice in 118 separate countries. Inevitably, this process still provides an
incomplete picture of the world. For example, information on numbers of radiologi-
cal procedures was available for about one half of the world population in the case of
X ray examinations and only about one fifth for particular types of radiotherapy tre-
atment. It was therefore necessary to scale the available data in order to derive global
estimates of practice, and this extrapolation has been carried out by using a global
population model previously devised by UNSCEAR for this particular purpose.
The basis for this model is the broad correlation, illustrated in Fig. 1, between
the number of X ray examinations in a country and the number of physicians, which
is a more commonly known statistic. Accordingly, all countries of the world can be
categorized into four health care levels so that the available data within each level can
be averaged to provide representative frequencies or exposures which then allow
extrapolation to total populations. Clearly, this is a very simplistic approach; never-
theless, the model provides a sufficiently robust assessment of global practice in med-
ical radiology for the purposes of comparison with previous data and the assessment
of trends. Details of the population model are given in Table II. Health care level I
74 SHRIMPTON
TABLE III. WORLDWIDE DOSES FROM IONIZING RADIATION IN 2000 [1]
Source Worldwide annual per caput effective dose (mSv)

Natural background 2.4
Diagnostic medical examinations 0.4
Atmospheric testing 0.005
Chernobyl accident 0.002
Nuclear power production 0.0002
includes countries with more than 1000 physicians per million population, whereas
level IV largely includes the least developed countries, where the ratio is less than 100
physicians per million. Out of the total world population of 5.8 billion in 1996, about
one quarter are associated with health care level I, about one half with level II, and
about 10% with either levels III or IV. It should be emphasized that this classification
is solely for the purposes of modelling global practice and does not imply any judge-
ment on the quality of health care in the countries in question.
Estimates from the UNSCEAR 2000 Report for the worldwide doses from ioni-
zing radiation are summarized in Table III. Overall, the worldwide use of radiation
for medical diagnosis gives rise to an annual effective dose of about 0.4 mSv, avera-
ged over the entire population of the world, most of this being due to widespread
practice with X rays. In comparison, natural radiation is responsible for a per caput
effective dose of about 2.4 mSv per year. Diagnostic medical exposures therefore
account for about 14% of the overall average worldwide exposure to ionizing radia-
tion, while representing over 90% of that from all human-made sources. Such broad
analyses clearly establish medical radiology as an important topic for radiation pro-
tection.
Notwithstanding this general picture, the data collated by UNSCEAR also
show that there are significant differences in national practices with medical radia-
tions and a very uneven distribution of doses amongst the world population. For
example, over 80% of all the collective dose from diagnostic medical exposures ari-
ses from the countries with the highest provisions for health (classified in health care
level I), which represent just one quarter of the world population and where the
annual effective dose per caput is 1.3 mSv (Table IV). The corresponding per caput
dose for health care level IV is lower by a factor of about 60, at only 0.02 mSv per
year.
The periodic analyses by UNSCEAR also help identify changes in patterns of
practice with time. For example, estimates of the global frequency of medical X ray
examinations per 1000 world population have increased steadily between successive
reports published in 1988 [2] (280 per 1000), 1993 [3] (300 per 1000) and 2000 [1]
(330 per 1000). Similar increases in practice are apparent for health care level I: 810
ROLE OF UNSCEAR 75
TABLE IV. GLOBAL VARIATIONS IN PRACTICE WITH

DIAGNOSTIC MEDICAL EXPOSURESa [1]
Annual per caput effective dose (mSv)

Health care level I 1.3
Health care level II 0.15
Health care level III 0.03
Health care level IV 0.02
World 0.4
aDiagnostic examinations with X rays and radiopharmaceuticals.
medical X ray examinations per 1000 in 1988, 890 per 1000 in 1993 and 920 per 1000
in 2000.
4. CONCLUSIONS
UNSCEAR provides unique and wide ranging data on medical radiation expo-
sures as part of broad periodic reviews of the sources and effects of ionizing radia-
tion. The most recent authoritative analysis of this kind is presented in the UNSCEAR
2000 Report, which includes, in the Annex D of Volume I, qualitative and quantita-
tive information on the frequencies and doses for diagnostic and therapeutic proce-
dures, assessments of global practices, and evaluations of temporal and regional
trends. This analysis establishes radiation in medicine as a significant and increasing
source of exposure for the world population; yet large variations remain in national
and regional usage. There is a continuing need for new national survey data, particu-
larly from the developing world, as the basis for further reviews by UNSCEAR so as
to monitor the rapidly evolving and important practices in medical radiology. UNS-
CEAR also undertakes critical reviews of the effects of exposure to ionizing radiation,
with the most recent analysis presented in Volume II of the UNSCEAR 2000 Report.
These UNSCEAR reviews are not intended as means to optimize radiological proce-
dures or as guidelines for radiation protection, but nevertheless provide the essential
background for such work. In particular, information presented in the latest report
will help inform this important international meeting on patient protection.
REFERENCES
[1] UNITED NATIONS, Scientific Committee on the Effects of Atomic Radiation

(UNSCEAR), Sources and Effects of Ionizing Radiation (Report to the General
Assembly), UN, New York (2000).
76 SHRIMPTON

INTERNATIONAL COMMISSION ON RADIOLOGICAL
PROTECTION
F.A. METTLER
E-mail: fmettler@salud.unm.edu
The International Commission on Radiological Protection (ICRP) has been

involved with protection of patients in medicine since the commission was formed in
1928. The past and current work of the commission emphasizes the importance of
patient protection.
Committee 3 is concerned with the protection of persons and unborn children
when ionizing radiation is used for medical diagnosis, therapy of for biomedical rese-
arch as well as with the assessment of the medical consequences of accidental expo-
sures. The current committee membership includes eleven practicing physicians and
four physicists from ten different countries.
Recent publications in the medical field include:
— Protection of the Patient in Diagnostic Radiology and Protection of the Patient

in Nuclear Medicine (Summary of current ICRP principles) (1993) ;
— Radiological Protection in Biomedical Research, ICRP Publication 62 (1993);
— Radiological Protection and Safety in Medicine, ICRP Publication 73 (1996);
— Genetic Susceptibility to Cancer, ICRP Publication 79 (1999);
— Radiation Dose to Patients from Radiopharmaceuticals, ICRP Publication 80
(1999).
The current work of the committee has centred on producing short, readable,
user friendly documents related to important and current issues. In this regard the
committee and task groups have just published a document on Pregnancy and
Medical Radiation. A document on Avoidance of Radiation Injuries from Medical
Interventional Procedures is in press, and two documents, Prevention of Accidents to
Patients undergoing Radiation Therapy, and Management of Patient Dose in
Computed Tomography are being finalized for publication. Some of these documents
have been put on the Internet for comment, and many useful comments have been
received before manuscript completion.
The future work of Committee 3 will centre on whether new ICRP recommen-
dations are needed and, if so, how they will apply to medicine. Work in progress
includes appropriate use of reference values, education of medical students and gene-
ral practitioners, doses from new radiopharmaceuticals and release of patients after
77
78 METTLER
radionuclide therapy. Topic areas under review include paediatric issues, genetic sus-
ceptibility, medical low level waste disposal and high dose rate brachytherapy.
The ICRP and, in particular, Committee 3 are very interested in the comments
by participants of this meeting. Statements on what areas the ICRP should address in
the future are highly welcome.
ROLE AND RESPONSIBILITIES OF
MEDICAL PHYSICISTS IN
A. NIROOMAND-RAD
International Organization for Medical Physics
San Antonio, Texas
E-mail: nirooma@gunet.georgetown.edu
Abstract
The paper provides a brief history of the International Organization for Medical Physics
(IOMP), followed by some general comments on the radiological protection of patients. The
importance of establishing scientific guidelines and professional standards is emphasized, as is
the need to ensure the protection of patients undergoing radiation therapy. The responsibility of
qualified medical physicists in the protection of patients in nuclear medicine and in diagnostic
and interventional radiology is also discussed.
1. ABOUT IOMP
The International Organization for Medical Physics (IOMP) was founded in

1963 as an umbrella organization for national medical physics associations world-
wide. Today IOMP has 72 national organizations representing about 16 000 medical
physicists working in both clinical and research environments. IOMP has several cor-
porate members and four international regional organizations:
(1) EFOMP: European Federation of Organizations for Medical Physics with 32

nations,
(2) ALFIM: Latin American Medical Physics Association with seven nations,
(3) SEAFOMP: South East Asia Federation for Medical Physics with four nations,
(4) NAFOMP: North American Federation for Medical Physics.
The objectives of the IOMP are:
(i) To organize international co-operation in medical physics and to promote

communication between the various branches of medical physics and allied
sciences.
(ii) To contribute to the advancement of medical physics in all its aspects.
(iii) To advise on the formation of national organizations of medical physics in
countries lacking such organizations.
79
80 NIROOMAND-RAD
To achieve these goals, over the years IOMP has formed various committees:
the Education and Training Committee, Science Committee, Publication Committee,
Awards and Honors Committee and Professional Relations Committee. Most
recently, the IOMP has formed the International Advisory Council with representa-
tives from all regional chapters as well as international organizations with similar
interests (e.g. the International Atomic Energy Agency (IAEA), World Health
Organization (WHO), Pan American Health Organization (PAHO) and United
Nations (UN)).
To promote improvements in medical physics and biomedical engineering, the
IOMP and the International Federation for Medical and Biological Engineering
(IFMBE) formed a union in 1981 called the International Union for Physical and
Engineering Sciences in Medicine (IUPESM). The union became a full member of
the International Council for Science (ICSU), formerly known as the International
Council for Scientific Unions, in 1999.
At present the availability of medical physicists and medical physics educa-
tional programmes is unevenly distributed in the world. To change this we must
share resources, ideas, discoveries, and clinical protocols/standards via international
conferences. Furthermore, it is costly, both financially and in terms of staff, to assess
new diagnostic and therapeutic devices and to demonstrate the importance of vari-
ous clinical protocols in the management of cancer patients on a local scale.
Therefore, we must share our expertise and resources. Finally, the IOMP is dedicated
to protecting patients worldwide from unnecessary radiation exposure while provid-
ing optimal diagnostic and therapeutic dose in the management of diseases, espe-
cially cancer.
2. GENERAL COMMENTS ABOUT THE RADIOLOGICAL PROTECTION

OF PATIENTS
The benefits of ionizing radiation in the diagnosis and treatment of cancer, as

well as other conditions such as cardiac ablation, are well established. However, it is
clear from this international meeting and other similar scientific meetings that the
determination, monitoring and evaluation of patient doses are not easy. Furthermore,
radiation doses for individual patients may vary greatly from one radiological proce-
dure to another.
Attention is needed to reduce unnecessary radiation exposure to patients from
all types of radiation producing machines and equipment. The patient risk from
radiation injury — stochastic and/or deterministic — must be weighed against the
benefits of a proper medical examination or treatment as well as the risk of depriv-
ing the patient of necessary medical care. The arbitrary reduction of radiological
patient doses without regard to the final outcome is detrimental to proper medical
ROLE OF MEDICAL PHYSICISTS 81
care provided to the patient. Sacrificing image quality in order to reduce patient
dose is potentially harmful to the patient as well. We believe most individuals pre-
fer to bear the risk of radiation if it means finding a life-threatening lesion, instead
of missing it.
Furthermore, the role of radiation exposure incurred from screening procedures
such as mammography needs to be properly considered and differentiated from med-
ically indicated procedures. A known radiation induced risk needs to be balanced
against the diagnostic efficacy of a screening procedure. In these cases, regulations on
standards and guidelines for determination, monitoring, and evaluation of patient
doses may be appropriate. Trends in mammography quality before and after the
implementation of the US ‘Mammography Quality Standards Act (MQSA)’ of 1992
have recently been evaluated and published by Suleiman et al. [1]. In this report, the
technical data collected in the USA have been compared with the corresponding data
in Canada. However, even here it has been recognized that we cannot assume that one
dose limit fits all. It is advisable to consider individual patient specifics if it means the
difference between detection and missing something.
3. SCIENTIFIC GUIDELINES AND PROFESSIONAL STANDARDS
Universal standards and guidelines for determining, monitoring, and evaluating

the medical exposure of patients have long been the objectives of many scientific and
professional organizations, international regulatory bodies and government agencies.
Efforts directed at attaining these objectives have occupied the time and effort of med-
ical physicists worldwide. The evaluation of this apparent conflict between the two
sides of the radiation sword — benefit and harm — is the joint responsibility of qual-
ified medical physicists and authorized physicians. A qualified medical physicist has
been defined by several organizations [2, 3] as an individual who is competent to
practice independently and legally authorized to practice in one or more of the sub-
fields in medical physics. Similarly, an authorized physician has been defined by a
number of professional organizations [3–5] as a licensed physician with documented
training in and understanding of physics in one or more of the subfields of radiation
physics. Certification/licensing/national registry by a professional organization1 [6]
in the appropriate subfields(s), as well as continuing education in handling radiation-
producing equipment is essential. A qualified medical physicist and an authorized
physician have the expertise necessary to determine, monitor and evaluate this
1 American Board of Radiology, Tucson, AZ, USA, http://theabr.org; American Board of
Medical Physics, Galesburg, IL, USA, http://www.acmp.org/abmp/l; Canadian College Of

Physicists in Medicine, Edmonton, Alberta, Canada, http://www.medphys.ca/index.cfm.
82 NIROOMAND-RAD
tradeoff between patient dose reduction and the patient’s final outcome. They have
the expertise to establish protocols for radiation procedures and evaluate radiation
outcomes. Moreover, medical physicists are charged with educating hospital staff
(such as nurses and radiation technologists) in the proper handling of radiation pro-
ducing equipment and radioactive materials to avoid harmful practices. Experience
shows that a substantial dose reduction (nearly 40%) in radiological procedures is
possible by training of the physicians and staff [7, 8].
Standards for the performance of radiation procedures in radiotherapy, nuclear
medicine, radiology as well as interventional radiology have been developed by sci-
entific and professional organizations2 [2, 4]. The objective of these standards, which
are reviewed and revised on a periodic basis, is to improve the quality of radiation ser-
vices for patients using increasingly complex technology. These scientific standards
are not rules to be regulated but a code of practice to ensure high quality radiological
care of patients. An existing standard may be modified for an individual patient and
according to the available resources. The standards should not be deemed inclusive of
all proper methods of care or exclusive of other methods of care reasonably directed
to obtaining the same results. The ultimate judgement regarding the propriety of any
specific procedure or course of conduct is the responsibility of an authorized physi-
cian in consultation with a qualified medical physicist in light of all the circumstances
presented for the individual patient and/or situation.
To protect patients from unnecessary radiation, we need to understand the com-
plexities of as well as the limitations in the assumptions that are made in determin-
ing, monitoring and evaluating the patient doses in therapeutic and diagnostic proce-
dures. The role and responsibilities of medical physicists in the containment of radi-
ation dose to the patients are described briefly below.
4. PROTECTION OF PATIENTS IN RADIATION THERAPY
In radiation therapy the first responsibility of a medical physicist and a radia-

tion oncology physician is to the patient: they have to assure the best possible radia-
tion treatment given the state of the current technology, the skills of the staff, and the
resources available in the radiation oncology department. A radiation therapy physi-
cist brings a unique perspective — that of a scientist trained in physics, including
radiological and clinical physics — to the clinical team in a radiation oncology pro-
gramme to ensure accurate delivery of all aspects of a treatment prescription. In radi-
ation therapy the radiation protection of the patient is achieved by delivering an accu-
rately prescribed dose (within ± 5%) to the organ/tissue of interest while minimizing
the dose to the surrounding uninvolved organs/tissues. Because of potential serious
2 International Society of Radiology, Bethesda, MD, USA, http://209.67.209.116.

patient injury in radiation therapy, the radiation treatment beams have to be planned
by qualified medical physicists who give consideration to individual patient specifics.
In addition, due to the ever-increasing complexity in treatment planning computer
systems as well as treatment delivery equipment, the skills and training of qualified
medical physicists need to be updated on an ongoing basis. With proper education and
training of the physicists, the accidental overexposure of a large number of patients,
such as what occurred in Costa Rica in 1996, could have been avoided.
Radiation therapy physicists are involved in measuring and calibrating radiation
doses from radiation producing equipment such as cobalt machines, linear accelera-
tors, simulators, and computer tomography (CT) simulations, as well as brachyther-
apy sources and equipment such as low, medium, and high dose rate (LDR, MDR and
HDR) and intravascular devices. Following the guidelines and protocols provided by
scientific organizations, medical physicists measure head and collimator leakage, the
multi-leaf collimator (MLC) leakage/interleaf leakage for this increasingly complex
equipment to ensure patient protection from unnecessary radiation. Physicists also
perform characterization of radiation treatment beams by measuring and determining
various treatment parameters such as beam quality/energy, depth dose characteristics
of radiation beams, field size/shape dependence of radiation beams, characteristics of
beam modifiers (such as physical, universal and dynamic wedges), and intensity mod-
ulation of radiation beams in intensity modulated radiation therapy (IMRT).
In radiation therapy medical physicists are also involved in providing radiation
oncology physicians with optimal treatment plans using treatment planning comput-
ers with complex calculation algorithms that have inherent limitations in estimating
patient doses under all possible conditions or configurations. The limitations in the
existing dose calculation algorithms need to be understood and tested. Ensuring the
accuracy of treatment parameters (so-called ‘quality assurance’) in radiotherapy,
including correct transfer of parameters between the simulator, treatment plan and the
treatment machine, and periodic reviews of each patient’s chart are the responsibility
of medical physicists. As part of quality assurance (QA), medical physicists often
have the output of the radiation treatment beam(s) checked independently either by
another qualified medical physicist or by utilizing thermoluminescent dosimetry
mailing services 3.
Medical physicists are also involved in the in vivo dose measurements of radi-
ation patients using devices such as films, diodes, and thermoluminescent dosimeters
(TLDs). The use of these devices requires special knowledge and expertise.
Acceptance testing, commissioning of any radiation producing equipment and the use
of any measuring devices in radiation therapy also requires careful application and the
3 Radiological Physics Center, University of Texas at M.D. Anderson Cancer Center,

Houston, TX, USA, http://rpc.mdanderson.org/rpc/index.htm; IAEA, Vienna, Austria,
http://www.iaea.org.
84 NIROOMAND-RAD
attention of medical physicists. The role and responsibilities of medical physicists in

radiation therapy have been described in detail by scientific organizations in many
publications [9, 10].
5. PROTECTION OF PATIENTS IN NUCLEAR MEDICINE
In nuclear medicine qualified medical physicists are involved in testing, upon

installation, all imaging equipment used in nuclear medicine. They also monitor the
performance of the equipment on a periodic basis to ensure that everything is func-
tioning within the manufacturer’s stated specifications and acceptable performance
standards. In diagnostic nuclear medicine — intended for planar as well as tomo-
graphic imaging — the goal is to produce the diagnostic images of the highest possi-
ble quality consistent with the clinical use of the equipment and to obtain the intended
information from the examination. In general, the level of the radiation dose to the
patients undergoing nuclear medicine examinations is very low. Therefore, the level
of patient protection required in diagnostic nuclear medicine should be on a par with
the level of radiation doses.
Furthermore, in nuclear medicine procedures with therapeutic intent, the med-
ical physicist is responsible for preparing a table of organ doses for all the procedures
that involve administration of radiopharmaceuticals to patients. The table is specific
to the dosage schedule used at the facility. Models — Monte Carlo or otherwise —
used for organ calculations assume standard weight, height, size, shape for a standard
man, woman and child. Thus, separate tables for patient size and gender are needed.
Due to the complexities involved in calculating patient/organ doses in therapeutic
nuclear medicine, the radiation protection of patients should be the responsibility of
a qualified medical physicist.
6. PROTECTION OF PATIENTS IN DIAGNOSTIC AND INTERVENTIONAL

RADIOLOGY
In diagnostic and interventional radiology qualified medical physicists are

involved in the process of optimizing the radiation used for imaging. This involves
several specific actions. The first is to ensure that the quality of images is adequate
for the specific clinical objective. This is achieved through consultation on the selec-
tion of appropriate imaging equipment, evaluation of equipment performance in the
context of QA programmes, and the education of medical and technical staff on the
appropriate imaging procedures and protocols. The primary objective is to ensure that
an examination produces the necessary diagnostic information without the applica-
tion of unnecessary radiation to the patient. A physicist determines the amount of
radiation used for the different types of examinations. These data are used to ensure
that sufficient exposure levels are used to produce the required diagnostic information
and that appropriate patient dose limiting techniques are being applied. A related
function of medical physicists in diagnostic and interventional radiology is to ensure
that medical and technical personnel are utilizing appropriate practices to control the
levels of radiation to which they are exposed. The medical physicist is a major source
of information and a consultation resource to the clinical staff on the reduction of the
risk associated with inadequate image quality and incorrect diagnoses. Through this
process the medical physicist guides the use of radiation so that it is optimized to pro-
duce the necessary diagnostic information without unnecessary human exposure. The
role and responsibilities of the clinical medical physicist in diagnostic radiology have
been described in detail in many publications [11, 12].
In diagnostic radiology physicists are responsible for monitoring and evaluat-
ing the patient exposures and comparing them with the published surveys for similar
examinations and calculation of specific organ doses for diagnostic procedures and/or
for specific patients. The entrance skin dose (ESD) is still by far the simplest indica-
tor of a patient’s injury. The ESD can be measured directly with a TLD or ionization
chamber. It can also be estimated from the dose area product (DAP). These quantities
are used to determine the radiation risk. The ESD and DAP can be used for compar-
ison purposes with published values such as reference values (RV) (American
Association of Physicists in Medicine Task Group Report, in progress). The USA
adopted RVs that are similar to the diagnostic reference levels (DRLs) recommended
by the European Commission’s Medical Exposure Directive [97/43/EURATOM
(MED), 1997]. The RVs and DRLs are not and should not be regarded as regulatory
limits. They provide upper level guidelines of patient exposure that should initiate
facility investigation when the exposure is exceeded. The RVs and DRLs are estab-
lished based on the judgement of medical physicists and imaging physicians for stan-
dard imaging protocols. These protocols are based on some standard conditions (such
as phantom size and group of patients) with consideration given to adequate image
quality. However, we must realize that RVs and DRLs will vary depending on the
available technology, and may not exist for all procedures that are currently per-
formed in radiology. Moreover, we must recognize that the ESD is strongly depen-
dent on the patient’s thickness and beam quality. Thus, any arbitrary reduction in the
ESD can result in an increased ‘noise’ (or loss in contrast) and therefore loss in image
quality. There are times, however, that patient dose can be reduced without a sub-
stantial loss in image quality. The medical physicist is the best suited individual to
monitor patient doses and to reduce them (if possible) without substantially compro-
mising the efficacy of diagnostic procedures. Medical physicists are also in charge of
patient safety — including radiation, mechanical and electrical safety. They assist
physicians in the evaluation of quantitative studies, such as the measurement of car-
diac ejection fraction. In addition they are responsible for initial and continuing edu-
86 NIROOMAND-RAD
cation of the physician and imaging staff to ensure efficient and proper use of radia-
tion producing equipment.
In interventional radiology, an increasing number of invasive procedures,
mostly with therapeutic intent, involve the use of medical devices under fluoroscopic
guidance. These procedures, typically involving extended fluoroscopic time, are per-
formed by a variety of medical specialists who may not have proper training in the
use of radiation. As the number of interventional procedures has increased in the
recent past, medical physicists have become concerned about patients’ radiation expo-
sure in these procedures. Fluoroscopic devices can deliver radiation at a very high rate
of 5 cGy/min. Physicians need to be aware of the potentially serious radiation induced
skin injury caused by long periods of fluoroscopy employed in these procedures.
Also, in recent years with the increased use of mobile CT in surgical procedures, the
doses to the patients have increased considerably. Patients are often unaware that they
are exposed to radiation and thus are uninformed of the ill effects of radiation in their
procedures.
Examples of interventional procedures that typically require extended fluoro
exposure time include, but are not limited to, angioplasty (coronary and other ves-
sels), cardiac ablation, vascular embolization, stent placement, endoscopic cholan-
giopancreatography, biliary drainage and urinary or biliary stone removal. Although,
angioplasty often takes about 45 minutes, on some occasions the procedure may last
several hours. The types of injuries to the skin and adjacent tissues which may result
from long exposure to fluoro have been reported in the literature [13, 14].
The absorbed dose rate in the skin from a direct beam of a fluoro is typically
between 2 and 5 cGy/min, but may be as high as 50 cGy/min, depending on the size
of the patient and the mode in which the fluoro is operated. In addition, many fluoro
guided procedures involve image recording (fluorography) using films or digital
means to record images permanently. The recording modes usually involve much
higher dose rates than those used in fluoroscopy. Contributions from fluorography
must also be included in assessing the total absorbed dose to the skin.
Radiation injuries, with the onset of months or years after the interventional
procedures, cannot be diagnosed easily. When symptoms of injury occur, most inter-
ventional physicians may not be in direct contact with the patients. Therefore, many
of them are unaware of the potential radiation injuries to their patients. In addition to
skin injuries, there is an increased risk of late effects, such as radiation induced can-
cers in other tissues and organs. The potential for such late effects should be consid-
ered in the risk/benefit analysis, especially in paediatric and young adult patients, or
in procedures involving exposure to radiosensitive tissues such as the breast. For these
reasons, in 1994, the US Food and Drug Administration (FDA),4 [15] issued a public
health advisory warning to physicians about the potential risks of fluoro irradiation.
4 Food and Drug Administration, Rockville, MD, USA, http://www.fda.gov/cdrh/.

The FDA recommended that institutions:
(1) Adopt standard procedures and protocols for each fluoroscopic procedure,
(2) Determine radiation dose for each fluoroscope,
(3) Evaluate treatment plans to gauge the risk of radiation injury,
(4) Change treatment plans to reduce that risk,
(5) Record in each patient’s file the information needed to calculate the absorbed
dose of radiation to the skin and other organs.
However, it should be noted that the FDA has no authority to force physicians
or institutions to follow these recommendations. It is also worth noting that the inter-
ventional procedures could result in an increased occupational exposure to physicians
and staff, which is of concern to medical physicists.
7. SUMMARY
A major concern of medical physicists in any of the subfields of radiation med-

icine — radiology, interventional radiology, nuclear medicine and radiotherapy — is
to protect patients from unwarranted radiation. To achieve this, the IOMP concurs
with the European Commission’s Medical Exposure Directive requiring the services
of qualified medical physicist at all radiation facilities. Furthermore, the IOMP rec-
ommends adoption of such a policy by regulators and government agencies. The
IOMP also recommends establishment of a comprehensive standard operating proce-
dures manuals for each specific radiation procedure in any radiation facility. The pro-
cedures should be consistent with the scientific and professional standards, which are
established by national and international organizations. The manuals should address
all aspects of the radiation procedures including, but not limited to, patient selection,
normal conduct of the procedure, action levels in response to the complications, cal-
ibration procedures for all radiation producing equipment and radioactive sources,
quality assurance checks of the equipment and dose measuring devices, dose calcula-
tion protocol, in vivo dose measurement, monitoring, evaluation, and documentation
of patient dose(s), safety programmes, emergency procedures, patient education, and
staff continuing education. We recognize that each radiation facility is unique.
Therefore, the manual must be individualized based on the resources and goals of the
programme. However, the basic principles of monitoring and evaluation of the patient
doses as well as of the outcomes must be addressed on an ongoing, formalized, sys-
tematic, and comprehensive basis. It should also include sample quality assessment
and improvement plans that lend themselves to a multi-disciplinary, problem solving
approach that is consistent with the continuing quality improvement philosophy at a
radiation facility.
88 NIROOMAND-RAD
In conclusion, the IOMP endorses any effort that promotes the safe use of radi-
ation while minimizing unnecessary dose to the patients and staff. The IOMP does
not favour the arbitrary imposition of radiation limits by regulators that would limit
the ability of physicians and medical physicists to provide optimal therapeutic or
diagnostic radiation to the patient.
REFERENCES
[1] SULEIMAN, O.H., SPELIC, D.C., MCCROHAN, J.L., SYMONDS, G.R., HOUN, F.,
Mammography in the 1990s: The United States and Canada, Radiology 210 (1999)
345–351.
[2] AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE, Official AAPM
Definition of the Qualified Medical Physicist, AAPM Membership Directory, College
Park, MD (2001) 41.
[3] EUROPEAN UNION, Council Directive 97/43/EURATOM of 30 June 1997, Health
Medical Exposure. (Repealing Directive 84/466/EURATOM, O.J. No. L 265/1,
5.10.1984), Official Journal of the European Communities No. L 180/22-27,
Luxembourg (1997).
[4] AMERICAN COLLEGE OF RADIOLOGY, Standards, General Radiography, ACR,
Reston, VA (2000) 27–30.
[5] EUROPEAN UNION, Council Directive 96/29/EURATOM, of 13 May 1996, Basic
Safety Standards for the Protection of the Health of Workers and the General Public
against the Dangers arising from Ionizing Radiation, Official Journal of the European
Communities No. L 159/1–114, Luxembourg (1996).
[6] EUROPEAN FEDERATION OF ORGANISATIONS FOR MEDICAL PHYSICS,
Recommended guidelines of national registration schemes for medical physicists, Policy
Statement No. 6, Physica Medica XI (1995) 157–159.
[7] REHANI, M.M., KAUL, R., KUMAR, P., BERRY, M., Does bridging the gap between
knowledge and practice help? Example of patient dose reduction in radiology, J. Med.
Phys. 20 (1995) 18–22.
[8] ARCHER, B.R., WAGNER, L.K., Protecting patients by training physicians in fluoro-
scopic radiation management, J. Appl. Clinical Med. Phys. 1 1 (Winter 2000).
[9] AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE, The Role of the
Physicist in Radiation Oncology, AAPM Report 38, American Institute of Physics, New
York (1985).
[10] BELLETTI, S., et al., Quality assurance in radiotherapy: the importance of medical
physics staffing levels. Recommendations from an ESTRO/EFOMP joint task group,
Radiother. Oncol. 41 (1996) 89–94.
[11] AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE, The Role of the
Clinical Medical Physicist in Diagnostic Radiology, Report No. 42, American Institute
of Physics, New York (1994).
[12] EUROPEAN FEDERATION OF ORGANISATIONS FOR MEDICAL PHYSICS,

Radiation protection of the patient in Europe: The training of the medical physics expert
in radiation physics or radiation technology, Policy Statement Nr. 9, Physica Medica XV
(1999) 149–153.
[13] WAGNER, L.K., EIFEL, P.J., GEISE, R.A., Potential biological effects following high
X-ray dose interventional procedures, J. Vasc. Interv. Radiol. 5 (1994) 71–84.
[14] SHOPE, T.B., Radiation-induced skin injuries from fluoroscopy, Radiographics 16
(1996) 1195–1199.
[15] FOOD AND DRUG ADMINISTRATION, Avoidance of Serious X-Ray Induced Skin
Injuries to Patients during Fluoroscopically-Guided Procedures, FDA Medical Bulletin
24 2 (1994) 7–17.
THE ACTIVITIES OF THE INTERNATIONAL
RADIATION PROTECTION ASSOCIATION
IN RELATION TO THE RADIOLOGICAL PROTECTION
OF PATIENTS
G.A.M. WEBB
President,
International Radiation Protection Association
The International Radiation Protection Association (IRPA) was created in 1965

following an initiative from the United States Health Physics Society. The IRPA is an
international organization with membership of individual professionals who are
members of an affiliated national or regional radiation protection society. The asso-
ciation initially included 11 societies representing 16 countries. IRPA membership is
now approaching 20 000 individuals from 42 societies covering more than 50 coun-
tries.
The primary objective of the IRPA is to provide a medium whereby internatio-
nal contacts and co-operation may be promoted among those engaged in radiation
protection work, which includes relevant aspects of such branches of knowledge as
science, medicine, engineering, technology and law, in the effort to provide for the
protection of humans and their environment from the hazards caused by ionizing and
non-ionizing radiation and thereby to facilitate the exploitation of radiation and
nuclear energy for the benefit of humanity.
To accomplish this primary objective, the constitution lists a number of activi-
ties that are regarded as appropriate. In broad terms, they are:
— Establishment of radiation protection societies,

— Support for international meetings,
— Encouragement of international publications,
— Encouragement of research and education,
— Establishment and review of standards.
In the context of this conference, the IRPA can be seen as a representative of

the professionals in ‘radiation protection’ or ‘health physics’. The IRPA membership
includes most of the professionals working in all radiation protection areas and disci-
plines, including those concerned with protection in medicine, in essentially all deve-
loped and many developing countries.
It is also important to recognize what the IRPA is not. It is not a reviewer of
basic science such as the United Nations Scientific Committee on the Effects of
Atomic Radiation, not an issuer of recommendations such as the International
91
92 WEBB
Commission on Radiological Protection (ICRP) or the International Commission on

Radiation Units and Measurements and not a large United Nations organization such
as the IAEA or the World Health Organization. The officers and members of the exe-
cutive council who are elected at the general assembly held every four years are all
part time and unpaid. The annual IRPA budget is only just over US $50 000 in total.
Thus, although the IRPA has considerable resources in terms of expertise of its mem-
bership in its associate societies, it has only minimal resources in terms of central
effort and funds.
It is not possible in this brief paper to elaborate on all the activities of the IRPA.
A major focus of the IRPA effort is concerned with the control of occupational expo-
sure which, although very relevant to radiation protection in medicine, is not the topic
of this conference. However, an example that is relevant relates to the establishment
and implementation of radiation protection standards. The current process of setting
standards in ionizing radiation protection, which includes standards for the protection
of patients, relies heavily on the ICRP to make recommendations. These are then
translated into more or less binding form internationally (e.g. IAEA Basic Safety
Standards), regionally (e.g. Euratom directives) and nationally. This second phase
relies primarily on governmental nominees. This matter was discussed in depth at the
Associate Societies Forum during the IRPA-10 Congress in Hiroshima in May 2000.
A clear consensus existed among societies present that the IRPA must play a larger
role in the standard setting process. Procedures are now being developed with some
success. For example, the IRPA invited its member societies to comment on Professor
Roger Clarke’s proposals for revisions to the basic recommendations of the ICRP.
Many societies formed working groups, or undertook member consultation exercises,
in order to develop a view on the proposals. Following discussions in Hiroshima, the
IRPA produced a report entitled IRPA Member Societies Contributions to the
Development of New ICRP Recommendations and transmitted this to the ICRP. It is
clear from the subsequent presentations by Professor Clarke that the results of this
wide consultation were helpful to the ICRP in refining and developing the proposals.
The IRPA intends to continue to use this mechanism for major proposals for stan-
dards, including in due course the revision of the Interagency Basic Safety Standards.
Dissemination of information on such consultation processes and other aspects
of IRPA work including helpful information on ‘hot topics’ now takes place exclusi-
vely through the IRPA website, which was completely rebuilt during the second part
of the year 2000. The site can be found at www.irpa.net.
The individual members of the IRPA have a substantial responsibility for
implementing new standards, normally after they have been translated into national
regulations. Another IRPA activity that is relevant here is to encourage the establish-
ment of radiation protection societies throughout the world as a means of achieving
international co-operation among those engaged in radiation protection. This may be
seen as an activity aimed at improving professional levels and enhancing the global
ACTIVITIES OF THE IRPA 93
‘safety culture’. As the major use of radiation in a large number of countries throug-
hout the world is in medicine, this emphasis on improvement of professional stan-
dards should have a direct impact on the protection of patients which relies to a subs-
tantial extent on a safety culture rather than on the rigid application of limits. Over
the next few years particular attention will be paid to the promotion of new societies
in Africa. The IRPA hopes to enlist the support of the societies in South Africa, the
United Kingdom and France in this initiative. A complementary IRPA activity which
also contributes to the overall safety culture is to encourage and provide for educa-
tion, training and continuous professional development in radiation protection.
At the Hiroshima Congress, the IRPA Executive Council was asked to increase
the interaction between the IRPA and other professional societies, especially those in
the medical area. This conference will provide a useful and timely opportunity to do
so, and the IRPA is very pleased to have been invited to co-operate in the conference.
INTERNATIONAL SOCIETY OF RADIOLOGY AND
RADIATION PROTECTION
C.G. STANDERTSKJÖLD-NORDENSTAM
President,
International Society of Radiology
The purpose of the International Society of Radiology (ISR), as being the glo-
bal organization of radiologists, is to promote and help co-ordinate the progress of
radiology throughout the world. In this capacity and as a co-operating organization of
the IAEA, the ISR has a specific responsibility in the global radiological protection
of patients. In fulfilling this task, the ISR works together with other international
organizations, the World Health Organization and its regional subsidiaries, the
International Commission on Radiological Protection and the International
Commission on Radiation Units and Measurements, the International Society of
Radiographers and Radiological Technologists and now the IAEA and so many other
bodies and societies.
Globally, there are many users of medical radiation, and radiology may be prac-
tised in the most awkward circumstances. The individuals performing X ray studies
as well as those interpreting them may be well trained, as in industrialized parts of the
world, but also less knowledgeable, as in developing areas. The problems of radiolo-
gical protection, both of patients and of radiation workers, still exist, and radiation
equipment is largely diffused throughout the world. That is why a conference like this
is today as important as ever.
Radiation protection is achieved through education, on the one hand, and legis-
lation, on the other. Legislation and regulation are the instruments of national autho-
rities. The means of the ISR are education and information. Good radiological prac-
tice is something that can be taught. The ISR is doing this mainly through the bian-
nual International Congress of Radiology (ICR), now arranged in an area of radiolo-
gical need; the three previous ICRs were in China, in India and in South America; the
next one is going to be in Mexico in 2002. The goal of the ICR is mainly to be an ins-
tructive and educational event, especially designed for the needs of its surrounding
region.
The ISR is aiming at producing educational material. The International
Commission on Radiological Education (ICRE), as part of the ISR, is launching the
production of a series of educational booklets, which also include radiation protec-
tion. The ICRE is actively involved in shaping and organizing the educational and
scientific programme of the ICRs.
The ISR is also active in distributing informative material. Criteria for the
appropriate use of medical radiation, including the proper replacement of radiation
95
96 STANDERSKJÖLD-NORDENSTAM
methods by non-radiation imaging modalities, have been worked out by the American
College of Radiology (ACR Appropriateness Criteria 2000). The ISR is active in dis-
tributing this book to all the national societies of radiology for their perusal. The ISR
will also be involved in distributing other important information on radiation protec-
tion, such as the ICRP Report 84 on Radiation and Pregnancy.
In industrialized countries, medical radiation forms approximately one quarter
of the population exposure to ionizing radiation. Emerging modalities such as com-
puted tomography change the scene of radiation exposure continuously. We need to
participate actively in surveying this development and in informing the public and the
authorities on radiological problems arising. The ISR will be part of this activity and
in this context greets this IAEA meeting as a much needed one.
POSITION PAPER BY THE INTERNATIONAL SOCIETY
FOR RADIATION ONCOLOGY
H. SVENSSON
Representative of the International Society for Radiation Oncology
E-mail: hans.svensson@radfys.umu.se
I am very happy to be the representative of the International Society for

Radiation Oncology (ISRO). This society is a federation of regional and national
societies. These societies include about 80 000 radiation oncologists, physicists and
related specialists.
I should like to point out that today there are about ten million new cancer cases
per year in the world. The numbers of cases for developed countries are very high at
higher ages, and there are also many cases at somewhat lower ages in developing
countries. This is the present situation which will, however, change substantially.
Indeed, in 15 years time we expect instead, ten million new cancer cases per year in
developing countries, while in developed countries the situation will be much the
same as today. It is obvious that we shall need a lot of resources for the developing
countries in the future.
The incidence of cancer per year in developing countries is about 0.08 to about
0.2% of the population. In some developed countries, up to 0.5% of the population
will be diagnosed with cancer each year — this is a very high figure. You must also
look at prevalence: that is, how many of those that have had the diagnosis ‘cancer’ are
still alive. In some developed countries, up to 3% of the population have had the diag-
nosis ‘cancer’ at some stage in their life. The projected number of new cases in the
year 2000 is five million for developing and five million for developed countries. On
the basis of practices exercised today in many advanced developed countries, it is esti-
mated that 50% of these would need radiotherapy. In some countries, up to 60% of
cancer cases receive at least one course of radiation treatment.
Of course, good quality assurance is a matter of life and death for the patient,
and radiation protection and quality assurance are in many situations much the same
thing. What can the international societies do in this context? We can try to inform
and teach our friends in less developed countries. For this reason, many educational
meetings have been organized by the ISRO. The society tries to hold these meetings
outside developed areas such as Europe and north America, and to convene them in
developing regions of the world, instead. By including experienced teachers from
more developed areas, the society seeks to help those who do not yet have all the
knowledge they need.
97
98 SVENSSON
Finally, I want to corroborate the comment by the President of the Society, who
noted that international meetings help to point out the differences in problems in
various parts of the world, so that both developing and developed countries benefit
from participation in these meetings. I think this is a very important comment. We all
play a role in promoting safe and effective practice.
INTERNATIONAL SOCIETY OF RADIOGRAPHERS
AND RADIOLOGICAL TECHNOLOGISTS AND
RADIATION PROTECTION
A. YULE
President,
International Society of Radiographers and Radiological Technologists
E-mail: sandy.yule@uhw-tr.wales.nhs.uk
The International Society of Radiographers and Radiological Technologists

(ISRRT) is delighted to have been asked to co-operate in this seminar, and I appre-
ciate the opportunity to speak before this audience.
I would like to give you a very brief history and description of the organization
and show how it works to promote radiation protection for both patients and workers.
The ISRRT was formed in 1962 with 15 national societies and by the year 2000
has grown to comprise more than 70 member societies. The main objects of the orga-
nization are to:
— Improve the education of radiographers,

— Support the development of medical radiation technology worldwide,
— Promote a better understanding and implementation of radiation protection
standards.
The ISRRT has been a non-governmental organization in official relations with

the World Health Organization (WHO) since 1967. It is the only international radio-
graphic organization that represents radiation medicine technology and has more than
200 000 members within its 70 member countries.
Representatives of the ISRRT have addressed a number of assemblies
of WHO regional committees on matters relating to radiation protection and
radiation medicine technology. In this way, the expertise of radiographers
worldwide contributes to the establishment of international standards in vital areas
such as
— Quality control,
— Legislation for radiation protection,
— Good practice in radiographic procedures,
— Basic radiological services.
The ISRRT believes that good and consistent standards of practice throughout
the world are essential.
99
100 YULE
To promote these efforts, individual members of the ISRRT act as advisers or

consultants in specific WHO programmes related to radiation protection and in the
production of related educational material.
In 1971, the ISRRT participated in a seminar in Tehran organized jointly by the
WHO and the IAEA. The subject matter of this seminar was the training of radio-
graphers and other technical personnel in the use of ionizing radiation and radionu-
clides. Since that time the ISRRT has been working hard with societies and organi-
zations all over the world to promote the principles of the Tehran document.
The ISRRT is committed to the goals of the WHO and has established its own
working committee to advance these objectives in the speciality of medical radiation
technology. Within Europe, the society actively monitors all directives concerning
radiation protection, and an expert group has been set up in order to provide a rapid
and considered response. These directives are important to the practice of our profes-
sion but, unfortunately, many of them tend to arrive without notice and with little time
left before deadlines for comments. It is obviously important that such documents arrive
in good time if the valuable comments from this working party are to be considered.
— The international society considers that the radiographer or the radiological

technologist is the most important individual within the radiation medicine
team for the implementation of safe radiation protection practice.
It is estimated that more than 90% of ionizing radiation in medicine is applied

by radiographers or radiological technologists. By their expertise, skill and care, they
will determine, within agreed limits, the amount of radiation administered to patients.
The technologists’ prime expertise and responsibility is to undertake the whole
range of techniques in diagnostic imaging and radiation therapy and to subsequently
assess the quality and outcome of the work done.
To ensure that correct examination or treatment is performed effectively and
safely, the technologist must be
— Appropriately qualified,
— Able to communicate with patient and staff,
— Able to correctly position the patient,
— Set the parameters for the source of the radiation and image recording device,
— Use complex equipment safely and correctly,
— Assess the quality of the final image,
— Ensure that the image is delivered quickly to those responsible for the care of
the patient.
As we all know, the use and application of radiation medicine technology dif-
fer greatly all over the world. The ISRRT recognizes these differences, and one of its
ISRRT 101
fundamental aims is to support developing countries by assisting national societies to

formulate and maintain training programmes and continuing educational activities.
Professional organizations that are members of the ISRRT can therefore call on the
full range of education experience and practical expertise of the world’s leading
radiographic societies.
Different countries have different problems. In the majority of cases these pro-
blems can only be solved by those who have the responsibility for the delivery of
medical imaging and radiation therapeutic services in each individual country.
However, the requirement for education, training and continuing education of those
involved in the application of ionizing radiation to people should have high priority
on the agenda of all countries.
To promote these agenda the ISRRT is currently collaborating with the WHO
in the production of training manuals, to be used primarily as education tools for the
training of radiological technologists in developing countries. The first manual which
deals with the important subject of quality assurance should be available for free dis-
tribution by the WHO, by the end of July.
To encourage the exchange of information, the ISRRT organizes international
conferences, seminars and workshops in all regions of the world. In particular, impro-
vement in education is promoted through international teacher seminars being held in
various countries, specifically to further the understanding of the requirements for
radiation protection.
An important area of expertise available from the ISRRT is its close co-opera-
tion with smaller developing countries. As an example, several workshops have been
held for technologists in the African region. These workshops are extremely well
attended, and radiation protection of both patients and staff is given a prominent posi-
tion in these workshops. It is hoped that with the co-operation between the ISRRT and
governments, the number of workshops provided could be increased.
I would like to end by emphasizing that the ISRRT has both the expertise and
the ability to contribute to the improvement of safe radiation practices all over the
world by:
— Promoting awareness of the fact that the largest amount of ionizing radiation
received by individuals for medical purposes is administered by radiographers
or radiological technologists;
— Insisting that all those who apply ionizing radiation to humans should be appro-
priately trained and educated;
— Improving communication between all professionals involved in the delivery of
imaging and therapeutic services worldwide;
— Co-operating fully with the WHO and other international organizations;
— Assisting in the establishment of professional radiographic societies to promote
the development of education and, in particular, radiation protection;
102 YULE
— Promoting and encouraging research in practical areas;

— Developing and co-operating in the production of specialized publications;
— Organizing conferences, seminars and workshops in radiation protection;
— Being prepared to give advice and assistance whenever requested.
PROTECTION OF PATIENTS: POSITION PAPER BY
THE WORLD FEDERATION OF NUCLEAR MEDICINE
AND BIOLOGY
H. AMARAL
President,
E-mail: hamaral@alemana.cl
It is a great honour and a source of satisfaction for me to represent the World

Federation of Nuclear Medicine and Biology (WFNMB), which is an organization
with 60 member countries that are represented by their national nuclear medicine
societies and whose main aim is to promote the correct use of this form of medical
specialization.
I would like to congratulate the organizers of this conference for bringing to the
discussion table a topic of such importance, which unites the main international orga-
nizations and experts in a field that is currently highly sensitive. The radiological pro-
tection of patients has rarely been the focus of such attention as it is on this occasion.
In particular, I would like to thank the IAEA, the World Health Organization
and the Pan American Health Organization, as well as the Spanish authorities and the
European Union, for organizing this extraordinary event.
The world is undoubtedly changing at an unprecedented rate. We can now see
how human activities are pushing our physical and biological environment to the lim-
its of what appears to be tolerable. In the nineteenth century, the great hope for
progress was based on a generalized optimism that science would bring about a grad-
ual improvement in living conditions, and bring us even closer to a kind of paradise
on earth where technological advances would solve all our ills; in the second half of
the twentieth century, this same faith placed more emphasis on politics as the source
of progress for humanity. At the beginning of the new millennium, economic factors
will probably emerge as the dominant force in human development.
Now, at the dawn of the twentyfirst century, we are concerned to see that sci-
ence is losing ground in global decision making processes relating to progress. This
is particularly obvious as regards ionizing radiation. To a large extent, this is due to a
certain degree of public mistrust in technology, possibly owing to irresponsible man-
agement of this precious resource.
We are now living in a world where extreme positions and opposing visions
regarding progress flourish. On the one hand, we find ‘technophile’ movements,
which are based on the belief that humanity can find all it needs for its complete
realization and well-being in scientific and technological development. In opposition
to these groups, so-called ‘technophobe’ movements flourish apace that fanatically
103
104 AMARAL
believe that technology and, by extension, science are the root of all the evil in the
world. These groups attract, in particular, young people and some progressive intel-
lectuals. Everyone is acquainted with these groups. They structure and organize them-
selves as international movements. They can now count on a warm welcome on the
part of many communications media and put their opinions forward with great flu-
ency in the assemblies of many world organizations. Often, science has no place or is
simply not heeded in these fora. Nowadays, we often find important decisions regard-
ing an activity or a region being taken on the basis of somewhat emotional or even
pseudoscientific reactions. In many cases, propaganda, a pamphlet or a protest
demonstration carry more weight than a serious discussion of ideas.
Unfortunately, we must recognize that, as with all human advances, science
offers the hope of well-being and life for many, but it also has many aspects that can
be criticized.
Undoubtedly, science and technology have made great mistakes throughout his-
tory. In the case of nuclear energy, for reasons I will not go into here, we see that all
aspects of the development of this technology are especially vulnerable to public crit-
icism. One only needs to say the word ‘atomic’ or ‘nuclear’ for a significant number
of people to show an immediate negative emotional reaction.
Nuclear energy has benefited humanity tremendously and, provided it is kept
safe, will bring even more benefits in the future, considering its many peaceful uses.
The recent advances in our knowledge of the effects of radiation on biological sys-
tems should substantially enhance the public perception of nuclear energy. The fail-
ure to understand that ionizing radiation is an inherent part of nature gives rise to feel-
ings of anxiety and insecurity. Although ionizing radiation is a known carcinogenic
agent for humans, we now know that it is safe and effective if it is used responsibly.
Over the past fifty years, numerous epidemiological studies have been carried out of
adult human populations exposed to radiation through medicine, their occupation or
in the military, and the lowest radiation dose that has been found to constitute a sta-
tistically significant risk is 100 mSv (10 rem).
Another aspect worthy of note at this conference is the emphasis that has been
given to the relationship between radiation and biomedical research. Scientific
progress is not divorced from the negative phenomena referred to above. Moreover,
since this branch of science is closest to humanity it is probably the one that gener-
ates the largest number of ethical conflicts. Happily, we are now seeing increased
awareness in the design of medical research. It is inconceivable nowadays for a sci-
entific institution not to have an independent ethics committee that approves any
research project involving or affecting human beings at all stages of their develop-
ment. To take one example from the nuclear field: cases such as those that occurred
just a few decades ago, where disabled people, orphans, convicts and old people were
used as research subjects for nutritional studies and studies to evaluate the risk of
exposure to ionizing radiation, would be unthinkable today.
WORLD FEDERATION OF NUCLEAR MEDICINE AND BIOLOGY 105
These factors frequently go beyond the regulations, and we must bear in mind
that the ultimate responsibility for the protection of patients against ionizing radiation
lies with the doctor treating them. The training of professionals is therefore a critical
element in any plan aiming to reduce radiation levels in medical practices.
Medical research must now comply with strict bioethics criteria that are applied
almost universally. Factors such as social value, scientific validity, the risk/benefit
ratio and respect for people participating in research are now indispensable in the
design of any scientific project.
One of the great advances in medicine and medical research has been the accep-
tance that obtaining the informed consent of people participating in the research is an
essential requirement. This also means that we have to make sure that the individuals
understand the aim of the study and are aware of its risks and potential benefits as
well as the existence of possible alternatives. We are thus obliged to respect their free-
dom of choice to participate in, or subject themselves to, a study on an entirely vol-
untary basis, and their complete freedom to leave a study if they so desire.
I would like to take up one final point that relates to the rational use of
resources. Until quite recently, it was thought that any lawfully available technologi-
cal resource could be used, a view that was especially true in relation to medicine.
Nowadays, however, there is a strong trend towards the view that the use of both diag-
nostic and therapeutic techniques must be based on scientific evidence of their use-
fulness. The empirical use of available resources, without some evidence justifying
this use and without a favourable cost–benefit ratio, is no longer accepted as good
practice.
Conferences such as this one are undoubtedly the most serious manner in which
we can tackle these problems, and the conclusions and recommendations we reach
must be widely disseminated in the community. The medical applications of radiation
have the greatest potential for reversing the negative reputation of nuclear energy, and
our institutions and organizations should make every effort to conduct a worldwide
campaign to publicize the ‘good atom’ — a highly beneficial force for humanity when
it is used rationally and safely.
BRIEFING SESSION
Chairperson
H.M. OLERUD
Iceland
THE CURRENT USES OF RADIATION IN MEDICINE
P.C. SHRIMPTON
Chilton, Didcot, United Kingdom
Abstract
Ionizing radiation is firmly established as an essential tool for diagnosis and therapy in
medicine, although patterns of use vary widely around the world. Diagnostic examinations are
conducted mainly with X rays (diagnostic radiology) and less commonly by administering
radiopharmaceuticals to patients (nuclear medicine). Radiotherapy is mostly carried out using
external beams of radiation (teletherapy), although some patients receive direct applications of
sealed radionuclide sources (brachytherapy) or therapeutic administrations of
radiopharmaceuticals. Global data from the United Nations Scientific Committee on the
Effects of Atomic Radiation indicate an annual total of about 2500 million diagnostic
radiological examinations in 1996: 78% involving medical X rays (at a mean rate of 330 per
1000 world population), 21% involving dental X rays (mean rate 90 per 1000) and only 1%
involving nuclear medicine (mean rate 5.6 per 1000). Over 90% of the estimated annual total
of about 5.5 million complete courses of radiation treatment are conducted by teletherapy or
brachytherapy, with mean rates of 0.8 and 0.07 per 1000 world population, respectively;
radiopharmaceuticals are used in only 7% of all treatments (mean rate 0.065 per 1000). Over
three quarters of all diagnostic procedures and over half of all treatments occur in developed
countries, which collectively represent only one quarter of the world population. The general
global trend is for increasing numbers of procedures. The paper discusses the current uses of
radiation in medicine, including diagnostic radiology, diagnostic nuclear medicine and
radiotherapy.
1. INTRODUCTION
Ionizing radiation was first used in medicine at the turn of the 19th century, fol-
lowing the discovery of X rays. Over the last 100 years, radiology has found increas-
ing application in medicine and is today firmly established as an essential tool for
diagnosis and therapy. The overwhelming benefits to patients from properly con-
ducted procedures have fostered the widespread use of medical radiology, although
patterns of use vary significantly around the world.
Medical radiology can broadly be categorized into three general areas of appli-
cation. The most widespread use of radiation remains diagnostic radiology, which
involves imaging with X rays. Diagnostic procedures are also conducted by the
administration to patients of radiopharmaceuticals as biological tracers in the practice
109
110 SHRIMPTON
of nuclear medicine. Finally, radiation is used in a quite different manner in radio-

therapy, where the clinical intention is to deliver cytotoxic levels of dose to well
defined target volumes of the patient to effect treatment.
Global reviews of the use of radiation in medicine have been conducted period-
ically by the United Nations Scientific Committee on the Effects of Atomic Radiation
(UNSCEAR), most recently for the period 1991–1996 in the UNSCEAR 2000 report
[1]. Practice worldwide has been assessed by extrapolation from the limited national
TABLE I. PATTERNS OF PRACTICE WITH X RAYS
1996 [1] 1990 [2]

HCL IIIc
Examination HCL Ia HCL IIb and IVd Worlde World
Per cent contribution to annual total number of medical X ray

examinations
Chest 36 58 19 41 57
Skeleton 32 21 41 29 21
Head 6 4 14 6 4
Abdomen 4 8 7 5 4
GI tract 6 3 10 5 6
CT 6 1 0.4 5 3
Mammography 3 0.4 <0.1 2 1
Angiography and interventional 1 0.2 <0.2 1 0.6
All medical X rays Absolute annual number of examinations (millions)
1410 470 24 1910 1600
Annual frequency of examinations per 1000 population
920 150 20 330 300
All dental X rays Absolute annual number of examinations (millions)
475 42 0.1 520 —
Annual frequency of examinations per 1000 population
310 14 0.2 90 —
aHealth care level I: >1000 physicians per million population (26% of world population).
bHealth care level II: >300–1000 physicians per million population (53% of world population).
cHealth care level III: 100–300 physicians per million population (11% of world population).
dHealth care level IV: <100 physicians per million population (10% of world population).
eWorld population in 1996: 5800 million.
CURRENT USES OF RADIATION IN MEDICINE 111
data available on the basis of a global population model in which countries are strati-
fied into four levels of health care determined by the number of physicians per million
population, as defined in Table I. Results from this analysis by UNSCEAR of global
practice in medical radiology are presented below. These should not, however, be over-
interpreted beyond the significant uncertainties in the reliability and representativeness
of the data presented [1].
2. DIAGNOSTIC RADIOLOGY
Imaging with X rays utilizes a range of techniques. The most well established
and common technique is conventional radiography, in which a static image of the X
ray beam is captured, after transmission through the patient, using a film sandwiched
between intensifying screens in a cassette. Real time imaging is provided by
fluoroscopy, where generally an electronic image intensifier is used to detect the
X ray beam and images are displayed on a TV monitor. This is used, for example, in
studies of the gastrointestinal (GI) tract commonly known as barium meals and bar-
ium enemas, where barium is introduced into the stomach or colon to enhance image
contrast.
In the 1970s, diagnostic radiology was literally revolutionized with the devel-
opment of computed tomography (CT). This utilizes a rotating fan beam of X rays,
a bank of detectors and a computer to reconstruct high quality cross-sectional images
of the patient. Continuing technological developments, such as spiral (or helical)
scanning, multislice scanners and CT fluoroscopy, have improved both the speed and
the quality with which images are obtained and have fuelled a steady growth in CT.
CT represents one of the earliest forms of digital X ray imaging, in which images are
captured and stored in a digital format. More general developments in digital radi-
ology include digital fluorography based on the image intensifier, computed radiog-
raphy (CR) utilizing a special storage phosphor plate and, most recently, active
matrix detectors of amorphous selenium or silicon. Such digital imaging provides
key advantages in the manipulation, storage and transmission of images. For exam-
ple, images taken before and after an intravenous injection of iodine can be sub-
tracted so as to provide a clear image of the blood vessels, known as a digital sub-
traction angiogram.
The advances in imaging and in catheter technology have facilitated the devel-
opment of interventional radiological techniques, in which imaging is used to help
guide therapeutic procedures. For example, angioplasty involves placing and expand-
ing a balloon catheter inside a blood vessel so as to dilate the vessel and improve
blood flow. Interventional radiology continues to evolve, and other commonly used
techniques include embolization, in which blood vessels are occluded, and the place-
ment of catheters to drain abscesses, take biopsy samples and deliver drugs.
112 SHRIMPTON
Diagnostic radiology is in general conducted by doctors and technicians with

specialist training, such as radiologists and radiographers, although circumstances
may vary between different countries, particularly in the developing world. Some
examinations may also be performed by other groups, such as the use of fluoroscopy
in operating theatres by orthopaedic surgeons or interventional procedures conducted,
for example, by cardiologists.
Global practice with X rays is summarized in Table I, together with data con-
cerning regional and temporal trends. The annual number of all types of medical X
ray examination in the world was about 1900 million in 1996, corresponding to an
annual frequency of 330 examinations per 1000 world population. This frequency is
about 10% higher than the previous estimate by UNSCEAR of 300 per 1000 for the
period 1985–1990 [2], so that practice is clearly continuing to expand. It is also evi-
dent that there is a very uneven distribution of examinations between countries, with
much of the world having insufficient access to X ray services. Three quarters of all
examinations occur in the countries of health care level I, which account for only one
quarter of the world population. Only 1% arises from the lower health care levels III
and IV, which include one fifth of the world population. The average frequencies for
the levels vary by a factor of 50, being 920 per 1000 in health care level I and only
20 per 1000 in levels III and IV.
Table I also includes data concerning the relative importance of broad types of
examination. Chest X rays remain the most common procedure, representing about
40% of the total on a global scale. Examinations of the skeleton account for about a
further 30%, while the more complex procedures involving the GI tract and CT each
provide about 5%. There are also contributions of 2% from mammography and about
1% from angiography and interventional procedures.
As well as significant differences in the overall use of X rays between the dif-
ferent health care levels of the global model, the UNSCEAR analysis also reveals
variations in patterns of practice. Table I indicates clear differences in the relative
importance of each type of examination between the levels. In particular, complex
examinations, such as CT, and angiography and interventional procedures, are much
more important in health care level I. This is also the case for mammography, which
in many developed countries is used for population screening for breast cancer.
Moreover, the analyses by UNSCEAR reveal changing patterns of practice with
time. Global practice for 1990 [2] is also summarized in Table I. Apart from an
increase of 10% in the overall worldwide frequency of examinations between 1990
and 1996, particular increases in importance on a global scale are also apparent for
CT, mammography, and angiography and interventional radiology.
In addition to the above medical X ray examinations, X rays are also commonly
used in relation to dental care. Such dental X rays are often conducted by dentists,
working away from hospitals or medical clinics. On a global scale, there are about
500 million dental X ray examinations per year, which corresponds to a frequency of
90 per 1000 world population (Table I). This is just over a quarter of the rate of med-
ical X rays and once again there is a very uneven distribution between countries. Over
90% of all practice arises from the countries in health care level I, where the average
frequency is 310 per 1000 population. At the lowest levels (III and IV), the rate is
lower by a factor of 1500.
3. DIAGNOSTIC NUCLEAR MEDICINE
The second important use of radiation for imaging and diagnosis is in nuclear
medicine. This involves the administration of radionuclides to patients, by injection,
inhalation or ingestion, broadly as a biological tracer technique to study organ or tis-
sue function. Diagnostic nuclear medicine is more about physiology and pathology
than anatomy. The techniques hinge on incorporating a suitable radionuclide into a
pharmaceutical appropriate to the nature of the investigation. In practice a wide range
of pharmaceuticals are used, incorporating more than 20 radionuclides that meet the
necessary requirements for effective and efficient imaging, although 99mTc forms the
basis for over 80% of all radiopharmaceuticals. Iodine-131 is also still widely used in
many countries, particularly in the developing world.
Uptake of the radiopharmaceutical in particular organs, such as the thyroid, can
be measured with a simple radiation detector, whereas imaging is carried out using a
rectilinear scanner or, more commonly, a large field of view gamma camera. In addi-
tion to conventional planar imaging, techniques have also been developed to allow
emission tomography which, rather like X ray CT, provides cross-sectional informa-
tion. These techniques include single photon emission computed tomography
(SPECT) or the specialized technique of positron emission tomography (PET), which
uses short lived biologically active radionuclides, such as 15O, 11C, 18F and 13N.
Global practice in diagnostic nuclear medicine is summarized in Table II,
together with data concerning regional and temporal trends. Such procedures are
much less common than X ray examinations, by about a factor of 60. The annual
global total in 1996 was about 32 million procedures, corresponding to a frequency
of 5.6 per 1000 world population. This estimate is about 25% higher than the fre-
quency for 1990 and indicates quite a considerable expansion in practice. Once again,
procedures are very much concentrated in the developed world, with nearly 90% of
all practice occurring in health care level I, at a rate of 19 per 1000 population. The
mean frequency for the lowest levels (III and IV) is some 100 times lower.
Diagnostic nuclear medicine has applications across a wide range of medical
disciplines, with bone scans for metastases being the most common procedure on a
global scale, followed by thyroid scans and cardiovascular scans (Table II). Patterns
of practice also vary between different countries with, for example, uptake studies and
scans of the thyroid dominating in the lower health care levels. In terms of trends with
114 SHRIMPTON
TABLE II. PATTERNS OF PRACTICE IN DIAGNOSTIC NUCLEAR MEDICINEa
1996 [1] 1990 [2]

HCL III and
Procedure HCL I HCL II World World
IV
Per cent contribution to annual total number of diagnostic nuclear
medicine procedures
Bone 24 21 18 24 29
Thyroid scan 22 27 57 22 11
Cardiovascular 14 15 6 14 15
Liver/spleen 11 8 2 11 8
Lung perfusion 10 2 2 9 12
Brain 7 4 4 7 2
Renal 5 14 7 6 9
Thyroid uptake 5 3 2 5 5
Lung ventilation 2 1 0.1 2 7
All procedures Absolute annual number of procedures (millions)
29 3 0.2 32 24
Annual frequency of procedures per 1000 population
19 1.1 0.2 5.6 4.5
aSee footnotes to Table I for definitions of the UNSCEAR global population model.
time, bone scans, renal scans, and lung perfusion and ventilation studies have all
decreased in relative importance since the previous analysis by UNSCEAR for 1990
[2], whereas there have been relative increases for thyroid, liver/spleen and brain
scans.
4. RADIOTHERAPY
The third general application of radiation in medicine is in radiotherapy, which

is particularly important in the treatment of malignant disease. The clinical intention
may be either to eradicate cancer (curative treatment) or to alleviate symptoms (pal-
liative treatment). Three different treatment modalities are employed.
The principal mode of treatment is teletherapy, in which external beams of radi-
ation are focused onto a target treatment volume. Superficial treatments utilize lower
energy X ray beams or electrons, whereas deep seated tumours are treated with high
energy photon beams from conventional X ray units, linear accelerators (LINACs), or
large sealed radionuclide sources, principally 60Co. Treatments are carefully planned
and delivered, and typically include multiple fields and series of exposures over a
period of time. On a global scale, over a fifth of all teletherapy treatments involve the
breast (21% of the total number), with the next most important broad categories being
lung (17%), followed by head and brain (13%), gynaecological tumours (11%),
prostate (7%), lymphoma (5%) and rectum (4%). Treatments of leukaemia and
benign disease each account for about 3% of the total practice.
The second important treatment modality is brachytherapy, in which an encap-
sulated source, or group of such sources, is positioned on or in the patient by surface,
intracavitary or interstitial application. Sources may be implanted temporarily into
superficial and easily accessible tumours in the form of wires, pellets or needles of
137Cs, 60Co or 192Ir. These may be positioned manually or loaded remotely following
implantation of an applicator. Permanent implants are sometimes used for deep seated
tumours, as grains or sutures incorporating, for example, 198Au, 125I or 103Pd. One of
the most recent developments is endovascular brachytherapy to inhibit restenosis of
blood vessels after angioplasty. Brachytherapy is overwhelmingly used for gynaeco-
logical tumours (75% of all such treatments worldwide), often in combination with
TABLE III. PATTERNS OF PRACTICE IN RADIOTHERAPYa AND RADIO-

NUCLIDE THERAPY
1996 [1] 1990 [2]

HCL III and
HCL I HCL II World World
IV
Annual number of complete courses of treatment (millions)
Teletherapy 2.3 2.1 0.3 4.7 4.9b
Brachytherapy 0.3 0.05 0.02c 0.4 —
Radiopharmaceuticals 0.3 0.1 0.01 0.4 0.2
Annual frequency of treatments per 1000 population
Teletherapy 1.5 0.7 0.3 0.8 0.9b
Brachytherapy 0.2 0.02 0.02 0.07 —
Radiopharmaceuticals 0.2 0.04 0.01 0.065 0.04
aSeefootnotes to Table I for definitions of the UNSCEAR global population model.

bIncludesteletherapy and brachytherapy.
cAssumed value in the absence of full data.
116 SHRIMPTON
TABLE IV. DISTRIBUTION BY AGE OF PATIENTS UNDERGOING MEDICAL

RADIOLOGICAL PROCEDURES [1]
Age distribution (% )
0–15 years 16–40 years >40 years
Medical X rays 11 29 60
Dental X rays 8 47 45
Diagnostic nuclear medicine 5 12 83
Teletherapy 1 11 88
Brachytherapy 0 9 91
Radiopharmaceutical therapy 3 38 59
external beam therapy. In some areas of the world, these treatments are still conducted
for economic reasons using 226Ra sources, with which the technique was first devel-
oped. Brachytherapy is also used to provide a boost in dose in the treatment of breast
cancer (9% of all brachytherapy practice worldwide).
Radionuclide therapy is conducted by the direct administration to patients of
radiopharmaceuticals, generally incorporating medium energy beta emitters, to pro-
vide biological targeting of dose. Such radionuclide therapy is an important treatment
modality for both malignant and benign disease, particularly in relation to the thyroid
and the use of 131I. Treatments of hyperthyroidism account for nearly two thirds of all
practice, with thyroid malignancy providing about a further quarter. Other diseases
treated include bone metastases (4%), synovitis (3%) and polycythaemia vera (1%).
Global practice in radiotherapy and radionuclide therapy is summarized in
Table III. Overall, about 85% of all complete courses of radiotherapy treatment are by
teletherapy, with an annual total of 4.7 million treatments and a corresponding fre-
quency of 0.8 per 1000 world population. Brachytherapy and therapy with radio-
pharamaceuticals each provide about 0.4 million treatments per year. In each case, the
majority of practice arises from countries in health care level I. The combined fre-
quency of teletherapy and brachytherapy, 0.9 per 1000 world population, is about the
same as the estimate for 1990, whereas the figure of 0.07 per 1000 for radiopharma-
ceutical treatments represents an apparent rise of about 60%.
5. PATIENT POPULATIONS
Medical radiological examinations and treatments are distributed unevenly

amongst the population. Representative data for the age distributions of patients
undergoing different applications of radiation in health care level I are summarized in
Table IV [1]. The populations of patients are in general skewed towards older ages,
particularly for radiotherapy. The percentage of patients aged over 40 years is greater
for radiotherapy (teletherapy and brachytherapy) than for either diagnostic nuclear
medicine or X rays, although significant numbers of children do undergo radiologi-
cal procedures, particularly with X rays.
6. RADIOLOGICAL EQUIPMENT
Such widespread practice of medical radiology is underpinned by large

amounts of equipment for imaging and therapy. Worldwide estimates for the numbers
of principal types of equipment are summarized in Table V [1]. These amount broadly
to 1.5 million X ray units, 34 000 CT scanners, 12 000 gamma cameras and 9000 high
energy teletherapy machines, although these numbers are very much concentrated in
the more developed world (countries of health care level I).
7. CONCLUSIONS
Ionizing radiation is widely used in medicine, principally for diagnosis, with an

annual global total of about 2400 million X ray examinations and about 32 million
diagnostic nuclear medicine procedures. Therapeutic uses are also important, but less
common, with a further annual total of about 5.5 million complete courses of radio-
therapy treatment worldwide. There are significant variations in practice between
TABLE V. WORLDWIDE INVENTORY OF RADIOLOGICAL EQUIPMENT

IN 1996 [1]
Unit Thousands Per cent in HCL Ia

X rays Medical X ray 650 69
Dental X ray 850 79
Mammography 38 95
CT 34 79
Diagnostic nuclear medicine Gamma camera 12 92
Rectilinear scanner 2 62
Teletherapy Radionuclide 4 59
LINAC 5 85
aHealthcare level I: countries with >1000 physicians per million population (includes 26% of
world population).
118 SHRIMPTON
countries, with much of the world still having insufficient access to imaging and ther-
apy services. Over three quarters of all diagnostic procedures and over half of all
treatments occur in developed countries (classified in level I of the UNSCEAR global
population model), which collectively represent only one quarter of the world popu-
lation. The overall trends are for increasing numbers of diagnostic and therapeutic
procedures, furthered by continuing developments in technology and evolution in
clinical practices. For X rays, there will be particular growth in importance for com-
plex X ray procedures such as CT. New pharmaceuticals will continue to expand the
role of nuclear medicine, and ageing populations and improved delivery of dose will
lead to increased use of radiotherapy.
REFERENCES
[1] UNITED NATIONS, Sources and Effects of Ionizing Radiation, 2000 Report to the
General Assembly, Scientific Committee on the Effects of Atomic Radiation
[2] UNITED NATIONS, Sources and Effects of Ionizing Radiation, UNSCEAR 1993
Report to the General Assembly, UN, New York (1993).
RADIOLOGICAL RISKS ASSOCIATED WITH THE
VARIOUS USES OF RADIATION IN MEDICINE WITHIN
THE CONTEXT OF THEIR ASSOCIATED BENEFITS
F.A. METTLER
E-mail: fmettler@salud.unm.edu
Abstract
Medical procedures represent the largest source of human-made radiation exposure.
Most radiation sources expose populations to a risk and these persons may receive no benefit
or only an indirect benefit. There are some specific features of medical exposure that make the
benefit/risk assessment different from that for other sources of radiation exposure. In medical
exposure the exposed person is the direct recipient of an intended benefit that can be compared
with the potential risk to that same individual, and the exposure is voluntary. Most radiation
exposures should be limited to doses that are as low as reasonably achievable, but in medicine
the doses must be at least high enough to obtain an image of diagnostic quality or to eradicate
a tumour. The use of very high doses in radiation therapy makes it impossible to make
comparisons using effective dose. The paper addresses the radiation risks from diagnostic
radiology, nuclear medicine and radiotherapy; discusses the determinants of radiation risk, the
measures of benefit and the factors affecting the balance between benefit and risk; and reviews
the application of the radiation protection philosophy to medical exposure.
1. INTRODUCTION
Medical procedures represent the largest source of human-made radiation expo-

sure. UNSCEAR 2000 [1] has estimated that the worldwide annual per caput effec-
tive dose from diagnostic medical examinations is 0.4 mSv, and the dose from natural
background is 2.4 mSv. These values can be compared with 0.005 mSv from atmos-
pheric nuclear testing, 0.002 mSv from the Chernobyl accident and 0.0002 mSv from
nuclear power production.
It has always been difficult to treat medical exposure in a manner similar to
exposure from other radiation sources, for several reasons. Most radiation sources
expose populations to a risk, and these persons may receive no benefit or only an indi-
rect benefit. In medical exposure the exposed person is the direct recipient of an
intended benefit that can be compared with the potential risk to that same individual,
and the exposure is voluntary. Medical exposure is also limited to specific body parts
or is very inhomogeneous in distribution. Most radiation exposures should be limited
to doses that are as low as reasonably achievable, but in medicine the doses must be
119
120 METTLER
high enough to obtain an image of diagnostic quality or to eradicate a tumour. The use
of very high doses in radiation therapy makes it impossible to make comparisons
using effective dose.
2. BENEFIT AND RISK
There are a wide variety of terms used to estimate the value of a particular
action. A commonly used method is assessment of the benefit versus the risk. To
begin the process one must determine who the recipients of the benefit actually are.
Is it society as a whole, a group of persons or an individual? The definitions of benefit
and risk are also sometimes difficult to agree upon. Benefit is defined as an advantage
or useful aid. In medical situations it may apply to a wide variety of factors such as
making an accurate diagnosis, improving life span, improving psychological well
being or improving quality of life.
Definition of risk is also not simple. Risk usually means a possibility of danger
or the potential for an undesirable event. The probability of such events often can be
measured and quantified by scientific studies [2, 3]. Risk is not the only issue that
should be considered in such analyses. Monetary cost is an example of another factor
to be considered.
3. WHAT ARE THE RADIATION RISKS?
Adverse radiation effects are usually divided into two categories: stochastic and
deterministic effects. Stochastic effects most commonly refer to the radiation
induction of neoplasms or hereditary effects. These effects are due to unrepaired or
misrepaired DNA damage. The probability of incurring these effects is a direct
function of dose and there is no known threshold below which these effects do not
occur. However, at low doses the probability of the effects may be so small as to be
impossible to find using epidemiological or population studies. The severity of
stochastic effects is dose independent. Epidemiological studies have shown that the
mean latent period, the time from exposure to clinical appearance, is 7–10 years for
leukaemia and about 20 years for solid tumours [1, 4].
Deterministic effects are mostly due to cell killing. If only a few cells in a given
tissue are killed, no effect will be apparent. If enough cells are killed, there will be an
obvious clinical effect. An example of a deterministic effect is skin necrosis. Thus for
deterministic effects there is a threshold below which the clinical effect will not be
apparent, and the severity of a deterministic effect is a direct function of dose.
The title of this paper broadly refers to radiation risks associated with the
practice of medicine. Obviously there are potential risks to the patient, medical staff,
RADIOLOGICAL RISKS AND BENEFITS OF RADIATION IN MEDICINE 121
families and possibly the public. In the context of this conference, this paper deals
with the risks to the patient only.
4. WHAT ARE THE RADIATION RISKS FROM VARIOUS PRACTICES?
4.1. Diagnostic radiology
Diagnostic radiology includes plain film radiography and mammography,

which have organ doses in the range 1–20 mGy. It also includes computed tomo-
graphy, which gives organ doses in the range 10–100 mGy. In all these cases the risks
are relatively small and are predominantly from tumour induction.
Diagnostic radiology also includes the use of fluoroscopic machines. These
machines produce dose rates of 0.02 Gy/min in normal mode but can produce
0.2 Gy/min in high dose rate mode. Use of these machines in high dose rate mode for
30–100 min can result in deterministic injuries to the skin (including ulceration). It
should be pointed out here that one typically thinks of diagnostic radiology as being
performed only by radiologists. However, fluoroscopic machines are often used by
cardiologists, pulmonologists, gasteroenterologists and orthopaedic surgeons, who
have little or no knowledge regarding radiation risks and effects.
4.2. Nuclear medicine
Risks as a result of diagnostic nuclear medicine examinations are related to

potential late induction of tumours. Risks from the use of unsealed radionuclides as a
therapeutic modality are specific to deterministic effects in the tissues where the
radiopharmaceuticals accumulate. Examples are bone marrow depression from treat-
ment of diffuse metastases with 89Sr or radiation parotitis as a result of 131I therapy
for thyroid cancer.
4.3. External radiotherapy and brachytherapy
Radiotherapy has been predominantly used to treat malignancies but it also is

occasionally used to treat benign diseases. Adverse effects from radiotherapy can
occur both early and late as a result of deterministic effects. As a result of extensive
clinical experience, radiotherapists have constructed tables of the tolerance dose of
different tissues. They also have experience regarding what dose is required for
disease control. Combining these two parameters results in a prescribed dose and
treatment schedule. The prescribed dose is usually in a fairly narrow range since
normal tissue tolerance and cancer radiosensitivity are not very different. Doses less
than the correct prescribed dose will result in few complications but also few cures.
122 METTLER
Higher doses will result in an unacceptably high rate of severe complications. In

addition to adverse deterministic effects, if the patients survive more than several
years, there is an increased risk of radiogenic tumours in and around the treatment
area.
5. WHAT ARE THE DETERMINANTS OF RADIATION RISK?
The most obvious factor affecting risk of radiation effects is absorbed dose. The
higher the dose, the higher will be the probability of stochastic effects and the more
severe will be the deterministic effects. Dose rate also plays a role. As the absorbed
dose is spread out in time, the tissues have more chance to repair themselves and the
effect will be less. Dose rates in diagnostic radiology are relatively high and there is
little opportunity to reduce risk by reducing dose rate. In radiotherapy, doses are usu-
ally protracted or fractionated, allowing the use of higher doses.
Radiation risks are significantly affected by patient age. Risks usually are
higher the younger the age at exposure. For reasons that are incompletely understood,
for a given absorbed dose, infants and children are at about a 2–4 fold higher risk for
radiation induced tumours than are adults. This has been well documented for both
breast and thyroid cancer. The latent period also plays a role relative to risk varying
with age. Obviously, if solid tumours have a mean latent period of 20 years between
irradiation and clinical presentation, radiation induced neoplasms are not likely to be
expressed in persons who are 60–80 years of age at exposure.
The body part irradiated plays a major role in radiation risk for both
stochastic and deterministic effects. There is only a risk to that tissue which is
irradiated. A CT scan of the head or pelvis will pose no risk in terms of radiation
induced lung cancer or breast cancer. Deterministic effects also occur only in those
tissues directly irradiated. The clinical impact will be completely different if
radiosensitive tissues such as lung and spinal cord are in the field than in the case
where the same dose is applied to a body part that is relatively radioresistant (such
as an extremity).
There is a possibility of increased risk from medical exposure to persons who
are genetically susceptible to cancer as a result of a variety of conditions. Overall, this
issue does not appear to be a problem in most diagnostic radiology or nuclear
medicine. It can be a problem in those patients receiving radiotherapy or who have
experienced high exposures from prolonged fluoroscopy [5].
While this discussion is focused on radiation risks, one should not lose sight of
the fact that there are non-radiation risks or costs associated with medical tests and
therapy. There are monetary, logistical and psychological problems associated with
false positive and false negative results of medical tests [6, 7]. There are also well
documented reactions to intravenous contrast used for certain procedures. Finally,
there may be significant negative ramifications associated with not having a certain
diagnostic test or refusing a certain therapy.
6. WHAT ARE THE MEASURES OF BENEFIT?
In order to balance benefit and risk from medical radiation we must also define
benefit and review the contributing factors. It will soon become clear that assessment
of benefit is much more difficult than determining radiation risk.
For diagnostic radiology and nuclear medicine one can examine the broad
category of ‘efficacy’. A number of authors have attempted to grapple with this pro-
blem with various degrees of success [8]. A first level of efficacy is related to technical
factors and image quality. This would include such parameters as resolution or image
sharpness. A second level of efficacy is related to the sensitivity, specificity and
accuracy of an examination test or procedure. Evaluation of data accumulated relative
to a specific test is a complex process since it depends on the population that was
examined, the prevalence of disease, the type of disease and a number of other factors.
A third level of efficacy relates to whether the test actually was helpful in
making the diagnosis or changed the diagnosis. As one might suspect, simply having
made a diagnosis with a certain test does not help the patient much if there was no
change in planned therapy or if the therapy was ineffective [9, 10]. Some measures of
benefit in outcome may be reduced morbidity and mortality or improved quality of
life [11, 12]. Some authors use an additional term of societal efficacy, which relates
to cost effectiveness as judged from a societal viewpoint.
7. WHAT AFFECTS THE BENEFIT/RISK BALANCE?
There are a number of factors that affect the benefit/risk balance. Some of these
are general and some are specific to an individual patient.
7.1. General factors
Change in the natural history of the disease (prevalence/incidence) can affect

the benefit/risk balance. Certain screening and clinical practices are based upon how
likely the disease is to be present in the population. Obviously there is little need to
perform screening for tuberculosis in countries where it is extremely uncommon. An
outbreak of tuberculosis, however, might justify the reinstitution of screening proce-
dures. In a similar fashion, screening may reflect the fact that certain diseases occur
more frequently in specific populations; for example, screening for gastric cancer is
practised in Japan but not in the USA.
124 METTLER
7.1.1. Resources
Lack of resources in terms of equipment, supplies and trained staff all will limit
the potential benefit available to a population. On a simplistic basis one might
suppose that the more resources available the better the benefit/risk ratio would be.
7.1.2. Education
Education of the patient, physicians and technical staff should always improve
the benefit/risk ratio. Examples include knowing which study is appropriate, what
advanced techniques will improve cures in radiotherapy, or technicians simply
knowing enough to collimate the radiation beam and select appropriate technical
factors. Lack of education in radiation effects has recently surfaced as a major issue
in the occurrence of radiation injury from interventional procedures.
7.1.3. Regulations
It may not be intuitively obvious how regulations can play a role in changing
the benefit/risk ratio, but the experience regarding use of mammography in the USA
can be illustrative. United States federal regulations require evaluation of dosimetry,
image quality, physician experience and even continuing medical education. Recent
programmes have shown that as a result of the regulations, image quality has
significantly improved and dose has been reduced.
7.1.4. Technology
Even though there are clear relationships between the availability of equipment
and potential benefit, even with a specific level of resources there can be differences
in equipment that provide better images or less radiation exposure. Examples of this
may be the availability of fast screens and film. One should not surmise that newer
technology always improves the benefit/risk ratio. Use of digital imaging techniques
often results in a higher absorbed dose to the patient without a clear improvement in
disease outcome. There are also simple technologies (such as shielding) that can
sometimes be used to reduce the risk without interfering with diagnostic quality.
7.2. Patient specific factors
7.2.1. Patient age
As we have seen, risk changes with age at exposure. The benefit also changes
with patient age but in a much more complex way depending upon the disease. In
mammography screening the radiation risk decreases with age but the disease
incidence increases with age, and the breast parenchyma becomes less dense, making
lesions more conspicuous [13–15]. All these factors tilt the balance greatly towards
the benefit side with increasing age. With other diseases the balance may shift in the
other direction, particularly for diseases that predominantly occur in children or
adolescents.
7.2.2. Risk factors
Clearly any patient with a known set of risk factors should receive more benefit
from an appropriate test. For example, a person with hypertension and hypercholes-
terolaemia and who is a smoker is likely to obtain more benefit from a nuclear
medicine myocardial perfusion scan than a person without such risk factors.
7.2.3. Stage of the disease in an individual
A chest radiograph may be valuable in the initial assessment of a patient with

lung cancer but in a terminal patient there is usually little value in monitoring the
growth of a tumour or metastases. There are also similar differences in the use of
radiotherapy relative to the stage of the disease. Curative treatment of cervical cancer
in possible with localized disease but with widespread disease the treatment would be
only palliative or perhaps not even indicated.
8. RADIATION PROTECTION PHILOSOPHY APPLIED TO MEDICAL

PRACTICE
Most practising physicians have minimal knowledge of either radiation effects

or radiation safety and often have little interest in these subjects. It is important to
provide radiation protection and safety without unduly burdening physicians or
restricting the benefits of medical radiation exposure. Any radiation protection
philosophy that does not take into account the real world of clinical practice is
doomed to failure [16].
The current philosophy of the International Commission on Radiological
Protection (ICRP) relative to medical practice is that any use of radiation should be
justified [17]. A simple example of this would be the question, “Does mammography
find more tumours than it causes?” [18]. Even if scientific studies show this to be true
for a given population, it still does not mean the test is right for everybody. There
needs to be individual justification. This is normal procedure for physicians. They do
not routinely order mammograms for young women but rather for older women or for
high risk women who are more likely to benefit from the procedure. Individual
126 METTLER
justification takes into account many of the patient specific factors mentioned in
Section 7.2.
After there has been justification, it is important to optimize the procedure. In
radiography this means using as low a dose as reasonable to obtain an image of
diagnostic quality. In nuclear medicine it may mean adjusting administered activity in
nuclear medicine to body size, and in radiotherapy it may mean using conformal
techniques.
Recently there has been discussion about the concept of controllable dose and
whether a radiation protection philosophy can be developed on this basis. Whether
such a philosophy could be practically applied to medical exposure remains to be
seen.
9. SUMMARY
In some instances it is clear that a certain test or therapy is ineffective or unnec-

essary. Unfortunately, even though there are tens of thousands of articles published in
the medical literature each year and there is a push for evidence based medicine, there
is very little literature to provide the physician with concrete information or data that
can be applied to the individual patient situations encountered each day [19, 20]. A
number of organizations [21, 22] have provided appropriateness guidelines based on
a review of the literature and using a Delphi method for obtaining consensus by a
panel of experts. It is not clear that such efforts have had a significant impact on
medical practice, much less on patient outcome. Ever changing technology and the
market place rather than a true analysis of the benefit/risk ratio predominantly drive
the uses of radiation in medicine. The practice of medicine remains largely an art and
less an evidence based science.
REFERENCES
[2] SLOVIC, P., Perception of risk, Science 236 (1987) 280–285.
[3] NATIONAL RESEARCH COUNCIL, Improving Risk Communication, National
Academy Press, Washington, DC (1989).
[4] METTLER, F.A., UPTON, A.C., Medical Effects of Ionizing Radiation, 2nd edn,
Saunders Publishing, Philadelphia, PA (1996).
[5] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Genetic
Susceptibility to Cancer, Publication 79, Pergamon Press, Oxford and New York (1998).
[6] RIMER, B.K., BLUMAN, L.G., The psychosocial consequences of mammography,

J. Natl. Cancer Inst. Monogr. 22 (1997) 131–138.
[7] LERMAN, C.E., RIMER, B.K., Psychosocial impact of cancer screening, Oncology 7 4
(1993) 67–72.
[8] NATIONAL COUNCIL ON RADIATION PROTECTION AND MEASUREMENTS,
An Introduction to Efficacy in Diagnostic Radiology and Nuclear Medicine
(Justification of Medical Radiation Exposure), Commentary No. 13, NCRP, Bethesda,
MD (1995).
[9] Guide to Clinical Preventive Services, Report of the U.S. Preventive Services Task
Force, 2nd edn, Lippincott Williams & Wilkins, Baltimore, MD (1996).
[10] BLACK, W.C., WELCH, H.G., Screening for disease (review article), Am.
J. Roentgenol. 168 (1997) 3–11.
[11] FRAZIER, A.L., COLODITZ, G.A., FUCHS, C.S., KUNTZ, K.M., Cost-effectiveness
of screening for colorectal cancer in the general population, J. Am. Med. Assoc. 284
(2000) 1954–1961.
[12] NATIONAL CANCER INSTITUTE, PDQ, Screening and Prevention (1999), http://
cancernet.nci.nih.gov/pdqfull.htm.
[13] HARRIS, R., Variation of the benefits and harms of breast cancer screening with age,
[14] FLETCHER, S.W., Breast cancer screening among women in their forties: An overview,
[15] FEIG, S.A., HENDRICK, R.E., Radiation risk from screening mammography of women
aged 40–49 years, J. Natl. Cancer Inst. Monogr. 22 (1997) 119–124.
[16] FRIEDELL, H.L., Radiation Protection — Concepts and Trade-Offs, Lauriston
S. Taylor Lecture Series in Radiation Protection and Measurements, Lecture No. 3,
National Council on Radiation Protection and Measurements, Washington, DC (1979).
[17] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION,
Radiological Protection and Safety in Medicine, Publication 73, Pergamon Press,
Oxford and New York (1996).
[18] METTLER, F.A., et al., Benefits versus risks from mammography: A critical
reappraisal, Cancer 77 (1996) 903–909.
[19] SAENGER, E.L., Ethics, Trade-Offs and Medical Radiation, Lauriston S. Taylor
Lecture Series in Radiation Protection and Measurements, Lecture No. 6, National
Council on Radiation Protection and Measurements, Washington, DC (1982).
[20] WEBSTER, E.W., Dose and Risk in Diagnostic Radiology: How Big? How Little?,
Lauriston S. Taylor Lecture Series in Radiation Protection and Measurements, Lecture
No. 16, National Council on Radiation Protection and Measurements, Washington, DC
(1992).
[21] ROYAL COLLEGE OF RADIOLOGY, Making the Best Use of a Department of
Clinical Radiology, Guidelines for Doctors, 4th edn, Royal College of Radiologists,
London (1998).
[22] AMERICAN COLLEGE OF RADIOLOGY, Appropriateness Criteria, American
College of Radiology, Reston, VA (1996).
CURRENT LEVEL OF RADIATION DOSE TO PATIENTS
A. SERVOMAA
STUK — Radiation and Nuclear Safety Authority,
Helsinki, Finland
E-mail: antti.servomaa@stuk.fi
Abstract
Assessment and optimization of the radiation dose received by patients in diagnostic and
interventional radiological procedures are important tasks in radiological protection. The
United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) collects
global data on all significant sources of ionizing radiation. The published reports of UNSCEAR
also contain views and trends concerning both the use of ionizing radiation in medical
radiology and radiation doses to patients. The IAEA, jointly with other international
organizations, has issued general requirements and specific guidance levels pertaining to dose
and dose rate for radiological examinations. The European Medical Exposure Directive
(97/43/Euratom) sets requirements for regular follow-up of radiation doses to patients and for
comparisons with national reference dose levels. The European Commission has issued
guidelines and quality criteria with reference dose recommendations for various types of X ray
examinations for adult and paediatric patients. The review paper deals with the current level of
radiation doses to patients in X ray examinations.
1. INTRODUCTION
The United Nations Scientific Committee on the Effects of Atomic Radiation

(UNSCEAR) has collected and published data on the medical use of radiation since
its foundation in 1955. The latest report was issued in 2000 [1], the previous one in
1993 [2]. The UNSCEAR Survey of Medical Radiation Usage and Exposures
(1991–1996), supplemented by an extensive literature review, has improved the esti-
mates as to worldwide medical use of radiation and patient doses. Among the world’s
population, medical exposures constitute the greatest share of human-made radiation
exposures per capita. The collective effective dose from diagnostic X ray examina-
tions is estimated to account for more than 90% of the dose from all diagnostic med-
ical examinations.
Together with the Food and Agriculture Organization of the United Nations
(FAO), the International Labour Organisation (ILO), the OECD Nuclear Energy
Agency (NEA/OECD), the Pan American Health Organization (PAHO) and the
World Health Organization (WHO), in 1996 the IAEA issued the International Basic
Safety Standards for Protection against Ionizing Radiation and for the Safety of
Radiation Sources [3]. This set of safety standards includes radiological protection
129
130 SERVOMAA
requirements for the medical use of radiation and guidance levels concerning dose
and dose rate for various X ray examinations.
The Council of the European Union has adopted the Medical Exposure
Directive (97/43/Euratom of 30 June 1997) concerning the medical use of radiation
[4]. The Member States of the European Union were obligated to implement the
directive in their respective national regulations by 13 May 2000. The directive intro-
duces the concept of diagnostic reference levels (DRLs) as a tool for optimization and
quality assurance, requiring regular assessment of patient doses and comparison with
the reference dose levels. Special attention is focused on paediatric diagnostic exam-
inations, health screening programmes and high dose procedures.
The European Commission has financed several radiological projects in the
framework research programmes, has established and financed working groups for
setting up European guidelines on quality criteria for various X ray examinations
[5–7], and has organized European meetings for patient dose estimation [8–10].
Reference dose values have been incorporated into the European guidelines on qual-
ity criteria for diagnostic radiographic images of adult [5] and paediatric [6] patients
and for computed tomography (CT) [7], and are being developed for paediatric
fluoroscopy and CT [11]. In Europe, national and regional surveys on patient doses
originating from X ray examinations have shown wide variations in doses between
hospitals, and have demonstrated the need for quantitative guidance on patient
exposure [12–14].
Generally recommended measurable dose quantities are the entrance surface
dose (ESD) for individual radiographic projections and the dose–area product (DAP)
for complete X ray examinations. The ESD can be directly measured with thermolu-
minescence dosimeters (TLDs), or it can be estimated on the basis of measured
radiation output values for the X ray tube. The total DAP from a complete examina-
tion, even when it involves both fluoroscopy and radiography, can be measured with
a DAP meter and then compared directly against an appropriate reference level. Since
dose is critically dependent on patient size, it is recommended that measurements
should be made for a representative sample of standard sized patients. The average
dose of such a sample for each particular type of radiograph or examination would
provide a good indication of the typical clinical practice in each room of an X ray
department. The average doses should also be compared against national reference
doses, in order to assess local performance.
The ESD and the DAP are directly measurable quantities. They can be used for
comparison against reference levels and for other quality assurance purposes, but they
are not directly risk related quantities. Effective doses are needed in order to assess
the population’s collective effective dose arising from the medical use of radiation.
Organ doses and/or the effective dose cannot be measured but can be estimated on the
basis of measured ESD or DAP values. Tables of coefficients and computer programs
are available for such calculations for adult and paediatric patients [15–17].
CURRENT LEVEL OF RADIATION DOSE TO PATIENTS 131
2. WORLDWIDE TRENDS IN RADIATION DOSES TO PATIENTS

IN X RAY EXAMINATIONS
In the UNSCEAR 2000 report [1], the global model developed in the earlier
reports [2] was applied to extrapolate the information on national practices received
from a sample of countries in order to obtain worldwide assessments of global prac-
tices, even though the calculated results may involve significant uncertainties. The
mean annual effective dose per capita varies significantly between the four health care
levels defined in the global model, reflecting large differences in examination
frequencies between the four levels. In the first-level countries, the mean annual
effective dose per capita is 1.2 mSv from medical X ray examinations and 0.08 mSv
from nuclear medicine procedures. In the second-level countries, the dose per capita
is 0.14 mSv from X ray examinations and 0.008 mSv from nuclear medicine.
Head
Chest radiography
Abdomen
Pelvis and hip
Average eff. dose
Thoracic spine
Lumbar spine
Upper GI tract
Urography
Lower GI tract
CT
Angiography
Interventional proc.
0 5 10 15 20 25
Effective dose (mSv)
FIG. 1. Effective doses from diagnostic X ray examinations and interventional procedures in
health care level I (1991–1996) ([1], from Table 30).
132 SERVOMAA
Head
Cervical spine
Limbs and joints
Mammography
Thoracic spine
Abdomen
Pelvis and hip
Chest radiography
Urography
Interventional proc.
Lower GI tract
Angiography
Lumbar spine
Upper GI tract
CT
0 10 20 30 40 50
Fraction (%) of collective dose
FIG. 2. Contribution to collective dose from various types of diagnostic X ray examinations in
health care level I (1991–1996) ([1], from Table 31).
Figure 1 shows the mean effective doses for some examination types, and
Fig. 2 the relative contributions to the total collective dose derived from all diagnos-
tic X ray examinations, as reported in the UNSCEAR 2000 report [1] for the first
health care level in 1991–1996. The effective doses are the highest in the interven-
tional procedures, angiography and CT. The differences between Figs 1 and 2 result
from the different examination frequencies employed. For example, CT accounts for
about 6% of the total frequency of all X ray examinations and for about 40% of the
collective effective dose. In interventional procedures and angiography, the average
effective doses per examination are higher than in CT but, owing to their low fre-
quencies, the percentage contributions to the collective dose are only about 5–7%. As
an example of a low effective dose, chest radiography accounts for about 30% of the
total frequency but for only about 3% of the collective effective dose from all X ray
examinations.
Chest
Head
CT
Mammography
Abdomen
Pelvis and hip

1991-1996
Lumbar spine
1980-1990
Urography 1970-1979
Upper GI tract
Angiography
Lower GI tract
0 5 10 15
Effective dose (mSv)
FIG. 3. Trends in average effective doses from diagnostic X ray examinations in health care
level I (1991–1996) ([1], from Table 35).
Figure 3 shows some temporal trends in the mean effective doses from diag-
nostic X ray examinations. In most examinations, the doses decreased from the 1970s
to the 1980s. From the 1980s to the 1990s, the doses decreased for some examina-
tions but increased clearly for some others, especially CT examinations.
3. RADIATION DOSES TO PATIENTS FROM X RAY EXAMINATIONS IN

VARIOUS COUNTRIES
In the UNSCEAR Survey of Medical Radiation Usage and Exposures, the mean
patient doses vary, on relatively wide scales, between countries. Table I presents the
mean ESDs and DAPs for radiographic examinations in countries of the first health
care level. The mean DAPs for fluoroscopic examinations are given in Table II.
Table III shows the average effective doses to patients undergoing some com-
mon types of diagnostic X ray procedures in various countries. These mean values
(per examination) are independent of examination frequencies, and thus reflect the
134 SERVOMAA
examination methods and techniques. The mean values per capita, as well as the col-
lective doses, are also proportional to the frequencies. Table IV shows, for all diag-
nostic X ray examinations combined, the mean effective dose per examination and the
mean annual effective dose per capita in countries of the first health care level. In the
various countries the effective dose per examination ranges from 0.5 to 1.5 mSv, and
the annual effective dose per capita from 0.45 to 1.9 mSv. In countries of other health
care levels the annual effective dose per capita is much lower.
The DAPs of five X ray examination types were measured in a regional Nordic
study conducted at several hospitals in each of the Nordic countries [12, 13]. Table V
TABLE I. PATIENT DOSES FROM DIAGNOSTIC RADIOGRAPHIC EXAMI-

NATIONS (PROJECTIONS) IN VARIOUS COUNTRIES
(data from UNSCEAR Survey of Medical Radiation Usage and Exposures in Health
Care Level I ([1], from Table 16))
TABLE I(a). ESD (mGy)
Skull Chest TH spine LS spine Abdomen Pelvis

AP/PA LAT PA LAT AP LAT AP LAT AP AP
Australia 1.9 1.2 0.12 0.63 6.1 15.1 4.2 3.9
Canada 0.68 0.11 1.82 3.34 2.35
Finland 3.4 1.9 0.24 0.73 4.9 11.6 8.8 18.2 7.1 6.2
Greece 3.5 2.7 0.69 2.9 8.3 10.9 18.9 44.9 11.2 12.5
Lithuania 2.1 2.7 0.81 1.4 22.8 35.5 20.4 21.4
New Zealand 3.0 1.56 0.22 1.24 4.32 13.3 5.47 18.9 4.57 3.98
Poland 0.20 0.88 5.1 8.3 7.5 12.0 4.7 2.5
UK 3.0 1.5 0.16 0.57 4.7 13.0 6.1 16.0 5.6 4.4
TABLE I(b). DAP (Gy•cm2)
Skull Chest TH spine LS spine Abdomen Pelvis

AP/PA LAT PA LAT AP LAT AP LAT AP AP
Finland 1.6 0.44 4.1 8.3 6.9 3.8
Germany 1.07 1.37 3.51 9.32 3.62 3.62
New Zealand 0.96 0.57 0.17 0.62 1.54 3.53 1.88 3.92 2.67 2.37
Norway 0.64 7.6 3.5
Notes: AP: antero-posterior; LAT: lateral; LS spine: lumbo-sacral spine; PA: posterio-anterior;
TH spine: thoracic spine.
TABLE II. MEAN DAP (Gy•cm2) IN DIAGNOSTIC FLUOROSCOPIC EXAMI-

NATIONS IN VARIOUS COUNTRIES
(data from UNSCEAR Survey of Medical Radiation Usage and Exposures in Health
Care Level I ([1], from Table 16))
Upper GI tract Lower GI tract Urography ERCP

Urography ERCP
Swallow Meal Enema
Germany 13.1 35.9 61.5 20.3 33.7
Iceland 43.6–7.4
Norway 7.41 24.8 49.1 18.1 31.8
Switzerland 13.5 68.5 37.1
UK 9.3 13.0 25.8 13.4
Note: ERCP: endoscopic retrograde cholangiopancreatography.
shows the mean DAP values, ranges, medians, third quartiles and Nordic Guidance
Levels for the DAP for complete examinations. The results show that the examination
techniques are rather similar in the five countries. There are large variations between
hospitals, but the differences in the national mean DAP values between the Nordic
countries are much smaller than the variations within each country.
In the United Kingdom, the National Radiological Protection Board (NRPB)
and the X ray departments have performed very extensive measurements of doses to
patients [14, 15]. The 1995 review included the results of 21 000 ESD evaluations and
31 000 DAP measurements from 25% of all UK hospitals. Tables VI(a) and VI(b)
show the summaries of the mean ESD per room for radiographic projections, and of
the mean DAP per room for complete examinations for adult patients in 1988–1995.
Typically, 30–40% reductions from the earlier survey were reported in the mean doses
for common types of radiographic examinations. Less than 10% of the hospitals
exceeded the national reference doses for common X ray procedures, compared with
25% in 1983–1985.
4. PAEDIATRIC RADIOLOGY
The European Commission has organized several working groups for studying
radiation doses to paediatric patients. Table VII shows the summary of ESD mea-
surements from surveys of paediatric radiography in Europe [1]. Cook et al. reported
reduced doses in paediatric radiography when attention was paid to good techniques
[18]. The doses were remarkably lower than the measured doses shown in Table VII.
This indicates that patient doses in paediatric X ray examinations can be reduced
136 SERVOMAA
TABLE III. AVERAGE EFFECTIVE DOSE PER PROCEDURE (mSv) TO

PATIENTS UNDERGOING SOME COMMON TYPES OF DIAGNOSTIC
MEDICAL X RAY PROCEDURES (1991–1996)
(data from UNSCEAR Survey of Medical Radiation Usage and Exposures in Health Care
Level I ([1], from Table 15))
AU FIN GER JPN NL N P SE SUI UK Av.

Chest radiography 0.02 0.1 0.3 0.057 0.06 0.13 0.11 0.15 0.1 0.02 0.14
Chest fluorography 0.053 0.23 0.82 0.5 0.65
Limbs and joints 0.06 0.02 0.1 0.05 0.06
Lumbar spine 2 2.3 2 1.45 2 1.1 4.33 3 1.5 1.3 1.8
Thoracic spine 1 0.7 0.65 1 0.5 3.03 1 0.8 0.7 1.4
Cervical spine 0.2 0.2 0.26 1 0.2 0.2 0.2 0.27
Pelvis and hips 0.6 1.3 0.8 0.58 1 0.5 0.61 1.5 1 0.7 0.83
Head 0.1 0.03 0.09 0.1 0.2 0.1 0.1 0.1 0.04 0.07
Abdomen 1 2.2 1.2 0.24 1 1 2.2 2.5 0.5 0.7 0.53
GI tract (upper) 9 8.3 3.33 6.4 4 14 3 5 2.6 3.6
GI tract (lower) 9.7 17.7 2.68 4.7 8 22.7 8 5 7.2 6.4
Cholecystography 7.1 0.88 6 8 2.3
Urography 4.5 4.9 2.47 4 2 3.1 5 4 2.4 3.7
Mammography,
screening 0.1 0.1 0.1 0.06 0.07
Mammography,
clinical 0.2 0.1 0.12 0.2 0.21
CT, head 2.6 1.3 2.6 1.7 2 2 2 2 2.3
CT, body 10.6 7.9 15.4 10.2 10 10 5 9 13.3
Angiography,
cerebral 1 2 2.0
Angiography,
cardiac 14.8 5.56 5 12 10 7.3
PTCA 23 5 7 22 10 22
Notes: AU: Australia; FIN: Finland; GER: Germany; JPN: Japan; NL: Netherlands; N:
Norway; P: Poland; SE: Sweden; SUI: Switzerland; UK: United Kingdom; Av.: average of
health care level I; PTCA: percutaneous transluminal coronary angioplasty.
considerably. The potential reduction in the doses to infants is about 75%. The dif-
ference is smaller in the groups of five-year-olds and ten-year-olds.
The optimization of paediatric fluoroscopic examination techniques was stud-
ied in four hospitals in Finland, in one hospital in Germany and in one hospital in the
UK [19] by measuring the detectability of iodine contrast material details in fluoro-
scopic images of phantoms of various sizes. It was found that, without impairing
image quality, the doses could be reduced, on average, by 35%. The image quality and
TABLE IV. MEAN EFFECTIVE DOSES (mSv) FROM ALL

DIAGNOSTIC X RAY EXAMINATIONS COMBINED
([1], from Table 29)
Effective dose Annual effective dose

per examination per capita
Australia 1.3 0.8
Canada 1.05 0.94
Denmark 0.7 0.36
Finland 0.63 0.45
France 1.0
Germany 1.5 1.9
Netherlands 1.0 0.6
Poland 1.2 0.8
Sweden 1.2 0.68
USA 0.5 0.5
radiation dose levels at the Finnish hospitals were much higher than at the reference
hospitals. Reduction of the dose was attempted at two Finnish hospitals, and the
image quality remained sufficiently good for examination purposes, even though the
dose rates were decreased by 30–80%, depending on the hospital and the patient size.
Dosimetry in paediatric radiology is difficult owing to the large variations in the
size of paediatric patients. Radiation doses are sometimes given for standard phantom
ages of 0, 1, 5, 10 or 15 years and sometimes for specified age groups, such as <1,
1–4, 5–9 and 10–15 years. Owing to the large variations in patient size, comparison
of the doses may be difficult. Patient size may vary much within a single age group,
TABLE V. RESULTS FROM MEASUREMENTS OF DAP (Gy•cm2) OF FIVE

X RAY EXAMINATION TYPES IN THE NORDIC COUNTRIES
(DAP values are given for complete examinations)
Chest Pelvis Lumbar spine Urography Barium enema

Mean DAP 0.54 3.3 9.0 22.4 43.5
Range DAP 0.10–3.0 0.73–12.4 0.39–35.7 6.8–65.7 5.5–165.6
Median DAP 0.47 2.6 7.9 19.2 34.7
75% DAP 0.65 3.9 10.9 28.9 53.1
NGLa DAP 1.0 4.0 10 20 50
a NGL: Nordic Guidance Level.

138 SERVOMAA
TABLE VI(a). SUMMARY OF DATA ON MEAN ESD (mGy) PER ROOM FOR
ADULT PATIENTS IN THE UK (1988–1995)
Mean Range Third quartile

Lumbar spine AP 6.4 1.0–42.0 7.4
Lumbar spine LAT 15.0 2.2–75 19.0
Chest PA 0.17 0.01–1.9 0.2
Chest LAT 0.73 0.04–3.6 0.77
Abdomen AP 5.8 0.8–28.0 7.2
Pelvis AP 4.7 0.9–25.0 5.4
Skull AP/PA 2.8 0.1–10.0 3.7
Skull LAT 1.5 0.1–6.0 1.9
Thoracic spine AP 4.2 0.2–27.0 5.0
Thoracic spine LAT 12.0 0.5–5.0 14.0
Notes: AP: antero-posterior; LAT: lateral; PA: posterio-anterior.
TABLE VI(b). COMPLETE EXAMINATIONS: SUMMARY OF DATA ON DAP

(Gy•cm2) PER ROOM FOR ADULT PATIENTS IN THE UK (1988–1995)
Mean Range Third quartile

Barium enema 27.0 6.9–79 33
Barium follow-through 12.0 4.2–40.8 16.0
Barium meal 13.0 2.8–54.0 16.0
Barium swallow 9.8 2.4–39.0 12.0
IVU 16.0 4.5–39.0 24.0
Venogram 3.0 1.7–5.9 3.8
causing large uncertainties in the mean ESD. Methods for comparison of doses as a
function of patient size have been developed for paediatric patients [20].
5. ANGIOGRAPHY AND INTERVENTIONAL RADIOLOGY
Patient doses in fluoroscopic examinations are measured mostly with a DAP

meter for the complete examination. Calculation of the effective dose is difficult
because it is not possible in practice to record all of the changes in the techniques dur-
ing the examination. One way to estimate the magnitude of the effective dose is to use
TABLE VII. SUMMARY OF ESD (µGy) MEASUREMENTS FROM SURVEYS

OF PAEDIATRIC X RAY EXAMINATIONS IN EUROPE
Infant (10 months) Five-year-old Ten-year-old

Chest AP (1 kg ) 45
Chest PA/AP 75 67 71
Chest AP mobile 90 68 91
Chest LAT 140 153
Skull PA/AP 930 967 1036
Skull LAT 703 577
Pelvis AP 485 812
Thoracic spine AP 887
Thoracic spine LAT 1629
Lumbo-sacral spine AP 1146
Lumbo-sacral spine LAT 2427
Abdomen AP/PA 440 588 729
Notes: AP: antero-posterior; LAT: lateral; PA: posterio-anterior.
proper conversion factors from DAP to effective dose. Table VIII shows the ranges of
the average DAP and effective dose per procedure from angiographic examinations as
presented in the literature [1]. For all examinations and studies, the average DAP
ranges from 5 to177 Gy•cm2 and the average effective dose from 1 to 24 mSv.
In interventional radiology, it is possible on some occasions that the ESD is so
high that deterministic effects may appear on the skin. Table IX shows the ranges of
average DAP and effective dose per interventional procedure [1]. The average DAP
varies between 20 and 520 Gy•cm2 and the average effective dose between 2 and
84 mSv.
6. COMPUTED TOMOGRAPHY
The effective dose from CT examinations accounts for about 40% of the col-
lective dose from diagnostic X ray examinations. Table X shows the mean effective
doses per procedure from CT in some European countries. The mean effective doses
are relatively high and vary from one country to another by a factor of 2 to 4. The
newest EC guidelines on quality criteria for CT [7] recommend the weighted CT dose
index (CTDIw) and the dose–length product (DLP) as measurable patient dose quan-
tities. Table XI shows the estimated values of CTDIw and DLP on the basis of UK
survey data [21].
140 SERVOMAA
TABLE VIII. RANGES OF AVERAGE DAP AND OF AVERAGE EFFECTIVE

DOSE PER PROCEDURE FROM ANGIOGRAPHIC EXAMINATIONS IN
VARIOUS STUDIES PRESENTED IN THE LITERATURE
Range of average DAP Range of average effective dose

(Gy•cm2) (mSv)
Coronary 13.3–58.7 3.1–10.6
Cerebral 27.4–98 1.6–10.6
Abdominal 39.8–177 6–23
Peripheral 4.9–78 0.9–14
TABLE IX. PATIENT DOSE PER PROCEDURE DURING INTERVENTIONAL

RADIOLOGY IN VARIOUS STUDIES
Range of average DAP Range of average effective dose

(Gy•cm2) (mSv)
PTCA 28.5–143 6.9–28.9
PTA 43.5–140 10–12.5
TIPS 77–525 8–83.9
Radiofrequency ablation 43.6–116 17–25
Embolization 79–391 1.67–68
Biliary 20.1–150 6.9–38.2
Stent (superior vena cava) 42 5.8
Notes: PTCA: percutaneous transluminal coronary angioplasty; PTA: percutaneous

transluminal angioplasty; TIPS: transjugular intrahepatic porto shunt.
7. CONCLUSIONS
(1) Comparison of the UNSCEAR 1993 and 2000 reports [1, 2] reveals that the
overall mean effective dose per examination has risen by about 20% and the
annual collective effective dose by nearly 50%. The overall trends in radiation
exposures originating from diagnostic examinations involving X rays stem
from changes in the type and frequency of procedures carried out, and from
changes in the dose levels to individual patients for given procedures.
(2) Doses are affected by quality assurance, patient protection and the continuing
advances in techniques for the production, detection and control of radiation,
including the development of alternative modalities for diagnosis. Development
TABLE X. MEAN EFFECTIVE DOSE PER PROCEDURE (mSv) TO ADULT

PATIENTS FROM CT IN VARIOUS COUNTRIES
Head Cervical Chest Abdomen Liver Kidneys Pelvis Lumbar

Head Chest Abdomen Liver Kidneys Pelvis
spine spine
Australia 2.6 5.2 10.4 16.7 12.7 11.0 5.2
Finland 1.3 5.1 11.6 5.0
Germany 2.6 9 20.5 27.4 9.0
Norway 2.0 11.5 12.8 11.9 9.9 9.8 4.5
Sweden 2.1 6 10 10 10 10 10 6
UK 1.6 11.5 9.7 12.0 10.3 9.1 9.8 3.3
TABLE XI. ESTIMATED VALUES OF CTDIw

AND DLP FROM UK SURVEY DATA [21]
CTDIw DLP
(mGy) (mGy•cm)
Head 50.0 882
Chest 20.3 517
Abdomen 25.6 597
Pelvis 26.4 443
of imaging technology, particularly technology involving non-ionizing radia-

tion, will have a significant effect on the practice of radiology and on the med-
ical exposure of the population. Digital radiological techniques also offer the
potential of improved image quality, although in general this comes at the
expense of higher patient doses.
(3) The requirements laid down by the Medical Exposure Directive
(97/43/Euratom) [4], stipulating that hospitals start regular patient dose mea-
surements and that the authorities establish national reference dose levels, have
advanced the radiation protection of patients. Many Member States of the
European Union have started both patient dose measurements and the estab-
lishment of the dose reference levels. An extensive task for the near future is the
implementation of the current European radiation protection requirements in
countries that do not as yet belong to the EU. Education and training courses on
radiation protection in medical radiology will be needed for a long time to
come.
142 SERVOMAA
(4) Large variations occur in the effective doses both between various countries and
between hospitals. The national average doses in many countries are much
lower than the European recommendations. This indicates that national refer-
ence levels are needed.
(5) National radiation dose measurements show that radiation doses in paediatric
radiographic and fluoroscopic examinations can be reduced, as indicated by the
doses measured when good techniques were used [1, 18, 19].
(6) In CT, the doses per examination are relatively high. Since the number of exam-
inations is increasing, CT examinations result in a high and growing collective
dose.
(7) In some cases, the patient skin doses in interventional radiology may be so high
that acute skin effects appear. More research work is needed in order to develop
dosimetry and reference dose levels for interventional radiology. One problem
in establishing these reference dose levels is the complexity of the procedures
involved.
REFERENCES
[4] EUROPEAN UNION, Council Directive 97/43/Euratom of 30 June 1997 on Health
Medical Exposure (Repealing Directive 84/466/Euratom, O.J. No. L 265/1, 5.10.1984),
[5] EUROPEAN COMMISSION, European Guidelines on Quality Criteria for Diagnostic
Radiographic Images, EUR 16260 EN, European Communities, Luxembourg (1996).
Radiographic Images in Paediatrics, EUR 16261 EN, European Communities,
Luxembourg (1996).
[7] EUROPEAN COMMISSION, European Guidelines on Quality Criteria for Computed
Tomography, EUR 16262 EN, European Communities, Luxembourg (1998).
[8] Radiation Protection in Interventional Radiology (Proc. ERPET Training Course,
Madrid, 1997), Ref. XII-237-98, European Commission, Luxembourg.
[9] Training Course for Medical Physicists on Establishment of Reference Levels in

Diagnostic Radiology, Passau, 1999.
[10] Medical X Ray Imaging: Potential Impact of the New EC Directive (Proc. Workshop,
Malmö, 1999), Radiat. Prot. Dosim. 90 1–2 (2000).
[11] SHRIMPTON, P.C., WALLl, B.F., “Reference doses for paediatric computed tomogra-
phy”, Medical X Ray Imaging: Potential Impact of the New EC Directive (Proc.
Workshop, Malmö, 1999), Radiat. Prot. Dosim. 90 1–2 (2000) 249–252.
[12] SAXEBÖL, G., et al., “Nordic guidance levels for patient doses in diagnostic radiol-
ogy”, Reference Doses and Quality in Medical Imaging (Proc. Workshop, Luxembourg,
1997), Radiat. Prot. Dosim. 80 1–3 (1998) 99–101.
[13] GRON, B., et al., A Nordic survey of patient doses in diagnostic radiology, Eur. Radiol.
10 (2000) 1988–1992.
[14] HART, D., HILLIER, M.C., WALL, B.F., SHRIMPTON, P.C., BUNGAY, D., Doses to
Patients from Medical X Ray Examinations in the UK: 1995 Review, NRPB-R289,
National Radiological Protection Board, Didcot (1996).
[15] HART, D., JONES, D., WALL, B.F., Estimation of Effective Dose in Diagnostic
Radiology from Entrance Surface Dose and Dose–Area Product Measurements, NRPB-
R262, National Radiological Protection Board, Didcot (1994).
[16] HART, D., JONES, D., WALL, B.F., Coefficients for Estimating Effective Doses from
Paediatric X Ray Examinations, NRPB-R279, National Radiological Protection Board,
Didcot (1996).
[17] SERVOMAA, A., TAPIOVAARA, M.J., “Organ dose calculation in medical X ray
examinations by the program PCXM”, Reference Doses and Quality in Medical Imaging
(Proc. Workshop, Luxembourg, 1997), Radiat. Prot. Dosim. 80 1–3 (1998) 213–219.
[18] COOK, J.V., et al., Guidelines on Best Practice in the X-Ray Imaging of Children: A
Manual for All X-Ray Departments, St. Hellier NHS Trust, Carshalton, Surrey, Ian Allan
Printing, UK (1998).
[19] TAPIOVAARA, M.J., SERVOMAA, A., SANDBORG, M., DANCE, D.R., “Optimising
the imaging conditions in paediatric fluoroscopy”, Medical X Ray Imaging: Potential
Impact of the New EC Directive (Proc. Workshop, Malmö, 1999), Radiat. Prot. Dosim.
90 1–2 (2000) 211–216.
[20] HART, D., WALL, B.F., SHRIMPTON, P.C., DANCE, D.R., “The establishment of ref-
erence doses in paediatric radiology as a function of patient size”, Medical X Ray
Imaging: Potential Impact of the New EC Directive (Proc. Workshop, Malmö, 1999),
Radiat. Prot. Dosim. 90 1–2 (2000) 235–238.
[21] SHRIMPTON, P.C., et al., Survey of CT Practice in the UK, Part 2: Dosimetric Aspects,
NRPB-R249, National Radiological Protection Board, Didcot (1991).
LESSONS LEARNED IN RADIOLOGY
D.J. GOODENOUGH
George Washington University Medical Center,
Washington, D.C.,
Abstract
The paper reviews aspects of the history of radiology with the goal of identifying lessons
learned, particularly in the area of radiological protection of the patient in diagnostic and
interventional radiology, nuclear medicine and radiotherapy. It is pointed out that since the days
of Röntgen there has been a need not only to control and quantify the amount of radiation
reaching the patient but also to optimize the imaging process to offer the greatest diagnostic
benefit within allowable levels of patient dose. To this end, in diagnostic radiology, one finds
the development of better films, X rays tubes, grids, screens and processing techniques, while
in fluoroscopy, one sees the increased luminance of calcium tungstate. In interventional
radiology, one finds an improvement in catheterization techniques and contrast agents. In
nuclear medicine, the development of tracer techniques into modern cameras and isotopes such
as technetium can be followed. In radiotherapy, one sees the early superficial X rays and
radium sources gradually replaced with radon seeds, supervoltage, 60Co and today’s linear
accelerators. Along with the incredible advances in imaging and therapeutic technologies
comes the growing realization of the potential danger of radiation and the need to protect the
patient (as well as physicians, ancillary personnel and the general population) from
unnecessary radiation. The important lesson learned is that we must walk a tightrope, balancing
the benefits and risks of any technology utilizing radiation to produce the greatest benefits at
the lowest acceptable risk. The alternative techniques using non-ionizing radiation will have to
be considered as part of the general armamentarium for medical imaging whenever radiation
consequences are unacceptable.
1. INTRODUCTION
The end of the 19th century was indeed a remarkable time. The medical signif-
icance of Wilhelm Röntgen’s discovery of X rays in 1895 is linked to their ability to
cause light scintillation in phosphor screens as well as their direct and indirect (via
light) property of producing a latent image in film. In fact, Röntgen’s discovery of X
rays was more an ‘observation’ of these image producing properties. Certainly, it is
our ability to transduce or extract energy from the X ray beam that produces the great
imaging tools X rays offer today. Unfortunately, the biological effects of the
accompanying cellular deposition of radiation energy present a simultaneous
145
146 GOODENOUGH
challenge to the safe and efficacious use of X ray and gamma ray radiation in medical
imaging.
2. RADIOLOGY
This section examines some of the history and lessons learned over time, from
the first publication announcing the discovery of X rays to the comprehensive
guidance document of the International Basic Safety Standards for Protection against
Ionizing Radiation and for the Safety of Radiation Sources (BSS) [1].
As has been noted many times, the rate of introduction of the practical and com-
mercial applications of the discovery of X rays by Röntgen was amazing. Rarely has
such a discovery propagated into the heart and fabric of society as did these rays that
showed bone and other parts of the body. By the time Röntgen died in 1923, at the
age of 78, of carcinoma of the intestines, “X rays were out of the tube” and medical
imaging science never looked back.
In 1896, the Dean of the Medical School of Vanderbilt University was
persuaded to undergo a skull examination to try to image his brain. Unfortunately, not
only was his brain not seen, but within three weeks his hair fell out [2]. Even more
alarming among other early subjects of irradiation was the rapid observation of
dermatitis, burns and ulcers of the flesh. The first acknowledged fatality from excess
radiation appeared to be the case of Clarence Dally in 1904 [3]. Dally was an assistant
of Edison who routinely used his hand in the field to adjust and calibrate X ray
equipment. Many other cases of injury or death were subsequently associated with the
early use of radiation.
The unfortunate lesson learned was that great discoveries may bring great
benefit but may also sometimes be accompanied by negative sequelae such as
cancer induction. Radiation must be used cautiously to achieve the desired medical
images, and unnecessary exposure to patients and medical personnel must be
avoided.
In 1898, William Herbert Rollins, a New England dentist and brother-in-law of
Francis H. Williams (who was known as the ‘first American radiologist’) suffered
X ray burns to his own hands while experimenting [3]. He subsequently urged the use
of the smallest exposure to accomplish the purpose.
In addition, he suggested several precautions in using X rays:
— Shield (lead paint) the tube box;

— Shutter the X rays during warm-up;
— Use dual intensifying screens;
— Use rectangular collimators (not introduced into general practice until the
1950s);
LESSONS LEARNED IN RADIOLOGY 147
— Use remote controlled collimator and centring devices;

— Use selective filtration of the X ray beam;
— In fluoroscopy, irradiate only the necessary area — cover the rest with opaque
(lead) material;
— Use pulsed fluoroscopy because of the integration time of the eye.
Why was Rollins generally ignored? Part of the problem was poor public
relations. Another problem was that Rollins had a poor writing style and was poorly
published.
The lessons learned are to publish or (have your ideas) perish! How many
radiation injuries may have been prevented if Rollins’ suggestions had been followed
in the early years?
Although people learned to respect the dangers that could be associated with
X rays, the desire for improvement in image quality continued. Thus, increased
system speed (shorter patient exposure and patient motion), decreased X ray statisti-
cal noise, improved contrast and latitude characteristics, and decreased scatter
inevitably lead to improved intensifying screens, scatter rejection grids, H&D film
characteristics, and improvements in X ray generation design for improved X ray
spectra and maximum milliampere high output tubes. Along with hardware develop-
ments, such as cones, diaphragms and filters, came improvements in radiographic
technique and positioning. Still, these improvements were slow in becoming gener-
ally available and the consequences were profound. For example, in 1980, Smith and
Doll published data showing that British radiologists who entered the profession
before 1921 showed a death rate from cancer some 75% higher than that of other
medical practitioners [4].
A good example of the sometimes competing desire for improved image quality
even at the expense of increased dose to the patient was the need for grids. In 1903,
Otto Pasche developed slit apertures, and by 1913 Gustav Bucky practised with
honeycomb grids. From 1913 to 1917, Bucky, Eugene Caldwell and Hollis E. Potter
further improved grids by moving parallel slits [3]. Scatter was decreased and image
quality improved, but patient dose increased.
Grids were also important because with less scatter, image receptors could
become larger than glass plates, and one finds the conversion to film.
2.1. Interventional radiology
The very important area of interventional radiology came from the introduction
of contrast agents and angiographic techniques along with improved catheters.
In 1964, Charles Dotter and Melvin Judkins made the important but incidental
observation of recanalization of totally occluded right common iliac artery during a
conventional angio study. Many remarkable developments soon followed [5].
148 GOODENOUGH
During the 1960s and 1970s, many developments in catheters were witnessed,
ranging from catheters with two side holes to the double lumen balloon catheter. The
techniques performed were: intravenous thrombolisis, emblotherapy and transvenous
interruption of vena cava. In 1970, the first commercially safe device was brought to
the market with the Mobin Uddin umbrella filter. Likewise, precuteous aspiration
biopsy and abscess drainage were developed in 1960 by S. Franzen and others using
a thin needle technique. This technique would prove important for modern CT and
ultrasound guidance applications.
2.2. Image quality and dose
At this point in time, it is important to understand the often competing demands

of increased image quality and decreased patient exposure. The ultimate limit for
detectability is the statistical fluctuation in the number of detected X rays (the
quantum sink). Unfortunately, improved image quality by reduced noise places a
quadratic demand on patient dose. Then too, improvements in the spatial resolution
of many image receptors usually require thinner image receptors with lower detective
quantum efficiency (or stopping power) and often place a linear demand on patient
dose. Scatter rejecting devices such as grids place their own demands (probably at
least linear) on patient dose, depending on the degree of scatter rejection. Thus,
increased image quality by simultaneously decreasing noise, increasing resolution
and decreasing scatter could easily place a cubic or quartic demand on patient dose!
The key question then emerges as to how much image quality is enough.
This question is rhetorical because one would first need to identify what anom-
aly or signal one is trying to detect or rule out. Although clearly the radiologist should
be able to use the radiation dose necessary to perform the imaging task required, he/she
should be well aware of the risks, such as those shown in Tables I and II.
It is also important for the physician to be aware of the data shown above and
to justify the procedure or consider non-ionizing alternatives which may exist to
TABLE I. RISK COEFFICIENTS (%·Sv–1) FOR CANCERS IN BOTH SEXES AT

LOW DOSES AND DOSE RATES AND AT HIGH DOSES AND DOSE RATES [6]
Fatal cancer Total cancer
Whole population 5.0 (10) 6.1 (12.2)

Working population 4.0 (8) 4.9 (9.8)
Individuals up to age 15 years, exposed
in utero 3.0 (6) 6.0 (12.0)
Note: Values in parentheses are for high doses and high dose rates.
TABLE II. FATAL CANCER RISK COEFFICIENT BY AGE AT EXPOSURE [6]
Workers
Age at exposure (years) 0–20 21–40 41–60 61–80 >80
18–65
Lifetime probability
of fatal cancer (%·Sv–1) 11.5 5.5 2.5 1.2 0.2 4.0
acquire similar diagnostic results. In particular, ultrasound and magnetic resonance

imaging offer non-ionizing alternatives for many imaging tasks.
What we do know is that the physician should be the final arbiter of the required
levels of image quality. However, it is the duty of the physicist, engineer and radiog-
rapher to attempt to optimize equipment and techniques that minimize unnecessary
patient dose. An important example can be seen from a recent study on scoliosis [3]
which illustrates the resulting dose to the breast (Table III).
This retrospective cohort study conducted in 5573 female patients with scolio-
sis who were treated at any of the 14 orthopaedic treatment centres in the USA from
1912 through 1965. Patients underwent an average of 25 radiographs, and the total
mean estimated radiation dose to the breast was 10.8 cGy. A key lesson learned is that
for these women a statistically significant 70% excess risk of dying of breast cancer
was observed compared with the general population. Patterns were consistent with
radiation as a causative factor, in that risk increased with increasing number of diag-
nostic radiographic examinations and cumulative radiation dose to the breast.
TABLE III. ESTIMATED RADIATION DOSE TO BREAST (cGy) FROM A

FULL SPINE RADIOGRAPHIC EXAMINATION, BY AGE AT EXAMINATION
AND FOR VARIOUS TIME PERIODS [7]
Age (years) and view 1940–1959 1960–1975 1976–1989
>13
Anteroposterior 0.588 0.350 0.090
Posteroanterior 0.005 0.005 0.005
Lateral 0.300 0.225 a
<13
Anteroposterior 0.780 0.470 0.125
Posteroanterior 0.003 0.003 0.003
Lateral 0.300 0.225 a
a Parameters were not available for this view in this time period.
150 GOODENOUGH
Potential confounding between radiation dose and severity of disease may explain
some of the excess risk observed.
Most of the examinations in this study were made before 1976, when the doses
to patients were considerably higher than with current techniques. For example, the
adult (>13 years) breast dose from a full spine anteroposterior view in 1940–1959
was approximately six times higher than the dose in 1976–1989, as shown in
Table III. A lesson learned is that using a posteroanterior rather than an anteroposte-
rior view reduces the breast dose significantly. With more recent techniques, a full
spine posteroanterior view provides a breast dose approximately 20 times lower than
the anteroposterior view.
Likewise, in fluoroscopy, clearly the interventionist should take as much time
as necessary to perform the intervention required. However, he/she should be well
advised of the data presented in Table IV.
In addition, a lesson learned is that there are methods of reducing entrance dose
during high dose rate fluoroscopy (see Table V).
Knowledge of data shown in Table IV and V should help the interventionist
reduce unnecessary doses not only to the patient, but also to the doctor and ancillary
personnel.
TABLE IV. RISK OF FATAL CANCER ATTRIBUTABLE TO RADIATION FROM

FLUOROSCOPYa [6]
Risk of fatal cancerb attributable to fluoroscopy time of:

Age
(years) Sex 1 hour 2 hours 3 hours 4 hours
1–14 Male 1:460 (1.0%) 1:230 (1.9%) 1:155 (2.9%) 1:115 (3.9%)
Female 1:380 (1.2%) 1:190 (2.3%) 1:130 (3.5%) 1:95 (4.6%)
15–34 Male 1:640 (0.7%) 1:320 (1.4%) 1:120 (2.1%) 1:160 (2.8%)
Female 1:500 (0.9%) 1:250 (1.5%) 1.165 (2.7%) 1:125 (3.6%)
35–54 Male 1:980 (0.4%) 1:490 (0.9%) 1.325 (1.4%) 1:250 (1.8%)
Female 1:1087 (0.4%) 1:540 (0.8%) 1:360 (1.2%) 1:270 (1.6%)
55–74 Male 1:1220 (0.4%) 1:610 (0.7%) 1:410 (1.1%) 1:305 (1.4%)
Female 1:1520 (0.3%) 1:760 (0.6%) 1:510 (0.9%) 1:380 (1.32%)
All Male 1:760 (0.6%) 1:380 (1.2%) 1:250 (1.8%) 1:190 (2.3%)
Female 1:730 (0.6%) 1:360 (1.2%) 1:240 (1.8%) 1:180 (2.4%)
a Reproduced, with minor editorial changes, from Ref. [8] with permission from Excerpta
Medica, Inc.
b The chance of developing a fatal cancer induced by radiation is also expressed (in paren-
theses) as a percentage of the spontaneous fatal malignancy rate for each group and sex.
TABLE V. TECHNICAL FACTORS FOR REDUCING

ENTRANCE DOSE IN FLUOROSCOPY [6]
Methods of reducing entrance dose Relative entrance dose (%)
Collimation 60
Removal of grid 50
Increased applied potential 60–90
Additional filtration 40–80
Pulsed fluoroscopy 10–80
3. RADIATION THERAPY
In radiation therapy, there has been a progression from the early radium and soft
X ray systems to orthovoltage approaches to modern cobalt and supervoltage
machines, leading to today’s linear accelerators and intensity modulated radiotherapy
(IMRT), as well as the evolving fields of modern brachytherapy and high dose rate
techniques (HDRT), as well as current monoclonal antibody approaches.
An important lesson learned in the process of development is the importance of
accurate measurement of dosimetry, and the need for calibration and quality control
of radiation output for the adequate treatment of the patient and protection of the
patient and operating personnel.
Intensity modulated radiotherapy is a modification of external beam radiation
therapy where the photon fluence delivered to the patient is varied over space
and/or time to optimize dose (conformably) to the target region and minimize dose
to normal tissue. In a strict sense, this new concept builds on the 30-year-old tech-
nique developed by Henry Kaplan and others to utilize partial thickness blocks
overlaying parts of the complex treatment field to deliver different daily doses to
help reduce dose to normal tissue. In IMRT, the concept is extended to subdivide
the treatment beam intensity with a number of ‘leafs’ of various transmission intensity.
In some respects, IMRT represents a type of inverse of CT involving back-projection
of intensity readings, whereas in IMRT, forward projection of modulated intensities
achieves a localization of intensity to a given region. As finer leafs appear in
multiple-leaf collimators, one can achieve even finer treatment (spatial) resolution
and even better conformal dose distributions.
Of course, brachytherapy utilizing relatively low range beta or photon radiation
is also employed to even further try to optimize dose delivery to the target lesion
while minimizing dose to normal tissue. With monoclonal antibody approaches, the
search continues for the ‘golden bullet’ which will provide dose delivery only to the
cancerous cells with little or no effect on normal cells.
152 GOODENOUGH
Along these lines, the need for dose optimization in radiotherapy to deliver the
dose necessary to kill the cancer cells while minimizing damage to non-cancerous
cells is important for the protection of the patient. Radiation to normal tissue has a
number of possible negative sequelae including the possible induction of secondary
cancers. For example, the study by Biti et al. [9] showed an increased secondary
tumour risk observed in treatment of Hodgkin’s disease, especially when the initial
treatment was with chemotherapy. Other non-cancer complications are encountered,
such as urinary and rectal complications in cervical and prostate treatment. Several
studies have shown that morbidity (sometimes fatal) is significantly related to the vol-
ume of irradiated normal tissue (such as the rectum) as well as the actual dose deliv-
ered to the normal tissue.
4. NUCLEAR MEDICINE
Nuclear medicine followed the concept of radiotracers developed by George

Hevesy in the 1920s. One sees a progression from radium C tracer studies by
Blumgart et al. in 1926 [10], measuring blood transit times, to the concept of artifi-
cially produced radionuclides (originally used for therapy), to widespread use of 131I
for diagnosis and treatment of thyroid disease [3]. However, it was the work of
Benedict Cassen on the rectilinear scanner in the 1940s, and Hal Anger’s large field
of view gamma camera in the late 1950s, that led to useful image devices. Similar
contributions were made by Kuhl and Edwards in SPECT in the 1960s and 1970s.
Michel Ter-Pogossian, Michael Phelps and others made similar contributions for PET
in the 1970s [3].
In particular, the utilization of 99Tcm by Paul Harper in 1961 led to the wide-
spread use of this tracer for numerous human studies. This generator-produced
isotope had excellent image properties and could be safely produced by ‘hot labs’ at
local hospitals. Technetium based agents are widely used and result in reasonable
radiation dose levels to the patient and staff.
4.1. Patient precautions in nuclear studies
Good axioms for the protection of the patient and staff, as well as efficacy of
procedures, include: checks must be in place so that the correct patient receives the
correct amount of radioactivity for the indicated study; all studies must have correct
requisitions; patient identity must be clearly established (for example by checking
wristband or asking for date of birth). In terms of radiopharmaceuticals, kits should
be colour coded so that, for example, a bone agent is not confused with a thyroid
agent; the radionuclide must be assayed and compared with the recommended
activity; the syringe must be properly labelled; the correct route of administration
must be used; in addition, caution must be used to prevent administration of a useless
radiation dose to the patient, such as extravasation.
In the USA, the Nuclear Regulatory Commission requires that for 131I or 125I
procedures greater than 30 mCi, or for any other unsealed source therapy procedures
such as 32P or 89Sr, a written directive must be completed by the authorized user (i.e.
the nuclear medicine physician authorized for unsealed source therapy procedures).
The written directive must identify the patient, the procedure, the radiopharmaceuti-
cal form, and the route of administration. The directive must be signed and dated, and
before administration the patient must be identified in two ways. Prior to administra-
tion by the authorized user, the material must be assayed and documentation provided
that the radioactivity is within 10% of the prescribed amount. It must also be docu-
mented that the administration is in accordance with the written directive, for exam-
ple by having the authorized user who administers the procedure sign the dose slip.
Written documentation must be kept on file. In the USA, such policies and precau-
tions should be contained in the institution’s written quality management pro-
gramme [11].
4.2. Technical developments
In terms of imaging developments, improvements are found in the number and

quantity of photomultiplier tubes, crystal size and thickness (intrinsic resolution), and
collimator design (extrinsic resolution), leading to improvements in image quality in
such areas as resolution and uniformity. In addition, the development of multihead
cameras led to increased sensitivity and the practical acquisition of SPECT studies.
One can note, however, that the fundamental limitations imposed by finite patient
dose and emitted gamma ray fluence, along with the limited solid angle of capture,
losses in efficiency due to collimation and the need to reduce scatter, make gamma
ray imaging particularly sensitive to noise resulting from the finite number of
detected gamma rays making up the final image. Thus nuclear medicine studies are
forced to work with spatial resolution levels an order of magnitude worse than most
diagnostic studies (X ray and CT), and several orders of magnitude lower count den-
sity per unit area. For example, nuclear medicine spatial resolution is of the order of
several millimetres compared with fractions of a millimetre for CT and image inten-
sifiers, and for radiography of the order of 100 mm or better.
An important lesson learned is that we can work with much lower spatial
resolution and much more noise when the target signal is relatively large and when
the target somewhat self-isolates from a relatively unstructured background, as
provided, for example, by CT. An important lesson learned is that tomographic
approaches that extract signals from complex backgrounds have very high diagnostic
yields.
154 GOODENOUGH
5. SUMMARY
As can be seen, the history of radiology offers many examples of lessons

learned. In the quest for better diagnosis in X ray and nuclear studies, better inter-
vention in cardiology and angiography, and better radiation therapy treatment, it is
important to understand ways to improve efficacy and provide protection for patients
and staff. We must walk a tightrope, balancing the benefits and risks of any technol-
ogy utilizing radiation to produce the greatest benefits at the lowest acceptable risk.
The alternative techniques using non-ionizing radiation will have to be considered as
part of the general armamentarium for medical imaging whenever radiation conse-
quences are unacceptable.
ACKNOWLEDGEMENTS
The author would like to acknowledge the help and encouragement of C. Borrás
in identifying sources and concepts discussed in this paper. Likewise, the help of
L.K. Wagner in identifying certain source material is gratefully acknowledged.
Lastly, source material in a number of excellent publications on the history of
radiology (particularly Ref. [3]) is also acknowledged.
REFERENCES

ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN
[2] WOOD, B.P., “The terrible power of the rays”, A Century of Radiology, Radiology
Centennial, American College of Radiology, Reston, VA (1993).
[3] EISENBERG, R.L. (Ed.), Radiology: An Illustrated History, Mosby Year Book, Mosby,
St. Louis, MO (1992).
[4] SMITH, P.G., DOLL, R., Mortality from cancer and all causes among British radiolo-
gists, Br. J. Radiol. 54 (1981) 187–194.
[5] DOTTER, C.T., JUDKINS, M.P., Transluminal treatment of arteriosclerotic obstruction.
Description of a new technic and a preliminary report of its application, Radiology 172
3, Pt 2 (1989) 904–920.
[6] WORLD HEALTH ORGANIZATION, Efficacy and Radiation Safety in Interventional
Radiology, WHO, Geneva (2000).
[7] DOODY, M.M., et al., Breast cancer mortality after diagnostic radiography: Findings
from the U.S. Scoliosis Cohort Study, Spine 25 (2000) 2052–2063.
[8] MACKLIS, R., WEINHOUS, M., HARNISCH, G., Intensity-modulated radiotherapy:
rethinking basic treatment planning paradigms, Int. J. Radiat. Oncol. Biol. Phys. 48
(2000) 317–318.
[9] BITI, G., et al., Second solid tumors and leukemia after treatment for Hodgkin’s disease:
An analysis of 1121 patients from a single institution, Int. J. Radiat. Oncol. Biol. Phys.
29 (1994) 25–31.
[10] BLUMGART, H.L., WEISS, S., YENS, O.C., Studies on the velocity of blood flow, J.
Clin. Invest. 4 (1927) 1–31.
[11] BERNIER, D.C., CHRISTIAN, P.E., LANGAN, J.K., Nuclear Medicine Technology
and Techniques, 4th edn, Mosby, St. Louis, MO (1997).
THE INTERNATIONAL REGULATORY CLIMATE
J.-F. LACRONIQUE
Ministry of Health,
Office de Protection contre les Rayonnements Ionisants,
Le Vésinet, France
E-mail: jflacronique@opri.fr
Abstract
The paper describes how it has been possible to change the situation in regard to the
radiation protection of patients from one of almost total professional freedom to worldwide
organized control, thanks to a ‘climate’ that has stimulated changes across national boundaries,
cultures and traditions.
1. INTRODUCTION
The scene is the Earth. Forces of different origins are evident, crossing all
boundaries, sometimes changing direction. These forces carry energy that has
unexpected consequences, leading here to major changes that reshape the landscape,
there to mere amendment, and elsewhere to nothing. Patterns can be described
showing countries that share the same way of responding to these forces. This paper
deals with ‘climate’ at a time when global changes are under discussion. However, the
term climate is here applied to something different from temperature, humidity, wind
and rain. Instead, a climate is described that pertains to regulations in the field of the
medical use of radiation on an international level.
The beginning of the 21st century coincides with the application, in many
European countries, of a new directive that aims at protecting individuals against the
dangers of ionizing radiation in relation to medical exposures. The Directive should
have been implemented simultaneously in 15 countries, beginning in May 2000, after
being signed by all the Ministers of the Member States in June 1997. A Directive is
one of the regulatory measures that the European Commission can issue. In the case
of radiation exposure, all the regulatory texts have to be placed under the Euratom
Treaty, signed in 1957. Article 2(b) of the Euratom Treaty states that “the Community
shall establish uniform safety standards to protect the health of workers and of the
general public against the dangers arising from ionising radiation and ensure that they
are applied.”
The same Treaty defines the hierarchy of the different provisions in its
article 161:
157
158 LACRONIQUE
— A regulation shall have general application. It shall be binding in its entirety

and directly applicable in all Member States.
— A directive shall be binding, as to the result to be achieved, upon each Member
State to which it is addressed, but shall leave to the national authorities the
choice of forms and methods.
— A decision shall be binding in its entirety upon those to whom it is addressed.
— Recommendations and opinions shall have no binding force.
To give illustrations of these different provisions, the Basic Safety Standards

(BSS) [1] are linked to a directive, such as the directive on external workers, the one
on medical exposures or the one on shipment of radioactive waste.
Regulations were issued on imports of foodstuffs in 1986, after the Chernobyl
accident, after several recommendations.
A directive imposes on all Member States the requirement to integrate into their
national regulations the entire substance of a text that has been prepared at a supra-
national level. The effort towards protecting the public against the risks attached to
medical exposures is not unique to Europe. Many other countries are heading in the
same direction, but with various degrees of acceptance and application. One objective
of this conference is to compare the level of maturity in this process. In some
instances, these new requirements will be considered as futile and unnecessary pre-
cautionary principles. But for the majority, the new regulations constitute a historical
landmark in the general idea of protecting the public from the possible harmful effects
of radiology and nuclear medicine.
2. THE NATURE OF THE FORCES
The forces that were mobilized were numerous. The most important is
represented by the professionals in the field, and we will show that nothing would
have been possible without the strong involvement of the professional bodies.
However, we must first analyse why and how the professionals have been proponents
and not opponents of this change. Radiologists are not known to be prone to any kind
of regulation. The large majority of them do not like constraints on what they con-
sider as the most important feature in the practice of medicine, which is freedom. A
large number of them are working as independent private practitioners. They have
made large financial investments in their equipment, and they hope to enjoy returns
on this investment. Others work in public institutions, and they have quite different
motivations, but they share the same appetite for freedom as the vast majority of
MDs, and they do not like administration. Except for this simplistic sociological
analysis of the profession, we would be facing a rather complicated international
INTERNATIONAL REGULATORY CLIMATE 159
TABLE I. ITEMS OF EQUIPMENT IN DIFFERENT COUNTRIES IN 1999
Number of machines Number per million inhabitants
MRI CAT PET MRI CAT PET
USA 7 452 7 453 170 28 28 0.64

Japan 3 825 10 250 37 30 81 0.29
Germany 1 148 1 654 75 14 20 0.91
Italy 444 1 154 10 8 20 0.17
Spain 340 457 9 9 12 0.23
UK 313 296 13 5 5 0.22
France 182 595 5 3 10 0.08
Turkey 115 192 1 2 3 0.01
Belgium 55 236 17 5 23 1.67
scene, with a strongly contrasting picture of the practice of radiology among

countries.
On the European scene alone, the ratio of items of equipment to population
(Table I) shows considerable differences. These differences determine differences in
access of the population to care, differences in health investment and expenditures,
and differences in the health care production function. The question of the similarity
of ‘needs’ in terms of quality assessment and control is certainly a good one, but I
doubt that this has been seriously studied. The term ‘need’ is one of those which gen-
erates allergies and rejection among makers of health policy.
How do these diverse types of practitioners react to the new regulation princi-
ples? The expectation is that there should be very different professional attitudes
among various groups and among various countries and cultures. However, even
while that is partially true, I would say that these variations are not perceptible for the
time being, and that there is little evidence that rejection has been observed so far. But
we are still far away from a widely implemented policy.
The reason for this apparent current consensus is that radiologists cannot escape
from social pressure. They know that the patients, in all countries, are paying much
greater attention to radiation, and that they could be vulnerable if they do not display
a sensitivity to the risk of patient exposure.
Another important source of evolution in the minds of the professionals lies in
the coherence between the different regulatory approaches in the different uses of
radiation. If expectations for the safety of the public have to be respected, then how
is it possible to make acceptable, without concern, doses that sometimes exceed
several hundred times the annual basic safety standards?
160 LACRONIQUE
Patient irradiation started to be a real concern in the 1970s, when it was widely
published that the level of radiation in the medical field represented 99% of all
human-made exposure to the public. Until then, the undesirable side effects of the
medical applications of radiation were limited to the practitioners, who paid quite a
large price in terms of harmful effects. But no incident or accident was ever reported
in the normal use of radiology for the patient, even in the most exposed groups of
patients. However, visible effects of radiation can still be noticed on patients after
exposures during interventional radiology procedures, in the form of rashes, with
doses that cannot be considered as low.
But schematically, the need for special attention came with the epidemiological
and the biological advances that showed that there could be a long term effect of
radiation at relatively low doses. The issue of the ‘no threshold linear hypothesis’ by
the International Commission on Radiological Protection (ICRP) opened a new door
in the evaluation of risks attached to radiation exposure: a simple calculation could be
made, implying that X rays used in normal practice could generate thousand of deaths
per year by cancer. The fear of legal action then followed, and the professional bod-
ies made the strategic decision to accept the challenge, and to take a position that
would be interpreted as intended to protect the patient.
3. RECOMMENDATIONS PRECEDE REGULATION
These changes are reflected in the evolution of the ICRP: in 1957, a series of
recommendations specifically devoted to the methods of evaluation of the exposure
of humans arising from medical procedures was issued. Committee 3 of the ICRP was
created in 1962, devoted to radiological protection in medicine. However, most of the
published work of the ICRP during the two subsequent decades was focused on the
study of the impact on health of the radionuclides which were the main concern
during the emerging civil use of nuclear power. The first specific text from the ICRP
on the protection of patients was published in 1970 [2], followed by an update in
1982 [3].
The role of the ICRP is very unusual on the international scene, since it gives
to a non-governmental organization the power to initiate a ‘flow of information’ that
can lead to regulations. I do not know of any other health protection fields where
national regulatory powers have been that much influenced by the ‘climate’ generated
by an organization that is self-administered and self-appointed. The nature of radia-
tion and its capacity to have unknown delayed effects might explain the need for an
independent scientific body that has an international status. This very original role
preceded the work of all other international organizations, such as the International
Atomic Energy Agency, the World Health Organization and the European
Commission, and the ICRP became naturally not only a source of scientific data, but
the inspiration for all regulatory actions undertaken by all other international and
national bodies.
In the European countries, the EC directives are directly based on the ICRP
recommendations (this is specifically mentioned in the preamble of the first 84/4666
EC directive), setting the basic safety measures relating to the protection of persons
undergoing a medical examination or treatment. The first EC directive had a great
deal of influence, with or without implementation at the national regulatory level. As
a matter of fact, this first directive was followed by very different attitudes in the then
12 European Member States. However, from the point of view of practical imple-
mentation, the comparative situation in the behaviour of the professionals in the field
does not show the contrast that could be expected from this diversified scene. An
example is provided by the attitude towards direct fluoroscopy, which has been
considered as potentially highly harmful, but which in many countries has not been
banished from the list of authorized equipment. It is to be hoped that this outmoded
equipment is not being used in practice, but the trend for its withdrawal has not been
stimulated by regulations but rather by other ‘natural forces’.
4. THE SPIRIT OF LAWS
Montesquieu said in 1735, “Laws, in their most extended meaning, must reflect
the forces that derive from the natural order of things.” There cannot be a better
citation for the understanding of when and why it became necessary to regulate the
field of patient irradiation in medical practices.
The forces that Montesquieu referred to are concentrated, in our area of inter-
est, mostly in the professional bodies. These bodies have many personal international
ties, and most of the decision makers in this field exploit the international scene to
keep their countries in the mainstream of practice. There are journals, congresses and
visits that continuously animate the exchanges. These ‘natural’ international forces
are stimulated by the manufacturers of equipment, particularly in radiology, where
there exists a tendency towards concentration and internationalization. The advances
in technology, which have been continuous in the past 50 years, have been the
principal source of the evolution that has most often preceded any kind of regulation.
5. WORKING TOGETHER
It follows from this analysis (and from Montesquieu) that the legislation, even
if it comes from national regulatory bodies, has only a small chance of being applied
if it fails to involve organizations outside the regulatory framework. The full endorse-
ment of professional representatives is necessary to ensure compliance with the
162 LACRONIQUE
standards adopted at an international level. This wide consultation must include the
national professional bodies, who have the responsibility for the prescription (on the
demand side), and those who have to fill the prescription (on the offer side). That
includes:
— The professional unions, particularly the general practitioners, at the individual

level. The practising physicians do not remember the basics of physics that they
learned in the first years of medical school, and they have little concern about
the doses that patients receive during a radiological procedure. Most often, they
do not want to learn about previous radiological examinations, and they do not
hesitate to make a new prescription. There is almost nowhere (except in Austria,
to my knowledge), a mention of the total doses encountered by a patient, and
regulations are far from implementing this requirement in the near future.
— The medical societies in radiology. These are often subdivided into many chap-
ters (geographical and/or thematic: paediatrics, neurology, cardiovascular). In
contrast to what was said about general practitioners, these bodies have had
very positive reactions to the new regulations, and have organized working
groups that have issued recommendations and guidelines.
The reason for these bodies to accept regulation, after decades of relative
freedom, is the perception of a new challenge issuing from the demand for safety in
health care, after numerous worldwide controversies such as the contamination of
blood with HIV, bovine encephalopathy, the rise of thyroid cancer after Chernobyl
and so on. In medical diagnosis, the profession is now volunteering control of irradi-
ation that would protect them from potential future claims by patients.
Thus, a second set of ‘natural forces’ can now be seen, where the administra-
tion would like to anticipate a ‘public expectation’ that is, for the time being,
relatively discrete and limited in its expression to a very small number of militant
anti-nuclear organizations. So far, these organizations have made little criticism of
radiology, which maintains a rather positive image in the public mind. Radiology
enjoys a deserved reputation of being far more useful than harmful, but nobody can
predict how long this privilege can be kept untouched: in nuclear medicine, for
example, criticisms are much closer to being accepted.
What has been said so far means that there is no hurry. Since there is still no
sense of emergency, the process of regulation can involve a series of actors that can
play a role in the implementation of the regulations, and in that sense, the subject is
a model in public health issues, since it involves a lot of potential ‘partners’:
— Another set of bodies that have to be included in the consultation process are
the agencies that are in charge of the licensing, safety and quality assurance of
medical devices. In the United States of America, the model would be the Food
and Drug Administration, and this model has been copied in many countries. In
France, for instance, the former ‘Drug Agency’ was transformed in 1998 into a
new national agency for the safety of health products (AFSSAPS), with a strong
regulatory power that applies to all kinds of consumer goods that relate to
health care. This agency issues the authorization to sell drugs or devices to the
public. It deals only with efficacy and safety and does not set prices. It also has
the power to withdraw a product that would not meet the quality requirements.
To give an example, the agency was asked to cancel the authorization for
operating various mammography devices that were not judged satisfactory by
experts in 1999.
— In some countries there now exist distinct agencies that are responsible for the
evaluation and/or the accreditation of health facilities. In the USA, this role is
played by the Agency for Health Care Research and Quality, which sets up clin-
ical practice guidelines. However, this agency shares this responsibility with the
previously mentioned medical societies, and offers only a methodological
framework. In the United Kingdom, this role is given to the National Health
Services Executive, the practical work being done by the Royal College of
Radiologists. The same scheme is followed in France with the National Agency
for Evaluation and Accreditation in Health Care (ANAES) and the French
Society for Radiology (SFR). In addition, these agencies also have the role of
determining cost/benefit ratios, particularly in comparison with other diagnos-
tic procedures (other imaging techniques, endoscopies, biology), with the help
of health economics experts.
— The bodies that validate the price of medical procedures are another set of
administrators that have a major role in the regulation of medical examinations.
Such administrators sometimes set ratios of equipment per population, when
this equipment can lead to heavy public expenditures. Setting ratios,
reimbursement prices or coverage prices can lead to complex reactions in the
market. One key element is the prices given to different techniques that can be
considered as complementary or additive. For example, CAT scan and MRI are
not identical in terms of clinical performance, but there exist a large number of
situations where substitution can be discussed. In countries where a scarcity of
this equipment exists, the demand is high, and the real price (and not the official
price), which includes the waiting lines and sometimes a black market price,
can be very high. There appears a new dimension that cannot be underesti-
mated, which is the inequality of access, which is obviously encouraged by sit-
uations of shortage. I have to recognize that in that field, the French situation is
not a model. In France, radiology is clearly viewed by the public health insur-
ance system as one of the most important sources of diagnostic costs, and its
proportion in total health expenditures is increasing with time. For that reason,
there will inevitably be a conflict between the ‘pure’ objectives of public health,
164 LACRONIQUE
when the issue of radiation control is brought about for safety reasons, and the
‘impure’ objectives of justification of radiological procedures. The question of
whether the ethics of health economics (i.e. an optimal use of public resources)
can exploit the ethics of safety is an important one, and one that has already had
dramatic echoes in the press.
— The associations that are interested in radiation control, environmental protec-
tion or patient advocacy can also be included in the planning process. In some
areas, such as the prevention of breast cancer, they have a major role, illustrat-
ing the real behaviour of the patient facing technocratic programmes, and for
this they are a key element in view of their practical features.
— Last but not least, the radiation protection authorities are a good candidate for
the co-ordination of the whole system. They can translate the regulatory texts
into practice, and they can explain the scientific principles of the whole
construction of the system and show the logic in it.
Economics is also the science of the distribution of resources, and we have

already mentioned the international market. In other countries, the fear of ‘supply
generating demand’ has led to control of equipment that is sometimes interpreted as
a rationing policy. Numerous experimental regulatory mechanisms have been imple-
mented in many industrialized countries, sometimes showing their limits: the
Certificate of Need or the Professional Standard Review Organizations that were tried
in the USA in the early 1980s are interesting examples of vanished regulations. Other
planning mechanisms have been applied, creating a complex situation without any
model or unity in the definition and responsibilities of the regulatory authorities.
Moreover, inspectors or experts in this particular field are scarce, and there is
currently no internationally accepted protocol for their intervention. The IAEA, the
European Commission, the World Health Organization and the Pan American Health
Organization would certainly be welcome in stimulating a co-ordinated effort in that
direction.
At the other end of the spectrum of the distribution of wealth among nations,
this body of inspectors could perform the task of stimulating the supply of equipment,
because in the vast majority of developing countries, the worry is not the over-
consumption of X ray examinations, but the insufficient use of them. In these
countries, radiological machines are lacking, and radiological procedures are too
expensive for the majority of the population. The UNSCEAR Report distinguishes
two sets of countries where the annual frequency of X ray examinations is in the
range of 10 per 1000 inhabitants, one hundred times less than the ratio in developed
countries (of the order of one per inhabitant). It is obvious that the safety regulations
in these countries do not have the same order of priority as in the most developed
ones. UNSCEAR indicates that two thirds of the world’s population is still lacking
adequate diagnostic imaging and radiation therapy services, and the priority here is to
stimulate utilization rather than to control it. However, the dramatic need for
equipment in these countries should not be interpreted as a lower need for safety and
quality insurance.
In conclusion, the ‘climate’ for regulation in the area of medical exposure of the
patient is like the weather on the globe: it is changing; it is different among countries
and continents; it causes very different problems to the northern and the southern
populations. It also needs a concerted effort to reach a common goal, the protection
of the population against the potential harm of radiation. But one has to bear in mind
that radiology and radiotherapy have brought immense and indisputable benefits to
the human race, and that the risks attached to their possible over-utilization, in
comparison, are low in magnitude.
Would a ‘global climate’ be sufficient to change the behaviour of the many
professionals involved, of the patients or the general public? Certainly not.
Regulations have to make things respected. National laws are necessary to organize
and unify a change, and recommendations that comes from international bodies can
be ignored. But laws without enforcement measures have similar weaknesses, and
good regulatory principles must include all application measures, such as evaluation
and inspection, marketing and teaching programmes, and even penalties for violators.
The objective is that a culture of radioprotection should prevail, meaning that
any practice using ionizing radiation be justified and optimized, and that basic safety
standards be adopted the in same way all over the world. It is to be hoped that, in
contrast to the conference on the world climate last November in The Hague, there
can be hope of an achievement in the international negotiations towards this common
goal.
REFERENCES

[2] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Protection
of the Patient in X Ray Diagnosis, Publication 16, Pergamon Press, Oxford and New
York (1970).
[3] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Protection
of the Patient in Diagnostic Radiology, Publication 34, Pergamon Press, Oxford and
New York (1982).
CONTENTS
OPENING SESSION
Opening Address
Opening Address
J.Á. Azuara . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Opening Address
Opening Address
R. Ruiz Cruces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Opening Address
F.A. Mettler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Opening Address
A.J. González . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Opening Address
K. Schnuer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Opening Address
C. Borrás . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Opening Address
H. Ostensen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31


C. Borrás . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
H. Ostensen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
P.C. Shrimpton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
g
F.A. Mettler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
of patients
A. Niroomand-Rad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
G.A.M. Webb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
H. Svensson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
A. Yule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
H. Amaral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
BRIEFING SESSION

P.C. Shrimpton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
F.A. Mettler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
A. Servomaa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
D.J. Goodenough . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
J.-F. Lacronique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
TOPICAL SESSIONS


M.M. Rehani . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
h
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178


J.E. Gray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199


R. Padovani . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223


L.K. Harding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234

(Topical Session 5)

M. Rosenstein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259


C. Streffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275

(Topical Session 7)
i
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285


Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325


J. Liniecki . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 343


Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 357


L.K. Wagner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 361
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 375

j
K. Faulkner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 379
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 386


J. Cassar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 391
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 398
ROUND TABLES

caregivers? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 455

Author Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 587
k
IN GENERAL DIAGNOSTIC RADIOLOGY
(Topical Session 1)
Chairperson
C.G. STANDERTSKJÖLD-NORDENSTAM
Finland
PROTECTION OF PATIENTS IN GENERAL
RADIOGRAPHY
M.M. REHANI
All India Institute of Medical Sciences,
Institute Rotary Cancer Hospital,
New Delhi, India
E-mail: mmrehani@vsnl.com
Abstract
As over 90% of the workload in diagnostic radiology in many countries is general
radiography, it is a major contributor to the collective dose. Many technological advances, in
particular the developments in film screen systems, have made it possible to achieve dose
reductions of a factor of 100 or more as compared with direct film radiography. Many countries
still use calcium tungstate screens, whereas rare earth screens have the potential to give patient
dose reductions of over three. Type approval of X ray machines is an efficient method of
ensuring conformity to specifications and should be incorporated into countries’ regulatory
frameworks. Users should verify the regulatory requirement of minimum tube filtration, as
some equipment might not comply. Operators can play a significant role in reducing doses by
the appropriate choice of exposure factors without compromising on image quality. Periodic
quality control checks on diagnostic X ray equipment lose their significance unless coupled
with rectifying malfunctions. Experience with acceptance testing in some countries with less
maintenance infrastructure suggests that in the majority of occasions new machines have
malfunctions that necessitate adjustments. Thus acceptance testing is essential to ensure that
one starts with a properly functioning machine. Stronger emphasis needs to be placed on the
maintenance of equipment. Manual film processing may be responsible for nearly 50% of
retakes against only 6% when automatic film processing is used. Experience suggests that a
nearly 40% reduction in patient dose is achievable by appropriate training. Establishing
reference dose levels allows X ray departments to compare their performance and decide
whether action is needed to reduce the doses given; European Commission quality criteria are
extremely useful in this respect. Conventional darkroom fluoroscopy is still in use in many
countries, which needs to be discouraged in view of the higher radiation exposures to patients
and staff.
1. INTRODUCTION
In many countries general radiography constitutes over 90% of all examina-

tions in diagnostic radiology [1]. Ever since the discovery of X rays by Roentgen in
1895 and the production of the first clinical radiograph soon after, the basic princi-
ple of radiography has remained unchanged, that is the production of an image on a
169
170 REHANI
receptor film by a beam of X rays having undergone differential attenuation in a body.

However, the major change has been witnessed in patient dose, which has been
reduced by a factor of 100 or more.
2. MANAGING PATIENT DOSE
The factors responsible for managing patient dose are:
— Developments in equipment and accessories,

— Techniques,
— Referrals,
— Education and training,
— Dosimetry,
— Quality criteria and reference dose levels.
These are discussed below.
2.1. Equipment and accessories
The technical development responsible for the most significant contribution to

patient dose reduction has been the intensifying screen. From direct film radiography
to modern rare earth phosphors (typically oxysulphides or oxybromides of gadolin-
ium and lanthanum), dose reductions of a factor of 15 to 500 have been made possi-
ble, depending upon the type of screen and film used. Rare earth screens have three
to five times better dose efficiency as compared with calcium tungstate screens, which
are still in common use in many countries even though they have been replaced in
many others. The spectral sensitivity of a film should match the emission spectrum of
the intensifying screen used. Any mismatch means financial losses in addition to
increased radiation doses to patients. A fact that may not be sufficiently well known
is that rare earth intensifying screens with emissions in the blue range are available
for use with the films currently used. There is thus an immediate scope for dose
reduction in many countries by switching over to rare earth screens. Reduction of
patient exposure may imply reduced loads on X ray tubes, which will result in the
lengthening of tube life; this, in the long term, may compensate for the extra costs of
the rare earth screens. As computed tomography (CT) and other advanced imaging
modalities is uncommon in many countries whose infrastructure is less well devel-
oped, the collective dose and individual patient dose reduction by a one time invest-
ment of a switchover to rare earth screens is phenomenal.
Equipment with unsatisfactory safety and quality features is sometimes sup-
plied to some countries whose infrastructure is less well developed for testing.
GENERAL RADIOLOGY 171
Registration of diagnostic X ray machines may not have started in many countries and
may not be complete in many others. There is hence a genuine need and demand for
registration as radiotherapy and nuclear medicine services are reasonably well con-
trolled, whereas radiology is not. Type approval of X ray machines and registration is
an efficient method of ensuring conformity to specifications and should be incorpo-
rated into a country’s regulatory framework.
The author’s experience of testing new X ray equipment suggests that over 80%
of the time new machines have malfunctions in one or more of their radiological para-
meters, including kilovoltage, timing, beam congruence and centring, and mil-
liampere second linearity of some of their mechanical parameters. Since acceptance
testing is widely practiced at the author’s institution it was possible to detect such
malfunctions. If no acceptance testing is carried out, there is a four in five chance of
starting with a poorly functioning unit.
It is common practice to see equipment older than ten years in use in many
countries that has not been properly maintained, especially in those countries with
less resources and less maintenance infrastructure. Much of this equipment functions
only partially, with, for example, a light source for a collimator either not functioning
or malfunctioning; this can lead to unnecessary exposures. It is very common to find
that no quality control checks are carried out during the lifetime of a machine span-
ning 10 years or more. Stronger emphasis needs to be placed on maintenance policy,
the benefits of which outweigh the economic considerations.
Filters in X ray tubes play a very important role in cutting down low energy X
rays. In the past, the onus of setting appropriate filters into X ray beams was on the
users, which could result in situations where they miss adding them correctly, thus
resulting in the delivery of fairly high doses to patients. Currently, manufacturers have
to provide a minimum fixed filtration, which should be permanently in the beam, plus
add on filters for operators to choose in specific circumstances. Since there is much
non-standard equipment available in many countries, there is a need for users to check
the filtration and not take it for granted. The minimum total filtration recommended
for a diagnostic X ray unit operating at up to 100 kV is 2.00 mm of Al and for 100 to
150 kV it is 2.5 mm of Al.
Changing some of the accessories may result in a patient dose reduction.
Considerable attention has been given to the introduction of carbon fibres in table
tops. Typically, the mean value of per cent transmission [2] for a table is 82% (range
74–89%), 89% for a carbon fibre table top and 95% (range 81–98%) for a mattress.
When deciding on priorities for change, it is important to assess the impact of any
potential modification in terms of both patient dose and cost. Unless the new equip-
ment to be purchased is replacing that of some age, the expected dose saving will
vary between 6 and 1% [3]. Such dose savings may not receive a high ranking in a
cost effectiveness analysis, except in paediatric examinations involving lower kilo-
voltages.
172 REHANI
2.2. Technique
The radiological technique should be selected so that only the desired area is in
the field of view, using the appropriate exposure factors of, for example, kilovoltage,
milliampere seconds, target to skin distance, air gap, angulation, instructions to
patients on breath holding, proper labelling or film annotation. The principle of
ALARA (as low as reasonably achievable) applies here. Repeat rates between 10 and
30% have been reported [4, 5] and should be reduced by quality control procedures
involving equipment and staff. The economic implications of retakes are enormous,
so much so that the savings accrued on reducing retakes can provide the salary of half
of the staff strength of an X ray department. The experience of monthly quality con-
trol checks for many years on routine radiography equipment indicates that for one
third of the time malfunctions were observed [6]. This implies that if film is overex-
posed it may be that the kilovoltage delivered by the generator is higher by, for exam-
ple, 20% or if an important part of the body has been excluded in an image it may be
due to a shift in the light field from the radiation field. Examples of organs that should
be shielded by collimators but commonly found to be in the path of the primary beam
include the thyroid gland in both chest and skull imaging, the inclusion of both arms
in baby trunk imaging and the inclusion of the abdominal organs (the liver, spleen and
kidneys in particular) in baby chest imaging. Even if operators use their best judg-
ment in choosing exposure parameters, malfunctions in the machine may be respon-
sible. Similarly, if the equipment is working perfectly but is improperly used, poor
quality images may be obtained. Handling and processing of film, particularly where
manual film processing is involved, constitute by far the greatest contributor to poor
quality images and thus to retakes. A study indicates that 52% of poor quality images
were due to handling and processing; this went down to 5% on switching over to auto-
matic film processing [5]. Maintenance of film processors is essential to avoid roller
marks and other faults.
Raising tube potential by 10 kV in lumber and thoracic spine examinations
results in a 26 to 36% reduction in the entrance dose and a 20 to 25% reduction in the
effective dose [7].
Exposing the wrong patient or the wrong part of the body is not an uncommon
occurrence that often goes unreported. Besides radiation protection issues, this aspect
can mar the reputation of a facility and organization and can have serious implica-
tions. Extreme precaution must be taken to avoid such occurrences.
2.3. Referrals
A useful radiological investigation adds confidence to a clinician’s diagnosis or

will alter a patient’s management; however, a report in the British Medical Journal
indicates that a fifth of radiographic examinations carried out in Britain are clinically
unhelpful [8]. The situation in most other countries is unlikely to be different.

Elimination of such examinations would result in a potential saving of collective
dose. The Royal College of Radiologists has published a booklet, Making the Best
Use of a Department of Clinical Radiology [9], which gives guidelines intended to be
used by hospital doctors and general practitioners alike. The continued use of recom-
mendations of this kind leads to a reduction in the number of referrals for investiga-
tions and also to a reduction in medical radiation exposures [10–13]. Evidence based
medicine is becoming an accepted practice, along with evidence based radiology [14]
and clinical audits in radiology [15].
2.4. Education and Training
There is a statutory requirement in some countries for all those clinically or

physically directing medical radiation exposures to have received adequate training
[16, 17]. The Basic Safety Standards [18] also stipulate that training criteria be spec-
ified. The role played by training and education must be emphasized when it comes
to the dose reductions possible in the hands of operators, developing expertise to
advise manufacturers, making the right choice of equipment at the time of purchase
and spreading a culture of radiation protection among colleagues. Experience shows
that a substantial (nearly 40%) dose reduction is achievable by training staff in using
simple methods of information dissemination [19]. Training has an important place in
fluoroscopy.
2.5. Dosimetry
Knowledge of the radiation doses imparted is essential to achieve dose reduction.

There is a need to develop a dosimetry protocol in diagnostic radiology that will be
internationally acceptable. The dose quantities recommended for diagnostic work are:
— The entrance dose measured on the surface of a patient in the middle of an inci-
dent X ray beam for individual radiographs, or
— The cumulative dose–area product for complete examinations in fluoroscopy.
Measurements are made on a representative sample of patients for a particular

type of radiographic examination and the mean value is taken as a measure of the typ-
ical dose delivered to an average adult patient at that hospital. These directly mea-
sured doses can be compared with national reference levels to provide a useful indi-
cation of relative performance with respect to patient protection. However, such mea-
surements cannot be readily compared with the radiation doses from other diagnostic
procedures, such as CT or nuclear medicine, that are measured in a different way and
result in different dose distributions within a body. Nor can they be directly related to
174 REHANI
the radiation risk for a patient, for which the effective dose is probably the most rel-
evant quantity in which to express and compare the dose given. A number of national
surveys have revealed that the doses used by different hospitals for the same types of
X ray examination vary widely [20, 21]. Based on this knowledge, national protocols
for dose measurements have been developed in some countries. The protocols allow
X ray departments to compare their own performance against national norms and to
decide whether action is needed to reduce the doses given. An exciting example is the
reduction by about 30% in the mean doses observed in a 1995 survey in the United
Kingdom as compared with those in a survey 10 years before [22]. For many non-CT
examinations the new typical doses were between 25 and 60% lower, whereas for
abdominal and pelvic CT examinations they were about 35% higher. Table I lists
guidance levels for diagnostic examinations as given by the IAEA, the Commission
for the European Communities, the National Radiological Protection Board (NRPB)
of the UK and the Center for Devices and Radiological Health of the United States of
America. With wide ranges in dose evident between different hospitals, there is no
justification for quoting the typical effective dose to more than one or two significant
figures. Patient doses can be compared with guidance levels to get an idea of if doses
TABLE I. GUIDANCE LEVELS AS PRESCRIBED BY VARIOUS AGENCIES

FOR DIAGNOSTIC RADIOLOGICAL EXAMINATIONS
CDRH
NRPB BSS
Radiograph Procection CEC [25] median value
[20] [18]
[21]
Chest PA 0.3 0.17 0.3 0.4
LAT 1.5 — 1.5 1.5
Abdomen AP 5.6 10 10
Pelvis/hip AP 10 — 10 10
Skull AP/PA 5 — 5 5
LAT 3 1.6 3 3
Cervical spine AP — 1.5 — —
LAT — — — —
Thoracic spine AP — — 7 7
Lumber spine AP 10 6.4 10 10
LAT 30 — 30 30
Note: CEC — Commission for the European Communities; CDRH — Centre for Devices and
Radiological Health; NRPB — National Radiological Protection Board; BSS — Basic Safety Standards;
PA — posterioanterior; AP — anteroposterior; LAT — lateral.
are on the high side. Each country is encouraged to develop its guidance level based
on nationwide data collection. The conversion coefficients to estimate the effective
dose to a standard adult patient from the entrance surface dose and the dose–area
product are available for a wide range of common diagnostic X ray procedures [23],
as are also computer programs such as the one from the NRPB (X-dose). One study
estimates effective dose from dose–area products within 30% of the value obtained
using specific organ doses [24].
Often, no information is available on doses imparted to patients, and hence
there is a need to ensure that this information is available.
2.6. Quality criteria and reference dose levels
In order to achieve an adequate image quality at a reasonably low dose, the

Commission for the European Communities has suggested image criteria, criteria for
radiation doses to patients and examples of good radiographic technique [25]. To
encourage their widespread use, the image criteria have been expressed in a manner
that requires personal visual assessments rather than the objective physical measure-
ments that need the type of sophisticated equipment unavailable to most X ray depart-
ments. However, the assessment of compliance with the criteria for the radiation dose
to a patient for a specific radiograph unavoidably involves some form of dose mea-
surement. This requires a representative sampling of the patient population. A method
to grade the image quality that can be used to compare two techniques or interven-
tions for dose reduction has recently been proposed [26].
Regulatory authorities should create provision for obtaining periodic reports
from users on image quality, quality assurance activities and patient dose.
3. FLUOROSCOPY
Many fluoroscopy units use conventional systems without image intensifiers,

that is darkroom systems rather than daylight ones, especially in countries with fewer
resources to replace them. Hundreds of such systems are sold every year in many
countries. Some of the older systems have lenses for optical intensification. Image
intensified fluoroscopy is finding a place in teaching and corporate hospitals, in par-
ticular for cine angiography for cardiac examinations. Barium examinations form the
major part of the workload in many countries, followed by hysterosalpingography,
sinography and fistulography. Chest fluoroscopy is still used even though it is associ-
ated with large radiation doses and low diagnostic yields; surprisingly it is used as a
cost saving method in many countries where film is unavailable. The cost of uninten-
sified fluoroscopy systems is almost half or even one third that of image intensified
systems, which has been responsible for its continued preference in situations of
176 REHANI
financial stringency. Despite recommendations against the use of unintensified fluo-

roscopy, the market demand for lower cost systems has resulted in the continued pro-
duction and sale of such units. The national regulatory authorities should deal with
ministries of health and other bodies to implement the recommendation of the IAEA
for the switchover to image intensified fluoroscopy in a phased manner. Considering
the two- to threefold milliampere second reduction in image intensified fluoroscopy,
coupled with the shorter fluoroscopy times, the action of national authorities has
implications in the management of patient dose.
Further, it is not uncommon to find radiographers performing fluoroscopic
examinations in some countries. Invariably, these radiographers will not be gradu-
ates and will have only undergone on the job training, or in better situations have
taken a certificate or diploma course. Under such circumstances deterministic skin
injuries, particularly to the hands of operators (radiographers), are a possibility and
have been observed even though not reported. Owing to financial difficulties, pro-
tective lead aprons are lacking in many X ray departments in some countries. Lead
aprons can cut down radiation exposures to staff by more than 85% at a trivial cost
compared with many other expenses in a hospital, hence it is vital that the necessary
funds for them for persons engaged in fluoroscopy are provided. Modern digital spot
imaging fluoroscopy systems yield substantial dose reductions. Training and educa-
tion has an important role as untrained operators/doctors often take longer by a fac-
tor of two to three as compared with trained operators.
4. NEW DEVELOPMENTS
In X ray technology film screen systems are increasingly being replaced by new
image detector types such as storage phosphors, selenium cylinders or silicon flat
panel image detectors. The time consuming process of film development, which is
often sensitive to disturbances, is thereby eliminated, and the disadvantages of film
screen system fog at low doses and a shoulder at high doses are also avoided. X ray
quanta are converted with a very good efficiency to electrical signals and are imme-
diately digitized.
More recently, reports have appeared repeatedly about new types of X ray
detectors that are supposed to be capable of reducing doses by several orders of mag-
nitude. Such a saving, though, is only possible at the cost of images based on large
pixels, for which it is then no longer possible subsequently to improve the definition.
Thus producing, for example, an X ray image with a pixel size of 1 mm instead of
100 mm means that 100 times as many quanta are incident on the larger pixel area,
so that either the signal to noise ratio is ten times better or the dose can be reduced by
a factor of 100 while maintaining the same signal to noise ratio. Such an effect, how-
ever, does not require a new detector: since the eye averages over the image surface,
it is possible with existing systems to make exposures with reduced doses when it is
a question of recognizing only coarse details.
In the past, patient dose has never been a major issue with users or buyers of
equipment and thus the market did not demand it from manufacturers. With increas-
ing awareness there is a greater realization, and thus the demand is growing. One
manufacturer, having taken advantage of this situation, has named its product
LODOX, that is low dose X ray equipment. This digital equipment is aimed specifi-
cally at the needs of emergency medical centres.
REFERENCES
[1] UNITED NATIONS, Sources and Effects of Ionizing Radiation (Report to the General
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mattresses (correspondence), Br. J. Radiol. 69 (1996) 283–284.
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using low attenuation materials in table tops, Br. J. Radiol. 69 (1996) 249–255.
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[7] MARTIN, C.J., DARRAGH, C.L., MCKENZIE, G.A., BAYLISS, A.P., Implementation
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increases in tube potential, Br. J. Radiol. 66 (1993) 228–233.
[8] GIFFORD, D., Reducing radiation exposure of patients, Br. Med. J. 301 (1990)
451–452.
[9] ROYAL COLLEGE OF RADIOLOGISTS, Making the Best Use of a Department of
Clinical Radiology: Guidelines for Doctors, 4th edn, RCR, London (1998).
[10] MATTHEWS, I.P., ROBERTS, C.J., ROBERTS, G.M., FIELD, S., BRINDLE, M.J.,
Guidelines for the choice of radiographic projections: the need to define policy, assume
responsibility and assure compliance, Clin. Radiol. 49 (1994) 535–536
[11] NATIONAL RADIOLOGICAL PROTECTION BOARD, ROYAL COLLEGE OF
RADIOLOGISTS, Patient Dose Reduction in Diagnostic Radiology, Documents of the
NRPB, Vol. 1, No. 3, HMSO, London (1990).
[12] ROYAL COLLEGE OF RADIOLOGISTS WORKING PARTY, Influence of the Royal
College of Radiologists’ guidelines on hospital practice: a multi-centre study, Br. Med.
J. 303 (1992) 740–743.
[13] ROBERTS, C.J., The Royal College of Radiologists Multicentre Guideline Study: impli-
cations for clinical practice, Clin. Radiol. 45 (1992) 365–368.
[14] DIXON, A.K., Evidence based radiology, Lancet 350 (1997) 509–12.
178 REHANI
[15] GODWIN, R., DE LACEY, G., MANHIRE, A. (Eds), Clinical Audit in Radiology,
Royal College of Radiologists, London (1996).
[16] WALL, B.F., HART, D., Revised radiation doses for typical x-ray examinations, Br. J.
Radiol. 70 (1997) 437–439
[17] The Ionising Radiation (Protection of Persons Undergoing Medical Examination or
Treatment) Regulations 1988, HMSO, London (1988).
HEALTH ORGANIZATION, WOLRD HEALTH ORGANIZATION, International
[19] REHANI, M.M., KAUL, R., KUMAR, P., BERRY, M., Does bridging the gap between
knowledge and practice help? Example of patient dose reduction in radiology, J. Med.
Phys. 20 (1995) 18–22
[20] NATIONAL RADIOLOGICAL PROTECTION BOARD, INSTITUTE OF PHYSICAL
SCIENCES IN MEDICINE, COLLEGE OF RADIOGRAPHERS, National Protocol for
Patient Dose Measurements in Diagnostic Radiology, NRPB, Didcot (1992).
[21] UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD
AND DRUG ADMINISTRATION, CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH, Nationwide Evaluation of X-ray Trends (NEXT), CDRH, Washington, DC
(1984).
Patients from Medical X-ray Examinations in the UK: 1995 Review, NRPB-R289,
National Radiological Protection Board, Didcot (1996)
[23] HART, D., JONES, D.G., WALL, B.F., Estimation of Effective Dose in Diagnsotic
Radiology from Entrance Surface Dose and Dose-Area Product Measurements, NRPB-
R262, National Radiological Protection Board, Didcot (1994).
[24] LE HERON, J.C., Estimation of effective dose to the patient during medical x-ray exam-
inations from measurement of the dose-area product, Phys. Med. Biol. 37 (1992)
2117–2126.
[25] STIEVE, F.E., “Radiological requirements for the specification of image quality crite-
ria”, Optimization of Image Quality and Patient Exposure in Diagnostic Radiology
(Workshop Oxford, 1988), BIR Rep. 20 (MOORES, B.M., et al. Eds), British Institute
of Radiology, London (1989) 221–238.
[26] REHANI, M.M., RAO, K., KUMAR, P., BERRY, M., Grading imaging quality in chest
radiography, Ind. J. Radiol. Imag. 4 (1994) 27–30.
DISCUSSION
C.G. STANDERTSKJÖLD-NORDENSTAM: Perhaps M.M. Rehani could say

a few words about the reliability of dose measurements.
M.M. REHANI: This is an important aspect of IAEA co-ordinated research
projects such as the one on radiation protection in diagnostic radiology referred to in
paper IAEA-CN-85-81.1 The dose estimates of all the participants in that project will
be standardized by one participating laboratory, such as the one in New Zealand, so
that there is then a comparative table taking care of the various factors.
Where there is no such project the facilities for calibrating diagnostic radiology
dosimetry equipment may not exist. This is a need that must be met.
E. VAÑÓ CARRUANA: In general diagnostic radiology the training of pre-
scribers is a very important issue from the point of view of patient protection. I hope
it will receive due emphasis in the conclusions of this conference.
In commenting on paper IAEA-CN-85-157, which is about the evaluation of
the dosimetric performance characteristics of fluoroscopy systems used in medicine,
M.M. Rehani stated that some quantities represented equipment characteristics and
outpatient doses, especially for fluoroscopy examinations. Patient dose evaluation in
fluoroscopy examinations is important and should receive due emphasis, since peo-
ple sometimes only compare the characteristics of fluoroscopy systems with the
IAEA guidance levels or some other published references, and that is not enough for
the protection of patients or for the formulation of advice on the verification of clin-
ical practices.
O.W. LINTON: Various ways of improving radiography have been proposed. In
my opinion, the most important thing is paying attention to the problem.
C.G. STANDERTSKJÖLD-NORDENSTAM: I agree. That is a question of
training, including the training of prescribers. Regulations are important, but the key
issue is how to implement them in practice.
K. FAULKNER: Given the cost pressures on health care budgets, is there not a
case for using calculational methods in patient dosimetry, rather than physically car-
rying out the measurements, which is more expensive?
M.M. REHANI: Yes, but one needs to carry out some measurements at some
stage. For example, the radiation output of an X ray machine varies significantly, so
at least that has to be measured.
We compared the radiation outputs of 15 machines for the purpose of develop-
ing a computer program where we could feed in the kilovoltage (peak) and focus–skin
distance and obtain the radiation output. However, we found that the filtration value
was crucial; the total filtration of the X ray machine has to be measured.
However, calculational methods can replace measurements to some extent.
H. OSTENSEN: What, in M.M. Rehani’s view, are the best ways of improving
the radiological protection of patients in countries with very scarce resources?
1 All paper numbers refer to papers in Radiological Protection of Patients in

Interventional Radiology, Nuclear Medicine and Radiotherapy, Contributed Papers, C&S
Papers Series 7/P, IAEA, Vienna (2001).
180 REHANI
M.M. REHANI: Firstly, the improvement of education and training. Secondly,

upgrading of the technology used in radiography, for example switching to rare earth
screens.
A.F. ALMARI: Could M.M. Rehani say something about the export of used
equipment from advanced to developing countries and the associated radiation hazards?
M.M. REHANI: The export of used X ray and teletherapy machines has been
going on to some extent for a number of years. X ray machines are safe enough as
they do not generate radiation until they are switched on, and there have not been
many problems with teletherapy machines.
Some developing countries do not want used equipment even if they cannot
afford new equipment, and their import procedures are correspondingly complex;
sometimes used equipment is held up at airports or seaports for many months.
Complex import procedures can also delay the importation of items other than
used equipment. In one developing country that I know of imported molybdenum
generator kits took 15 days to be cleared through the airport, so that when they arrived
at where they were to be used there was not enough activity for even one patient.
P. ORTIZ-LÓPEZ: I had the impression from something M.M. Rehani said that,
in his view, diagnostic equipment that is over ten years old should not continue in use.
In my view, even diagnostic equipment as much as 15 years old is perfectly accept-
able as regards safety and image quality if it has undergone reasonable maintenance
and there has been some minimum of quality assurance. That does not apply, of
course, to interventional radiology equipment.
M.M. REHANI: I was referring to a paper whose authors stated that with equip-
ment over three years old they had difficulty in meeting the dose specifications, and
I said that in my view there need not be such difficulties with old equipment.
What is the difference between old and new equipment? When there is a dif-
ference, it is usually that some part of the old equipment is not functioning properly,
for example the diaphragm is not opening and closing accurately; there is nothing
wrong with the radiation output. The problems with old equipment tend to be
mechanical, and they can be avoided or overcome through good maintenance.
P.A. KAPLANIS: A major problem with fluoroscopy examinations is the fact
that different operators take different amounts of time to perform them; the times can
differ very markedly.
M.M. REHANI: I agree that it is a major problem. The only solution is better
eduction and training.
RADIOLOGICAL PROTECTION ISSUES
IN SPECIFIC USES OF DIAGNOSTIC RADIOLOGY
(Topical Session 2)
Chairperson
G. KLEMPFNER
Australia
RADIOLOGICAL PROTECTION ISSUES IN
MAMMOGRAPHY AND COMPUTED TOMOGRAPHY
J.E. GRAY
Mayo Graduate School of Medicine,
Rochester, Minnesota, United States of America
Lorad Medical Corporation,
Danbury, Connecticut, United States of America
E-mail: jgray@loradmedical.com
Abstract
The history of mammography and computed tomography (CT) is briefly reviewed and
typical radiation doses are discussed. Patient protection issues in mammography are limited
and handled well in countries with mammography regulatory or certification programmes.
Both patient dose and image quality must be monitored through quality control programmes.
CT is a high dose procedure, a point which is not clearly understood by physicians,
radiologists, medical physicists or radiographers. It is essential to undertake an extensive
programme of CT dose reduction. Eight factors affecting the radiation dose to CT patients are
discussed as well as the fact that most facilities use the same technical factors regardless of
patient size or the body part being imaged. Many new techniques or applications of CT will
increase doses to patients and staff. Radiology staff must take the appropriate steps to minimize
their doses during CT procedures. In order to optimize CT doses it is essential to educate all
medical personnel on the high dose potential of CT, and inform them that they should make
every effort to reduce CT doses to a level as low as reasonably achievable, that they should
assure that all CT scanners are equipped with automatic exposure control equipment and that
they should address the eight factors affecting radiation doses to patients. It is essential that
medical imaging professionals remain in the forefront of the technology being applied in
mammography and CT.
1. RADIOLOGICAL PROTECTION ISSUES IN MAMMOGRAPHY
1.1. Introduction
Mammography is the imaging of the breast used for the diagnosis of breast
cancer or other conditions. It is a highly specialized form of radiographic imaging
using low energy X rays at 25 to 28 kVp. Since a molybdenum (Mo) X ray tube anode
and filter are used the X ray spectrum is predominated by the Mo characteristic
radiation occurring between 17.4 to 19.6 keV. This extremely low energy spectrum
provides an image with a relatively high contrast, which is required since the
183
184 GRAY
difference in absorption coefficients of fat or glandular tissue and that of malignant

tissue is quite small. However, this low energy radiation is readily absorbed by breast
tissue, resulting in relatively high radiation doses — the half value layer in tissue for
the typical mammographic spectrum is approximately 1 cm.
Mammography also uses a specialized screen film imaging system. Unlike
most radiographic imaging systems, which use two intensifying screens and a dual
emulsion film, mammography uses a single, thin intensifying screen and a single
emulsion film. This optimized screen film system assures that the image sharpness is
maximized, with a resolution of approximately 15 to 20 cycles/millimetre (c/mm),
compared with approximately 5 c/mm with conventional radiographic screen film
imaging systems.
Major advances have been made in mammographic imaging since the mid-
1970s in both image quality and patient dose. Before that time breast imaging was
carried out with a tungsten target X ray tube using aluminum filtration at approxi-
mately 35 kVp. The higher energy radiation produced images of very low contrast.
Industrial X ray film was used as the primary image receptor, resulting in high patient
radiation doses; for example, entrance skin doses were approximately 0.1 Gy and
higher. It was difficult to visualize pathology in the breast much smaller than a few
centimetres in extent. Microcalcifications, a major indicator of malignant disease,
were not visible.
Another system that was used during this era was xeromammography. This
approach used a selenium image receptor that produced an image in a manner similar
to most photocopiers today. Xeromammography had the ability to image microcalci-
fications, and the radiation doses were reduced to about 0.03 Gy. However, this
imaging process was mechanically unreliable.
Single screen, single emulsion image receptors were introduced in 1972,
but were not used widely until the introduction of dedicated mammography equip-
ment using a Mo–Mo anode–filter combination. The combination of new screen
film image receptors, dedicated mammography equipment and Mo–Mo anode–
filter combinations resulted in a high contrast imaging system. The system is
capable of imaging microcalcifications and lesions less than 1 cm in size, there-
by allowing for the early detection of breast cancer, often while it is still
localized. Screen film mammography systems require an entrance dose of about
0.01 Gy.
Full field digital mammography is the most recent technological advance in
mammographic imaging. The full field detectors utilize the dedicated mammographic
equipment and Mo–Mo anode–filter combination but replace the detector with a large
area digital detector. Patient doses with digital mammography are similar to those
obtained with screen film imaging. The primary advantage of digital mammography
is the long dynamic range of the detector and the ability to postprocess the image to
enhance the information present.
MAMMOGRAPHY AND COMPUTED TOMOGRAPHY 185
1.2. Screening versus diagnostic mammography
Most radiographic imaging is carried out for diagnostic purposes; that is, a
problem is suspected by a physician. This problem is then evaluated using X ray
imaging. For example, there may be a palpable lump in a patient’s breast.
Mammography can be used to determine the characteristics of this lump and, perhaps,
determine if the lump is a benign cyst or cancerous tumour.
Screening uses X ray imaging techniques to examine individuals without sus-
pected problems, usually a group that may be at a higher risk for disease than the
majority of the population. Most countries acknowledge the need for mammographic
screening of women over 50 years of age since they are at an increased risk for devel-
oping breast cancer. If these cancers can be located when they are still small, for
example less than 1 cm, then it is often possible to remove the lump and prevent its
growth or spread to other areas of the body. Since tumours of this size would not be
palpable, these individuals are considered to be asymptomatic. Examinations of
asymptomatic persons are screening examinations. Another example of screening
examinations is the chest X rays widely used in the 1950s to screen for tuberculosis.
1.3. Mammography regulations, accreditation and other requirements
Mammography is highly regulated today in Australia, Canada, Europe and the

United States of America. In fact, mammography is probably the most regulated
medical procedure in the world today. For example, in the USA the Food and Drug
Administration (FDA) has published extensive regulations that include dose limits
(no more than 0.003 Gy mean glandular dose), image quality standards, quality con-
trol requirements, minimum training and experience standards, and continuing edu-
cation requirements for personnel involved in mammographic imaging.
There are two bodies involved in the oversight of mammography in the USA.
Accrediting bodies such as the American College of Radiology provide accreditation
for mammography facilities. Once a facility is accredited it can then be certified
by the FDA. In this scenario the FDA has oversight of the entire process, but relies
on other organizations for the actual evaluation of image quality and other standards
at the mammography facilities. (The accrediting bodies are not necessarily profes-
sional, peer review organizations. They may also be state radiation protection
agencies.)
All countries with regulations regarding mammographic imaging specify
maximum radiation doses (usually 0.002 to 0.003 Gy mean glandular dose per view
— the mean glandular dose is approximately 10 to 12% of the entrance skin dose). In
addition, image quality standards have also been established. Consequently, in
countries with active regulatory or accreditation programmes radiation doses and
image qualities have been optimized, and there are few problems to be considered.
186 GRAY
1.4. Digital mammography
Digital mammography is the latest technology to be applied to breast imaging.

However, its acceptance has been limited primarily owing to the high cost of this
technology. A conventional mammographic system costs about US $80 000, com-
pared with the cost of a digital mammography system of approximately US $400 000.
Furthermore, digital mammography has not been shown to provide any significant
benefits over screen film mammography that might help justify the added cost of the
system.
The resolution of digital mammography is lower than that of screen film mam-
mography. However, the low frequency contrast of digital mammography is superior
to that of screen film systems. The ability to absorb radiation and produce quality
images, quantified by the detective quantum efficiency, is superior to that of screen
film systems. Digital mammography does offer the potential for other approaches to
imaging the breast, including tomosynthesis, dual energy imaging (to provide better
images of microcalcifications) and subtraction imaging. It also offers the potential for
lower doses through the use of different anode and filter materials and the use of a
higher kilovoltage (peak).
Digital mammography has one potential weakness — it offers the possibility of
almost unlimited radiation doses to patients. The dose to a patient is limited with
screen film imaging by the fact that if the dose is increased significantly the film will
be too dark to be usable. Digital mammography uses a detector with a much broader
dynamic range. Consequently, it is possible to record a digital mammographic image
with much higher doses than would be useful in screen film mammography, for exam-
ple two to four times higher or more. In fact, these higher doses result in an even
better image quality as the appearance of quantum mottle, or noise, is eliminated from
the image.
1.5. Patient protection issues in mammography
There are few, if any, radiation protection issues in those countries with active
mammography regulatory or accreditation programmes. Similar approaches should
be applied in other countries to bring mammographic imaging to the same standard
throughout the world in terms of both radiation protection, that is the dose to a patient,
and, more importantly, the quality of mammographic images. Unfortunately, it has
been the experience in the countries with active regulatory or accreditation pro-
grammes that voluntary programmes are not effective. It is apparent that optimized
doses and image qualities can only be obtained in mammography when oversight
programmes are put in place by regulatory bodies.
Digital mammography presents a potential problem owing to its ability to
record quality images at high radiation doses. Consequently, it is essential to monitor
doses to patients in facilities where digital mammography is used. (It is possible for
digital mammography equipment to provide an estimate of the patient dose for each
image. This data can be entered into a database by the digital mammography system
for review by the user at a future date.) Only through such monitoring can one assure
that doses to patients do not increase over time. In addition, it is necessary to moni-
tor image quality to assure optimum quality diagnostic information for the best care
of patients.
1.6. Staff protection issues
The staff protection issues in mammography are rather minimal owing to the
low energy of the radiation and the small scatter volume. Shielding requirements can
readily be met in most cases with two layers of drywall or gypsum board, owing to
the low energy of the mammography spectrum and the high calcium content of dry-
wall or gypsum board.
The amount of radiation scattered from the breast is quite low owing to the low
energy of the spectrum and the small volume of tissue being irradiated. Even in small
mammographic examination rooms, for example 2 × 2 m, the amount of scattered
radiation reaching the walls is quite low. Only walls in direct line of sight of the breast
volume irradiated need to be considered for shielding purposes. The X ray equipment
itself provides significant protection from scattered radiation and the patient’s body
absorbs virtually all the radiation scattered in that direction.
1.7. What must be done?
As noted earlier, doses to patients and image quality must be monitored through
quality control programmes. Patient dose is important, especially in digital
mammography where virtually unlimited doses can be used to produce diagnostically
acceptable images. However, as in all diagnostic imaging, image quality is of
paramount importance. If quality images are not produced then the radiation dose
received by a patient does not provide the benefit necessary to outweigh the risk
associated with a radiation dose.
2. RADIOLOGICAL PROTECTION ISSUES IN COMPUTED

TOMOGRAPHY
2.1. Introduction
Computed tomography (CT) was introduced to the diagnostic imaging

community in 1972 and has been one of the most significant advances in medical
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imaging since the discovery of X rays by Roentgen in 1895. Projection imaging is

used in most examinations in conventional diagnostic radiology. This superimposes
many structures on top of one another. For example, in a chest X ray image the ribs
are superimposed on vascular structures, which are both superimposed on the lung
parenchyma. This superimposition makes detecting differences in one type of struc-
ture difficult. If one is looking for lung cancer then the ribs and vascular structures
tend to obscure the parenchyma and small tumours associated with it. However, if one
is looking for a rib fracture the lung parenchyma and vascular structures obscure
subtle, but important, differences in the bone.
CT eliminated the superimposition of structures by ‘slicing’ the body perpen-
dicular to its long axis in slices 1 cm thick, or thinner, such as one slices a loaf of
bread. This allows the clear visualization of all structures in the chest without any
superimposition of other structures. CT provides a view of the body that has almost
completely eliminated the need for exploratory surgery and allows one to visualize
small, low contrast details that are invisible through any other X ray imaging
modality.
2.2. CT is a high dose procedure
A study at a large, tertiary care facility has shown that 35% of the collective
effective dose to patients is from body CT, which comprises only 5% of diagnostic
X ray examinations [1]. This was confirmed by the National Radiological Protection
Board in a more broadly based study in the United Kingdom [2]. However, most
radiologists and physicians today do not appreciate the high radiation doses received
by patients when using CT.
Many physicians are concerned about referring a 45 year old woman for a
mammogram that requires a mean glandular dose of about 2 mGy. However, they are
not concerned about referring a young woman, perhaps a teenager, for a chest CT
where the breast dose is of the order of 40 mGy or higher. In fact, many chest CT
protocols require images without and with contrast, so the breast dose could be
80 mGy or higher — at least 40 times higher than that used for mammography. Most
importantly, the risk of radiogenic breast cancer is 15 times higher for a 15 year old
as compared with a 45 year old.
Effective doses for CT are significantly higher than for most other radiological
examinations (Table I). In fact, effective doses for CT are similar to those used for
interventional procedures, which are recognized as very high dose procedures. There
are limitations of the effective dose as a dose quantity in diagnostic radiology where
the exposures are localized to a specific region or part of the body. The United
Nations Scientific Committee on the Effects of Atomic Radiation stresses this and this
must be kept in mind while relating dose to the biological effects or risks of diagnos-
tic exposures. In addition, it should be stressed that the risk of diagnostic exposures
TABLE I. EFFECTIVE DOSES FOR CT AND COMMON X RAY

EXAMINATIONSa
Male effective Female effective

Examination
dose (mSv) dose (mSv)
Chest, anteroposterior and lateral 0.04 0.07
Lumbar spine, anteroposterior and 0.25 0.40
lateral
Thoracic and lumbar spine, 0.60 1.10
anteroposterior and lateral
CT, head 0.60 0.60
Upper gastrointestinal 1.30 1.70
Barium enema 2.00 3.70
Cardiac catheterization 6.90 7.40
CT, abdomen and pelvis 11.20 9.80
CT, chest 14.80 28.60
CT, kidneys 24.30 26.50
a Unpublished data as derived by the author.
is usually offset by the benefit of that exposure received by the patient. The risks from
CT examinations as derived by the author are commensurately high, as shown in
Table II [3], assuming one accepts the linear, non-threshold hypothesis.
The radiation doses for CT noted above (see Table I) are typical of those found
nationwide in the USA [4, 5]. The entrance doses for body CT in a recent survey in
Pennsylvania of 105 CT scanners ranged from 12 to 90 mGy. This means that some
facilities are using doses that are 7.5 times higher than other facilities to perform the
same examination.
2.3. CT dose reduction — its time has come
CT dose reduction is not a new topic in the literature [6–18]. In 1986 Lassen
[10] discussed methods of reducing CT doses for paediatric patients. However, today
most facilities have not applied the techniques of Lassen or others. Recently in the
USA the popular press reacted to three papers that appeared in the American Journal
of Roentgenology regarding doses to patients in paediatric CT [19–21]. The
American College of Radiology posted a response on its web site [22] to the articles
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TABLE II. PROBABILITY OF DEATH FROM RADIATION INDUCED CANCER

AND OTHER CAUSESa
Probability per
Activity
10 000 exposed
Smoking, one year (all causes) 30
CT of the kidneys or liver, one examination 12
Smoking, one year (only cancer) 12
Mining, one year 6
Construction, one year 4
Farming, one year 4
Cardiac catheterization, one examination 3
Driving a car, one year 2
Anaesthesiology (elderly patient), one procedure 2
Excretory urogram, one examination 2
Boating, one year 0.5
Anaesthesiology (all patients), one procedure 0.3
Hunting, one year 0.3
Anaesthesiology (outpatients), one procedure 0.2
Ionic contrast media, one examination 0.2
Anteroposterior lumbar spine, one examination 0.2
Non-ionic contrast media, one examination 0.05
Chest, anteroposterior and lateral, one examination 0.02
Commercial airline flight, one flight 0.002
a The figures are meant to give relative comparisons and are not to be used in the absolute
sense.
appearing in the lay press, such as those in USA Today; similarly, an editorial
appeared in the British Medical Journal on this topic [23]. The International
Commission on Radiological Protection (ICRP) is also addressing the issue of high
CT doses [24].
Unfortunately, the diagnostic imaging community was put in the position of
reacting to information in the lay press. This was particularly difficult since many in
the imaging community were not prepared for the questions posed by the media. The
response by the medical community, including paediatricians, was to downplay the
risks, but the data presented were difficult to refute. This experience indicates that
radiologists and medical physicists must ensure that they provide the best image
quality possible at radiation doses that are optimized for each modality. The recent
experience in the USA clearly demonstrates that the diagnostic imaging community
will be held responsible by the public for the quality of care and the radiation doses
given to patients.
2.4. Factors affecting radiation doses in CT
There are at least eight factors that affect radiation doses in CT. Most of these
are under the control of the radiologist responsible for a facility or the radiographer
operating a CT scanner. These include the following.
— Procedures are often ordered without and with contrast, which doubles the
radiation dose to a patient. It would be prudent in many cases to have an exam-
ination carried out either without or with contrast. The images should then be
reviewed by a radiologist before continuing with the CT examination, thus each
case should be judged on its own merits.
— The slice width can be selected by the radiographer from 1 mm (or less) to
10 mm or more. Thinner slices provide greater anatomical detail along the long
axis of the body but also exhibit higher noise levels for the same patient dose,
since proportionately fewer X ray photons are used to make the image. In order
to compensate for this the dose to a patient is increased. For example, using a
2 mm slice instead of a 4 mm slice requires an increase in patient dose of a fac-
tor of two to obtain the same noise level.
— Slices may be acquired contiguously, with gaps in between or overlapping.
Contiguous slices provide a complete coverage of all the anatomy present.
Imaging with small gaps can often be used when surveying large areas of the
body where clinically indicated or where there are no clinical contraindications
in terms of the possibility of missing small lesions. For example, a slice width
of 4 mm may be selected with a 1 or 2 mm space between slices. This will result
in a dose reduction to a patient of 20 to 33% with little or no loss of diagnostic
information. However, some practitioners carry out CT scans with an overlap
between slices, which results in increased doses to patients with no gain in
diagnostic information.
— Some scanning modes are not fully understood by radiographers and are
misused. For example, one manufacturer has two scanning modes called HS
and HQ, which one might infer stands for high speed and high quality. The
milliampere seconds used to produce an image are reduced when operating in
the HQ mode, so most radiographers assume that the radiation doses to patients
are reduced for this type of scan. However, there is a significant overlap of the
slices in this mode, resulting in a 33 to 300% increase in the doses to patients.
— Most facilities use the same kilovoltage (peak) and milliampere seconds
regardless of the anatomy being imaged. Typically one uses approximately a
0.15 mGy entrance dose for an anteroposterior chest radiograph and 3.0 mGy
for an anteroposterior lumbar spine, a difference of 20 times, to produce com-
parable densities on the film. In CT an entrance dose of 40 mGy, or more, may
be used at some facilities for all body parts, which is an undesirable practice.
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This means that some body parts in CT are receiving doses 20 times higher than
necessary to produce quality diagnostic images.
— Most facilities use the same technique, and dose factors, regardless of the size
of a patient. The parameters set for a 50 kg patient are the same as for a 130 kg
patient. In fact, 10 or 20 kg paediatric patients usually are scanned at the same
parameters as 50 or 130 kg patients. In many instances the images of the
130 kg patient are noisy, perhaps indicating that a higher dose may be needed
to obtain an adequate image quality. However, the images of the 10, 20 and
50 kg patients are noise free, thereby indicating that the doses to patients are
excessively high.
— X ray tube kilovoltage affects the hardness of the beam — the higher the
kilovoltage (peak) the harder the beam and the more photons that penetrate
the patient. This results in more photons at the detector and proportionately
fewer photons absorbed by the patient. In other words, one can reduce the
dose to a patient while maintaining the same noise level in the image by
increasing the kilovoltage (peak). Interestingly, some institutions have been
using a lower kilovoltage for paediatric patients, thinking that there are lower
radiation dose levels for the same milliampere seconds. However, this fails to
take into account the absorption of the photons by the body — the major
factor impacting on patient dose. The lowest doses to patients may be
possible at the highest kilovoltages (peak), assuming the milliampere sec-
onds are adjusted appropriately to yield the same noise level in an image.
Images produced at 140 kVp are likely to produce a lower patient dose
than those produced at 80 or 120 kVp, with little apparent difference in
contrast.
— Patient dose can be reduced significantly by increasing the filtration in an X ray
beam or the half value layer of the beam. Not all CT scanners use high levels
of filtration. In fact, some of them barely meet the minimum half value layer
specified by the FDA compliance regulations (3.2 mm Al at 120 kVp, which is
comparable to 2.3 mm Al at 80 kVp). Increasing the half value layer can
significantly reduce doses to patients by eliminating more of the low energy
photons that are normally absorbed by the patients. (The increased aluminum
filtration should be left in the beam for all examinations carried out on the CT
scanner. Every patient and body part can benefit from the dose reduction
obtained by increasing the half value layer.)
2.5. Surveys of radiation doses in CT
The primary survey in the USA of radiation doses is the Nationwide Evaluation
of X Ray Trends (NEXT) [4]. This survey is carried out annually by the FDA through
a contract with the Conference of Radiation Control Program Directors and the state
radiation protection agencies in the USA. This programme is funded through US

government sources and the American College of Radiology. NEXT surveys one
X ray projection each year. In 1990 a survey was carried out for head CT. Body CT
will be addressed in the near future. This survey covered 105 CT scanners in
Pennsylvania and, to date, is the only comprehensive survey of body CT practices and
doses in the USA. This survey indicates that there is significant variation in the
radiation doses used for body CT in Pennsylvania. In addition, broad variations in the
half value layers of the beams were found, even though most CT examinations are
carried out at 120 kVp.
The National Radiological Protection Board of the UK has published reports of
a survey of CT and other radiological examination doses [25, 25]; there have been
similar surveys in other countries. A 30% reduction in radiation doses was noted over
a 10 year period for conventional radiography, while an increase in radiation doses of
about 35% were found for CT of the abdomen and pelvis [26].
2.6. Single versus multislice CT
Some of the original CT scanners used in the 1970s acquired two or more slices
at a time. This was necessary owing to the long scan times (three to five minutes)
required to obtain the data to produce an image. Since that time most CT scanners use
a single slice acquisition approach. However, recently manufacturers have introduced
several multislice scanners with the ability to acquire data for up to 16 or more slices
simultaneously. This has been made possible by the high data handling capabilities of
modern computers and by the advent of X ray tubes and housings that can tolerate
high heat loads. These scanners acquire data for a single slice image in one second or
less.
Multislice CT provides the potential for significantly increased radiation doses.
Increasing heat loading capabilities means that most patients can be scanned from
head to toe without overheating the X ray tube. Consequently, larger portions of
patients are being imaged with CT scanners. In addition, the high heat load capabil-
ity makes multiple image acquisitions of the same patient easier, for example increas-
ing the use of without and with contrast CT scans.
More importantly, multislice CT uses thinner slices since these systems usually
offer the ability to reconstruct slices in other than the transaxial orientation.
Consequently, higher radiation doses are used to minimize the amount of quantum
noise in an image.
Thin slice CT produces increased radiation doses through more overlap
between slices. This is often due to the amount of penumbra around the radiation
slice. If there is a 0.5 mm penumbral area on each side of the slice with a 1 mm slice,
that means that an area twice as wide as needed is being irradiated, that is 100% of
additional area, although the radiation level in the penumbral area is lower than in the
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imaged portion of the slice. If this same 0.5 mm penumbral area is present in scans
that are 4 mm wide, then only 25% of additional area is being irradiated
Furthermore, multislice CT adds radiation dose owing to the method of acqui-
sition. Most multislice scanners acquire data using a helical scan, that is the patients
are moved along their long axis while the CT scanner is moving around them
collecting data. A CT radiographer has the ability to acquire data in many ways,
including using overlapping slices, contiguous slices or with spaces between slices.
Scan motions and scanning protocols are complex and many radiographers do not
have a thorough understanding of the consequences of selecting one scan protocol
over another. Using one mode as opposed to another can result in an increased patient
dose of the order of 33 to 300% for a virtually identical image quality, as discussed
earlier.
2.7. New applications of CT
CT is replacing conventional radiography in many areas of diagnostic imaging.

In the USA CT is being introduced in trauma centres in place of conventional
radiography. CT provides significantly more information than screen film radio-
graphy in trauma radiology, with the additional advantage that a patient does not have
to be moved to produce the different projections required for conventional radiogra-
phy. This additional information comes at a higher cost — higher doses to patients.
It has an additional benefit in the US health care system — one is reimbursed signif-
icantly more for a CT scan in a trauma centre than for screen film imaging; as much
as three times or more.
A recent innovation in medical imaging in the USA is the use of CT scans as
part of the physical examination of individuals. Some centres will carry out a
prophylactic CT scan from head to toe of an individual undergoing an annual
physical examination. This is not covered by insurance and must be paid for by the
individual. However, the lay press has reported that these examinations are benefi-
cial and has provided anecdotal evidence to support their claims and sufficient
evidence to develop a consumer demand for such imaging. Since prophylactic
CT scans are carried out on asymptomatic persons, this is considered screening
CT with little or no direct benefit to an individual to outweigh the risk of the high
radiation dose.
Another recent application of CT is the use of fast CT to estimate the amount
of coronary calcium. The amount of atherosclerosis, which contains calcium, in
coronary arteries is directly related to the progression of coronary artery disease.
Consequently, there is much interest in this procedure. However, there is significant
controversy in the literature about this procedure, which must be considered a
screening procedure since it is carried out on asymptomatic persons and provides
little or no direct benefit to the patient.
In the past the heat loading capabilities of X ray tubes limited the number of
slices acquired for a patient examination. New tubes have much higher heat load
capacities, which means that significantly more slices can be obtained without
overheating the X ray tube and housing.
Higher X ray tube heat load capabilities and shorter scan times mean that more
patients can be scanned per hour. This results in increased radiation outputs from CT
scanners and has the possibility of an increased radiation dose to diagnostic radiology
staff and hospital or clinic staff in adjacent rooms unless additional radiation shield-
ing is added between the rooms.
CT fluoroscopy is the latest technical advancement in CT. This technique offers
the potential for even higher doses than with conventional fluoroscopy. Consequently,
the risk exists for skin burns from CT fluoroscopy, similar to those from interven-
tional fluoroscopy. However, instead of a small patch of skin burned by con-
ventional fluoroscopy, CT will produce a ring burn completely around a patient’s
body.
Conventional fluoroscopy is limited to 100 mGy/min, or possibly higher in
some situations, by federal regulations in the USA. CT fluoroscopy dose rates range
from 120 to 400 mGy/min. If one assumes the threshold for an erythema is 2 Gy, then
CT fluoroscopy could produce skin burns in five minutes.
2.8. CT is a digital modality
The fact that CT is a digital modality is both a positive and negative point. As
a digital modality it offers radiologists significant potential in processing and
displaying an image. However, the fact that it is a digital modality means that CT, like
any other digital modality (computed radiography, digital radiography, full field
digital mammography, etc.), has the potential for an almost unlimited radiation dose.
Screen film imaging limits the dose to patients by the amount of film darkening.
If the dose to a patient is increased the film becomes darker. With only a relatively
small dose increase, for example a factor of two, the film is too dark for proper
diagnosis.
Digital modalities can produce diagnostic quality images with almost un-
limited radiation doses to patients since the detectors are linear over long ranges.
In addition, a computer can then manipulate the digital image to present a pleasing
image to the radiologist. There is no way of knowing what dose was used to produce
an image by looking at the image alone. Consequently, it is essential that a method be
provided by CT equipment manufacturers to allow radiologists, medical physicists
and radiographers to monitor doses to patients. Most importantly, it is essential that
these dose values be monitored on a regular basis for examinations of specific body
parts.
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2.9. CT may produce higher doses in the future
Based on potential advances in technology, CT may be capable of producing

higher doses to patients in the future. As scan speeds increase and X ray tube and
housing heat loading capacities increase, one may anticipate higher throughputs for a
single scanner and higher doses to patients for single examinations. Consequently, it
is essential that imaging professionals closely monitor CT doses to patients now and
in the future.
2.10. Staff protection issues
Any staff that must be in a CT room during a scan is at risk for receiving
high radiation doses from scattered radiation. Consequently, radiologists responsible
for CT scanner facilities should assure that no one remains in the room with a
patient unless absolutely necessary. In this case protective barriers and lead aprons
should be used. It should be stressed that CT fluoroscopy raises this potential risk
even higher owing to the exceedingly high dose rates possible. CT fluoroscopy will
require at least the radiologist to be in the room and close to the patient during the
procedure.
Lead shielding requirements must be considered carefully by a qualified
medical physicist to assure the adequate protection of personnel and patients in adja-
cent areas. Newer CT scanners can produce higher doses and have significantly
higher throughputs, thereby increasing the amount of scattered radiation produced in
the room. CT rooms are often small, with walls as close as 1 m from the patient,
especially at the back of the scanner.
CT shielding requirements should be carefully considered for floors and
ceilings, especially with the thinner concrete slabs being used in medical facility
construction today. It may be necessary to add lead shielding to floors or ceilings,
especially for scanners with high patient throughputs and for scanners dedicated to
head CT. In this latter case floor, ceiling and wall doses from scattered radiation may
be higher than anticipated since there is no body to absorb radiation along the long
axis of the patient, at least in the cranial direction.
2.11. What must be done?
First, and foremost, it is essential to educate all of those in health care about the
potential risks from high dose CT examinations. This includes referring physicians,
radiologists, medical physicists and radiographers. It must be emphasized that CT is
a high dose procedure. At the same time referring physicians and patients must be
assured that CT is a highly beneficial X ray imaging procedure and should not be
feared when the benefit of the examination clearly outweighs the risk.
Second, medical imaging professionals must make every effort to reduce

radiation doses from CT as low as reasonably achievable while assuring that impor-
tant medical diagnostic information is still available in an image. This can result in
patient dose reductions by factors of 2 to 10 or even 20 in some cases.
Third, referring physicians and radiologists must triage patients for CT
examinations, especially with respect to the use of contrast media. It may be possible
to eliminate the need for a second scan by having the radiologist review the initial
scan before proceeding with the examination.
Fourth, we must require that all CT scanners, without exception, provide full
automatic exposure control. This would tailor the radiation doses to patients based on
the patient’s size and body part being examined. Automatic exposure control is a
feature available since the 1960s in fluoroscopy and screen film imaging, and is
something we use today on all of our X ray image modalities except CT.
Fifth, each of the eight factors effecting radiation doses in CT, as noted above
and also discussed in Ref. [24], must be addressed. This will result in significant
patient dose reductions while maintaining or improving image quality.
Sixth, radiographers must be educated on the scan parameters they have
available so that they appreciate how slight changes in a scan protocol can signifi-
cantly increase or reduce a patient’s radiation dose.
Finally, medical imaging professionals must remain in the forefront of CT
imaging and be aware of the changes and advances offered by manufacturers.
Improvements in image quality or the ability to image rapidly often come at the
expense of radiation doses to patients.
Radiologists, medical physicists and radiographers must take the lead in CT
patient radiation dose reduction. They cannot claim to be the imaging professionals,
especially in the eyes of the public and the referring physicians, if they do not
optimize their imaging techniques. They must assure that they produce CT images
with the maximum amount of diagnostic information possible while maintaining
patient radiation doses as low as reasonably achievable. In other words, they must
assure that each and every CT scan is optimized with regard to image quality and
patient radiation dose, taking into account the patient’s size and body part being
imaged.
REFERENCES
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[3] GRAY, J.E., unpublished data

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DISCUSSION
G. KLEMPFNER: What three measures would you recommend above all for
reducing patient exposures during CT?
L.K. WAGNER: Firstly, I would recommend that scanning protocols be
checked with a view to ascertaining whether or not too many scans are being carried
out, that the right kind of sequencing and the right milliampere seconds and kilovolt-
age (peak) values are being used, and so on.
I would then recommend that checks be made in order to ensure that the tech-
niques being employed are appropriate to the organ and the size of the patient in ques-
tion.
Finally, I would recommend that quality assurance programmes involve
technologists, so as to make sure that they are aware of, for example, what the
scanning protocols mean in terms of image quality and patient dose. Technologists
can learn a lot from radiologists, and vice versa.
J.E. ALDRICH: There has been a great deal of talk about the dose increases
associated with CT but very little about other aspects of the technique. With the
advent of multislice machines there has been a shift in the types of procedure being
carried out, for example most diagnostic angiography is now performed with
multislice machines, and a vast increase in the number of slices.
L.K. WAGNER: That is why I recommend the checking of scanning protocols.
There are dose increases associated with CT, but it enables us to look at the anatomy
in a totally different perspective. How useful is this, however? With time it will no
doubt be possible to minimize the dose increases by technological means, but we
shall still have to ask whether the benefits outweigh the risks associated with the addi-
tional radiation being delivered to patients.
K. FAULKNER: With regard to the question of whether mammography is
overregulated, I think it is a mistake to incorporate detailed quality assurance items in
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legislation. If they are dealt with outside legislation they can be changed as practices
change. Legislation is harder to modify, and unchanging legislation can act as a brake
on technological development.
With regard to quality assurance, in my view there is little point in subjecting
diagnostic procedures to very rigorous quality assurance if other issues are not subject
to an appropriate level of quality assurance as well. For example, there is evidence
that surgical performances are worst with a relatively small caseload. Thus quality
assurance does not stop at diagnostic radiology.
L.K. WAGNER: I agree with both those statements.
M.M. REHANI: What are your views regarding the use of organ shielding
devices in CT?
L.K. WAGNER: I am not convinced of their usefulness. If they reduce doses to
organs and the image quality remains unchanged, perhaps you are using an
excessively high dose technique and should simply reduce the radiation level to what
is really needed.
IN INTERVENTIONAL RADIOLOGY
(Topical Session 3)
Chairperson
V. SINITSYN
Russian Federation
RADIOLOGICAL PROTECTION IN
INTERVENTIONAL RADIOLOGY
R. PADOVANI
Maria Rosa Malisan,
S. Maria della Misericordia Hospital, Udine, Italy
E-mail: dir.fissan@aoud.sanita.fvg.it
Abstract
Interventional radiology (IR) reduces the need for many traditional interventions,
particularly surgery, so reducing the discomfort and risk for patients compared with traditional
systems. IR procedures are frequently performed by non-radiologist physicians, often without
the proper radiological equipment and sufficient knowledge of radiation protection. Levels of
doses to patients and staff in IR vary enormously. A poor correlation exists between patient and
staff dose, and large variations of dose are reported for the same procedure. The occurrence of
deterministic effects in patients is another peculiar aspect of IR owing to the potentially high
skin doses of some procedures. The paper reviews the use of IR and the radiological protection
of patients and staff, and examines the need for new standards for IR equipment and the
training of personnel.
1. INTRODUCTION
C.T. Dotter first treated transluminally an atherosclerotic obstruction of the iliac

arteries using interventional radiology (IR) on 16 January 1964 [1]. The number and
complexity of interventional procedures performed in medical practice have grown
enormously in developed countries since then, particularly in the past ten years, owing
to the availability of more suitable materials and the refinement of imaging techniques.
Today, IR reduces the need for many traditional interventions, particularly
surgery, so reducing discomfort and risk for patients. As pointed out by Thomson [2],
IR “is ideally suited to the cost-reduction strategies for health care now in place in
most developed countries.” IR, however, currently has a low impact on health care in
developing countries owing to the lack of available resources.
IR is not only performed under X ray fluoroscopy or computed tomography
(CT) guidance; some procedures are performed under ultrasound or magnetic reso-
nance imaging guidance, or else under direct view in an operating room. However, the
vast majority of procedures are performed in a radiological room under fluoroscopic
guidance, simply because vascular procedures predominate.
There is a debate among radiologists concerning who should perform IR. Two
different views are presented in the literature, one summarized by Amiel [3], which
203
204 PADOVANI
maintains that these procedures should be carried out by organ based diagnostic radi-
ologists, and the second presented by Adam [4], which favours an individual disci-
pline approach, as a transverse speciality across a variety of organ systems. Both of
these positions are based upon there being a central role for radiologists as the spe-
cialists entitled to carry out the procedures, as the most important skill required for
their performance is the ability to interpret radiological images.
IR is taken to include invasive diagnostic procedures and therapeutic proce-
dures that require radiological guidance. Interventional cardiology and interventional
neuroradiology are types of IR where dedicated fluoroscopic equipment should be
used. There are also other invasive, radiologically guided procedures performed by
non-radiologist physicians, such as orthopaedic surgeons, gastroenterologists, pneu-
mologists and vascular surgeons, that are frequently carried out without proper radi-
ological equipment and a sufficient knowledge of radiology and radiation protection.
The levels of doses to patients and staff in IR vary enormously as a function of
procedure type, fluoroscopy time, number of images acquired and equipment perfor-
mance. A poor correlation exists between patient and staff dose, and large variations
of dose are reported for the same procedure. The experience of the first operator in
conducting a clinical procedure, and the subsequent training of the whole staff on
radiation protection, quality assurance and radiology techniques, are other important
factors influencing the exposure of both patients and staff.
The occurrence of deterministic effects in patients is another peculiar aspect of
IR, owing to the potentially high skin doses given in procedures such as radiofre-
quency cardiac ablation, percutaneous transluminal coronary angioplasty (PTCA)
and aneurysm ablation, or when high dose procedures are repeated [5]. Deterministic
effects to staff, such as eye lens injuries [6] resulting from the prolonged use of non-
dedicated fluoroscopic equipment, the poor level of individual protection devices,
personnel dosimetry and radiation protection knowledge, have also been reported.
All these considerations have persuaded international bodies [7–9] and national
bodies and scientific societies [5, 10–12] to publish recommendations and require-
ments for the optimization of IR practices. These requirements include the use of ded-
icated radiological equipment, quality assurance programmes that include quality
control, the assessment of patient and staff doses, and advanced training.
2. FREQUENCY OF PROCEDURES IN DEVELOPED COUNTRIES
Interventional radiology is becoming more and more frequent and new proce-
dures are being introduced daily.
The recent United Nations Scientific Committee on the Effects of Atomic
Radiation report [13] provides detailed information on IR procedures collected
worldwide. Table I shows the absolute and relative frequencies per head of popula-
INTERVENTIONAL RADIOLOGY 205
tion for angiographic and PTCA procedures for different health care levels. In devel-
oped countries the frequencies are high, while in developing countries these proce-
dures are not yet applied owing to the high cost of equipment and disposable materi-
als. The age distributions of patients in Table II show that a significant percentage of
cerebral procedures are performed on relative young people.
Owing to the relatively high levels of patient dose (up to 29 mSv for PTCA pro-
cedures or 84 mSv for transjugular intrahepatic portosystemic shunts (TIPS)), these
procedures can provide a significant contribution to the collective dose in developed
countries (7% from angiographies and 5% from interventional procedures). These
two types of procedures will probably become the second highest contributors to the
collective dose after CT (41%).
3. JUSTIFICATION OF IR PROCEDURES
ICRP Report 73 [14] recommends that for complex procedures such as IR jus-
tification should be performed on an individual basis. To do this the estimated patient
dose should be considered and discussed by the radiological practitioner and the
referring physician.
TABLE I. ANNUAL NUMBER OF INVASIVE PROCEDURES PER 1000 MEM-

BERS OF THE POPULATION AND PERCENTAGE CONTRIBUTION TO THE
TOTAL NUMBER OF X RAY PROCEDURES IN DIFFERENT
COUNTRIES/AREAS
Country/area Angiography Interventional procedures
Health care level I 6.8 (0.8%) 2.7 (0.4%)

Switzerland 11 4.7
Health care level II 0.48 (0.2%) 0.94 (0.4%)
Health care level III 0 0
Health care level IV 0 0
TABLE II. AGE DISTRIBUTION OF PATIENTS FOR VARIOUS PROCEDURES
Angiography Angiography Angiography

PTCA
(cerebral) (cardiac) (other)
Age 16–40 years (27%) 16–40 years (7%) 16–40 years (10%) 16–40 years (15%)
distribution (%) >40 years (71%) >40 years (91%) >40 years (88%) >40 years (85%)
206 PADOVANI
In IR the process of justification is complex, as the risks from the radiation

exposure to patients and staff and the risks of the invasive intervention (e.g. contrast
media reactions and dissection of vessels) need to be balanced against the benefits of
a simpler procedure compared with the greater risk and complexity of alternative sur-
gical procedures.
Advances in the justification process for IR procedures are necessary and will
require a multidisciplinary approach from several medical specialists (e.g. surgeons,
vascular surgeons, interventional radiologists and interventional cardiologists)
4. STAFF EXPOSURES
Information on staff exposures is included in Ref. [15].

IR procedures performed by radiologists are mainly conducted in dedicated X
ray rooms in radiological departments. Outside radiological departments, however, in
areas such as:
— Orthopaedic rooms
— Cystoscopy units
— Cardiac catheterization laboratories
— Operating surgery rooms
— Coronary care units
— Gastrointestinal units
— Lithotripsy units
several types of specialist perform an increasing number of procedures that are

becoming more and more complex, with potentially high doses given to patients and
staff.
Most of the procedures that are performed in the areas shown above are carried
out with the aid of fixed or mobile fluoroscopic equipment, and in general the per-
sonnel involved have a low knowledge of imaging methodology and technology and
radiation protection.
The level of radiation exposure varies with the nature of the procedure carried
out and with the specific exposure parameters employed (e.g. the type of imaging
equipment, source to image distance, fluoroscopy time and distance from the scatter-
ing area on the patient). Using standard precautions and according to the level of
exposure for the staff, the procedures can be classified as in Table III [15].
Table IV [15] gives detailed information on the potential level of unshielded
exposures for typical procedures, expressed in terms of the number of procedures per
week necessary to reach annual doses of 1 mSv or 25 mSv.
TABLE III. CLASSIFICATION OF PRODEDURES
Annual unshielded effective dose (mSv/a)
Low exposure procedures <1

Medium exposure procedures >1 to <25
High exposure procedures >25
TABLE IV. COMMON FLUOROSCOPIC PROCEDURES AND POTENTIAL

STAFF EXPOSURES
Equipment Exposure potentiala

(fixed (No. of procedures per week)
Procedure Location Duration
(F)/mobile Annual dose Annual dose
(M)) of 1 mSv 25 mSv
F/M Angiography or Catheterization 20 min 0 1

digital substraction laboratory
angiography
F/M Coronary angioplasty Catheterization 20 min 0 1

laboratory
F/M Electrophysiology Catheterization 20 min 0 1
laboratory
F/M Line placement Catheterization
laboratory,
critical care unit 2 min 0 20
F/M Cystoscopy Operating room 5 min 0 7
M Lythotripsy Operating room 3 min 1 13
M Extracorporeal Operating room 30 min 0 1
shock-wave
lithotripsy
M Hip pinning Emergency room, 2 min 0 7
operating room
M Reduction of fracture Emergency room, 2 min 0 20
operating room
F/M Endoscopic retrograde Endoscopic suite 5–20 min 0 7
cholangiogram
F/M Cholangiography Operating room 1 1 41
M Pacemaker lines Catheterization 1–2 min 1 27
M laboratory,
critical care unit,
operating room
M Transplant biopsy Critical care unit 40 min 0 1
a Assuming a dose rate at the patient’s skin of 50 mGy/min.
208 PADOVANI
The dosimetry quantities of interest are effective doses for stochastic effects
and, for deterministic effects, absorbed doses to eye lenses, hands, knees and ankles.
Typical air kerma rates for patients and staff for different classes of procedure are
shown in Table V [15]. These values demonstrate that the highest potential dose in
fluoroscopic procedures is usually where staff work close to the scattering areas on
patients during exposures.
Several reports have shown measured staff doses in different fluoroscopic and
IR procedures. Table VI [17] summarizes staff doses in terms of the effective dose for
a single procedure and normalized to the patient dose expressed as a dose–area prod-
uct (DAP). The effective dose has been calculated according to the model proposed
by Niklason et al. [16] when a body is partially exposed, as in the case of personnel
wearing protective aprons. The personal dosimetry systems used were either single or
double dosimeter methods, worn under and over protective aprons. There is a high
variability of doses between the different studies, demonstrating clear differences in
practice and a real need for the optimization of staff protection. Excluding the values
shown in Table VI, the variability is reduced if the effective dose is normalized to the
patient DAP, but only in a few cases was it possible to evaluate this quantity.
From the reported data the following comments can be derived:
— Many variables affect staff exposure (e.g. type of equipment used, distance
from the patient, beam direction, use of protective screens, type of procedure,
operator skill, training and equipment performance).
— The comparison of personal doses was difficult or, in same cases, impractica-
ble when:
• Different dosimetry methods are used or the reported data did not indicate the
type and number of procedures performed.
TABLE V. TYPICAL DOSES FROM ROUTINE IMAGING PROCEDURES
Air kerma rate at Air kerma at 1 m Cumulative air

Exposure
Modality patient surface (scatter) (mGy/min) kerma at 1 m
time/procedure
(mGy/min) (µGy)
Fluoroscopy 10–100 Long (minutes) 10–100 250 (5 min)
Cine angiography 100–1000 Short (tens of 100–1000 100 (10 s)

seconds)
Radiographic 18 000 Very short 18 000 30 (1 film)

spot film (<0.1 s)
• Dosimeters are worn in different positions on the body.

• The doses reported are very low, suggesting that the dosimeters were not worn
all the time by the operators.
— Staff dose monitoring in IR requires a proper dosimetry method that takes into
account the protective devices adopted in a facility (individual and collective):
• For the evaluation of effective dose with single or, better, double dosimeters.
• For the evaluation of partial body doses to eye lenses, hands and the lower
extremities.
The normalization of the personal dose to the workload, expressed in terms of

the number of procedures or DAPs, allows a straightforward comparison between
facilities and helps to identify those clinicians who are not taking effective radiation
safety precautions.
Dose constraints [29, 30] are also a useful instrument that can be used in IR as
an indication of optimized staff exposure for standardized and frequent IR proce-
TABLE VI. STAFF DOSES PER PROCEDURE AND PER UNIT DAP IN INTER-
VENTIONAL CARDIOLOGY
Effective dose Effective dose/DAP Hand dose

Reference
(µSv/procedure) (µSv/Gy·cm2) (µSv/procedure)
Wu et al. [18] 0.2 — —

Renaud [19] 2.8 — —
Li et al. [20] 8.0 — —
Steffenino et al. [21] 15.1 — 300–545
Folkerts et al. [22] 2.0 — —
Watson et al. [23] 1.8 — —
Zorzetto et al. [24] 3.7 — —
Vañó et al. [25] 18.8 0.34 364
Padovani et al. [26] 2.2 (CA), 8.8 (PTCA) 0.035 (CA), 0.054 (PTCA) 50 (CA), 140 (PTCA)
Williams [28] 0.013 —
DIMOND — 1999 Spain 2.2 (CA), 4.4 (PTCA) 0.022 (CA)– 0.033 (PTCA) —
DIMOND — 1999 Italy 0.5 (CA), 1.0 (PTCA) 0.006 (CA)–0.006 (PTCA) —
DIMOND — 1999 Greece 1.0 (CA), 2.0 (PTCA) 0.008 (CA)–0.011 (PTCA) —
Notes: CA — coronary angiography; DIMOND — the Digital Imaging: Measures for Optimizing
Radiological Information Content and Dose (DIMOND) research programme. The results for the
DIMOND programme have not been published.
210 PADOVANI
dures. As a proposal, dose constraints in IR should be expressed in terms of effective

dose per procedure or effective dose per unit of DAP. It seems necessary to propose
a standardized collection of staff doses in order to establish constraint values useful
in the optimization process.
Finally, staff protection also requires:
— A frequent reassessment of the practices being carried out;

— The use of dedicated equipment for IR;
— The adoption of appropriate procedures (e.g. number of frames, fluoroscopy
times, frame rates, magnifications, beam orientations and field sizes) and radi-
ological techniques (e.g. kilovoltages, contrast curves, image quality in fluo-
roscopy and fluorography, grids, filters);
— The adoption of proper protection devices;
— Training in radiological imaging and radiation protection.
When IR procedures are performed by non-radiologists the implementation of

these actions are particularly difficult and the availability of guidelines or mandatory
requirements for collaboration with radiologists, medical physicists and radiogra-
phers should be pursued.
5. PATIENT EXPOSURE
In IR, where doses to patients can be substantial, the optimization process must
include patient dose assessment. In fluoroscopically guided procedures, patient dose
is affected mainly by fluoroscopy time, number of images acquired, field size and
entrance angle, image magnification and image quality, patient size and the perfor-
mance of the X ray system used.
Typical values of fluoroscopy time, DAP and effective dose are reported in Ref.
[13] and are summarized in Tables VII and VIII.
A number of points are evident: the large variability of doses, the presence of
procedures with typical low or high doses, the possibility to have interventional pro-
cedures delivering skin doses higher than the dose threshold for skin injuries and the
absence of differences between analogue and digital technologies.
The International Commission on Radiological Protection (ICRP) recognizes
that the following procedures give potentially high skin doses:
— Embolization: aneurysm and arteriovenous malformations.

— Angioplasty (PTCA).
— Radiofrequency ablation.
— TIPS.
TABLE VII. SAMPLE OF REPORTED TECHNICAL DATA AND PATIENT

DOSE IN INVASIVE ANGIOGRAPHIC PROCEDURES
Fluoroscopy time DAP Effective dose

Procedure Technique
(min) (Gy·cm2) (mSv)
Coronary Cine film 3.6–9.8 16.1–98 2–15.8

Digital cine 5.7 47.7 9.4
Cerebral Digital substraction 1.2–36 12–120 2.7–23.4
angiography/
conventional
Abdominal Hepatic digital 2.3–28.6 28–279 4–48
substraction
angiography
Renal digital 5.5–21 41–186 6–34
substraction
angiography
Renal angiography 0.5–9.3 17–327 2.8–11.5
TABLE VIII. SAMPLE OF REPORTED TECHNICAL DATA AND PATIENT

DOSE IN INVASIVE INTERVENTIONAL PROCEDURES
Localized dose to Fluoroscopy time Effective dose

Procedure DAP (Gy·cm2)
skin (Gy) (min) (mSv)
PTCA 0.05–5 3–92 20–402 7.5–57
Percutaneous 0.4 5–68 5–338 10–12.5

transluminal
angioplasty
TIPS 0.4–5 9–115 7–1131 2–181
Radiofrequency 0.1–8.4 3–195 7–532 17–25

ablation
Embolization 0.2–0.5 1–90 7–918 6–43

212 PADOVANI
It is frequently difficult to compare literature data and derive typical doses,

because:
— The statistics of reported data are frequently poor owing to the difficulty in col-
lecting a sufficient number of cases for low frequency procedures;
— Different patient dose indicators are adopted, such as entrance surface doses,
DAPs, fluoroscopy times, number of images, organ and effective doses, local-
ized or maximum skin doses;
— The variability of doses is not well correlated to pathology severity or proce-
dure complexity;
— The skill and experience of operators is not considered;
— Measurements are taken either in real practice or under simulated conditions;
— Rapid changes in practices do not allow the comparison of data collected at dif-
ferent times.
From these observation some comments and needs can be expressed:
— There is a need for standardized dosimetry methods and to develop reliable

methods for the evaluation of the maximum skin dose in high risk procedures
where skin injuries have been reported.
— It would be useful to establish an international database of doses in IR.
— The introduction of reference values for standardized procedures can help prac-
titioners, medical physicists and qualified experts in the optimization process,
as demonstrated in conventional and CT radiology.
— The protection of patients is not separate from that of staff, hence a unified
approach of radiation protection is required; re-evaluation of legislation requir-
ing separate processes could therefore be required.
6. RADIATION INJURIES
In recent years several authors have reported radiation injuries to patients and
staff performing IR procedures [5, 6, 31, 32]; there has been a reported increase in the
number of skin injuries to patients [31] (Table IX). Vañó et al. [6] has reported a case
of an injury to a lens of an eye of a radiologist performing IR.
Radiation induced skin injuries are not usually observed immediately, but after
a latent period of from a few hours to two to three years. Radiation injuries to skin
(transient erythema) have been observed at absorbed doses of about 2 Gy. More
severe effects may occur following larger absorbed doses. In most cases procedures
were not well documented and hence it is difficult to make accurate estimates of the
skin doses involved.
TABLE IX. FREQUENCY OF SKIN LESIONS FROM FLUOROSCOPY GUIDED

INTERVENTIONAL PROCEDURES REPORTED BY THE FDA IN THE PERIOD
1992–1995
Type of procedure No. of skin lesions
Radiofrequency cardiac ablation 12

Positioning of a catheter for chemotherapy 1
TIPS 3
PTCA 4
Renal percutaneous transluminal angioplasty 2
Multiple procedures (e.g. percutaneous transluminal
angioplasty, stent, biopsy) 3
Percutaneous colangiography and multiple embolization 1
Since individual sensitivities may vary, the Food and Drug Administration
(FDA) of the United States of America suggests that the potential for injury be noted
in patients’ records for any procedure able to result in skin doses equal to or greater
than 1 Gy.
It is still an open question as to which methods should be used for the routine
evaluation of maximum skin doses, and more research efforts are required to develop
practical systems that can be implemented in angiographic procedures.
7. GUIDANCE/REFERENCE LEVELS FOR PATIENTS
The Basic Safety Standards (BSS) [33] require the development and use of
guidance levels (equivalent to the European reference levels) for diagnostic medical
exposures. These values are usually based on patient dose surveys and correspond to
the 75th percentile in a cumulative frequency histogram of doses to patients.
With respect to fluoroscopy, the guidance levels for entrance surface dose rates
proposed in the BSS are based on the expected levels of performance of fluoroscopy
systems in clinical use (in normal operation 25 mGy/min, in a high level mode 100
mGy/min). They are intended to be used as a tool in radiation protection to identify
systems in which doses to patients may be too high. The same approach is adopted
by the FDA [5] but with higher reference values: 87 and 174 mGy/min, respectively.
Equipment performance is the first aspect to be considered, but other and more
complex factors, as mentioned, influence patient dose. In the development of a sys-
tem of reference levels in IR the following stages should be considered:
214 PADOVANI
— First level: equipment performance (BSS and FDA reference levels);

— Second level: procedure factors (the number of images acquired and the fluo-
roscopy time needed);
— Third level: patient dose (DAP values or effective dose and, if required, maxi-
mum skin dose levels).
As an example, for levels 2 and 3 Table X shows a proposed set of reference

values for coronary angiography and PTCA procedures, evaluated as the 75th per-
centile of the cumulative frequency histogram of data collected in a sample of Italian
cardiac centres [26].
In complex procedures an index that takes into account the severity of the
pathology can allow more specific derivations of reference values, thus allowing bet-
ter optimization of the practice in a facility. This approach, which requires more
investigation, has been applied to a sample of PTCA procedures collected in an
Italian hospital [26]. The relationship between clinical and technical factors versus
fluoroscopy time and DAP was examined. Good correlation was found with the
number and type of lesions treated, the use of double wire or double balloon tech-
niques, the use of ostial and bifucation stenting or simple stenting techniques, the
age of vessel occlusion and the presence of moderate or severe vessel tortuosity.
From that observed a complexity index was derived that allowed a classification of
the procedures into three groups according to the different grades of complexity.
Figure 1 shows the mean fluoroscopy time and DAP of the groups according to their
classification as simple, moderate or complex PTCA procedures. This result con-
firms the feasibility of a larger study to derive procedure complexity-dependent ref-
erence values.
TABLE X. REFERENCE VALUES PROPOSED FOR TWO COMMON INTER-

VENTIONAL CARDIOLOGY PROCEDURES IN ITALY
Reference values
Fluoroscopy DAP
No. of images
time (min) (Gy·cm2)
Left catheterization, coronary angiography, 1300 5 70

left ventriculography and one to two
other image acquisitions
Angioplasty (PTCA) 1800 24 120
Simple Simple
Medium Medium
Complex Complex
2500 250
2000 200
Fluoroscopy time (s)
DAP (Gy·cm )
2
1500 150
1000 100
500 50
0 0
FIG. 1. Mean fluoroscopy time and DAPs for a simple, medium and complex PTCA procedure.
A classification of PTCAs as a function of complexity of intervention (and hence

of patient exposure) has also been suggested by Federman et al. [34] after reviewing a
sample of 245 PTCA procedures performed at the Mayo Clinic in the USA.
8. QUALITY CRITERIA FOR IMAGES
An important aspect of an optimization strategy is the adoption of methods

for image quality assessment. The approach of the European Commission (EC)
document on Quality Criteria for Radiographic Images [35] can be assumed as a
model for the implementation of a similar methodology for IR images. An example
is the proposal of the DIMOND group for a set of quality criteria for coronary angiog-
raphy images.
The proposed criteria applicable to left coronary angiography images where the
quality criteria are assessed as visibility levels of important anatomical and patholog-
ical markers are as follows.
1. If necessary to avoid diaphragm superimposition or to change anatomic rela-

tionships they should be performed at full inspiration (and at all times in cases
of apnoea).
2. Arms should be raised clear of the angiographic field and the spine should
appear as little as possible.
216 PADOVANI
3. There should be a visually sharp reproduction of vessel walls.

4. There should be simultaneous and full opacification of the vessel lumen at least
until the first critical lesion (>70% by visual estimation).
5. Panning should be limited. If necessary, panning should be in steps rather than
continuously, or subsequent cine runs to record remote structures should be
made.
6. There should be a visually sharp reproduction of the origin, proximal, mid and
distal portion of the left anterior descending and circumflex arteries in at least
two orthogonal views.
7. There should be a visually sharp reproduction of the side branches larger than
1 mm of the left anterior descending and circumflex arteries in at least two
orthogonal views; the origin should be seen in at least one projection.
8. There should be a visually sharp reproduction of the lesions in vessels larger
than 1 mm in at least two orthogonal views.
9. There should be a visualization of collateral circulation when present.
10. When criteria 6–9 have been fulfilled, extra projections should be avoided (i.e.
mainly left anterior oblique semiaxial projections).
Two small trials have been performed on a set of 15 studies obtained in four
European centres and analysed by six independent cardiologists. A consensus on the
methodology has been reached and, for a semiquantitative assessment of quality, a
scoring system was adopted in order to weight the different criteria. Research on this
and larger trials are foreseen in the context of the DIMOND III research project,
which is investigating the possibility of developing quality criteria for the most fre-
quent invasive and interventional radiology procedures.
9. EQUIPMENT AND X RAY ROOMS FOR IR
As part of the optimization process, the selection of appropriate equipment is

required by an EC directive on medical exposures [12]. Refs [7] and [8] give the
requirements for the important safety and image performance characteristics of fluo-
roscopic X ray equipment for IR, which can be summarized as the need for:
— Overcouch image intensifiers.

— Source intensifier tracking.
— Concave couch tops.
— DAPs measurement or evaluation.
— The display of fluoroscopy times, total DAPs and an estimation of entrance skin
doses.
— Iso scatter dose distribution data for both normal and boost modes.
— All commands and switches to be clearly indicated (e.g. for normal and high
dose rate modes).
— Limits for entrance dose rates: 25 mGy/min and 100 mGy/min, respectively
[33], or 87 mGy/min in the normal mode and 174 mGy/min for high dose rates
[5].
— User selectable dose rates and image quality.
— Additional filtration.
— Removable grids.
— Last image hold facilities.
— Flexibility of automatic exposure control (image or dose weighted).
— Recursive temporal filters.
— Road mapping for image simulation and the region of interest (i.e. low noise
images in the centre surrounded by low dose images).
Other important aspects for the optimization of a facility, so far not included in
the standards, are:
— That protective devices for operators are not part of the equipment specifica-
tions, and that these aspects are totally due to users;
— That patient dose data are not stored and are not available on a network (this is
a requirement for the Digital Imaging and Communications in Medicine
(DICOM) standard);
— The requirements for maximum dose assessments;
— The protocols for simple and frequent quality control procedures for complex
equipment
For the design of X ray rooms the following aspects should be considered:
— The interventional room should have enough space to accommodate easily

the patient, several operators, equipment, auxiliary devices and disposable
material;
— The control room should large enough to accommodate several operators and
should have a large protected window;
— Aspects of hygiene and sterility and the need for an ancillary surgery room for
emergencies during high risk procedures should be considered.
Both the ICRP [9] and the European Union [12] request frequent quality con-
trol tests on X ray equipment used in IR. The World Health Organization (WHO) [7]
and the DIMOND project have proposed a set of frequent and easy to do tests to be
performed on fluoroscopic units.
218 PADOVANI
TABLE XI. TRAINING OBJECTIVES FOR DIFFERENT SPECIALISTS PER-

FORMING IR AND FLUOROSCOPY GUIDED PROCEDURES
Training area DR/MDa IC/MDb MDc RDd NUe MEf
Atomic structure, production m 1 1 m 1 m

and interaction of radiation
Nuclear structure and m 1 — m 1 m
radioactivity
Radiological quantities m m 1 m 1 m
and units
Physical characteristics of m m m m 1 h
X ray and therapy machines
Fundamentals of radiation 1 1 1 m 1 h
detection
Fundamentals of radiobiology, m m m m 1 1
biological effects of radiation
Radiation protection h h m h 1 m
(general principles)
Operational radiological h h m h m m
protection
Particular patient radiological h h h h m m
protection aspects
Particular staff radiological h h h h m m
protection aspects
Quality control and quality m m 1 m 1 h
assurance
National and European m m m m 1 h
regulations and standards
Suggested number of 30–50 20–30 15–20 40–100 15–20 40–60
training hours
a DR/MD — diagnostic radiology specialists.
b IC/MD — interventional cardiology specialists.
c MD — other medical doctors using X ray systems.
d RD — radiographers.
e NU — nurses.
f ME — maintenance engineers.
l — low, m — medium, h — high level of knowledge.

10. TRAINING OF PERSONNEL
Training of personnel performing IR is a recommendation of the WHO, the

ICRP and the FDA, and a requirement of the European Union directive on medical
exposures [12]. A large and increasing part of IR practice, mainly interventional
cardiology, is performed by non-radiologists, and for this reason the training of per-
sonnel in imaging radiology, radiation protection and quality assurance is of para-
mount importance. Teaching objectives and experiences are today available for
defining the contents and the level of knowledge necessary for IR staff. The WHO
[7], the EC [36] (see Table XI) and the DIMOND group experiences provide a good
base of information.
As shown in Table XI, in fluoroscopic procedures operators must know how the
following parameters influence patient dose: fluoroscopy time, number of sequences
and total number of images, number of images per second in the cine acquisition
mode, zooming, focus to patient distances, diaphragm setting, image quality in fluo-
roscopy and fluorography.
It is also requested that training sessions are provided when new methodologies
are introduced, new X ray systems are installed and new personnel join the staff of a
department.
In both large hospitals and in teaching hospitals there is a need for frequent
training sessions by qualified medical physicists and radiologists; these invariably are
expensive. In the future the development of multimedia training tools will be neces-
sary. The Madrid University Complutense group is developing a multimedia and
audiovisual tool for IR, based on experience acquired some years ago in developing
video tools for training purposes.
11. CONCLUSIONS
There is an increased interest for IR procedures in general and for invasive

fluoroscopy guided procedures; the benefit for patients is important when an IR
procedure is performed instead of an alternative, but more hazardous, surgical pro-
cedure.
This positive trend in health care at the same time poses radiation protection
problems, because:
— A larger number of clinicians and support personnel are using X ray equipment,
— Some procedures require long patient and staff exposure times,
— Complications during complex procedures or repeated complex procedures can
constitute a potential risk of skin doses exceeding the threshold for the deter-
ministic effects of ionizing radiation.
220 PADOVANI
It is also necessary to underline that in interventional radiology and in fluoro-

scopically guided procedures performed outside radiological departments it is diffi-
cult to separate the protection of patients from the protection of staff, and that the
optimization process should be balanced between patient and staff protection. The
role of radiation protection officers and medical physicists must be clarified in the
legislation of most countries.
Usually it is difficult to implement optimization actions when procedures are
performed outside radiological departments by non-radiologist clinicians. Guidelines
or mandatory requirements for collaboration with radiologists, medical physicists and
radiographers are necessary. Requirements must include appropriate training in radi-
ological imaging and radiation protection.
Other important needs underlined in this paper are:
— Justification criteria for interventional procedures;

— Patient dosimetry methods and the enlargement of patient and staff dose data;
— Advances in the design and use of reference levels for optimized procedures;
— Tools for the initial and continuous training of personnel;
— Improvements to X ray systems and room designs, including dose data record-
ing and networking.
In conclusion, great attention and effort should be directed to all aspects of the
optimization of radiation protection in this fast developing field of medicine.
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BUNDESGESUNDHEITSAMTES, Efficacy and Radiation Safety in Interventional
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COMMUNITIES, Radiation Protection in Interventional Radiology (Meeting London,
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Radiation Protection for Procedures Performed Outside the Radiology Department:
Recommendations, Report No. 133, NCRP, Bethesda, MD (2000).
[16] NIKLASON, L.T., MARX, M.V., CHAN, H.P., The estimation of occupational effective
dose in diagnostic radiology with two dosimeters, Health Phys. 67 (1994) 611–615.
[17] PADOVANI, R., RODELLA, C.A., “Staff dosimetry in interventional cardiology”, Dose
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Workshop Dublin, 1999, Radiat. Prot. Dosim. 94 (2001) 99–104.
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framing speed, Br. J. Radiol. 69 (1996) 860–864.
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risk for employees of a heart catheterization laboratory, Z. Kardiol. 86 (1997) 258–263.
[23] WATSON, L.E., RIGGS, M.W., BOURLAND, B.D., Radiation exposure during cardi-
ology fellowship training, Health Phys. 73 (1997) 690–693.
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exposure to patients and operators during diagnostic catheterization and coronary angio-
plasty, Cathet. Cardiovasc. Diagn. 40 (1997) 348–351.
[25] VAÑÓ, E., GONZALEZ, L., GUIBELALDE, E., FERNANDEZ, J.M., TEN, J.I.,
Radiation exposure to medical staff in interventional and cardiac radiology, Br. J.
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Protection for Medical Exposures, Radiation Protection 116, EC, Luxembourg (2000).
DISCUSSION
M.M. REHANI: In interventional radiology we seem still to be at the stage of

assessing patient dose and stating that there is potential for dose reduction. Would you
agree?
R. PADOVANI: I have seen papers with recommendations on how to reduce
patient dose and the probability of skin injuries. Such papers deal with the technical
aspects of procedures, the protocols of procedures, the orientation of beams, the qual-
ity of images and so on.
M.M. REHANI: In other words, there appears to be no one who can say ‘Yes,
I have been able to reduce the doses to such and such an extent’. There needs to be a
strong emphasis on patient dose reduction in the coming years.
A. RAMÍREZ: I noted the strong emphasis on the follow-up of patients that
had endovascular treatments of abdominal aortic aneurysms in paper
IAEA-CN-85-1291.1 It is the first documented case of these effects detected by the
iatrogenic effects. It would regrettable if the use of this technique had to be discon-
tinued or reduced owing to the effects observed in the follow-up.
R. PADOVANI: There were two papers recommending the follow-up of
patients who receive a dose to the skin of more than 1 Gy. One paper is particularly
interesting because, during the follow-up of a number of patients for three months
after the procedure in question, it was found that some of them had skin burns even
with doses of 0.5 Gy. That suggests that there is an underreporting of skin burns in
the case of that procedure.
J. LINIECKI: What is the meaning of ‘unshielded effective dose’?
R. PADOVANI: It means the dose that the operator receives if he or she does
not use any protective device.
J. LINIECKI: In my view, it is a misleading concept; you can easily incur a
dose exceeding the annual dose limit if you do not wear a protective apron, but what
sane person would not wear one? The difference between the unshielded and the
shielded effective dose is about a factor of 30.
R. PADOVANI: The concept is useful in the case of procedures involving, for
example, potential eye exposures, where it is necessary to pay particular attention to
optimizing the radiological protection of staff.
H.M. JOHNSON: At what point should radiation protection experts start inter-
acting with senior cardiology staff regarding the doses to patients from various pro-
cedures? For example, knowing the output of the equipment and deriving an entrance
skin dose of, for example, 1 Gy, should the radiation protection expert insist on see-

224 PADOVANI
ing the patient again whenever the duration of the procedure exceeds, for example, 50
min at, for example, 2 mSv/min?
And if erythema is detected, should the radiation protection expert look into the
approach of the clinician in question?
R. PADOVANI: In my view, it is first necessary for the radiation protection
expert, or, in my case, the medical physicist, to understand what the cardiologists are
doing; he or she often knows about patient and staff doses, but not about the proce-
dure and the problems involved. So there is a real need for close contact with cardi-
ologists.
After that one can think about looking into, for example, the mean fluoroscopy
times of different operators, as each operator has his or her own experience and skills,
and perhaps identifying what additional training is needed.
That is not an easy task, especially with new procedures and materials being
introduced every few months.
P. ORTIZ-LÓPEZ: Your very useful classification of procedures as simple,
medium and complex is a big step towards the possible establishment of guidance lev-
els or reference levels. Does it relate, however, just to the nature of the particular pro-
cedure, so that you know in advance whether a procedure is complex, or also to unex-
pected difficulties that may arise, so that you cannot classify a procedure before you
perform it?
R. PADOVANI: In one of the papers I referred to the procedures were classi-
fied on the basis of the number of vessels treated, so the classification depended on
the pathology. In the other paper other factors were taken into account, but all the fac-
tors, for example the tortuosity of the vessels, related to the pathology.
IN NUCLEAR MEDICINE
(Topical Session 4)
Chairperson
J. KONISHI
Japan
NUCLEAR MEDICINE
L.K. HARDING
City Hospital NHS Trust,
Birmingham, United Kingdom
E-mail: l.k.harding@bham.ac.uk
Abstract
The key factor in medical exposure is justification, that is ensuring that the benefit
exceeds the risk. Nuclear medicine studies are comparable in cost to more sophisticated
radiological tests such as ultrasound, computed tomography or magnetic resonance. Radiation
doses are similar from X ray and nuclear medicine procedures. Having justified exposures the
next step is optimization, namely using a radiation dose as low as is reasonably practicable.
Diagnostic reference levels may be set nationally or locally such that the balance of diagnostic
quality and radiation burden is optimized. In therapy the aim is to achieve a therapeutic dose
while keeping the dose to non-target tissues as low as reasonably practicable. Variations in
activities may be required for overweight patients, those in severe pain, those with certain
conditions and in the case of tomography. Any woman who has missed a period should be
assumed to be pregnant; there should be notices to patients emphasizing this. Following the
administration of longer lived pharmaceuticals it is important to avoid pregnancy for a time
such that the dose to a foetus will not exceed 1 mGy. A similar situation applies to a child who
is being breastfed when a mother receives a radiopharmaceutical. In the case of children
undergoing investigations the activity needs to be reduced to maintain the same count density
as in adults. With the administration of an incorrect pharmaceutical an attempt should be made
to enhance excretion, and the referring doctor and the patient should be informed.
Extravasation usually requires no action. Positron emission tomography results in higher doses
both to staff and patients. Research should use subjects over the age of 50, and avoid anyone
who is pregnant or is a child. Nuclear medicine procedures result in a very small loss in life
expectancy compared with other common risks.
1. JUSTIFICATION
The key factor in medical exposure is justification of the exposure to ensure that
the benefit to a patient offsets the detriment from the radiation [1].1 Ultrasound or
nuclear magnetic resonance should be used in preference when they are available,
because they incur no radiation dose. However, the cost of investigations varies: in a
private United Kingdom hospital a nuclear medicine investigation costs about £400,
an ultrasound scan about £200 and a computed tomography or magnetic resonance
scan about £600. In addition, nuclear medicine investigations should only be
227
228 HARDING
undertaken when they are the most suitable investigation for the purpose; this infor-
mation should be derived from evidence based guidelines [2].
Nuclear medicine and radiological procedures give approximately similar
effective doses to patients, as shown in Fig. 1 [3].
2. OPTIMIZATION
All radiation doses should be as low as reasonably achievable, and as an

initial step diagnostic reference levels (administered activity) should be set either
nationally or locally. These levels will be those that provide the optimum clinical
information. With too low a diagnostic reference level the information is not of diag-
nostic quality, whereas with too high a level an extra radiation burden is incurred with
no benefit.
3. ADMINISTERED ACTIVITY VARIATIONS
The diagnostic reference level normally determines the administered activity

for a study. For an individual patient there may be other considerations. For example,
on the basis of count density a patient of, for example, 100 kg will require twice the
administered activity compared with an average 70 kg patient [4]. Additional activity
may also be given to patients who require a shortened investigation, such as those
who are in severe bone pain as a result of cancer or are ill for other reasons.
Sometimes the clinical condition indicates that a different amount of radiopharma-
ceutical should be injected; for example, in patients with renal failure it is generally
necessary to increase the administered activity in order to visualize the kidneys.
Occasionally equipment requirements dictate a different administered activity, the
commonest situation perhaps being the use of tomography, where rather more activ-
ity may be given.
1 The International Basic Safety Standards for Protection against Ionizing Radiation and
for the Safety of Radiation Sources establish that “medical exposures should be justified by
weighing the diagnostic or therapeutic benefits they produce against the radiation detriment
they might cause, taking into account the benefits and risks of available alternative techniques
that do not involve medical exposure.”
NUCLEAR MEDICINE 229
4. PREGNANT WOMEN
Because of the dose to a foetus the possibility of pregnancy should be

considered in all women, and pictorial notices should indicate to patients that they
must inform staff if they think that they might be pregnant. A regularly menstruating
woman who has missed a period must always be considered to be pregnant, although
particular care has to be taken with adolescents and with the menopausal. If in doubt
an intravenous pregnancy test is recommended. In those known to be pregnant our
policy is to discuss the case with the relevant medical consultants, and determine if
Nuclear
X ray mSv medicine
50
Heart perfusion (TI)
Barium enema 10.0 Heart perfusion (Tc)

Chest MUGA (heart)
computed tomography
IVU, barium meal Bone
5
90% range
European Kidney (Tc)
Lumbar spine background
Abdomen
Thoracic spine 1.0 Lung perfusion

Thyroid (Tc)
0.5
Lung ventilation
Skull 0.1 (gas)
GFR–EDTA
0.05
Dental
Chest
FIG. 1. Radiation doses from common X ray and nuclear medicine procedures.
230 HARDING
the investigation can be postponed. Usually this is not the case, and the investigation
proceeds. In some departments a reduced amount of activity is given to pregnant
women, but we take the view that the highest quality images must be obtained so that
a definitive diagnosis can be made. This is particularly true of ventilation and perfu-
sion imaging with pregnant women, as the problem with anticoagulation of women in
labour has to be taken into account.
A further aspect is to advise women to delay subsequent pregnancy for a time
after certain types of radiopharmaceutical administration. These delays are listed in
Table I [5]. The figures are derived on the basis of a dose to a foetus that will not
exceed 1 mGy during the course of a pregnancy. Breastfeeding women present a
particular problem in nuclear medicine, and a large amount of work has been put into
collecting data from breast milk so that proper advice can be given. This has been
summarized by Mountford [6]. Nuclear medicine departments should have this
information displayed, for example in the injection room, and within the department
there should be pictorial notices asking women to inform staff if they are breastfeed-
ing. Because some of a radiopharmaceutical is passed into milk, the time for which
breastfeeding should be discontinued has to be tailored to the radiopharmaceutical,
and has to take into account the fact that the cessation of breastfeeding should be for
the minimum period in order to try and ensure that a mother restarts breastfeeding at
the end of a period of interruption.
TABLE I. RECOMMENDED PERIODS TO DELAY PREGNANCY AFTER THE

ADMINISTRATION OF RADIOPARMACEUTICALS
All activities up Avoid pregnancy

Nuclide and form For treatment of
to (MBq) (months)
198Au colloid Malignant disease 10 000 2
131I iodide Thyrotoxicosis 800 4
131I iodide Carcinoma thyroid 6 000 4
131I MIBGa Phaeochromocytoma 7 500 3
32P phosphate Polycythemia, etc. 200 3
89Sr chloride Bone metastases 150 24
90Y colloid Arthritic joints 400 0
90Y colloid Malignancy 4 000 1
169Er colloid Arthritic joints 400 0
aMIBG — meta-iodobenzylguanidine.
Note: The administration of quantities smaller than those indicated does not imply that the
advisory period to avoid pregnancy may be reduced.
5. CHILDREN
Children are a particular example of patients where an administered activity has

to be amended considerably; Table II shows the recommendations of the paediatric
group of the European Association of Nuclear Medicine [7]. These have been adopted
by a number of countries. They are based on achieving the same count density as for
an adult.
6. MISADMINISTRATION AND MALADMINISTRATION OF

RADIOPHARMACEUTICALS
Misadministration is the administration of an incorrect radiopharmaceutical, or

a wrong amount, or giving it to the wrong patient. In such circumstances the patient
takes priority and consideration should be given to any measures that might enhance
excretion or reduce the dose to organs such as the bladder. It is important to inform
the patient and the referring doctor, and to notify the incident in accordance with
national legislation.
Maladministration is administering a radiopharmaceutical incorrectly; a
common example would be extravasation [8]. Although local skin doses can be large
with extravasation, it is usual to take no active steps to diffuse the radiopharmaceuti-
cal; the local application of heat seems to have little effect. Some have argued for
surgical excision, but this is not generally felt necessary.
TABLE II. RECOMMENDED AMENDMENT OF ADMINISTERED ACTIVITY

FOR CHILDREN
Weight Weight Weight

Fraction of adult Fraction of adult Fraction of adult
(kg) (kg) (kg)
3 0.1 22 0.50 42 0.78

4 0.14 24 0.53 44 0.80
6 0.19 26 0.56 46 0.82
8 0.23 28 0.58 48 0.85
10 0.27 30 0.62 50 0.88
12 0.32 32 0.65 52–54 0.90
14 0.36 34 0.68 56–58 0.92
16 0.4 36 0.71 60–62 0.96
18 0.44 38 0.73 64–66 0.98
20 0.46 40 0.76 68 0.99
232 HARDING
7. POSITRON EMISSION TOMOGRAPHY
Data relating to positron emission tomography are generally less common than
those for gamma emitters. The higher energy of photons creates difficulties in shield-
ing, and radiation doses both to patients and to staff are greater than with gamma
emitters. For example, 400 MBq of fluorodeoxyglucose will give an effective dose of
10 mSv to patients, approximately twice the comparable figure for 400 MBq of a
typical technetium radiopharmaceutical.
8. RESEARCH
Research is dealt with elsewhere in the conference, but there are particular
problems relating to nuclear medicine. As with all research studies there must be a
consideration of whether there is a direct benefit to the subject, whether there is no
direct benefit to the subject and whether they are healthy volunteers. The project
should always be referred to an ethics committee or competent authority, and consent
must be both free and informed. In the case of nuclear medicine procedures, subjects
should, where possible, be over the age of 50, and no pregnant or breastfeeding
women should be included. There is also a reluctance to undertake such studies in
children. In the case of subjects under 50 there should be a substantial benefit when
the effective dose is greater than 10 mSv, as this corresponds to a risk of greater than
1 in 1000 [9].
9. THERAPEUTIC NUCLEAR MEDICINE
Therapeutic nuclear medicine may be used for either benign or malignant

conditions, and the aim is to produce deterministic effects. Such effects include
hypothyroidism following 131I therapy, suppression of thyroid nodules and bone mar-
row suppression following 32P therapy. In the case of 90Y injected into joints the
effects are on the synovium, and this is the beneficial effect required [10].
Increasingly, isotopes (e.g. 89Sr) are being used in the palliation of bone pain,
especially with prostate cancer; the costs are comparable with radiotherapy.
10. COMPARATIVE RISK OF RADIATION
Radiation risks have to be compared with the risk of not diagnosing or treating
a patient’s disease. Radiation risks are small in comparison with other risks of every-
day life, as Fig. 2 based on Ref. [11] shows.
Alcoholism
Smoking (men)
Smoking (women)
15% overweight
Cardiovascular
Cancer
Diabetes
Car accident
Homicide
Nuclear medicine test
0 500 1000 1500 2000 2500 3000 3500 4000 4500

Days of life lost
FIG. 2. Loss of life expectancy: comparison of risks (based on Ref. [11]).
REFERENCES

[2] EUROPEAN COMMISSION, Referral Guidelines for Imaging, Radiation Protection
118, EC, Luxembourg (2000).
[3] BRILL, A.B., HARDING, L.K., THOMSON, W.H., “Radiation risks and patient
issues”, Clinical Nuclear Medicine, 3rd edn (MAISEY, N.M., BRITTON, K.E., COL-
LIER, B.D., Eds), Chapman and Hall, London (1998).
[4] WILLIAMS, N.R., NOTGHI, A., HARDING, L.K., “How much extra 99Tcm activity is
needed for the obese heart patient?” British Nuclear Medicine Society Autumn Meeting
Nottingham, 1999, Nucl. Med. Commun. 21 (2000) 210.
[5] ADMINISTRATION OF RADIOACTIVE SUBSTANCES ADVISORY COMMIT-
TEE, Notes for guidance on the clinical administration of radiopharmaceuticals and use
of sealed radioactive sources, Nucl. Med. Commun. 21 Supplement (2000).
[6] MOUNTFORD, P.J., Risk assessment of the nuclear medicine patient, Br. J. Radiol. 70
(1997) 671–684.
234 HARDING
[7] PAEDIATRIC TASK GROUP, EUROPEAN ASSOCIATION OF NUCLEAR

MEDICINE, A radiopharmaceuticals schedule for imaging in paediatrics, Eur. J. Nucl.
Med. 17 (1990) 127–129.
[8] BRAY, D., THOMSON, W.H., HARDING, L.K., Is extravasated 99Tcm a problem, Nucl.
Med. Commun. 18 (1997) 299.
[9] EUROPEAN COMMISSION, Guidance on Medical Exposures in Medical and
Biomedical Research, Radiation Protection 99, EC, Luxembourg (1998).
[10] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Dose
Coefficients for Intakes of Radionuclides by Workers: A Replacement of ICRP
Publication 61. Includes Summary of the Current ICRP Principles for Protection of the
Patient in Nuclear Medicine, Publication 68, Pergamon Press, Oxford and New York
(1993).
[11] COHEN, B.L., Catalog of risks extended and updated, Health Phys. 61 (1991) 317–335.
DISCUSSION
L.K. HARDING: I gather that no one in this audience has seen ulceration of an
injection site owing to the use of 201Tl. I do not believe that ulceration occurs for this
reason, and I would therefore be interested to hear of any cases.
While I have the floor, I should like to say, with regard to the activity adminis-
tered to pregnant women, that I strongly hold the view that, if you are performing
optimum studies, you should administer the normal diagnostic reference level.
I would be interested in knowing what, for example, J. Konishi does.
J. KONISHI: I would not do that in the case of a pregnant woman unless the
situation was really critical.
C. STREFFER: It depends on the gestation age of the embryo or foetus in
question. For example, if you use iodine in the late stages of a pregnancy there will
be a much higher dose in the thyroid of the foetus than in that of the mother, so one
should look at the specific biokinetic data.
L.K. HARDING: This rarely happens with iodine, because with iodine you try
to persuade them not to do it. The common problem is ventilation, perfusion imag-
ing. Actually, there is not a great choice as long as the consultant has said ‘We need
to do it’. I would not accept a house officer, it has to be the consultant. You just have
to do them, I find. It is very rare that you can persuade anyone that it is not the right
thing to do. If it is iodine — we don’t use 131I for diagnosis in the UK at all — but
even with 123I, you are absolutely right.
C. STREFFER: I agree that in the UK and Germany we do not do that, but there
are countries where it is still done, and some such countries are represented here. That
is why I mentioned it. The same holds true for technetium; pertechnetate will give the
same biokinetics.
G. KLEMPFNER: One way we have of coping with the problem is to perform

a perfusion scan but not a ventilation scan. When women are young and fit, which
they usually are, the scans are clear cut one way or the other. In other words, if it is a
normal scan, you do not have to perform a ventilation scan.
I used to diagnose pulmonary embolism without ventilation scans. You do not
really need a ventilation scan if there are multiple defects. It is only in cases of
intermediate probability that you may later have to perform a ventilation scan. So we
perform a perfusion scan, which involves a lower radiation dose, and follow-up with
a ventilation scan in only a few cases.
L.K. HARDING: You spoke of ‘a normal scan’. Obviously, you do not live in
a large city, where many people have chronic bronchitis and/or smoke. Many years
ago I tried to dispense with ventilation imaging, but the results of these tests are
difficult to interpret with my group of patients.
I am sure that you have been doing the right thing for your population, but we
rarely obtain an absolutely normal perfusion image.
M. TELLEZ DE CEPEDA: Do you always inform the patient when some-
thing has gone wrong with the administration of a radioisotope for diagnostic
purposes?
L.K. HARDING: Extravasation is, of course, fairly normal. After a perfectly
good injection, a small amount, less than 10%, leaks; we would not tell the patient in
such a case as the image obtained would be of sufficiently high quality for diagnos-
tic purposes. If a further injection was necessary we would naturally tell the patient
that he or she was going to have to receive an additional amount of activity.
S. GROTH: In nuclear medicine quality is closely related to the injected
activity, or to the dose, as in diagnostic radiology. However, it is also very much a
question of the time you are prepared to spend on acquiring a scan. In many cases
doses may change but you can still get a high quality scan if you change the acquisi-
tion time. What determines the doses — the injected activities? Is it a matter of
protection of patients? Is it a matter of protection of staff? Or is it only a matter of
tradition?
L.K. HARDING: This is a very important question. In many ways what you are
asking is ‘How do you set diagnostic reference levels?’
You can take longer over a study, but a limiting factor will be the length of time
for which patients can be expected to lie still. We use an arbitrary figure of 20 min-
utes; if the study is going to take more than 20 minutes with a given amount of
activity, we administer a larger amount. Another limiting factor is the workload with
which departments can cope; longer studies increase the workload.
It becomes a matter of agreement among professionals as to what the diagnos-
tic reference levels should be; it is not a precise science. You might like to take count
density as the basis, but that does not work in practice. Consequently, I recommend,
as a good basis, the figures given in the supplement to Nuclear Medicine
236 HARDING
Communications 2000. They are generally felt to be slightly on the low side, but they
are the figures being used in the UK and are well worth looking at.
Of course, staff doses depend on patient doses; the latter is the prime determi-
nant of the former.
J. KONISHI: A question about dosage. In the case of cardiac single photon
emission computed tomography studies, we feel that the diagnostic reference level is
rather low compared with those for other studies. What do you think?
L.K. HARDING: The figure in the UK is 80 MBq. The effective dose is
25 mSv, as I recall. That is what worries people; 25 mSv is close to the higher end
for nuclear medicine diagnostic studies. All I can say is that in the UK we cope with
that.
There is a debate about whether it should be increased, and larger amounts are
being allowed in certain limited investigations; in lymphoma, but not in cardiac,
investigations. A group is currently discussing the question of overweight cardiac
patients and the ‘correct’ amount of thallium to administer. Perhaps we shall have the
answer in about a year’s time.
D.T. SKOURAS: What is the situation regarding the radiological protection of
persons, relatives and so on, who are likely to come into close contact with patients?
L.K. HARDING: In the case of patients undergoing radiotherapy, we always
provide a set of instructions for such persons.
An International Commission on Radiological Protection (ICRP) working party
under my chairmanship is currently drawing up guidelines that should be ready
within a year or so.
E. VAÑÓ CARRUANA: With some of the new systems for positron emission
tomography imaging it is possible to obtain images of sufficient quality using only
half of the activity necessary with some older systems. What do you think about these
new systems?
L.K. HARDING: I am delighted that you have found a system for which you
need only half of the activity needed previously; I have not found such a system.
Belgian colleagues who now use three headed cameras tell me that with
such cameras one needs to administer more, not less, activity; the reason being that
there are things one can diagnose with a three headed camera (and more activity)
that one cannot diagnose with a two headed camera (however much activity one
administers).
A. BEN-SHLOMO: We carried out a survey in Israel and found that all the
nuclear medicine tests performed in hospitals approximately fitted the reference level
system. When we calculated the average dose per caput from all nuclear medicine
procedures, however, we obtained a value of 0.3 mSv, compared with the 0.18 mSv
average for level 1 countries in the United Nations Scientific Committee on the
Effects of Atomic Radiation’s country classification. In my opinion, there is a lack of
one dimension in the reference level system, namely the average dose to the
population in each country. When we tried to work out where the problem lay, we
found that we were carrying out many thallium tests for cardiac procedures.
Is there any recommendation regarding the use of thallium as against
technetium in cardiac procedures, since the patient dose will differ?
L.K. HARDING: Yes and no: a combined rest and exercise study. I will just
quote the figure for the UK: 1000 MBq total technetium activity to a patient.
With thallium, of course, you have to give only one injection, and by the time
you have looked at all the factors it becomes a very interesting debate as to which is
the right way.
Personally (and this is for hibernating myocardium), I always use a technetium
agent since, in my view, the quality of the image is better. However, there are people
who have been using thallium for many years and claim that it is a much better agent.
So, I think it is an unresolved issue.
J. PORTE: Is there a formula that gives a reliable estimate of the thyroid dose
owing to the administration of radioiodine. I ask this because a small percentage of
our patients return for a further radioiodine dose, and it would be useful to know what
dose(s) they had already received.
L.K. HARDING: I would be surprised if you could not find such a formula in
an ICRP publication.
F.A. METTLER: In your presentation you talked about administering 400 MBq
to patients undergoing therapy, for which, of course, there are no reference levels.
I used to administer 400 MBq, but after I had treated about a thousand patients
I noticed that 10 to 15% were returning for further treatment. I then started going to
about 600 MBq, since there does not seem to be a significant difference in the whole
body dose if one hydrates the patients. What are your views on this?
L.K. HARDING: The Royal College of Physicians, the National Radiological
Protection Board and various other bodies established a group that concluded that that
the 400 MBq level is the level to use. So, it is a national guideline that I would not go
against without a very good reason, especially as I was a member of that group.
M.J. MYERS: The diagnostic reference levels in the United States of America
are in general about twice as high as those in the UK. Is there any evidence of a
detriment owing to higher doses or, on the other hand, of benefits in the form of better
image quality?
L.K. HARDING: We recently reviewed the diagnostic reference levels in the
USA and found that, although they tended to be higher than those in the UK (much
higher in some cases), they were not twice as high.
I think the question you have in mind is ‘Are low doses harmful?’ As far as any-
one can tell, the answer to that is ‘Yes, there is no threshold’.
E. MARSHALL-DEPOMMIER: I understood that you disagree with the
authors of paper IAEA-CN-85-1921 about adapting activity to the weight and height
of a patient. I should be interested to know why you disagree.
238 HARDING
L.K. HARDING: The ICRP takes the view that one should not adapt the
activity unless there is a difference of 20% or more.
A more important consideration, in the case of women and men, is excessive
weight, but so far there is no agreement on what to do. I have proposed that patients
weighing over 100 kg receive twice the diagnostic reference level, and so far no one
has argued against that proposal.

DEVELOPING AND USING GUIDANCE (REFERENCE) LEVELS
IN RADIOLOGY AND NUCLEAR MEDICINE EXAMINATIONS
(Topical Session 5)
Chairperson
E. VAÑÓ
Spain
DIAGNOSTIC REFERENCE LEVELS IN
MEDICAL IMAGING
M. ROSENSTEIN
Montgomery Village, Maryland, United States of America
E-mail: smrmr@msn.com
Abstract
The paper proposes additional advice to national or local authorities and the clinical
community on the application of diagnostic reference levels as a practical tool to manage
radiation doses to patients in diagnostic radiology and nuclear medicine. A survey was made
of the various approaches that have been taken by authoritative bodies to establish diagnostic
reference levels for medical imaging tasks. There are a variety of ways to implement the idea
of diagnostic reference levels, depending on the medical imaging task of interest, the national
or local state of practice and the national or local preferences for technical implementation. The
existing International Commission on Radiological Protection (ICRP) guidance is reviewed,
the survey information is summarized, a set of unifying principles is espoused and a statement
of additional advice that has been proposed to ICRP Committee 3 is presented. The proposed
advice would meet a need for a unifying set of principles to provide a framework for diagnostic
reference levels but would allow flexibility in their selection and use. While some illustrative
examples are given, the proposed advice does not specify the specific quantities to be used, the
numerical values to be set for the quantities or the technical details of how national or local
authorities should implement diagnostic reference levels.
1. INTRODUCTION
The purpose of this paper is to provide additional advice to national or local

authorities and the clinical community on the application of diagnostic reference lev-
els as a practical tool to manage radiation doses to patients in diagnostic radiology
and nuclear medicine. It is assumed that the goal of achieving acceptable image qual-
ity or adequate diagnostic information, consistent with the medical imaging task, is
the overriding clinical objective. Diagnostic reference levels are then used to manage
radiation doses to patients so that they are commensurate with the clinical purpose.
A survey was made of the various approaches that have been taken by authori-
tative bodies, working in concert with professional medical groups, to establish ref-
erence levels, variously named, for medical imaging tasks. While the approaches are
not uniform in aim and methodology, it is concluded that there are a variety of ways
to implement the idea of diagnostic reference levels, depending on the medical imag-
ing task of interest, the national or local state of practice and the national or local pref-
erences for technical implementation. The advice given here meets a need for a uni-
241
242 ROSENSTEIN
fying set of principles to provide a framework for diagnostic reference levels but
allows flexibility in their selection and use. While some illustrative examples are
given, the advice does not specify the specific quantities to be used, the numerical val-
ues to be set for the quantities or the technical details of how national or local author-
ities should implement diagnostic reference levels.
This paper briefly reviews the existing International Commission on
Radiological Protection (ICRP) guidance, summarizes the survey information,
espouses a set of unifying principles and translates the principles into a proposed
statement of additional advice from ICRP Committee 3.
2. EXISTING ICRP GUIDANCE
ICRP Publication 60 [1] provided the following recommendation in the section

on the optimization of protection in medical exposure in paragraph S34:
“Consideration should be given to the use of dose constraints, or investigation levels,
selected by the appropriate professional or regulatory agency, for application in some
common diagnostic procedures. They should be applied with flexibility to allow
higher doses where indicated by sound clinical judgment.”
ICRP Publication 73 [2] introduced the term ‘diagnostic reference level’,
explained where it fits into the ICRP concept of reference levels and expanded
the ICRP Publication 60 recommendation in paragraph S34 in more detail (para-
graphs 99 through to 106 of ICRP Publication 73). The main points are summarized
below.
— The term used is diagnostic reference level.

— The purpose is advisory. It is a form of investigation level for identifying unusu-
ally high levels, which calls for a local review if consistently exceeded. In prin-
ciple, there could also be a lower level. They are not for regulatory or commer-
cial purposes, not a dose constraint and not linked to limits or constraints.
— The examination types include diagnostic radiology and nuclear medicine (i.e.
common examinations and broadly defined types of equipment).
— Their selection is by professional medical bodies, using a percentile point on
the observed distribution for patients, and specific to a country or region.
— The quantities should be easily measured, such as an absorbed dose in air or tis-
sue equivalent material at the surface of a simple standard phantom or repre-
sentative patient for diagnostic radiology and administered activity for diag-
nostic nuclear medicine.
MEDICAL IMAGING 243
3. SURVEY OF REFERENCE LEVELS IN MEDICAL IMAGING
There have been a number of approaches to reference levels used for medical
imaging. Typically, reference levels are used as investigation levels (i.e. a quality
assurance tool) and they are advisory, but there are exceptions where the approach
uses ‘achievable levels’ indicative of more optimum conditions, mentions dose con-
straints or incorporates a dose limit or suspension level (i.e. for mammography used
for screening).
There have been fairly consistent criteria for selecting reference levels,
although the criteria differ for diagnostic X ray procedures and nuclear medicine. For
diagnostic X ray procedures reference levels are usually derived from distributions of
dosimetric quantities for patients observed in practice in the relevant region or coun-
try. Usually, only upper levels are selected and lower levels are not specified. For
nuclear medicine procedures reference levels are derived from pragmatic values of
administered activity based on accepted custom and practice. Typically, all reference
levels are developed through co-operation between radiation protection authorities
and professional groups or specialists (i.e. clinical peer involvement).
There have been different aims for various reference levels. While reference
levels apply to a selected medical imaging task, often the clinical and technical con-
ditions are not fully defined, with the degree of definition dependent on the aim. At
least three general aims can be identified:
— To triage a national or regional distribution observed for a general clinical task,

that is to reduce the number of unjustified high or low values in the distribution;
— To promote good practice for a specific clinical application;
— To promote the optimum use of medical radiation exposure for a specific clin-
ical protocol.
There have been a number of different quantities used for reference levels. The
quantity selected is dependent on the type of clinical procedure, for example whether
it is an individual radiographic projection, a procedure or examination consisting of
multiple projections or field locations, or a diagnostic nuclear medicine procedure
(i.e. for a specific radiopharmaceutical and clinical purpose). The quantity used is
also quite dependent on the body setting the reference level, and is related to the
desired aim, local preference and the unique irradiation conditions.
The observations given above highlight the array of considerations and
approaches to reference levels, whose features are displayed in Tables I and II and
which are surveys of approaches and values that have been selected by a number of
authorized bodies in recent years.
244
TABLE I. APPROACHES TO REFERENCE LEVELSa
Document Term used Examination type: measured quantity Selection Purpose
International Commission Diagnostic Diagnostic radiology and nuclear medicine Professional Advisory: form of investigation level,
on Radiological Protection reference (common examinations and broadly defined medical bodies; identify unusually high levels; in princi-
[2] level types of equipment): easily measured quanti- percentile points ple, lower level also; not for regulatory
ties (for radiology, absorbed dose in air or in on observed dis- or commercial purposes; not a dose
tissue-equivalent material at the surface of a tributions for constraint; not linked to limits or con-
simple standard phantom or representative patients; specific straints
patient; for nuclear medicine, administered to a country or
activity) region
Conference of Radiation Patient Medical, mammography and dental: Derived from Non-regulatory: tied to specific
ROSENSTEIN
Control Program Directors, exposure ESE in mR; measurements in air, no phantom inspection of technique factors — patient thickness,
Inc. (1988) [3] guides data from US SID, grid, film speed, kilovoltage (peak)
surveys; reflects (for dental)
the state of cur-
rent practice
Institute of Reference Radiographs: ESD in mGy Rounded third p. 15: “… could be construed as dose
Physical Sciences in dose Examinations: DAP in Gy·cm2 (average quartile values constraints that have been set at the
Medicine [4] levels for at least ten adult patients, avoid extremes from UK sur- national level”; “achievement of doses
in physique (70 ± 10 kg)) veys below reference levels should not be
construed as an indication of satisfactory
or optimum performance”
Basic Safety Standards [5] Guidance Radiographs: ESD in mGy (for film screen Derived from Corrective actions if doses fall
levels combinations with relative speed 200; reduce wide scale sur- substantially below levels with no useful
by factor of two to three for film speeds of veys for typical information or medical benefit, or if
400 to 600) adults doses exceed levels
Computed tomography: MSAD in mGy (on
a For abbreviations see the footnote at the end of the table.

axis of rotation, water phantoms for head and

body)
Mammography: AGD in mGy; 4.5 cm, 50/50;
Mo–Mo
Fluoroscopy: ESD rate in mGy/min
Nuclear medicine: administered activity in MBq
National Radiological Suspension Radiographs: ESD; mGy for adults, µGy for Reference doses: Suspension level (screening
Protection Board [6] and level paediatrics third quartile dis- mammography)
Administration of (screening Mammography: MGD in mGy for the tribution of mean If exceeded, subject to an immediate
Radioactive Substances mammo- standard breast model values, UK sur- review of practices
MEDICAL IMAGING
Advisory Committee, graphy), Dental radiographs: intraoral, PED in veys Reference doses
Department of Health (UK) reference mGy; panoramic, DWP in mGy·mm Achievable doses: Investigation levels: threshold for the
[7] doses, Fluoroscopic exams: DAP in mGy·cm2 values achievable internal investigation of potentially poor
achievable Computed tomography: single slices, CTDIw in by standard practices within a department; not a for-
doses and mGy; examinations, DLP in mGy·cm means in wide- mal regulatory tool
DRLs Nuclear medicine: administered activity in MBq spread use Achievable doses
(nuclear Radiographs: mean Supplemental to reference doses; promote
medicine) value for facili- optimization of practice
ties meeting Diagnostic reference levels (nuclear medi-
European recom- cine)
mendations Pragmatic values based on accepted
Mammography: customs and practice; thresholds above
value based on a which special justification is required;
UK survey of required by certificate issued by regula-
good technique tory authority (previously MUAs)
Diagnostic reference
levels: guidance
for practitioners
in the UK
245
246
TABLE I. (cont.)
European Commission [8] Diagnostic Radiographs: ESD in mGy Radiography: X ray examinations: groups of
reference Fluoroscopic exams: DAP in mGy·cm2 third quartile standard sized patients or phantoms;
levels (average for at least ten adults; avoid values from Eu- broadly defined types of equipment;
extremes in physique (70 ± 3 kg)) ropean surveys levels expected not to be exceeded when
Mammography: ESD in mGy for a standard Nuclear medicine: good and normal practice is applied;
phantom administered when consistently exceeded, review pro-
Nuclear medicine: administered activity in MBq activity neces- cedures and equipment
sary for a good Nuclear medicine: optimum values;
image during a for children, a fraction of adult values
standard proce-
ROSENSTEIN
dure
European Commission Reference Radiographs: ESD; mGy for adults, µGy for Third quartile Investigation levels (investigate
[9–13] dose value paediatrics values from reason for exceeding): tied to diagnostic
(criteria Mammography: 4.5 cm; grid not specified [9] European sur- requirements; image criteria and good
for radia- Mammography: ESD in mGy; 50 mm veys radiographic technique
tion doses breast = 45 mm PMMA; OD = 1.0 [10]
to Mammography: ESD in mGy; 5 cm, Mo
patients) target, Mo/Al filter [11]
Computed tomography: single slices,
CTDIw in mGy; examinations, DLP in
mGy·cm (head phantom, 16 cm diameter;
body phantom, 32 cm diameter; PMMA)
Adults: use sample of ten patients near
standard size, 60–80 kg
Paediatric: use sample of ten patients, four
to six years old, 15–25 kg
European Commission [14] Limiting Mammography: ESAK and AGD in mGy; Conversion from p. 49: “dose constraints”; “used to
value 45 mm PMMA; OD = 1.0 the Ref. [10] cover different terms like limiting val-
value for ESD ues, reference levels, action levels, etc.”
European Commission [15] Dose limit Mammography: AGD in mGy, craniocau- Adapted from Regulatory requirement (shall not exceed):
dal view; using an accepted FDA phantom; the American for screening mammography; quality
for all systems; for technique factors and College of assurance test, perform at least annual-
conditions used clinically for a standard Radiology quali- ly; part of extensive equipment quality
breast (4.2 cm; 50/50) ty control assurance requirements (provision effec-
manual tive April 1999)
MEDICAL IMAGING
American Association of Reference Radiographs: ESAK in mGy (ESE in mR); Derived from the Non-regulatory: to assist medical
Physicists in Medicine Task value measurements in air, no phantom 75th or 80th professionals in evaluating exposure
Group [16] Computed tomography: CTDI in mGy, in percentiles of levels; if exceeded, facility investigates
phantom with backscatter US survey data reason; reduce, if possible without sacri-
Fluoroscopy: ESAK rate in mGy/min ficing image quality
(ESE in mR/min)
National Radiological Reference Radiographs: ESD in µGy Rounded values Provisional reference doses: a useful
Protection Board [17] dose Complete examinations: DAP in mGy·cm2 of third quartile and practical way of promoting opti-
Paediatric ages: neonate, 1, 5, 10 and 15 European sur- mization of patient protection; refer-
years (use measured values for individual veys enced to concepts in ICRP publications
children, normalized to standard size of near- and the EC Medical Exposure Directive
est paediatric age)
Abbreviations DRL — diagnostic reference level. ESE — entrance skin exposure

AGD — average glandular dose. DWP — dose–width product. (free in air).
CTDI — computed tomography dose ESAK — entrance surface air MGD — mean glandular dose.
index (USA). kerma (free in air). MSAD — multiple scan average dose.
CTDIw — weighted computed tomography ESD — entrance surface dose MUA — maximum usual activity.
dose index (EC). (with backscatter). OD — optical density.
247
DAP — dose–area product. ESD rate — entrance surface dose rate PED — patient entrance dose
DL — dose–length product. (with backscatter). (free in air).
248
TABLE II. LISTING OF REFERENCE LEVELSa
General, USA General, UK BSS General, EC General, USA General, NRPB

(Ref. [3]) (Ref. [4]) (Ref. [5]) (Refs [8, 9, 11]) (Ref. [16]) (Ref. [6])
Medical imaging task

Radiographs (values are ESD in mGy, except as noted for Refs [3, 6, 16])
(Note: Ref. [3] entries were converted from ESE in mR (× 0.00876) to ESAK in mGy)
Dental panoramic 65
Dental (periapical) 7 (DWP in mGy·mm)
AP dental (ESAK in mGy) 5 (ESAK in mGy)
Dental cephalometric 0.3 0.25
Dental intraoral (bite wing) Function of kVp and speed 2.3 (70 kVp, E) Mandibular molar
(exl. 70 kVp and E speed) 2.1 to 3.1 (range) 3.5 (70 kVp, D) 4, 1.8 (PED, mGy)
ROSENSTEIN
PA or AP skull 5 5 5 5, 1.5
LAT skull 1.3, 0.6 3 3 3 3, 1
AP cervical spine 1.2, 0.8 1.25
PA chest 0.1, 0.04 (no grid) 0.3 0.4 0.3 0.25 0.3
0.2, 0.1 (grid)
LAT chest 1.5 1.5 1.5 1.5
AP thoracic spine 7
LAT thoracic spine 20
AP full spine 2.3, 1.3
AP abdomen 4.3, 2.6 10 10 4.5 10, 6
AP or PA lumbar spine 3.9, 3.1 10 10 10 5 10, 5
LAT lumbar spine (Two film speeds: 30 30 30 30, 12
200, then 400)
LAT lumbar spine 40 40 40 40, 24
(lumbo-sacral joint)
a For abbreviations see the footnote at the end of the table.

General, USA General, UK BSS General, EC General, USA General, NRPB
(Ref. [3]) (Ref. [4]) (Ref. [5]) (Refs [8, 9, 11]) (Ref. [16]) (Ref. [6])
AP pelvis 10 10 10 10, 4
AP hip joint 10 (Reference dose,
then achievable
dose)
AP urinary tract 10
(plain film or before contrast)
AP urinary tract (after contrast) 10
Paediatric radiographs (values are ESD Paediatric Paediatric General, NRPB
MEDICAL IMAGING
in µGy, except for the MCU examination) (Ref. [17]) (Refs [8, 12]) (Ref. [6])
0 1a 5a 10 a 15 a
AP and PA chest 50 70 120 100 (5 a) 100 (5 a)
LAT chest 200 (5 a) 200 (5 a)
AP chest (newborns) 50 80 (newborn) 80 (newborn)
PA or AP skull 800 1100 1100 1100 1500 (5 a) 1500 (5 a)
LAT skull 500 800 800 800 1000 (5 a) 1000 (5 a)
AP pelvis (infants) 200 (infant) 200 (infant)
AP pelvis (older children) 500 600 700 2000 900 (5 a) 900 (5 a)
AP or PA abdomen (with vertical beams) 400 500 800 1200 1000 (5 a) 1000 (5 a)
MCU examinataion (note: DAP in mGy·cm2) 600 900 1200 2400
(Note: quality criteria, but not reference levels, also given for the following paediatric radiographs in Ref. [12])
PA or AP full spine Micturating cystourethrography AP or PA urinary tract

PA or AP segmental spine AP or PA urinary tract (after contrast)
LAT segmental spine (without or before contrast)
249
250
TABLE II. (cont.)
General, UK BSS CT General General General, USA

(Ref. [4]) (Ref. [5]) (Ref. [13]) (Ref. [6]) (Ref. [8]) (Ref. [16])

Fluoroscopy (values are in mGy/min)
Normal mode 25 (Mode not given)
High level mode 100 (ESD rate) 65 (ESAK rate)
Examinations (values are DAP in Gy·cm2)

Lumbar spine 15 15 nv, 10
Barium enema 60 60 60, 50
ROSENSTEIN
Barium meal 25 25 25, 25
Intervenous urography 40 40
Abdomen 8 8
Pelvis 5 5 nv, 4
Chest nv, 1
Urography 40, 20
(Values cited: UK, then Norway)
(nv, no value)
Computed tomography (values are MSAD in mGy)

CT head 50
CT lumbar spine 35
CT abdomen 25
General, UK BSS CT General General General, USA
(Ref. [4]) (Ref. [5]) (Ref. [13]) (Ref. [6]) (Ref. [8]) (Ref. [16])
Computed tomography (values are in mGy (CTDIw, CTDI) or mGy·cm (DLP), as noted)
(Values are for CTDIw (slice), then DLP (exam)) (CTDI (exam))
Routine head 60, 1050 60, 1050 60 (head)
Routine chest 30, 650 30, 650 40 (all body sites)
Routine abdomen 35, 780 35, 800
Routine pelvis 35, 570 35, 600
Face and sinuses 35, 360
Vertebral trauma 70, 460
HRCT of the lung 35, 280
MEDICAL IMAGING
Liver and spleen 35, 900
Osseous pelvis 25, 520
(Note: quality criteria, but not reference levels, also given for the following CT procedures in Ref. [13])
Skull base Pharynx Kidneys

Petrous bone Larynx Pancreas
Orbits Lumbar spine, discal hernia Adrenal glands
Sella and hypophysis Spinal cord Osseous shoulder
Salivary glands (parotid Chest, mediastinal vessels
and submandibular)
251
TABLE II. (cont.)
252
General, USA General, EC BSS General, NRPB Mammography, EC Mammography, USA
(Ref. [3]) (Refs [8, 9, 12]) (Ref. [5]) (Refs [6, 7]) (Refs [10, 14]) (Ref. [15])

Mammography (values are ESD, ESAK, AGD or MGD in mGy, as noted)
[Note: Ref. [3] entries were converted from ESE in mR (nominal BF = 1.1) and AGD in mR)
LAT breast 10 (Ref. [11]))
MLO breast 7 (Ref. [9], 10 (Refs [8, 11]) 3, 2, 1.5a
CC breast 7 (Ref. [9]), 10 (Ref. 8]) 3 ,2, 1.5a 12, 11, 2.3 3
Screen film (no grid) 3.3, 0.6 1
Screen film (grid) 6.7, 1.4 10 (Ref. [11]) 3
Xerox (positive) 8.6, 4.0
ROSENSTEIN
Xerox (negative) 6.5, 3.4
(ESD, then AGD) (ESD) (AGD) (MGD) (ESD, ESAK, AGD) (AGD,
(aSuspension level, dose limit)
reference dose,
then achievable dose)
Nuclear medicine (values are administered activity in MBq, for adults); examples
Bone imaging (MDP/HDP) 400, 600 600 600
Liver/spleen studies (colloid) 80, 80 80 80
Liver/spleen studies (IDA) 40, 150 150 150
Lung perfusion imaging (MAA) 100, 100 100 100
Renal imaging (DMSA) 80, 80 160 80
Dynamic renal scanning (DTPA) 80, 300 350 300
Dynamic renal scanning (MAG3) 40, 100 100 100
(All 99Tcm) (Values cited (Guidance (DRLs (MUAs)
in Ref. [8]: levels) from Ref. [7])
Netherlands, then UK)
(Note: in Ref. [8] administered activities are given for several other countries, and one set of values for children)
Abbreviations
AGD — average glandular dose. ESE — entrance skin exposure (free in air).
BF — backscatter factor. HDP — hydroxymethylene diphosphonate.
CC — craniocaudal. HRCT — high resolution computed tomography.
CT — computed tomography. IDA — iminodiacetic acid.
CTDI — computed tomography dose index (USA). LAT — lateral.
CTDIw — weighted computed tomography dose index (EC). MAA — macroaggregated albumin.
DAP — dose–area product. MAG3 — mercaptoacetyltriglycine.
DLP — dose–length product. MCU — micturating cystourethrography.
DMSA — dimercaptosuccinic acid. MDP — methylene diphosphonate.
DRL — diagnostic reference level. MGD — mean glandular dose.
DTPA — diethylenetriaminepentacetic acid. MLO — mediolateral oblique.
MEDICAL IMAGING
DWP — dose–width product. MSAD — multiple scan average dose.
ESAK — entrance surface air kerma (free in air). MUA — maximum usual activity.
ESD — entrance surface dose (includes backscatter). PA — posterioanterior.
ESD rate — entrance surface dose rate (includes backscatter). PED — patient entrance dose (free in air).
253
254 ROSENSTEIN
4. NEED FOR A UNIFYING SET OF PRINCIPLES
There is a need for a unifying set of principles to implement the ICRP concept
of diagnostic reference levels in practice that adheres to the central objective of man-
aging the amount of tissue dose resulting from the conduct of a medical imaging task
to that commensurate with the clinical purpose, but that also provides sufficient flex-
ibility to accommodate local aims and technical preferences.
In order to interpret correctly the relationship between a change in the numeri-
cal value of a measured quantity that is used as a diagnostic reference level and the
tissue dose distribution in a body, the following conditions are necessary:
— The medical imaging task should be defined. The diagnostic reference level (i.e.
the numerical value) should be tied to identified clinical requirements, image
criteria or good radiographic technique. A selected numerical value for one sit-
uation may not be applicable to different clinical and technical requirements,
even if the same area of a body is being imaged.
— The relative tissue dose distribution in a body should not change appreciably for
the defined medical imaging task. Thus a proportional change in the measured
quantity will be unambiguously related to the expected dose distribution. That
is, there will be a uniform percentage change in all the individual tissue doses.
If the tissue–dose distribution in a body changes appreciably from the expected
distribution, owing to a different field size, field location, beam quality or other
technical factor that alters the internal dose distribution, then interpretation of a
proportional change in the measured quantity would be ambiguous. That is,
there would be unknown and non-uniform percentage changes in the individual
tissue doses.
In setting diagnostic reference levels, national and local authorities and profes-
sional groups should strive to satisfy these conditions.
5. EXPANDED ADVICE ON DIAGNOSTIC REFERENCE LEVELS

PROPOSED TO ICRP COMMITTEE 3
5.1. Objective of a diagnostic reference level
The objective of a diagnostic reference level is to promote the control of med-

ical radiation exposure to a level commensurate with the clinical purpose of a med-
ical imaging task, by helping to avoid radiation exposure that does not contribute to
the medical imaging task. This is accomplished by comparison between the numeri-
cal values of the selected diagnostic reference level (whether it be an upper or lower
MEDICAL IMAGING 255
level) with those observed in practice, and taking an appropriate local review when
the values observed in practice are consistently outside the upper or lower level. This
process impacts upon the amount of unnecessary tissue dose received by a patient
and, therefore, impacts upon the amount of unnecessary risk for associated radiation
health effects.
5.2. Uses for a diagnostic reference level
A diagnostic reference level can be used:
— To triage a national or regional distribution of observed results for a general

medical imaging task, in order to reduce the frequency of unjustified high or
low values;
— To promote the attainment of a narrower range of values that represent good
practice for a specific medical imaging task;
— To promote attainment of the optimum use of radiation exposure for a specific
medical imaging protocol.
Examples for each of these uses are given below.
5.3. Definitions
The term general medical imaging task refers to a task for a general clinical
purpose, with a minimum specification of other factors. An example would be a pos-
terioanterior (PA) chest radiograph with the clinical purpose and technique factors
unspecified.
The term specific medical imaging task refers to a task for a clearly defined
clinical purpose, but allows for differences among medical facilities in other techni-
cal and clinical details. An example would be a PA chest radiograph with the clinical
purpose and the general technique (e.g. high kilovoltage (peak)) specified, but the
detailed technique factors unspecified.
The term specific medical imaging protocol refers to a clinical protocol with a
fully defined set of specifications that is followed, or serves as a nominal baseline, at
a single facility (or several allied facilities). An example would be a protocol for a PA
chest radiograph that specifies the clinical purpose, the technical conduct of the pro-
cedure, the image quality criteria, any unique patient characteristics and other appro-
priate factors.
256 ROSENSTEIN
5.4. Local flexibility in setting diagnostic reference levels
The concept of a diagnostic reference level permits flexibility in the choice of

quantities, numerical values and technical or clinical specifications, in order to allow
local authorities to meet the aims relevant to their circumstances. The guiding princi-
ples for setting a diagnostic reference level are:
— The local aim is clearly defined, including the degree of specification of tech-
nical and clinical conditions;
— The measured quantity is specified and can be obtained in a practical way;
— The selected quantity can be justified as a viable measure of the impact on
unnecessary tissue doses and, therefore, on unnecessary patient risk for the
given medical imaging task;
— The application of the diagnostic reference level in practice is illustrated by
example.
5.5. Examples of diagnostic reference levels
Examples of measured quantities that could be useful as a diagnostic reference

level and their applications are noted below. This is not a complete listing of the pos-
sible quantities or applications. The examples would not constitute ICRP Committee
3 recommendations; however, they generally could meet the criteria given in Sections
5.2 and 5.4.
To triage a national or regional distribution of observed values for a general
medical imaging task in order to reduce the frequency of unjustified high or low val-
ues, the following quantities and their applications are noted:
— Entrance air kerma (no backscatter) in mGy (or entrance surface dose
(with backscatter) in mGy) for a given radiographic projection (e.g. PA
chest);
— Dose–area product in mGy·cm2 for a given type of fluoroscopic examination
that has a well defined anatomical region of clinical study (e.g. barium
enema);
— Administered activity in MBq for a given nuclear medicine imaging task using
a given radiopharmaceutical (e.g. lung perfusion with 99Tcm macroaggregated
albumin).
To promote the attainment of a narrower range of values that represent good

practice for a specific medical imaging task, the following quantities and their appli-
cations are noted:
MEDICAL IMAGING 257
— Entrance air kerma (no backscatter) in mGy (or entrance surface dose (with
backscatter) in mGy) for a specific radiographic imaging task. The clinical pur-
pose is defined, but the X ray equipment, technique factors and image quality
criteria may vary among facilities;
— Dose–length product in mGy·cm for a given type of computed tomography
(CT) examination that has a well defined anatomical region of clinical study
(e.g. a routine abdominal CT scan), with specified clinical objectives, image
quality criteria and technical factors. The X ray equipment (i.e. the CT system)
may vary among facilities;
— Dose–area product in mGy·cm2 for a specific fluoroscopic examination. The
clinical purpose is clearly defined, but the type of equipment, technique factors
and patient characteristics may differ within or among facilities. The relative
tissue dose distribution is expected to be minimally variable, such that a pro-
portionate change in dose–area product corresponds to a nearly proportionate
change in absorbed dose for each of the irradiated tissues.
To promote attainment of the optimum use of radiation exposure for a specific

medical imaging protocol, the following quantities and their applications are noted:
— The milliampere seconds for a specific CT protocol. The clinical purpose, type
of equipment, technique factors and patient characteristics are defined at a spe-
cific facility.
— The nominal value of absorbed dose in the skin (at the site of maximum skin
dose) for a specific protocol of a fluoroscopically guided interventional proce-
dure. The value is nominal because the actual conduct of an interventional pro-
cedure for a given patient is dependent on the clinical circumstance. In the case
of interventional procedures the quantity is not actually a diagnostic reference
level but the most direct quantity for monitoring whether the threshold doses for
deterministic effects are being approached or exceeded [18].
— The administered activity in MBq for a specific nuclear medicine imaging pro-
tocol. The clinical purpose, type of equipment, technique factors and patient
characteristics are defined at a specific facility.
REFERENCES

Publication No. 60, Pergamon Press, Oxford and New York (1991).
Radiological Protection and Safety in Medicine, Publication No. 73, Pergamon Press,
258 ROSENSTEIN
[3] CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS, INC.,

Average Patient Exposure Guides, CRCPD Publication 88-5, CRCPD, Frankfort, KY
(1988).
[4] INSTITUTE OF PHYSICAL SCIENCES IN MEDICINE, National Protocol for Patient
Dose Measurements in Diagnostic Radiology, Dosimetry Working Party, IPSM, York
(1992).
[6] NATIONAL RADIOLOGICAL PROTECTION BOARD, Guidelines on Patient Dose to
Promote Optimisation of Protection for Diagnostic Medical Exposures, Documents of
the NRPB, Vol. 10, No 1. NRPB, Didcot (1999).
[7] DEPARTMENT OF HEALTH (UK), Notes for Guidance on the Clinical Administration
of Radiopharmaceuticals and Use of Sealed Radioactive Substances, Administration of
Radioactive Substances Advisory Committee (ARSAC), Department of Health (UK),
London (1998).
[8] EUROPEAN COMMISSION, Guidance on Diagnostic Reference Levels (DRLs) for
Medical Exposures, Radiation Protection 109, EC, Luxembourg (1999).
[9] COMMISSION OF THE EUROPEAN COMMUNITIES, Working Document on
Quality Criteria for Diagnostic Radiographic Images, CEC XII/173/90, CEC,
Luxembourg (1990).
[10] EUROPEAN COMMISSION, European Guidance for Quality Assurance in
Mammography Screening, EUR 14821, EC, Luxembourg (1993).
[11] EUROPEAN COMMISSION, European Guidelines of Quality Criteria for Diagnostic
Radiographic Images, Eur 16260 EN, EC, Luxembourg (1996).
Images in Paediatrics, EUR 16261 EN, EC, Luxembourg (1996).
[13] EUROPEAN COMMISSION, European Guidance on Quality Criteria for Computed
Tomography, EUR 16262, EC, Luxembourg (1999).
[14] EUROPEAN COMMISSION, European Protocol on Dosimetry in Mammography,
EUR 16263 EN, EC, Luxembourg (1996).
[15] UNITED STATES FOOD AND DRUG ADMINISTRATION, Quality mammography
standards; correction; final rule, Federal Register 62 217 (1997) 60613–60632.
[16] AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE TASK GROUP,
Reference Values —Applications and Impact in Radiology, November 1999 Draft,
American Association of Physicists in Medicine, College Park, MD (1999).
[17] NATIONAL RADIOLOGICAL PROTECTION BOARD, Reference Doses and Patient
Size in Paediatric Radiology, NRPB-R318, NRPB, Didcot (2000).
of Radiation Injuries from Interventional Procedures, Pergamon Press, Oxford and New
York (in press).
MEDICAL IMAGING 259
DISCUSSION
A.J. GONZÁLEZ: It is obvious from M. Rosenstein’s presentation that we have
a serious problem of international harmonization. The problem starts with the use of
language, as we communicate by means of words, and it would be helpful if we all
used those words in the same way.
I am not so sure that ‘reference levels’ is a helpful concept. In radiation pro-
tection it is a generic concept embracing quantities intended somehow to constrain
doses. The action levels used in radiation protection are reference levels, and they are
intended to limit individual doses. In the Basic Safety Standards (see Ref. [5] in main
text) the expression ‘guidance levels’ is used in order to avoid any association with
the limitation of individual doses.
The concept of ‘constraints’ or ‘individual limits’ was introduced in radiation
protection for members of the public and occupationally exposed persons because
there the optimization of protection involves collective concepts. The benefit is not to
the exposed individual, and we are in a completely different situation, where opti-
mization is individually based and we should therefore try to avoid any association
with individual limitations, be they called ‘limits’, ‘constraints’, ‘action levels’ or
whatever.
I am not proposing that ‘guidance levels’ be internationalized as a concept, but
we need an expression in common that is dissociated from individual doses.
I should now like to comment on ICRP Publication No. 73 (see Ref. [2] in main
text). It seems to be implicit in that publication that guidance levels or reference lev-
els should be tailored to different countries or different regions. That might create
serious ethical and other problems at the international level, however. For example, it
might be argued that the levels should be higher in poor countries since otherwise it
will be impossible to carry out diagnostic radiology in those countries. The counter
argument is that, with higher levels, the authorities in those countries would have no
incentive to replace old equipment. I believe it is unhelpful to create the impression
that there are two types of radiation protection, one for rich countries and another for
poor ones.
C. BORRÁS: I agree with what A.J. González just said about ‘reference levels’
and ‘guidance levels’. What the Basic Safety Standards offer is guidance, and those
who helped to draft them were concerned lest the word ‘reference’ induce regulators
to use the numerical value as a basis for deciding whether a particular practice is
appropriate.
If there is no measure of image quality, one has no idea about the clinical prac-
tice; one is engaged in a dosimetric exercise. Perhaps we should consider the possi-
bility of having a range, a value below which we believe that one cannot obtain
appropriate diagnostic information. In addition, perhaps we should remember that in
the Basic Safety Standards it is stated that we should try to find out what happens not
only when a level is exceeded, but also when it is far from having been attained.
260 ROSENSTEIN
M. ROSENSTEIN: With regard to A.J. González’s comment about rich and

poor countries, the aims of medical imaging may well differ from country to country
or from one stage to another in a given country’s development. I have found that they
do so differ.
K. FAULKNER: In interventional radiology we are faced with the twin issues
of trying to avoid deterministic injuries and trying to minimize stochastic risks. In my
view, that necessitates an informed approach to the use of reference levels. If you con-
sider the Basic Safety Standards, measuring maximum skin dose rates on a phantom
is quite a good way of setting a reference level as it enables one to identify equipment
with a potential for causing skin injuries. On the other hand, one also needs to be able
to monitor the stochastic risks, and that requires measurements of some risk related
quantity, which in Europe would almost certainly be dose or air kerma area products.
If you look through the literature you will see that there has been a history of
serious injuries in international radiology, some equipment related and some proce-
dure related. In my view, that means that you need a two pronged approach to the
assessment of reference doses in interventional radiology, in order to differentiate
between equipment related and procedure related injuries.
M. ROSENSTEIN: I would tackle deterministic effects by first understanding
the nominal protocol before going into an examination, but recognizing that things,
depending on the complexity of the procedure being carried out, will not necessar-
ily turn out as planned. I would have a visual monitor that warns the interventional
radiologist (not the technician) that he or she is approaching deterministic levels. He
or she should be aware that, first, he or she can cause deterministic effects and, sec-
ond, to the extent that modifications can be made by simply moving the patient
around so that the beam is not on the same spot all the time and by using the data
being shown on the visual monitor (i.e. the cumulative dose), be aware that they can
either take action during that procedure or adjust what they are doing later. There
will be cases, however, where deterministic effects occur because there is nothing
that can be done, it is a life saving procedure being carried out and that they are one
of the costs of doing that procedure.
However, I think that we have to keep the two separate. Having a dose–area
product (DAP) meter and looking at that will not tell you where you are with regard
to the threshold, certainly not immediately, not without a lot of other data.
I think the priority in interventional radiology is the avoidance of the deter-
ministic effects: not that the others should be ignored, but I think that it is a higher
priority.
The ICRP is, I believe, about to publish a report on avoiding deterministic
effects in interventional radiology, so the ICRP has given it a lot of thought.
G. DREXLER: With regard to the reference level as an optimization tool, we
always have in mind that we should have doses as low as reasonably achievable
(ALARA), but here I think it is good to remember that we have to apply a dose that
MEDICAL IMAGING 261
is as high as necessary, so that ALARA is no longer valid in the sense of ‘as high as
necessary’. In many developing countries those reference levels are far below the ref-
erence levels in Europe, just because technique and image quality are poor. For exam-
ple, I know of investigations in Brazil where the reference levels are far below the
reference levels in the literature for developed countries, owing to the viewing box
not functioning correctly. If you have an average luminosity of 900 or 800 cd/m2, you
have to have a lower dose in order to have less blackening of the film and to be able
to see something. This is a complex situation and I do not think that it will be resolved
without a really sound definition of image quality.
M. ROSENSTEIN: The ideal solution, which is probably not achievable, would
be for every facility that carries out these procedures to have a written protocol of
how the technique is carried out and which image quality one is trying to achieve,
what it is one is trying to image and what level of whatever dosimetric quantity one
is using as one’s diagnostic reference level to get that image quality. That is going to
be different for every application and maybe every location, because the equipment
used is different.
That is the ideal situation. It means that you really must have what in the old
days were called ‘the proper technique factors’ for whatever procedure one is using,
and that one maintains them throughout the course of the work.
That is the ideal, and we cannot get there very easily. What we have observed
in practice is that, starting wherever you can, when you observe that the distribution
in a country, for example, is three, four, five orders of magnitude from the lowest to
the highest, it is not a bad idea to try to find the outliers and investigate what is wrong
and fix it. Then there is another level of not constantly narrowing the dose distribu-
tion. Then you have to go into the details of how the procedures are performed. So,
the three types of diagnostic level defined in that proposal are simply intended to cap-
ture the fact that there are different places of evolution, places where people are at a
given point in time. But the ideal would be locally to know exactly what one is doing
and to stay within those parameters.
P.A. KAPLANIS: Have any reference levels been set for CT fluoroscopy?
M. ROSENSTEIN: I do not believe there are reference levels, but I am not sure.
I think it is a case much like interventional radiology.
The priority may be different from what we are trying to do with the diagnos-
tic reference levels. So, if you are trying to avoid overt deterministic effects, you need
something that will tell you during the procedure that you are getting to that point.
So, I think it is a different problem for interventional radiology. You cannot apply this
approach and expect to solve the problem.
A. RAMÍREZ: As a clinical cardiologist who engages in invasive cardiology, I
need reference values in order that my team may adjust its clinical or haemodynamic
procedures safely. For about eight months we have been systematically recording the
DAPs and the haemodynamic procedures used, and we have encountered a great diver-
262 ROSENSTEIN
sity of values, some of which worry us. We are trying to obtain values that would
enable us to adjust our procedures, but we do not have a precise definition of the frame-
work levels within which it is possible to optimize our work. What is your opinion?
M. ROSENSTEIN: The problem with DAPs is that, unless you are looking at
an area that is fairly constant in size and at the same relative part of the body, you do
not get a unique value with regard to how the doses are changing inside the body. For
example, if you have a DAP value of x and you are on the front of the body and you
have a DAP value of 2x but you are on the back of a body, at the lower part, those
really cannot be compared if you are trying to say ‘What is the difference internally
owing to the doses to the tissues between those two cases?’
Unless you are using DAPs in cases where your exposure/irradiation conditions
are reasonably consistent, I do not see how you can interpret a proportional change in
a DAP with regard to whether you are improving or not improving the situation. Even
in the case of applying it for stochastic effects, you still have to control those other
irradiation factors and, as I have said before, in terms of controlling deterministic
effects I do not think it is the right quality to use.
C.J. HUYSKENS: Regardless of whether radiation specialists talk of ‘diagnos-
tic reference levels’ or ‘guidance levels’, what is needed are clear criteria for practi-
tioners, so that they understand what constitutes good medical practice.
There are criteria relating to the equipment used, but they are a matter for
another type of professional — medical physicists.
The other side of the story is the quality of the procedures. That is a matter of
the protocols and the practitioner’s skill, and it is these that should be addressed by
criteria for good medical practice.
I agree that it is important, at the international level, to have numerical values
for each procedure, but it is the task of medical physicists and radiation protection
specialists to adapt international guidance to the local situation. For example, A.
Ramírez would be helped much more by specific guidance regarding ‘What is a rea-
sonable time for fluoroscopy?’ and ‘What is a reasonable number of frames in my
practice?’
Let us not make it too complicated for operational radiologists or operational
cardiologists. Our task is to provide them with proper guidance values.
K.A. SPANSWICK: A thing that one notices in all reports on surveys relating
to performance and reference levels is the embarrassingly small sample sizes studied.
If these are due to the fact that the authors of those reports are overworked, that is per-
fectly acceptable. If they are due to the fact that the authors have had difficulty in per-
forming the measurements on which they are commenting, that is serious; what
chance is there of the users of the equipment being able to work within performance
levels that experts are unable to measure?
F.A. METTLER: In the cases that we have looked into where patients have
received burns, those burns were not due to the equipment or to dose rate aberrations.
MEDICAL IMAGING 263
They were due to, for example, the fact that staff had removed spacers, so that
patients were too close to the tube, to the fact that patients were very large and the
procedure lasted a very long time or to the fact that the tube overheated. In my view,
you can perform all the measurements you want, as the main cause of burns is oper-
ator error.
P. ORTIZ-LÓPEZ: I fully agree that the issue of deterministic effects should be
kept separate from that of stochastic effects, but I do not agree fully with M.
Rosenstein’s remark about DAPs for stochastic effects. Stochastic effects are also
important in interventional radiology. From the latest United Nations Scientific
Committee on the Effects of Atomic Radiation report (UNITED NATIONS, Sources
and Effects of Ionizing Radiation (Report to the General Assembly), UNSCEAR,
UN, New York (2000)) one can see how, taken together, angiography and interven-
tional radiology are becoming the second largest contributor to the collective dose,
inspite of the fact that the number of people exposed is relatively small. DAPs pro-
vides a good correlation with effective dose if you know the region of the body
exposed and, more or less, the beam quality; they are reasonable indicators in relation
to stochastic effects.
RADIOLOGICAL PROTECTION OF THE EMBRYO
AND FOETUS IN PREGNANT PATIENTS
(Topical Session 6)
Chairperson
W. LEITZ
Sweden
EFFECTS AFTER PRENATAL RADIATION EXPOSURES
C. STREFFER
University Clinics,
Essen, Germany
Abstract
The mammalian organism is highly radiosensitive during all prenatal developmental
periods. For most effects a dose relationship with a threshold is observed. These threshold
doses are generally above the exposures from medical diagnostic procedures. The quality and
extent of radiation effects are very much dependent on the developmental stage during which
an exposure takes place and on the radiation dose. An exposure during the preimplantation
period will cause lethality. Malformations are usually induced after exposures during the major
organogenesis. Growth retardation is also possible during the late organogenesis and foetal
periods. The lower limits of threshold doses for these effects are in the range of 100 mGy. A
radiation exposure during the early foetal period can lead to severe mental retardation and
impairment of intelligence. There are very serious effects with radiation doses above 0.3 Gy.
Carcinogenesis can apparently occur after radiation exposures during the total prenatal
development period. The radiation risk factor up to now has not been clear, but it seems that it
is in the range of risk factors for cancer that are observed after exposures during childhood. For
radiation doses that are used in radiological diagnostics the risk is zero or very low. A
termination of pregnancy after doses below 100 mGy should not be considered.
1. INTRODUCTION
It is generally accepted today that a comparatively high radiosensitivity is

observed for an embryo and foetus during the total prenatal period in utero. For most
deleterious biological effects after prenatal radiation exposures except carcinogenesis
and mutagenesis a dose–effect relationship with a threshold is observed. For the
application of ionizing radiation in medical diagnostic investigations it is important
that all diagnostic procedures have radiation exposures that are below these threshold
doses if they are performed in an appropriate way [1].
The prenatal development of mammals including humans is determined by the
proliferation, differentiation and migration of cells. Ionizing radiation can interfere
with all these processes. These are the reasons that developing embryos and foetuses
have a higher radiosensitivity than organisms during postnatal life. The quality of
radiation effects as well as the extent of these radiation effects depends very much on
the developmental stage during which an exposure takes place and on the radiation
dose. The prenatal development of mammals including humans is divided into three
major phases:
267
268 STREFFER
— The preimplantation period (up to around 10 days post-conception (p.c.)),

— The major organogenesis (up to around the end of the second month p.c.),
— The foetal period (up to the end of the pregnancy).
The knowledge of the radiation risk during prenatal development comes from
clinical experiences with humans and experimental data predominantly with rodents.
An extrapolation of the effects from animal experiments is possible if the specific
developmental stages of the different species are considered and compared with the
homologous development of humans. The risks of prenatal radiation exposures con-
nected with medically indicated procedures are discussed in Ref. [1].
2. RADIATION EFFECTS AFTER EXPOSURES DURING THE

PREIMPLANTATION PERIOD
The preimplantation period is characterized by a high rate of cell proliferation.

Exposures to ionizing radiation will interfere with these proliferative processes. With
preimplantation mouse embryos it has been shown that radiation doses of 0.25 Gy
and higher cause such disturbances. With increasing doses cell death occurs and if an
embryo is no longer able to compensate for the radiation damage death of the embryo
will occur [2–4]. There may exist a lower threshold dose for such effects in the range
of 100 mSv (Table I). Usually, the form of developmental damage during this stage
of development is death, not malformation [5]. In recent years it has been observed
with mice that express a genetic predisposition for malformation that the rate of mal-
formation can be enhanced by radiation exposures during the preimplantation period
[6, 7]. This is a very special mechanism, however, and will occur only in very rare
cases [8]. There is no such experience with radiation exposures occurring during
human pregnancies. In general there are no data for human development after radia-
tion exposure during the preimplantation period. This is due to the circumstance that
pregnancy generally is not recognized during this stage. Therefore extrapolations
from animal data to humans have to be performed.
3. CHANGES AFTER RADIATION EXPOSURES DURING THE MAJOR

ORGANOGENESIS
Exposures to ionizing radiation during this developmental stage can also

cause lethality. However, this effect occurs only after radiation doses that are higher
than those during the preimplantation period. The main effect that needs to be con-
sidered during this prenatal stage with respect to radiation risk is the induction of
PRENATAL RADIATION EXPOSURES 269
malformations [9]. With humans especially with small head circumferences micro-
cephalies and microphthalmia have been observed in the survivors of the atomic
bombings of Hiroshima and Nagasaki [10]. The estimated doses in these cases were
in the range of 0.5 Gy and higher. Also, from clinical data several case reports have
been described [11]. Quantitative risk estimates, however, can only be made from ani-
mal experiments. Very good dose–effect relationships have been observed with exper-
imental studies in rodents. It has been observed that there exists a threshold dose and
a steep increase of the frequency of malformations at doses higher than the threshold.
The lower limit of the threshold may be in the range of 100 mGy (Table I). The high-
est radiosensitivity for the induction of malformations in specific organs or skeletal
structures is always found during the period when the corresponding structure is start-
ing to develop [11].
TABLE I. BIOLOGICAL EFFECTS OF PRENATAL RADIATION EXPOSURES:

RISK COEFFICIENTS FOR THE RELEVANT DEVELOPMENTAL TIME
PERIOD AS WELL AS THE LOWER THRESHOLD VALUES FOR THE INDUC-
TION OF BIOLOGICAL EFFECTS AFTER EXPOSURES WITH LOW LINEAR
ENERGY TRANSFER RADIATION
Time after conception Lower threshold of dose

Risk coefficient
Effect where exposure for the induction of the
(% per mGy)
occurred effect (mGy)
Death during the Up to 10 d 100 0.1a

preimplantation period
Malformation 10 d–8 weeks 100 0.03a
Serve mental retardation 8–15 weeks 300 0.04a

16–25 weeks 300 0.01a
Intelligence test 8–15 weeks — 0.03

(IQ reduction) 16–25 weeks — 0.01
Malignant neoplasia Total — 0.006
Genetic defects Total — 0.0003 (female)

— 0.0001 (male)
a Increase above the threshold value.
270 STREFFER
There are no specific malformations induced by radiation, but it is generally

observed that those malformations that occur spontaneously will increase after
radiation exposures; thus certain patterns appear. Experimental studies with fraction-
ated or chronic exposures to low linear energy transfer radiations (X rays, gamma
rays) result in a large reduction of these biological effects [2, 12].
Usually, dose rate efficiency factors of the order of three to six are observed.
These dose rate efficiency factors can be even higher when radiation exposures are
very prolonged.
Besides the induction of malformations, it has to be taken into account that after
radiation exposures growth retardation may occur, which is frequently expressed dur-
ing postnatal development. Such effects have been observed after radiation exposures
during all the developmental stages, but these effects are most pronounced for expo-
sures during the late major organogenesis and foetal periods [9]. Significant effects
have been observed with X ray doses of 200 mGy and higher.
4. DEVELOPMENTAL EFFECTS OF THE CENTRAL NERVOUS SYSTEM
The effects on the development of the central nervous system are very impor-
tant for evaluating the radiation risk of prenatal irradiation. These effects can occur
during very wide periods of prenatal development, as the development of the central
nervous system starts during the first month of pregnancy and lasts until the end of
pregnancy [11]. However, the main effects are observed after radiation exposures dur-
ing the early foetal period.
4.1. Severe mental retardation
There are a number of animal studies, but the most important data come from
the studies on the survivors of the atomic bombs in Hiroshima and Nagasaki [13–15].
These studies provide clear evidence that prenatal radiation exposures 8 to 25 weeks
p.c. result in severe mental retardation if the doses exceed a threshold value. The best
estimates of the threshold values are about 0.6 Gy for exposures at 8 to 15 weeks p.c.
and 0.9 Gy for exposures at 16 to 25 weeks p.c. The lower 95% confidence limit on
the threshold dose for both study cohorts is about 0.3 Gy (Table I). The radiation risk
is especially high during the period of 8 to 15 weeks p.c. A radiation dose of 1 Gy
would cause an estimated 40% excess of mental retardation (Table II). At the later
period of 16 to 25 weeks p.c. there is a 9% excess at 1 Gy. No severe mental retarda-
tion is observed after exposures at a stage before 8 weeks p.c. or later than 26 weeks
p.c. (Table II).
TABLE II. MENTAL RETARDATION AMONG THE IN UTERO EXPOSED

COHORT OF JAPANESE ATOMIC BOMB SURVIVORS BY GESTATIONAL
AGE AND DS 86 DOSIMETRY
Gestational age (weeks)

Dose range Mean dose No. of
(cGy) (cGy) subjects 0–7 8–15 16–25 ³26
0 0 1069 205 (1)a 255 (2) 309 (1)1 300 (3)1
1–9 5 212 42 46 (2) 60 (0)1 64
10–49 23 215 33 61 (1)1 59 62
50–99 65 43 6 16 (3)1 16 5
100 138 26 2 12 (9) 8 (3) 4
Total — 1565 288 (1) 390 (17)2 452 (4)2 434 (3)1
a The number of cases of mental retardation associated with radiation or of unknown etiolog
are given in parentheses. The subscripted numbers are those probably due to specific causes
other than in utero radiation (e.g. Down’s syndrome). Adapted from Ref. [14].
4.2. Intelligence test scores
Intelligence test scores have been studied in the survivors of the atomic bombs,
and a similar time dependence has been observed as for severe mental retardation.
There were no radiation effects of exposures later than 26 weeks p.c., and only a few
case reports suggest the possibility of effects with high embryonic doses before 8
weeks p.c. For these effects a linear radiation dose–response model provided a satis-
factory fit for the atomic bomb cohort exposed at 8 to 15 weeks p.c. while a quadratic
model (with upward curvitures) provided a better fit for the 16 to 25 weeks p.c. cohort
[15]. With a linear model the reduced intelligence test scores (IQ) were 21 to 29
points per gray in the 8 to 15 weeks p.c. cohort. Again, during the time period of 16
to 25 weeks p.c. the radiation effects were smaller. A decrease in IQ of 10 to 21 IQ
points per gray has been observed. School achievement results occurred parallel with
the IQ test results, with dose related deficits for the 8 to 15 and 16 to 25 weeks p.c.
exposure cohorts. It was estimated that the impact of a 1 Gy dose was equivalent to
272 STREFFER
reducing school achievement potentials from the 50th percentile to the 10th per-
centile. The data that have been observed in populations with chronic exposures do
not give conclusive results with respect to the development of the central nervous sys-
tem and with respect to developmental disturbances such as intelligence test scores or
mental retardation.
5. INDUCTION OF MALIGNANT NEOPLASIA
There are a number of studies that suggest an appreciable childhood cancer risk
from prenatal radiation. However, there are also some controversial data. The most
important study is certainly the Oxford Survey of Childhood Cancer (OSCC) study
[16, 17]. Although there are some methodological weaknesses with this study, the
OSCC dose–response relationship and several studies of cancers among irradiated
twins from this as well as from further studies tend to support an association with radi-
ation exposures [18, 19]. The methodologically stronger cohort studies of prenatal
irradiation provide a negative result or only positive results for leukaemia. With stud-
ies on twins beside the OSCC study there is usually a trend for an increased relative
risk for solid cancer as well as leukaemia, but these data are usually not statistically
significant. If specific tumour entities are studied, an increase is found in the OSCC
study for acute lymphatic leukaemia, myeloid leukaemia, lymphoma, central nervous
system tumours, neuroblastoma and Wilms’s tumours [20]. The relative risk is usually
in the range of 1.4 to 1.6 after diagnostic radiation exposures [19, 21] (Table III).
These high risk estimates are, however, not in agreement with the number of
childhood cancers seen in the prenatally exposed atomic bomb survivors [24]. The
non-significant results in the atomic bomb survivors and in the cohort studies must be
seen critically and caution the scientific interpretation of the magnitude in general of
the in utero carcinogenetic effects. The large cohort case study by Monson and
McMahon [23] suggests that there may be an excess risk for leukaemia but relatively
little excess for solid tumours. Nevertheless, from the point of view of radiation pro-
tection and public health it seems reasonable that the risk after prenatal radiation is
real and should be taken into account [21]. It further needs to be recognized that the
risk from a prenatal radiation exposure is greater for the total lifetime risk than that
just seen in the first 10 to 15 years of life. This follows especially from the data in
Hiroshima and Nagasaki, where an increased number of cancers is observed at the
later lifetime periods [25]. These data indicate that the total risk from prenatal radia-
tion is likely to be similar to that seen following exposures in early childhood [26].
The comparative analysis of the results of radiation exposures in the early and later
parts of pregnancy show that radiation risks may be higher for early exposure than
during the later pregnancy periods [17]. However, the number of cases is very small
in these studies.
TABLE III. VARIATION IN RELATIVE RISK (RR) FROM IN UTERO EXPO-

SURE ACCORDING TO SPECIFIC TUMOUR TYPES
Type of malignancy RR (95% CI) No. of irradiated cases
OSCC study [22]

Lymphatic leukaemia 1.54 (1.34–1.78) 327
Myeloid leukaemia 1.47 (1.20–1.81) 134
Lymphoma 1.35 (1.07–1.69) 109
Central nervous system tumour 1.42 (1.20–1.69) 198
Neuroblastoma 1.46 (1.17–1.83) 108
Wilms’ tumour 1.59 (1.25–2.01) 93
Bone tumour 1.11 (0.74–1.66) 30
Other solid tumours 1.63 (1.33–1.98) 147
Northeastern USA study [23]
Leukemia 1.40 (1.11–1.76) 94
Central nervous system tumours 1.09 (0.75–1.59) 32
Other cancers 1.14 (0.80–1.63) 36
6. CONCLUSIONS AND RECOMMENDATIONS FOR THE PROTECTION

OF PATIENTS
The data presented in this paper demonstrate that there should be good medical
grounds for radiation exposures during pregnancy, as the radiosensitivity of
embryos/foetuses is high during all stages of development.
For most effects threshold doses are observed in the range of 100 mGy or
higher. Therefore, prenatal exposures from most diagnostic procedures (with radia-
tion doses below 100 mGy) do not, or only to a very small extent, cause a radiation
risk. The threshold doses and corresponding risk coefficients above the threshold
doses, if such a threshold exists, are summarized in Table I. From these data it is pos-
sible to estimate the radiation risk for an embryo or foetus if the radiation dose from
a diagnostic procedure is known. The time period where the highest radiosensitivity
occurs is presented in Table I. It can therefore be estimated if delaying a diagnostic
investigation to a later period, where the radiation risk may be lower, is reasonable.
The investigator has to decide whether such a delay may be possible, considering the
medical indications, without endangering the pregnant mother.
The higher doses that may be connected with interventional radiology or radio-
therapy can result in significant harm. In these cases the dose to an embryo or foetus
has to be considered on an individual basis; it needs to be considered whether such a
procedure should be performed after the birth of the child. Again, it is the judgement
274 STREFFER
of the medical doctor whether such a shift is possible taking into consideration the
medical indications and necessity.
Most of these aspects are summarized in the following statement:
“Termination of pregnancy is an individual decision affected by many factors.

Foetal doses below 100 mGy should not be considered a reason for terminating
a pregnancy. At foetal doses above this level, informed decisions should be
made based upon individual circumstances.” [1]
REFERENCES
[1] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Pregnancy

and Medical Radiation, ICRP Publication 84, Pergamon Press, Oxford and New York
(2000).
[2] FRIEDBERG, W., HANNEMANN, G.D., FAULKNER, D.N., DARDEN, E.B. Jr.,
DEAL, R.B. Jr., Prenatal survival of mice irradiated with fission neutrons or 300 kVp X-
rays during the pronuclear-zygote stage: Survival curves, effect of dose fractionation,
Int. J. Radiat. Biol. Relat. Stud. Phys. Chem. Med. 24 (1973) 549–560.
[3] RUGH, R., WOHLFROMM, M., VARMA, A., Low dose X-ray effects on the precleav-
age mammalian zygote, Radiat. Res. 37 (1969) 401–414.
[4] STREFFER, C., MOLLS, M., Cultures of preimplantation mouse embryos: A model for
radiological studies, Adv. Radiat. Biology 13 (1987) 169–213.
[5] BRENT, R.L., Radiation teratogenesis, Teratology 21 (1980) 281–298.
[6] PAMPFER, S., STREFFER, C., Prenatal death and malformations after irradiation of
mouse zygotes with neutrons or X-rays, Teratology 37 (1988) 599–607.
[7] MÜLLER, W.-U., STREFFER, C., KNOELKER, M., A genetic characterization of dif-
ferences in the sensitivity to radiation-induced malformation frequencies in the mouse
strains Heiligenberger, C57Bl, and Heiligenberger x C57Bl, Radiat. Environ. Biophys.
35 (1996) 7–40.
[8] HILLEBRANDT, S., STREFFER, C., MONTAGUTELLI, X., BALLING, R., A locus
for radiation-induced gastroschisis on mouse chromosome, Mamm. Genome 9 (1998)
995–997.
[9] KONERMANN, G., Postimplantation defects in development following ionizing irradi-
ation, Adv. Radiat. Biol. 13 (1987) 91–167.
[10] UNITED NATIONS, Genetic and Somatic Effects of Ionizing Radiation (Report to the
[11] GUMPRECHT, D., KINDT, A. (Eds), Wirkungen nach pränataler Bestrahlung, 2.
Auflage, Strahlenschutzkommission (SSK), Gustav Fischer Verlag, Stuttgart and New
York (1989).
[12] KONERMANN, G., Erholungsvorgänge bei Mäuseembryonen nach fraktionierter
Röntgenbestrahlung, Strahlentherapie 139 (1970) 73–83.
[13] MOLE, R.H., The effect of prenatal radiation exposure on the developing human brain,
Int. J. Radiat. Biol. 57 (1990) 647–663.
[14] OTAKE, M., SCHULL, W.J., LEE, S., Threshold for radiation-related severe mental
retardation in prenatally exposed A-bomb survivors: A re-analysis, Int. J. Radiat. Biol.
70 (1996) 755–763.
[15] OTAKE, M., SCHULL W.J., Radiation-related brain damage and growth retardation
among the prenatally exposed atomic bomb survivors, Int. J. Radiat. Biol. 75 (1998)
159–171.
[16] STEWART, A.M., KNEALE, G.W., Radiation dose effects in relation to obstetric X-rays
and childhood cancer, Lancet 1 (1970) 1185–1188.
[17] STEWART, A.M., KNEALE, G.W., Age-distribution of cancers caused by obstetric X-
rays and their relevance to cancer latent periods, Lancet 2 (1970) 4–8.
[18] MOLE, R.H., Antenatal irradiation and childhood cancer: Causation or coincidence?
Br. J. Cancer 30 (1974) 199–208.
[19] Shore, R.E., unpublished results
[20] KNOX, E.G., STEWART, A., KNEALE, G., GILMAN, E., Prenatal irradiation and
childhood cancer, J. Soc. Radiol. Prot. 7 (1987) 177–189.
[21] UNITED NATIONS, “Annex A: Epidemiological studies of radiation carcinogenesis”,
Sources and Effects of Ionizing Radiation (Report to the General Assembly), Scientific
Committee on the Effects of Atomic Radiation (UNSCEAR), UN, New York (1994).
[22] MOLE, R.H., Childhood cancer after prenantal exposure to diagnostic X-ray examina-
tions in Britain, Br. J. Cancer 62 (1990) 152–168.
[23] MONSON, R.R., MACMAHON, B., “Prenatal X-ray exposure and cancer in children”,
Radiation Carcinogenesis: Epidemiology and Biological Significance (BOICE, J.D.,
FRAUMENI, J.F., Eds), Raven Press, New York (1984) 97–105
[24] YOSHIMOTO, Y., KATO, H., SCHULL, W.J., Risk of cancer among children exposed
in utero to A-bomb radiations, 1950-84, Lancet 2 (1988) 665–669.
[25] YOSHIMOTO, Y., DELONGCHAMP, R., MABUCHI, K., In utero exposed atomic
bomb survivors: cancer risk update, Lancet 344 (1994) 345–346.
[26] DOLL, R., WAKEFORD, R., Risk of childhood cancer from fetal irradiation, Br. J.
Radiol. 70 (1997) 130–139.
DISCUSSION
L.K. WAGNER: Is there a threshold for malformations during the first two
weeks of pregnancy in cases of genetic susceptibility?
C. STREFFER: There is an extremely short period, on the first day, when there
is apparently no threshold, but you would of course not realize that in practice. At
later stages there is a threshold.
G. KLEMPFNER: What are the effects of irradiation before conception?
C. STREFFER: In the case of women there are the normal genetic effects.
In the case of men, it was assumed by Gardner et al. (GARDNER, M.J., et al.,
Results of a case-control study of leukaemia and lymphoma among young people
276 STREFFER
near Sellafield nuclear plant in West Cumbria, Br. Med. J. 300 (1990) 423–429), in
connection with workers at Sellafield, that very small doses increased the risk of
leukaemia in offspring. Having subsequently reviewed the data, most people believe
that the increased incidence of leukaemia in children living near Sellafield is not a
radiation effect. However, the situation is not altogether clear.
Studies that we have carried out with rodents indicate that spermatogonia are
more sensitive as regards radiation effects than spermatocytes or spermatids, the later
stages of sperm development. This suggests that irradiation a few days before con-
ception does not pose a higher risk than the genetic risk that we calculate using the
data obtained with rodents.
M.M. REHANI: We say that malformations are unlikely following doses of less
than 100 mSv, but that there may be a higher probability in the case of susceptible
individuals. However, we do not know who is susceptible and who is not.
C. STREFFER: As regards genetic susceptibility, at present we do not have
enough data to say whether the induction of malformations during organogenesis also
increases through genetic predisposition. We only have data, obtained with inbred
mouse strains, for the preimplantation period, where we see an increased frequency
of malformations.
As regards the mechanism of malformation induction, we have observed a dif-
ference between what happens after irradiation during the preimplantation period and
what happens after irradiation during organogenesis. In the case of irradiation during
the preimplantation period, it is a genetic factor and mechanism; in the case of irra-
diation during major organogenesis, it is mainly cell killing. So there are sensitive
cells in organ systems that are just developing. In these organ systems cells are killed
and then there is a change in development. That is one mechanism. The second mech-
anism is changes in differentiation, but again there will be many cells that have to be
changed in their differentiation, especially with regard to gene expression, and then
of course the mechanism is again different from the induction of malformations dur-
ing the preimplantation period and due to genetic susceptibility, for these are differ-
ent biological mechanisms.
L.K. WAGNER: Concerning the comparison group for mental retardation and
the two individuals with Down’s syndrome, when you remove those two, you come
up with a threshold that is different than before, obviously. My question is, when you
carry out the comparison do you remove the Down’s syndrome malformations from
the normal group as you do with the radiation group in order to obtain that threshold?
C. STREFFER: Both the analyses have been carried out, and both lead to a
threshold.
There have been discussions with W.J. Schull about whether or not we should
expect a threshold. From the biological point of view, for mechanisms you would
always expect a threshold. The epidemiological data were not clear on this, but I think
that in his latest paper W.J. Schull (SCHULL, W.J., “Ionising radiation and the devel-
oping human brain”, Risks Associated with Ionising Radiations, Ann. ICRP 22 (1991)
95–118) accepts that there is a threshold for this effect. Thus, also taking into account
the data that are becoming available on the Techa River population, where we do not
see any effect at all on mental retardation after radiation exposures that are quite appre-
ciable, I think that we can be fairly sure that there is a threshold for this effect.
H. RINGERTZ: Reverting to the question of pre-conception irradiation, what
do the Hiroshima and Nagasaki data indicate as regards Down’s syndrome?
C. STREFFER: As far as I know, there was no Down’s syndrome effect.
Down’s syndrome can only come from irradiation before conception, or usually
just after conception, for here we have a numerical aberration. This means that the
distribution of the chromosomes during maturation of the oocyte or the sperm is irreg-
ular, and in one of the sperms or one of the oocytes of chromosome 21 there are two
chromosomes, and therefore you have the trisomy.
In a paper published in the 1960s or 1970s it was stated that there was an
increased incidence of Down’s syndrome in Kerala, India, where the natural back-
ground radiation level is very high. Later papers relating to that region stated that such
an effect had not been noted, and it is now generally accepted that Down’s syndrome
as a result of irradiation is very rare and that, when it occurs, it must occur during the
first developmental stages, either by the distribution that I tried to explain for matu-
ration or during the first cleavages; there is also the possibility that cells derive that
then have a trisomy. However, at later stages, such as foetogenesis, this is no longer
possible. There may be some cells performing this incorrect chromosome distribution
during mitotic cell division, but these cells will not influence the development of the
organism in such a way that Down’s syndrome results.
F.S. PALA: Sometimes, women who undergo diagnostic X ray examinations
during pregnancy request an abortion. We generally reject such requests and suggest
that calculations be carried out, on the basis of the three year biological half-life of
lymphocytes, in order to determine the collective dose received over the previous
three years.
I should welcome your views regarding the following case. After a serious traf-
fic accident a women underwent multidiagnostic X ray examinations during the
third-eighth weeks of pregnancy. The baby was born with feet but no toes. This is a
hereditary disorder, but it had apparently not occurred in the family of the mother or
of the father for at least four generations. We took blood samples from the mother and
observed two dicentrics in 1000 metaphases, and we estimated from those a dose of
0.07 ± 0.3 Gy. Do you think that the malformation was due to the multidiagnostic
X ray examinations?
C. STREFFER: Such questions are difficult, if not impossible, to answer.
In such cases you should always perform individual dose calculations. You will
probably get a better dose estimate from physical measurements than from chromo-
somal aberrations studies.
278 STREFFER
Two dicentrics in 1000 metaphases could be a spontaneous effect, unconnected

with irradiation.
If you look at the literature you will find different values for the frequencies of
dicentric chromosomes from different laboratories. I would therefore not calculate the
radiation dose on the basis of chromosomal aberration studies; I would calculate it
from physical dosimetry, which you can do if you know where the X ray examina-
tions were carried out.
In general, of course, the diagnostic investigations occurred during the period
of organogenesis. Consequently, it is certainly possible that the malformation was
induced by X rays, but in such cases one should definitely carry out the dose estimates
on physical grounds and then you can make a better judgement of whether the mal-
formation could be induced by the radiation exposure.
K.K. KETIKU: As a radiotherapist I often have to deal with pregnant women
after a mastectomy. Unfortunately, I do not have the facilities for measuring doses to
the foetuses, so I usually have to wait until after delivery before starting with post-
operative radiotherapy. What would be your guidelines in such a situation?
C. STREFFER: In one of the papers that I reviewed, dealing with radiotherapy
planning in a mammary carcinoma case, it is reported that the dose to the uterus was
found to be slightly above 50 mGy. Under such circumstances there is certainly a car-
cinogenic risk to foetuses, but it is very small and I would not recommend an inter-
ruption of pregnancy. There is no malformation risk under these conditions.
L. ARRANZ: Regarding a possible threshold around 200 mGy for considering
the interruption of pregnancy, do you have any data on radiation induced effects in
comparison with spontaneous effects?
C. STREFFER: In Germany we have a spontaneous rate of malformations of
around 3%, and on the basis of data obtained in studies on mice we usually say that
the doubling dose is around 200 mSv (200 mGy of low linear energy transfer radia-
tion). This means that the risk increases from 3 to 6% after irradiation. This holds true
for organogenesis, for the time period from the end of the second week to the end of
the second month of pregnancy. However, it could be an overestimate of the risk, for
the data that we have from Hiroshima and Nagasaki suggest that the risk in humans
is less than that in mice.
(Topical Session 7)
Chairperson
P. CORR
South Africa
RADIOLOGICAL PROTECTION OF
PAEDIATRIC PATIENTS: AN OVERVIEW
H.G. RINGERTZ, S. BREMMER

Karolinska Hospital, Stockholm, Sweden
E-mail: hans.ringertz@ks.se
Abstract
Paediatric patients require special attention with respect to radiation protection, for
various reasons. The difference between a 1 kg premature baby and a 100 kg teenager puts
special demands on the radiographic techniques used, and the increased radiosensitivity of
growing tissue and the patients’ longer life expectancy put greater demands on the justification
of the procedures to be carried out. The optimization procedure involves practical aspects such
as immobilization, body build specific exposure parameters and body build specific anatomical
knowledge. These and other aspects of paediatric radiological protection are discussed in this
overview.
1. BACKGROUND
Paediatric radiology covers the whole age range from 0 to 15 years of age. The
diagnostic procedures of children involving ionizing radiation carry an increased risk
compared with those for adults. A young individual has a longer life expectancy and
growing tissue has a higher radiosensitivity. The normalized relative risks of late man-
ifestations summarizing the above factors and comparing with selected age groups are
given in Table I.
The relative lifetime risk of certain detrimental effects after an exposure during
the first ten years of life is three to four times greater compared with an exposure
between 30 to 40 years of age and five to seven times greater compared with an expo-
sure after the age of 50 years [1].
TABLE I. RELATIVE LIFETIME RISK WITH AGE
Age at exposure to Relative lifetime

ionizing radiation (years) risk of detrimental effects
0–10 1.00
30–40 0.25–0.35
Over 50 0.15–0.20
281
282 RINGERTZ and BREMMER
2. PAEDIATRIC DIAGNOSTIC RADIOLOGY
The worldwide use of diagnostic radiology for children can be assessed using
United Nations’ statistics. Countries in health care level I (with >1000 physicians per
million population) constitute 26% of the world’s population. Here children between
0 and 15 years of age represent 11% of all diagnostic radiology, which is 0.92 exam-
inations per person per year. Thus there are 155 million paediatric radiology
examinations per year at this health care level.
The health care level II (with 300 to 1000 physicians per million population)
comprises 53% of the world’s population. In these countries children represent a
larger portion, 18% of all diagnostic radiology, which is on average 0.15 examina-
tions per person per year. Calculations based on these figures gives an additional
83 million paediatric radiology examinations per year. Health care levels III and IV,
with 100 to 300 physicians and <100 physicians, respectively, per million population
perform much fewer radiological examinations. The dental radiological examinations
of 0.31 and 0.014 per person per year in levels I and II, respectively, have not been
included in the above calculations.
3. SPECIAL ISSUES
As can be seen above, about 250 million diagnostic radiological examinations

are performed on children in the world per year. From a radiological protection
point of view this is a considerable number that warrants special attention,
particularly because of the differences between paediatric and adult radiology,
such as the increase in cellular sensitivity in children over adults for carcino-
genesis.
One problematic aspect is the technical assessment of radiation dose in children
compared with adults. It has been questioned if the term ‘effective dose’ should be
applied to children. It is a useful term in adults, but in order to be applied to children
the values of radiosensitivity for different tissues and age have to be determined [2].
One part of the problem is that these data are only partially available today. Another
aspect is the practical problems with the assessment of dose in the clinical setting
where only dose–area products can be obtained.
Another issue is that of what precautions should be taken in developing coun-
tries. As the proportion of children and young individuals is higher and the spectrum
of disease is wider, special consideration might be required. The International
Commission on Radiological Protection (ICRP) Committee 3 is considering an eval-
uation of this issue. One aspect of the solution might be to have a relatively larger pro-
portion of ultrasound units compared with X ray units in many developing countries,
and these units could be utilized for extended diagnostic purposes.
PAEDIATRIC PATIENTS 283
There is a neonatal issue as the optimal exposure times in diagnostic radiology

might be so short that they cannot be accurately produced by the equipment used.
Another age specific problem with neonates is the sensitivity of the nervous system,
especially the brain, to radiation in early myelinization. In this respect the most
premature neonates are the most vulnerable.
It is also obvious that special training in paediatric techniques is important for
radiology technicians and nurses. One important area for this is the need for adjust-
ments to be made when examining children with computed tomography equipment.
It is important to stress that the benefit/detriment ratio can be different in children
compared with that in adults. There are also problems, such as the added risk of
anaesthesia, owing to the need to hold, restrain or sedate children.
4. RECOMMENDATIONS
A number of publications have addressed some of the problems. European

Guidelines on Quality Criteria for Diagnostic Radiographic Images in Paediatrics
were published in 1996 [3]. The ICRP definitions of justification and optimization,
with an emphasis on children, are discussed. The quality criteria for diagnostic
paediatric radiology when examining the chest, skull, pelvis, spine (including
scoliosis examinations), abdomen and urinary tract are stated. These criteria are
based on a summary of the European trials performed mainly by Fendel et al. [4, 5]
and Schneider et al. [6, 7]. Radiographic techniques, patient dose and image
quality as observed and changed by recommendations during the study period
are discussed. Quality criteria based on these experiences are given.
The problem of radiation protection in paediatric patients has also been
approached on a global level. It has been realized that the sophisticated scientific
recommendations may not have the expected impact. This is especially true when
considering the situation in developing countries. Both the World Health
Organization and the ICRP are trying to add a basic, direct approach to the problem.
The latter has recently produced a poster, ‘Practical Advice for Protection in
Paediatric X Ray Examinations’, and a sticker, ‘Child-SMART’.
5. CURRENT RESEARCH
The main areas of interest in radiation protection in paediatric diagnostic

radiology are: (a) the carcinogenic lifetime effects of low doses in paediatric expo-
sure, (b) radiation doses to children undergoing examinations in organs such as the
urinary tract, pelvis, gastrointestinal tract and total spine in scoliosis examinations, in
which the modalities of interest are computed tomography and conventional and
digital radiology, and (c) practical radiation protection measures in paediatric

radiology.
An example of (a) above is Lundell [8]. She studied the carcinogenic effects of
low dose irradiation in early childhood with data from 1920 to 1959. More than
16 000 infants <1.5 years of age (mean age 6 months) that had had gamma radiation
for skin hemangiomas were included. Follow-up was performed between 1958 and
1986. The mean age at follow-up was 38 years. During these years 300 cancers were
observed in the study cohort. The standardized incidence ratio (SIR) was 1.11
(0.99–1.24) for all cancers.
A special study was performed concerning radiation exposure to the breast
anlage (9675 women). The mean absorbed dose in that group was 0.39 Gy, but 1.5 Gy
in the 75 observed breast cancer cases. The SIR was 0.98–1.54 for breast cancer.
Another special study was made for thyroid cancers. The mean absorbed dose was
0.26 Gy, but 1.07 Gy in the 17 observed cancer cases. The observed SIR for thyroid
cancer was significant, 1.33–3.65. In the whole study population 77% of the organs
for which doses were calculated received doses <0.1 Gy.
REFERENCES
[1] UNITED NATIONS, Sources, Effects and Risks of Ionizing Radiation (Report to the
[2] AXELSSON, B., KHALIL, C., LIDEGRAN, M., SCHUWERT P., MORTENSSON W.,
Estimating the effective dose to children undergoing heart investigations — a phantom
study, Br. J. Radiol. 72 (1999) 378–383.
[3] KOHN, M.M., et al., European Guidelines on Quality Criteria for Diagnostic
Radiographic Images in Paediatrics, EUR 16261, European Communities, Luxembourg
(1996).
[4] FENDEL, H., Optimisation in paediatric radiology: are there specific problems for qual-
ity assurance in paediatric radiology? Br. J. Radiol. 18 Supplement (1985) 159–165.
[5] FENDEL, H., et al., “Specific principles for optimisation of image quality and patient
exposure in paediatric diagnostic imaging”, Optimization of Image Quality and Patient
Exposure in Diagnostic Radiology (Workshop Oxford, 1988), BIR Rep. 20 (MOORES,
B.M., et al., Eds), British Institute of Radiology, London (1989) 91–101.
[6] SCHNEIDER, K., et al., “Results of a dosimetry study in the European Community on
frequent X ray examinations in infants”, Dosimetry in Diagnostic Radiology, Proc. Sem.
Luxembourg, 1991, Radiat. Prot. Dosim. 43 (1992) 31–36.
[7] SCHNEIDER, K., et al., “Impact of radiographic imaging criteria on dose and image
quality in infants in an EC-wide survey”, Test Phantoms and Optimisation in Diagnostic
Radiology and Nuclear Medicine, Proc. Discussion Workshop Würzburg, 1992, Radiat.
Prot. Dosim. 49 (1993) 73–76.
[8] LUNDELL, M., Carcinogenic Effects of Low Dose Irradiation in Early Childhood, a
Dosimetric and Epidemiologic Study, PhD Thesis, Karolinska Institute, Stockholm
(1995).
DISCUSSION
D.T. SKOURAS: I have the impression that, as the number of X ray, computed
tomography (CT) and other examinations of children increases, we are trying to shift to
parents the responsibility for taking decisions about the medical care of their children.
H. RINGERTZ: In Sweden, and in many other countries, parents are wanting
to be more involved in taking such decisions. Through the Internet and other media
they are becoming very knowledgeable, to the point where they are able to diagnose
very accurately what is wrong with their children. A few weeks ago, for example, a
mother told me, quite correctly, that her four year old son had a Wilms tumour. With
such parents we have to say that the risk from not performing an indicated examina-
tion is greater than the radiation risk increase.
H. OSTENSEN: Are there any hard statistics demonstrating the benefits of CT
examinations in the case of children? One cannot help feeling that sometimes such
examinations are not carried out for sound medical reasons, but out of curiosity.
H. RINGERTZ: There are hard statistics for appendicitis in children. The fre-
quency of unnecessary operations used to be high, about 50%. The situation improved
with the introduction of ultrasonic examinations. Now, with the combined use of
ultrasound and CT on a very limited part of the abdomen it is proving possible to
reduce the number of unnecessary operations to a few per cent. Of course, appen-
dicitis is a very common disease. For rarer diseases, such as abdominal tumours in an
early stage, we do not have sufficient statistics.
B. BALABAN: Paediatric X ray examinations may be an important cause of
breast cancer, but in your presentation you did not include the breast among the
organs in children that may be affected by ionizing radiation. Why did you not
include it?
H. RINGERTZ: I should have included it as the breast anlage is very radiosen-
sitive. In a long-term study of women who in the 1940s and 1950s, at an age of zero
to two years, underwent radiation treatment for benign skin lesions we have found an
increased incidence of breast cancer in cases where the breast anlage was included in
the radiation field.
In order to reduce the dose to the breast anlage in CT examinations we are,
wherever possible, exposing patients posterior–anterior, so that the radiation reaching
the breast anlage is attenuated during its passage through the body.
L.K. WAGNER: One of your recommendations is to increase the kilovoltage. If
this increase is relative to 40 kV, I agree. If it is relative to 100 kV, I am not so sure
that I do, because of the contrast that one has to see within the image, so please
explain that recommendation a little better.
H. RINGERTZ: There is a worldwide tendency to have too low a kilovoltage
for chest X rays in children. Also, we often deal with equipment that is too old, so
there is compensation for the fact that a shorter time of the kilovoltage cannot be used.
That is an indication of why the users should probably have better equipment. Of
course, I am not saying that we should go up to 200 kV or so. The advice contained
in the ‘sticker’ is intended for places where they very seldom examine children, and
there might be a tendency to use kilovoltage to regulate the exposure rather than time
and milliamperes.
L.K. WAGNER: In the USA, with the growing use of helical and thin slice CT,
referring physicians are now pressing for three dimensional reconstructions of scol-
iosis patients. How useful are such reconstructions?
H. RINGERTZ: I doubt whether, in the case of scoliosis, three dimensional
reconstructions offer any advantages over and above posterior–anterior and lateral X
ray examinations.
C. STREFFER: Is ‘effective dose’ a realistic concept in the case of children?
There is a very strong age dependence with radiation induced cancer of the thyroid,
and thyroid cancer responds well to treatment, so ‘effective dose’, which is based on
mortality, does not seem to be realistic.
H. RINGERTZ: There are studies regarding thyroid risks. I was talking about
radiotherapy, but let us take children who are undergoing large numbers of X ray
examinations because they have a heart or lung malformation. At, I think, the
Radiology Department of Lund University Hospital, they took a large number of chil-
dren who had each undergone more than 100 X ray examinations during the paedi-
atric time range and they looked at the thyroid, and they were not able to see anything
wrong. When it comes to X rays, for example, the dose is relatively low, so you do
not have that much of a risk.
However, it should of course be taken seriously. It might be one of those cases
where you could use shielding directly during the examination.
C. STREFFER: What about CT of the skull?
H. RINGERTZ: From recent papers about shielding of the thyroid during CT
of the skull it appears that shielding does not make much difference; most of the radi-
ation that reaches the thyroid has been scattered through the body rather than through
the air.
Shielding of the thyroid is helpful in the case of chest X ray examinations as at
least part of the thyroid is often included in a normal collimation of the chest.
M. SÁNCHEZ VALLECILLO: In my view, patient exposures could be
reduced, for a given image quality, if referring physicians specified the diagnostic
purpose of requested examinations in greater detail. What do you think?
H. RINGERTZ: I agree with you.
In that connection, I would mention European Directive 97/43/Euratom, which

demands referral criteria for children. There is a section in the resulting document on
how to make the optimum use of clinical radiology departments, which sets out 35
paediatric radiology referral criteria.
Like you, I think we can probably obtain better results when dealing with pae-
diatric hospitals or paediatric radiology departments. I think that we have relatively
good contacts with our referring physicians. A couple of years ago we carried out a
study of referrals for ultrasound examinations, and we found that, with referrals from
outside the hospital, the question posed in the referral request could not be answered
with ultrasound in 30% of the cases, whereas with referrals from within the hospital
it could not be answered in only 6% of the cases. We need to inform referring physi-
cians about the possibilities not only of ionizing radiation but also of the alternatives.
G. PÄRTAN: The use of CT raises legal problems, as radiologists are pressed
to do the maximum that is technically possible regardless of the fact that the margin
between benefit and additional risk becomes very slim. What can one do about it?
H. RINGERTZ: The situation is difficult. We are calling upon parents to choose
between, on one hand, an examination that could lead to a malignancy in one out of
a thousand or ten thousand cases and, on the other, the possibility of not arriving at a
correct diagnosis early enough.
As regards the legal aspect, the best one can do is ensure that legislation that
will protect radiologists is in place, but there may be patients’ advocates pushing in
the opposite direction.
H. OSTENSEN: We have been talking here largely about marginal reductions
in radiation exposures. Recently, however, I have reviewed some 6000 chest X ray
images of neonates and small children, except that in many cases it is not just chests
but entire bodies that were exposed to X rays, and in some cases one can even see
mothers holding their child. That is the overexposure problem that we should be pri-
marily concerned about. When we have found a practical solution to that problem,
which affects some three billion people, we can focus on achieving further, marginal
reductions in exposure.
H RINGERTZ: Those who work in advanced countries cannot exert much
influence on what is happening in the rest of the world, where it is often extremely
difficult just to get an ordinary X ray image of the chest right. Organizations such as
the World Health Organization are much better placed than we are to resolve prob-
lems like the one you referred to.
H. OSTENSEN: I agree, but in my view it is important that such problems be
brought to the attention of people in developed countries.
J.L. MARTÍNEZ: In intensive care units you often have children who undergo
radiographic examinations as many as four times a day for many days. What is the
situation regarding the exposure of the other children to secondary radiation in such
a unit?
H. RINGERTZ: If you have, for example, incubators 2 m apart in an intensive

care unit the dose to a neighbouring child is very low, almost too low to be measured.
Secondary radiation is not a problem.
Having said that, I would emphasize that in my view four radiographic exami-
nations a day are too many, especially in the case of premature neonates weighing
300–500 g.
IN RADIOTHERAPY
(Topical Session 8)
Chairperson
C.A. PÉREZ
RADIATION PROTECTION IN PATIENTS TREATED
WITH RADIATION THERAPY
C.A. PÉREZ*, H. SVENSSON**, J.A. PURDY*
* Radiation Oncology Center,

Mallinckrodt Institute of Radiology,
Washington University Medical Center,
St. Louis, Missouri, United States of America
** Radiation Physics Department,

University of Umea,
Umea, Sweden
Abstract
Ionizing radiation is frequently used to treat patients with cancer and sometimes patients
with benign conditions. It has an established therapeutic benefit, not withstanding the primary
objective of radiation therapy, which is usually to attempt to cure or palliate patients with a
malignant neoplasm. It is critical to decrease substantially or eliminate any unnecessary
radiation exposure to patients, personnel or the public and to reduce as much as possible any
risk of the misadministration of radiation to patients. Strict regulations have been established
on radiation protection and quality assurance to achieve the above goals. They are succinctly
discussed in this review.
1. INTRODUCTION
The optimal care of patients with malignant tumours is a complex effort that
may combine surgery, radiation therapy or chemotherapy; many professionals in a
multidisciplinary team are intimately involved in the care of patients with cancer.
In the last century it was irrefutably established that irradiation alone or
combined with other modalities is an effective treatment for many patients with
cancer. It can completely eradicate the tumours in an irradiated volume or provide
palliative relief to patients with incurable cancer. Various irradiation doses will
yield different probabilities of tumour control, depending on the extent of the
lesion (i.e. the number of clonogenic cells present) and cellular radiosensitivity
[1]. It is axiomatic that large tumours require higher doses than those used to con-
trol small lesions or subclinical/microscopic metastases [1, 2]. Reports by Herring
[3] and Perez et al. [4] indicate a close correlation between the dose of radiation
given and the probability of tumour control at a primary site or in metastatic lymph
291
292 PÉREZ et al.
nodes, which may be influenced by the initial number of clonogenic cells and tumour
cell heterogeneity [5].
The effects of radiation on most normal tissues have been documented; an intri-
cate interrelationship of total dose, fraction size, volume of organ irradiated, mecha-
nism of injury repair and lack of correlation between acute and late effects has been
described [6]. The tolerance of normal tissues is related to the volume irradiated, the
nature and function of the organs within that volume, and the stage of the cancer
treated [2].
2. RADIATION PROTECTION
Radiation protection is a very important goal in today’s society, as there are

many sources of ionizing radiation to which the general population and special
groups may be exposed. It is obvious that patients with malignant tumours or some-
times with selected benign conditions are exposed to ionizing radiation when treated
with this modality. It is proposed that some concepts and regulations of radiation pro-
tection should not be used for patients treated by irradiation [7]. However, it is criti-
cal to deliver accurately the doses of radiation intended to specific targets and to
reduce as much as possible the unnecessary radiation exposure to other parts of the
body, to occupational workers and to the public at large.
The risks of radiation exposure are well known, and patients and practitioners
should understand those risks. The risks should be minimized within achievable lim-
its and with a reasonable cost benefit. In this paper we review the various steps nec-
essary to achieve the above goals.
TABLE I. AREAS OF CONCERN AND FOR MONI-

TORING IN RADIATION PROTECTION FOR
PATIENTS TREATED WITH RADIATION THERAPY
Basic treatment planning

Therapeutic dose prescription
Treatment delivery
— External beam
— Brachytherapy
Quality assurance
— Equipment
— Computers
— Dosimetry instrumentation
Record keeping
Quality assurance committees
RADIATION THERAPY 293
The protection of patients receiving radiation therapy can be accomplished

through quality assurance programmes that ensure the accurate planning and delivery
of radiation to specific targets, following the regulations proposed by governments
and organizations such as the World Health Organization (WHO) [8], the IAEA [9],
the United States Nuclear Regulatory Commission [10, 11] and the European
Commission [12, 13], recommendations by professional societies such as the
European Society for Therapeutic Radiology and Oncology (ESTRO) [14] and the
American Association of Physicists in Medicine (AAPM) [15], and guidelines given
in the Basic Safety Standards [16].
3. RADIATION SAFETY IN RADIATION THERAPY
Radiation safety encompasses at least four general areas:
— The equipment used in treatment planning, delivery, calibration and dosimetry

procedures;
— The procedures for the various phases of treatment planning and the adminis-
tration of irradiation;
— The training and qualifications of the personnel involved;
— Adequate record keeping and documentation of all aspects of radiation therapy.
Radiation protection policies should govern the operation of the following

devices or radioactive materials:
— Teletherapy units (60Co, 137Cs);

— Low, medium, pulsed and high dose rate brachytherapy remote afterloading
devices;
— Other radioactive materials in sealed or unsealed sources used for the treatment
of patients;
— X ray devices used for treatment planning, such as simulators, three dimen-
sional (3-D) simulators, X ray generators, etc.;
— Computers used in treatment planning or in the control of equipment used in
the delivery of radiation therapy;
— Dosimetry and physics instruments.
Linear accelerators at the present time are not specifically regulated in the
United States of America, but they should be part of a radiation protection and qual-
ity assurance programme.
Areas of concern and for monitoring in radiation protection for patients
receiving therapeutic radiation doses are outlined in Table I. In the therapeutic
294 PÉREZ et al.
TABLE II. RADIATION PROTECTION IN PATIENTS TREATED

WITH RADIATION THERAPY: ADDITIONAL CONCERNS
Treatment planning accuracy

Treatment delivery uncertainties
— Systematic
— Random
Equipment malfunctions
Operator errors
Radiation exposures to unintended body areas,
including whole body doses
Neutron contamination (high energy photon beams)
administration of ionizing radiation other areas of concern include the accuracy of

treatment planning and delivery, as well as equipment malfunctions, misadministra-
tions and possible neutron contaminations, which occur with high energy photon
beams [17] (Table II).
It is crucial for governments to promulgate to institutions as well as authorized
users radiation protection policies to which they must strictly adhere. A radiation pro-
tection programme chain of command and supervision must be established at each
institution where radioactive materials or sources of ionizing radiation are used. To
eliminate the possibility of misadministrations, written directives by authorized users
must be required in each instance in which patients are treated with radiation therapy.
The written directive should include:
— The name of the patient (with two methods of verification);

— The radionuclide (or source of ionizing radiation) used;
— The treatment site;
— The total dose, dose per fraction, number of fractions and exposure time (or
monitor units);
— The radiation safety precautions;
— The safety surveys, as necessary;
— The calibration procedures.
4. QUALITY ASSURANCE IN TREATMENT PLANNING AND DELIVERY
To ensure the appropriate treatment of patients with irradiation techniques, it is

critical to observe clearly outlined procedures for treatment planning and delivery
(Fig. 1).
The following procedures must be followed:
Chairman of Administration
radiation oncology
Treatment
Patient safety delivery
Quality
assurance
committee
Personnel safety Treatment
outcome
Dosimetry Teletherapy Treatment Brachytherapy

instrumentation equipment planning
FIG. 1. Procedures for treatment planning and delivery.
— Double checking with independent dosimetry verification systems the perfor-

mance of computers used in treatment planning.
— Verification with actual output measurements (spot checks) the calculations of
60Co units’ outputs using decay schemes, and of monitor unit calculations for
accelerators.
— Performing calculations for dose prescription and delivery by two different
individuals or independent methods.
— Verification by at least two individuals or methods the position of beam modi-
fying devices.
— Independent verification of electronic transfers of dose/treatment data to linear
accelerators.
— Verification of the accuracy of treatment portal positioning with radiographic
imaging methods and verification of the dose delivered with in vivo diodes or
thermoluminescent dosimeters.
— Computation of dose distribution and graphic displays; these are mandatory in
all curative cases or when palliative irradiation requires doses that approach the
tolerance levels of normal organs.
296 PÉREZ et al.
4.1. Acceptance testing and reliability checks for equipment and computers
The radiation safety measures to be undertaken when using 60Co teletherapy,

gamma stereotactic radiation therapy (radiosurgery) or remote afterloading
brachytherapy devices are outlined in Table III.
TABLE III. RADIATION SAFETY MEASURES TO BE UNDERTAKEN WHEN

USING SEALED SOURCES IN COBALT-60 TELETHERAPY, GAMMA
STEREOTACTIC RADIATION THERAPY OR REMOTE AFTERLOADING
BRACHYTHERAPY DEVICES
Installation, maintenance and repairs by licensed persons

Record keeping
Secure devices, console/keys, treatment rooms
Developing and maintaining emergency procedures (i.e. for equipment failures)
Annual training/emergency drills
Door to treatment room shielding and electrical interlock systems
Radiation monitors
Viewing and intercom systems
TABLE IV. RADIATION PROTECTION REQUIREMENTS: CALIBRATIONS OF

TELETHERAPY UNITS
Before first medical use

When spot check measurements show output differs by more than 5% from last calibration,
corrected for radioactive decay
After replacement of sources or the reinstallation of units
After a repair of a unit that includes a source removal
Routinely, at least once a year
Periodic spot checks
Outputs within ±3% for a range of field sizes and distances
Coincidence of light and radiation beams
Uniformity of the radiation beam
Timer accuracy
Accuracy of distance measuring devices
Mathematical correction of outputs every
— One month for 60Co
— Six months for 137Cs
— Intervals with 1% decay for other nuclides
Keep calibration records
The International Electrotechnical Commission (IEC) has specified require-

ments for the safety of gamma beam equipment and for medical electron accelera-
tors (generally linear accelerators) in the range of 1 MeV to 50 MeV [18]. A
detailed programme for the quality control of electron accelerators for medical use,
based on IEC recommendations, has been recommended by the French Hospital
Physics Association [19]. The United States Nuclear Regulatory Commission has
specific requirements for the calibration of teletherapy units, which are outlined in
Table IV.
More detailed calibration procedures for remote afterloading brachytherapy
devices are summarized in Table V.
It is critical to prevent any misadministration of therapeutic radiation and to
decrease unnecessary exposures to areas not treated in patients receiving irradiation
for medical purposes. The conditions that require reporting and notification of a med-
ical event are summarized in Table VI.
There is an increasing use and reliance on computers for treatment planning and
the control of radiation therapy treatment devices. It is extremely important to estab-
lish an acceptance test and periodic check programme for these computer systems, as
outlined in Table VII.
The main rationale and justification for quality assurance in radiation therapy is
to ensure that not only do patients receive good quality treatment but that they are also
protected from accidents and errors (both random and systematic). Quality assurance
aims at minimizing the occurrence of random errors and at eliminating large systemic
errors, which contributes to the minimization of morbidity rates and the maximiza-
TABLE V. RADIATION PROTECTION REQUIREMENTS: CALIBRATION OF

REMOTE AFTERLOADING BRACHYTHERAPY DEVICES
Before first medical use

After repairs of devices that include source removals or repairs or reinstallations of devices
Every three months for HDR, MDR and PDR units
Every year for LDR units
Parameters
— Outputs with ±5%
— Source positions with ±1 mm
— Source retraction with backup battery on power failure
— Timer accuracy and linearity
— Length of source transfer tubes and applicators
Periodic spot checks
HDR — high dose rate; MDR — medium dose rate; PDR — pulsed dose rate; LDR — low
dose rate.
298 PÉREZ et al.
TABLE VI. CONDITIONS THAT REQUIRE REPORTING AND NOTIFICATION

OF A MEDICAL EVENT
The dose differs from that prescribed by more than 0.05 Sv (5 rem) effective dose equivalent,
0.5 Sv (50 rem) to organs or tissue
The total dose delivered differs from that prescribed by 20% or more (misadministration)
The single fraction dose differs from that prescribed by 50% or more
Administration to unintended target
Administration of wrong radioactive drug
Administration by wrong route
Administration to wrong individual or human research subject
Leaking sealed sources
Unintended permanent damage
TABLE VII. ACCEPTANCE TESTS AND PERIODIC CHECKS FOR THERAPY

RELATED COMPUTER SYSTEMS
Source specific input parameters for dose calculations

Accuracy of dose, dwell time and treatment time calculations at representative points
Accuracy of isodose plots and graphic displays
Accuracy of software to determine the source position from radiographic images
Accuracy of electronic transfer of treatment delivery parameters from planning systems
tion of the cure rate of radiation therapy patients. This concept is emphasized in the
Basic Safety Standards [16]. Patient safety is therefore integrated within an overall
quality assurance programme of radiation therapy [9].
At the national level the establishment of a quality assurance programme
should take into account international recommendations and existing national guide-
lines. To ensure that radiation therapy centres have a common basis for developing
and implementing their quality assurance programmes, professional bodies repre-
senting radiation oncologists, medical physicists and medical radiation technologists
should develop national guidelines or standards for radiation therapy quality assur-
ance and set out a uniform quality assurance programme to be adopted by all radia-
tion therapy centres, taking into account the level of practice in the country. Several
major issues should be considered before the licensing and regulation of radiation
therapy equipment. The problems with the review process and compliance, the
cost–benefit analysis of setting up an independent external quality assurance pro-

gramme, the need to maintain confidentiality of patient records and the need to
respect professional standards should be considered.
The IAEA assists Member States in establishing and implementing national
quality assurance programmes through its programmatic activities and technical co-
operation projects. The IAEA’s assistance is directed at national regulatory bodies for
the establishment of a regulatory framework that complies with the Basic Safety
Standards, at standards laboratories for metrological traceability and at end users at
hospitals for the development and implementation of quality assurance programmes.
Traceability of radiation measurements for radiation therapy dosimetry and quality
audit services, such as in the IAEA/WHO postal thermoluminescent dosimetry service
for the verification of clinical beam outputs, is also offered by the IAEA to Member
States. To co-ordinate its activities in quality assurance in radiation therapy, close co-
operation is maintained with other international organizations and professional bodies
such as the WHO, International Commission on Radiation Units and Measurements
(ICRU), ESTRO and the International Organization for Medical Physics (IOMP) [20].
5. REQUIREMENTS FOR QUALITY ASSURANCE
Quality assurance in radiation therapy encompasses all procedures that aim to

ensure a consistent and safe fulfillment of dose prescriptions to target volumes while
minimizing doses to normal tissue and ensuring the minimal exposure to personnel
and the public. It involves all clinical, physical, technical and safety procedures. A
quality assurance programme should be established by professionals working in the
field of radiation therapy, taking into account the level of practice of the country and
following international recommendations and guidelines. Either voluntary quality
assurance guidelines or mandatory regulations could be used to achieve national uni-
formity. In both cases, however, a peer review programme to audit compliance with
the national standards, if they exist, or international guidelines should be established.
If necessary, compliance with national standards can be made a condition of the
licensing process.
The IAEA has established guidelines that take into account clinical, medical
physics, radiation protection and safety considerations for the design and implemen-
tation of radiation therapy programmes at the national level [9].
6. STRUCTURE OF A QUALITY ASSURANCE PROGRAMME
Practical guidelines for the implementation of a quality system in radiation

therapy have been recommended by ESTRO [21]. A quality system can be defined as
300 PÉREZ et al.
the organizational structure, responsibilities, procedures, processes and resources for

implementing quality assurance. Quality assurance is defined as the set of policies
and procedures instituted to ensure the proper and safe delivery of a prescribed dose
to a patient. Quality control constitutes the actual tests established to maintain and
improve the quality of a treatment.
A quality assurance programme is an interdisciplinary effort that involves radi-
ation oncologists, radiation physicists, dosimetrists, radiation therapists and other
professionals involved in the care of patients. Recommendations for quality assurance
have been previously published in the AAPM Radiation Therapy Committee’s Task
Group 40 Report on Comprehensive QA for Radiation Oncology [15] and the Task
Group 35 Report on Medical Accelerator Safety Considerations [22]. In addition, we
have incorporated recommendations by the WHO [8], the American College of
Radiology (ACR) [23, 24], the American College of Medical Physics (ACMP) [25],
government regulations, [10] and our own previous quality assurance reports [26–30].
The ACR recommends that a quality assurance programme contains a struc-
ture that lends support to the optimal quality of patient care, a process to assess and
control such care, and a mechanism for reviewing the outcome of radiation therapy.
At the heart of a modern quality assurance programme is a quality assurance com-
mittee established with appropriate professionals and strongly supported by the
chairman of the department of radiation oncology and the hospital’s administration.
The structure of a typical quality assurance committee is schematically shown in
Fig. 1.
A quality assurance committee must establish appropriate patient and person-
nel radiation protection guidelines, periodically review adherence to these policies,
review and correct deviation from the policies, and prepare periodic (e.g. quarterly)
reports on the quality assurance implementation programme.
7. DOSIMETRY AND INSTRUMENTATION FOR QUALITY ASSURANCE
There are many special quality assurance devices that allow the verification of
important parameters used in both treatment planning and the delivery of radiation
therapy. A list of the equipment typically used in a quality assurance programme for
treatment machines is listed in Table VIII.
Quality assurance devices include an array of ionizing chambers or diodes posi-
tioned in plastic or constancy phantoms that can be attached to the treatment machine
and allow direct measurements of radiation exposure to be made at fixed and repro-
ducible distances and under the appropriate testing conditions. Accurate beam data
acquisition with automated scanning systems and film densitometers is frequently
used and requires that the systems be subjected to a systematic performance test both
before use and periodically thereafter.
TABLE VIII. TYPICAL QUALITY ASSURANCE

TEST EQUIPMENT
Secondary standard dosimetry systems

Field use dosimetry systems
Parallel plate ionization chambers
Polystyrene or solid water stack phantoms
Plastic constancy phantoms for output checks
Water phantoms with fixed ion chamber holders
Devices to monitor beam symmetry
Film densitometer systems
Beam data scanning systems
8. QUALITY ASSURANCE PROGRAMMES FOR LINEAR

ACCELERATORS AND OTHER TELETHERAPY UNITS
The increasing number and complexity of the sophisticated medical electron

linear accelerators used in many radiation oncology centres throughout the world has
expanded the need for reliable quality assurance and preventative maintenance pro-
grammes for these devices. The decision to equip a facility with a megavoltage radi-
ation therapy linear accelerator carries with it a commitment to provide adequate
staff, testing equipment and instrumentation and the necessary machine time to
ensure that the unit is performing according to its specifications [31]. The doses pre-
scribed to patients and delivered by the linear accelerator are dependent on several
parameters that control the radiation beam, including matching dose calibration, the
percentage depth dose (or other dose ratios) used to calculate monitor unit settings,
off axis beam characteristics, and wedge and block factors. All parameters must be
carefully determined when the therapy machine is installed and periodically checked
as determined by the quality assurance programme.
A typical programme for linear accelerators or other teletherapy units may
include [19]:
— Daily checks performed each morning by the radiation therapy technologist

who normally operates the machine;
— Weekly checks performed by a physicist, dosimetrist or technologist;
— Monthly checks performed by a dosimetrist or physicist and preventive main-
tenance inspections performed by accelerator maintenance technicians;
— Annual full calibrations performed by a qualified medical physicist.
The responsibility of performing the various tasks is divided among physicists,

dosimetrists, maintenance technicians and technologists, but the exact distribution is
302 PÉREZ et al.
not critical. What is essential is that each individual competently performs and
records the results of their tests on a regular basis and that the overall responsibility
for a machine quality assurance programme be assigned to one individual, generally
a medical physicist.
All measurements should be recorded chronologically in bound notebooks.
Such logbooks and the data contained therein are a valuable resource in maintaining
treatment machines. All the parties involved should receive periodic reports on the
quality assurance measurements.
Quality assurance criteria should be established for each of the constancy
checks performed. The frequency of each quality assurance procedure to be per-
formed depends primarily on the stability of the parameter tested, based on one’s
experience.
For some tests, only a very quick observance only type test is required. For
example, a weekly light radiation field congruence test result can be analysed by
simply looking at a radiograph showing the light field and radiation field edges and
observing whether or not the agreement appears reasonable. Other tests require a
more careful quantitative analysis. For example, a quantitative light radiation field
congruence test would require that the film be analysed using a film densitometer
and the results carefully plotted on graph paper to determine the edge agreement
precisely.
The quality assurance tests should be designed to be quick and reproducible if
they are to be acceptable and performed faithfully. Many excellent guidelines address
Linac quality assurance programmes, which are included in Refs [15, 19, 22, 25, 26,
31–36]. Note that the discussion provided below is for general guidance and that the
actual quality assurance tests required at a particular institution must be developed by
that institution.
The manufacturer’s instructions for startup and operation of an accelerator
should be followed, and readings of the various meters, dials and gauges recom-
mended for monitoring should be recorded. The list of daily recommended parame-
ter checks is summarized in Table IX.
Other checks that are less critical to the accuracy of the daily operation of an
accelerator are performed only on a weekly basis (Table X). Other parameters that
vary less and are not as critical to the daily operation should be performed at least on
a monthly basis (Table XI).
A full calibration of a treatment machine and a review by trained technicians
under the supervision of a qualified medical physicist should be performed once a
year. This should include basic calibration and verification of the stability of the
dose per monitor unit, beam symmetry, output factors and central axis depth doses
for different field sizes. In addition, dose values for off axis factors, monitor lin-
earity, monitor end effects, wedge and tray factors, and bolus and compensating fil-
ter attenuation should be verified. Other parameters include checking the mechan-
TABLE IX. RECOMMENDED DAILY QUALITY

ASSURANCE CHECKS FOR LINEAR ACCELERA-
TORS AND OTHER TELETHERAPY UNITS
Machine operating parameters

Interlock lamp tests
Laser localization lights
Optical distance indicators
Patient audiovisual communication facilities
Radiation warning lights
X ray output constancy (cGy/monitor unit)
TABLE X. RECOMMENDED WEEKLY QUALITY

ASSURANCE CHECKS FOR LINEAR ACCELERA-
TORS AND OTHER TELETHERAPY UNITS
Light radiation field congruence

Radiation beam symmetry
Electron beam radiation output constancy
Electron output constancy (cGy/monitor unit)
TABLE XI. RECOMMENDED MONTHLY QUALITY ASSURANCE CHECKS

FOR LINEAR ACCELERATORS AND OTHER TELETHERAPY UNITS
Emergency off switches and interlocks

Mechanical and digital indicators (gantry, collimator, field size, couch)
Inspection of the mechanical parts of an accelerator, including blocking tray and treatment aids
Constancy checks of daily quality assurance systems
Photon beam energy (off axis ratios)
Electron beam energy (ionization depth ratios)
ical isocenter of a unit (within 2 mm) as the gantry is rotated through 360 degrees.
Finally, a continuing education course on machine operation, safety and quality
assurance procedures should be reviewed with the staff on an annual basis. It is also
critical that emergency procedures be reviewed with the staff at least on an annual
basis to ensure a clear understanding and proper interpretation of the procedures.
Newer accelerators rely heavily on computer technology for control systems.
Recent incidents have shown that such accelerators have the potential for massive
overdoses to patients as a result of software operational errors [37]. Therefore, it is
304 PÉREZ et al.
critical that appropriate acceptance testing procedures for new software and/or new
computer control features be designed specifically to test them initially and periodi-
cally thereafter. All safety interlocks should be rigorously tested after any repairs to the
equipment. To ensure safe operation, the interlocks should be tested in the clinical
modes used to treat patients, and this should be done under the supervision of quali-
fied physicists. Because software and hardware are intimately linked in a computer
controlled machine, even minor changes in hardware, such as the replacement of parts,
can produce aberrations in the operation of an accelerator if there is a flaw in the soft-
ware design or implementation. Integrity of software and data should be verified using
appropriate tools supplied by the manufacturer. Full acceptance testing may again be
necessary to ensure proper operation and treatment of patients if major repairs are per-
formed on an accelerator or if repairs involve replacement components.
9. TREATMENT PLANNING DEVICE QUALITY ASSURANCE

PROGRAMMES
We have identified three distinct methods of treatment planning that should be

considered in a quality assurance programme:
— Non-graphical planning, which is often used for dose calculations in single or

parallel opposed fields. The prescribed dose and monitor units are usually cal-
culated on the central axis at specified depths using central axis depth dose or
tissue maximum dose ratios and calibration tables.
— Traditional graphical planning, in which a target volume is defined on orthog-
onal simulation or computed tomography (CT) films. Field arrangements are
designed and dose distributions calculated on the central axis or a limited num-
ber of cross-sections of a patient’s treated volume.
— Three dimensional treatment planning using target volumes, normal tissue vol-
ume definitions, contours and multiple CT sections, virtual simulations, digi-
tally reconstructed radiographs, 3-D dose distribution representations and
dose–volume histograms. The procedures to be followed in 3-D or intensity
modulated treatment planning have been previously outlined [38].
10. QUALITY ASSURANCE OF INNOVATIVE TECHNOLOGY
A variety of new computer controlled high technology ancillary devices have

been incorporated into linear accelerators, including asymmetric collimators (jaws),
dynamic wedges and multileaf collimators, which require specific quality assurance
procedures as outlined by Purdy et al. [39].
These technologies foster the use of 3-D conformal or intensity modulated radi-
ation therapy with improved therapeutic ratios through the use of precisely tailored
physical dose distributions that cannot be achieved using traditional planning,
delivery and verification techniques, and, at the same time, provide more complete
and thorough safety systems.
Intensity modulation exploits the use of multiple fields in which photon fluence
is varied across a beam [40], generating concave dose distributions around a target
volume and providing sparing of specific sensitive normal structures within complex
treatment geometries. Beam intensity is made to be proportional to a target thickness
as assessed from a beam’s eye view as a beam rotates around a patient; where the tar-
get is thickest, the beam intensity is at its greatest, where it is at its thinnest, the inten-
sity is at its lowest.
Beam intensity modulation can be achieved with tomotherapy [41, 42], in
which radiation is delivered in a rotational fashion to only a small slice of a patient.
As a gantry rotates around a patient with the accelerator turned on, and the beam is
collimated to a narrow slit, the beam is turned on and off by driving a series of small
leaves in or out of the beam’s path. This modulation is produced in a contiguous slice
by slice fashion, and a complete treatment is accomplished by stacking a series of
slices. A second approach to beam intensity modulation is to use a conventional mul-
tileaf collimator with individually shaped multileaf collimator portals (step and shoot)
or using dynamic modes in which the multileaf collimator leaves change configura-
tion during gantry rotation as the gantry of the accelerator is rotating [33].
Quality assurance for dynamic therapy techniques is just now being developed,
and increased vigilance will be required; users of this technology must accept an even
greater responsibility with regard to patient safety. Acceptance testing and periodic
quality assurance is essential [15, 22, 31]. In addition, because serial tomotherapy
requires precise movement of the accelerator treatment table between slices, rigorous
tests must be performed to ensure that the accurate indexing of table movement
(±0.1 mm) can be reliably achieved. In addition, dynamic therapy techniques will
require both geometric and dosimetric verification for some part of the treatment or
to a phantom before each treatment is delivered. New approaches for these quality
assurance tasks are needed. Lastly, users must be concerned with the whole body dose
to patients from leakage radiation. This is increased with beam modulation systems
because the number of monitor units required to deliver a specific dose to a patient is
substantially increased (by a factor of at least two to three) [43].
11. CONCLUSIONS
In summary, general radiation protection procedures and specific quality assur-

ance policies are mandatory to ensure the appropriate treatment of patients receiving
306 PÉREZ et al.
radiation therapy and to eliminate the possibility of misadministration. Also, special

attention should be paid to the protection of the radiological workers involved in the
care of these patients and of the public in general.
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RADIOTHERAPY DOSIMETRY AUDIT: A EUROPEAN
PROGRAMME TO IMPROVE QUALITY AND SAFETY
IN RADIATION TREATMENTS
I.H. FERREIRA, A. DUTREIX

ESTRO EQUAL Measuring Laboratory,
Service de Physique, Institut Gustave-Roussy,
Villejuif, France
A. BRIDIER, D. MARRE, J. CHAVAUDRA

Service de Physique, Institut Gustave-Roussy,
Villejuif, France
H. SVENSSON
Radiation Physics Department, University of Umea,
Umea, Sweden
E-mail: equal@igr.fr
Abstract
In radiotherapy the dose needed for local tumour control is often very close to the dose
level that might cause serious and, in some cases, life threatening complications. The optimal
dose level is related to the treated volume, the sensitivity of the organs at risk close to or inside
the target volume and the fractionation schedule. Radiation oncologists rely on experience of
different treatment regimes at their own or other centres. In order to make use of this vast
experience the dosimetry must be coherent in time and for different types of irradiation setups,
both inside and between centres. The IAEA and the World Health Organization has
successfully introduced a thermoluminescent dosimetry audit system to reduce uncertainty in
reference dosimetry. The European Society for Therapeutic Radiology and Oncology has
extended this system. Checks of non-reference irradiation geometries are also included. A
detailed analysis has been carried out of data from 282 centres, which includes 654 beams. This
programme shows that dosimetrical accuracy is fairly good in the reference situation, but
improvements are often needed in non-references conditions, that is in irradiation geometries
that closely simulate those used in patient treatments.
1. INTRODUCTION
The IAEA and the World Health Organization (WHO) have carried out thermo-
luminescent dosimetry (TLD) audits of radiotherapy facilities since the late 1960s
[1]. Measurements for mainly 60Co units in a reference geometry have been per-
formed, and during the past 20 years they have almost exclusively been in centres in
309
310 FERREIRA et al.
developing countries. This is a very useful programme as it can reveal dosimetrical

errors and improve accuracy. However, it does not uncover all the problems in a
department, as this audit does not cover, for example, errors in patient treatments
using irregular fields, wedges and non-reference depths for tumour dose determina-
tion. It would, however, be too huge a task for international organizations to include
all centres in the world, especially as the number of measurements at each centre is
increasing. There are probably as many as 7000 to 8000 60Co units and accelerators
in the world, and the number is rapidly increasing. Regional and national programmes
ought therefore to be encouraged. These should, if possible, be co-ordinated with the
international organizations’ activities.
To cover more irradiation parameters, regional programmes in North America
[2] and Europe [3, 4], along with some national ones [5, 6], have been set up. The
results from a programme, called the Quality Assurance Network (EQUAL) pro-
gramme, sponsored by the European Union (EU) and set up in 1998 by the European
Society for Therapeutic Radiology and Oncology (ESTRO) are presented here. The
programme covers 23 European and two Mediterranean Basin countries. Co-opera-
tion with the IAEA has been established. In the EQUAL programme accuracy at the
end of the radiotherapy chain for treatments with photon and electron beams is
checked. Dosimetrical problems in beam calibrations, in beam data used as input to
the treatment planning system (TPS) used and in the algorithms used in the TPS could
also be discovered in the audits. In the first results of the EQUAL network, signifi-
cant deviations were observed in some European radiotherapy centres, especially
when using large field sizes and wedged beams [4]. This paper reports the third year’s
experience of the EQUAL programme.
2. MATERIAL AND METHODS
2.1. The EQUAL TLD system
For photon and electron beam dosimetry, the EQUAL measuring laboratory
uses a method that has been developed by the Medical Physics Department of the
Institut Gustave-Roussy. The dosimeters are made from lithium fluoride, LiF powder
type DTL 937, doped with Na, Mg and Ti. LiF powder with a density of 1.4 g/cm3 is
encapsulated into IAEA black polyethylene cylindrical containers. The dosimeters
are read on a PCL 3 automatic reader.
In the participating centres all TLD irradiations (photon and electron checks)
are performed in a water phantom using the corresponding IAEA holders.
The absorbed doses to water in photon and electron beams, measured with ion-
ization chambers, are determined following the procedure described in Ref. [7].
RADIOTHERAPY DOSIMETRY AUDIT 311
2.2. Uncertainties and traceability of the TLD measurements
The EQUAL reference dosimetry is linked to the IAEA dosimetry laboratory

and the Radiological Physics Center (RPC) dosimetry laboratory (Fig. 1) by periodic
comparisons. The combined standard uncertainty on the absorbed dose to water from
TLD measurements is estimated by the square root of the quadratic sum of individ-
ual uncertainties. These include the TLD calibration uncertainty using an ionization
chamber calibrated in terms of the dose to water in the French primary standard
dosimetry laboratory (PSDL) (linked to the Bureau international des poids et mesures
in France) and the uncertainties of the TLD correction factors. The combined stan-
dard uncertainty of the entire EQUAL TLD process at one standard deviation (SD) is
1.6% for 60Co ray beams and 1.7% for high energy photons and electron beams [8].
The traceability of the TLD measurements of the EQUAL laboratory is regu-
larly checked by internal quality controls, external audits and dosimetric intercom-
parisons performed together with international and national organizations.
Dosimetric intercomparisons are annually performed with the dosimetry laboratory of
the IAEA/WHO, the RPC, the University Hospital of Leuven (in Belgium) and the
Brazilian TLD external audit network (Programa de Qualidade em Radioterapia, the
PQR network).
EQUAL programme structure
Bureau international des

poids et mesures
ESTRO board
(France)
Reference centres:
Umea, Leuven, ...
Primary standard
dosimetry laboratory: EQUAL
Bureau national co-ordinating IAEA/WHO
de métrologie–
Laboratoire national committee and
Henri Bequerel
(France) national networks
IAEA Measuring centre

(Institut Gustave-Roussy–
EQUAL)
National Institute of Radiological
Standards and Physics Center (USA)
Technology (USA)
Participating centres
FIG. 1. Structure of the ESTRO EQUAL network and links with the BIPM, PSDLs, IAEA sec-
ondary standard dosimetry laboratory and other networks, dosimetry laboratories and inter-
national organizations.
312 FERREIRA et al.
2.3. Dosimetric parameters checked in photon beams
Four dosimetric parameters for photons beams are checked: the reference beam
output (RBO), the percentage depth dose (PDD), the beam output variation (BOV) for
open and wedged fields and the wedge transmission factor (WTF). A total of 15
dosimeters are used: 12 are mailed to the centre under investigation, including ten
dosimeters to be irradiated by the participating centre and two for monitoring and
control, while three are left in the EQUAL laboratory as a reference.
2.4. Dosimetric parameters checked in electron beams
For electron beams the beam outputs at three different field sizes are checked
for each energy (10 cm × 10 cm, 15 cm × 20 cm and 7 cm × 7 cm). When in clinical
practice different secondary standard doses (SSDs) are used (with a difference of 5
cm or more), a fourth output check is performed with a field size of 10 cm × 10 cm
at the second SSD (see Table I). A maximum of three electron beam energies are
checked for each participating centre.
2.5. Levels of deviation, actions and followup
The levels of deviation between measured and stated doses (Dm /Ds) and the cor-
responding EQUAL actions are given in Ref. [4]. However, based on a request of the
ESTRO’s radiation oncologists, some improvement were made in 2000 in the
EQUAL protocol for the case of a deviation of Dm /Ds larger than 5%:
— If any observed deviation is outside the tolerance level (deviation >±5% and
£±10%), but lower than the emergency level, a letter is sent at the earliest
opportunity to the physicist of the participating centre pointing out that an out
of tolerance deviation has been observed, and for which parameter(s). A second
TABLE I. IRRADIATION CONDITIONS AND TLD NUMBERS IN THE EQUAL

PROGRAMME FOR ELECTRON BEAM CHECKS
Depth in water Field size at SSD Dose delivered

TLD No. Geometry setup
(cm) (cm ¥ cm) (Gy)
1 and 2 As used SSD as used 10 × 10 2

3 As used SSD as used 15 × 20 2
4 As used SSD as used 7×7 2
5 As used SSD other if any 10 × 10 2
set of measurements is urgently required for confirmation and a second set of

TLDs is sent out within a few days. The results for the deviating beam para-
meter(s) are not sent out. However, the results for the other measurements are
reported if they are within the tolerance. It is recommended to the physicist to
consider carefully the possible causes of deviation and to send to EQUAL any
relevant comment or information. In addition, it is noted that it is the physicist’s
responsibility to inform the radiation oncologists of the possibility of a dose
deviation in the treatment of patients.
There are three possible outcomes from the second check:
— If the results from the second set of dosimeters are within the tolerance level,
then both sets of results are sent to both the physicist and the radiation oncolo-
gist. If no explanation has been supplied when the second set is returned to
EQUAL, information is requested on what actions have been taken to avoid a
repetition of the deviations and to facilitate an analysis of the deviations.
— If the second set of dosimeters are not accepted, not irradiated or not returned,
the deviation out of tolerance is considered, confirmed on the single measure-
ment, and the results sent as soon as possible to both the physicist and the radi-
ation oncologist, drawing attention to the presence of significant deviations in
the initial checks.
— If a significant deviation is confirmed by the second check, that is if the second
set of dosimeters confirms the first measurements by showing a similar magni-
tude of deviations, then the two detailed sets of results are sent as quickly as
possible to the physicist and to the radiation oncologist to inform them of the
confirmed out of tolerance deviation. EQUAL recommends that the physicist
again considers the possible causes of deviation and encourages comments to
be sent. A member of the EQUAL committee discusses the results by telephone
with the participating centre and offers to the centre a new external audit or an
on-site visit.
If any observed deviation is at the emergency level (deviation >±10%), the

same procedure is followed. However, in addition, before the initial letter is sent out
and at the earliest possible opportunity, a physicist from the EQUAL committee con-
tacts the participating physicist, indicating that a deviation at the emergency level has
been observed, but neither the sign (+ or –) nor the exact magnitude is given. The
necessity of an urgent second check of the beam(s) concerned is stressed. If a large
deviation is confirmed by the second check, the two detailed sets of results are sent
as quickly as possible to both the physicist and the radiation oncologist to inform
them of the confirmed deviation. A member of the EQUAL committee contacts the
physicist by telephone to discuss the results and offers an on-site visit.
314 FERREIRA et al.
3. RESULTS
3.1. General data
The general data include the radiotherapy structure, the dosimetry facilities and
the dosimetry protocols used in the centres as well as the beam qualities checked by
EQUAL from the beginning of the project in January 1998 to September 2000.
Figure 2 shows the number of participating centres (checked or scheduled to be
checked), the number of radiotherapy centres per country and the percentage of cen-
tres per country having applied to participate in the EQUAL programme for photon
and electron beams compared with the total number of radiotherapy centres in each
country.
A mean of 50% of the European centres have applied to join EQUAL, showing
the great interest of the radiotherapy centres in participating in external audits in order
to improve the accuracy of patient treatments: 93% of the checked centres belong to
the EU plus Norway and Switzerland, 5% belong to central Europe and 2% to the
Mediterranean Basin (Fig. 2). The countries with the largest number of participating
centres are Germany (86), Italy (74), France (59), Spain (40) and the United Kingdom
(21). Among these countries only the UK has an external audit programme that has
run for several years [9, 10].
No. of centres
that have applied
Checks part in
co-operation
with the IAEA
Netherlands
Czech Republic
Country
FIG. 2. Percentage of centres per country having applied to participate in the EQUAL pro-
gramme (data as in October 2000) compared to the total number of radiotherapy centres in
each country.
Following a memorandum of understanding signed with the IAEA, the IAEA

is always informed of applications from countries outside the EU. Depending on the
existing national programmes, it is agreed that if the country concerned is covered by
the IAEA or by a national programme sponsored by the IAEA, EQUAL does not
accept to check their centres, so as to avoid a duplication of efforts. However, for
these countries EQUAL accepts to perform TLD checks for their reference centres
and the laboratories running the national programmes.
Table II shows the quality distribution of the 654 photon beams checked in the
EQUAL project since January 1998. This distribution can be considered as represen-
tative for the photon beam qualities used in European radiotherapy centres. The beam
qualities most often checked are 6 MV (40%), 18 MV (13%), 60Co (11%) and 15 MV
(12%). Among the 277 electron beams checked in the EQUAL electron programme,
48% are low energy beams (£10 MeV) and 52% high energy beams (>10 MeV). The
electron beam qualities most often checked are 12 MeV (21%), 6 MeV (19%) and 9
MeV (12%).
The radiotherapy units (Linacs and 60Co) most often checked in Europe are
made by Philips-Elekta (27%), Varian (26%), Siemens (21%) and GE-MS (16%).
The dosimetry protocols used for the photon beam calibrations in the EQUAL
participating centres are the IAEA’s (36%) [11], the Deutsches Institut für Normung’s
(DIN 6800) (13%) [5] and the Institute of Physical Sciences in Medicine’s (IPSM)
(10%) [6]. Protocols derived from the IAEA’s [11], such as the Nederlandse
Commissie voor Stralingsdosimetrie’s (NCS) [12], the Sociedad Española de Física
Médica’s (SEFM) [13] and the Swiss Society of Radiation Biology and Radiation
Physics’ (SSRBP) [14], are also used. For electron beams the protocols most often
used are the IAEA’s [11] (18%), DIN 6800-2 (16%) [15] and the Hospital Physicists’
Association’s (14%) [16]. The high number of German centres in the EQUAL pro-
gramme can explain the large percentage of the DIN protocol used.
TABLE II. ENERGY DISTRIBUTION AS A PERCENTAGE OF THE 654 PHO-

TON AND 277 ELECTRON BEAMS CHECKED IN THE EQUAL PROJECT
Photon beams checked

Photon energy Co-60 3 4 5 6 8 9 10 12 15 16 18 20 23 25
(MV)
Per cent of 11 0.3 5 2 40 3 0.3 8 0.3 12 0.4 13 1 1 3
beams
Electron beams checked
Electron energy 4 5 6 7 8 9 10 12 14 15 16 17 18 20 ≥21
(MeV)
Per cent of 1 2 19 2 4 12 10 21 2 8 3 1 8 3 5
beams
316 FERREIRA et al.
Figure 3 gives the types of ionization reference chambers (as a percentage) used
by the participating centres to calibrate photon beams (282 centres) and electron
beams (81 centres). The information on chamber type is of importance as the dosime-
try protocols give correction factors that are specific for each particular chamber type.
(a)
PTW 31003
(9%) PTW 30001
NE 2581 (5%)
(11%) Others
(4%)
PTW 23332
(11%) PTW 233641 (3%)
NE 2561 (3%)
PTW 23331 (3%)

ESC/87 (3%)
PTW 31002 (2%)

Wellhöfer IC70 (2%)
NE 2571 NE 2505/3 (2%)
(38%)
Farmer in-house (1%)
PTW 23333 (1%)
Baldwin 0.6cc (1%)
PTW 30002 (0.4%)
(b)
NE 2505/3B
PTW Farmer’s 0.6 (8%) NE 2571
(8%) (6%)
Roos
(6%)
Holt
(5%)
NACP
(19%) PTW 23332
(4%)
ESC/87
(3%)
PTW 31003
(3%)
Markus PTW 23331 rigid
(30%) (3%)
NE 2581
(3%)
IC70
(3%)
FIG. 3. Types of reference ionization chambers used by the EQUAL participating centres for
(a) photons beam calibrations (282 centres) and (b) electron beam calibrations (81 centres).
In the first year of the EQUAL project a majority of the large centres (>2 exter-
nal radiotherapy units) had participated in an external audit. A large effort has been
made by the EQUAL committee to increase the number of small participating centres
(£2 units). Sixty nine per cent of the centres checked in Europe have only one or two
units (small centres), 17% have three units and only 14% more than four units.
3.2. Observed deviations: Photon beams
In order to evaluate the agreement between the measured quantities Qm and the
quantities stated by the participating centre Qs, the ratios of these two values Qm/Qs
are calculated for X rays and 60Co beams. The global results of the deviation level
(dQm/Qs) for photon beams are shown in Table III. This table gives the number of
beams with deviations d at each level considered in the EQUAL protocol [d(Qm/Qs)
£3%, 3 < dQm/Qs) £ 5%, 5% < dQm/Qs) £ 10% and dQm/Qs) > 10%] for the parame-
ters checked: RBO, PDD, BOV and WTF.
The global result analysis shows deviations >±5% in at least one point for 107
out of the 654 beams. Out of these 107 rechecked beams, 69 beams have deviations
>±5% owing to possible setup errors or to recalibrations of monitors and 38 beams
present real proven dosimetric problems.
The results show that 92% of the beam outputs checked in reference conditions
(RBO) are at the optimal level [d(Qm/Qs) £±3%], 7% have deviations between ±3%
and ±5% and only 1.3% have deviations outside the tolerance level [d(Qm/Qs) >
±5%]. Regarding the percentage depth doses, 93% of the beams are at the optimal
level, 5% have deviations between ±3% and ±5%, and 2% of the checked beams have
deviations outside the tolerance level (Table III).
For the beam output variation 85% (open beams) and 87% (wedged beams) are
at the optimal level, and 4% (open beams) and 3% (wedged beams) have deviations
outside the tolerance level (Table III). Eighty four per cent of the wedge transmission
factors are at the optimal level and 4% have deviations outside the tolerance level. The
BOV and the WTF present the highest number of deviations (10% and 12%, respec-
tively) outside the optimal level but within the tolerance level [d(Qm/Qs) between
±3% and ±5%].
The large number (4%) of deviations outside the tolerance level in the wedge
transmission factor is explained by the many errors made in irradiations with the
wedge; for example, for some beams the delivered dose was obviously 1 Gy instead of
2 Gy. The main dosimetric problems observed for the photon beams are errors in the
TPS data (PDD, WTF and output variation with the field sizes), errors in the reference
dose, errors in dose calculations (use of wrong PDD, wedge, etc), errors in electrom-
eter readings, errors in the wedge transmission factor, errors in the timer for the cobalt
machine, errors in the field size and errors in beam calibration (i.e. use of a plastic
phantom instead of a water phantom without correcting for the equivalent depth).
318 FERREIRA et al.
TABLE III. NUMBER OF PHOTON BEAMS AND PERCENTAGES AT EACH

DEVIATION LEVEL FOR THE REFERENCE BEAM OUTPUT, BEAM OUTPUT
VARIATION, DEPTH DOSE DATA AND WEDGE TRANSMISSION FACTOR
Deviation levels on the ratio Qm/Qs d(Qm/Qs) Total No.

Parameters checked
£3% >3–£5% >5–£10% >10% of beams
Reference beam output 582 (89%) 47 (7%) 17 (3%) 8 (1%) 654

602 (92%) 45 (7%) 5 (~1%) 2 (<0.3%) 654
Percentage depth dose 519 (87%) 52 (9%) 14 (2%) 9 (2%) 594

554 (93%) 32 (5%) 5 (1%) 3 (1%) 594
Beam output variation

Open beams 517 (84%) 71 (11%) 22 (4%) 8 (1%) 618
529 (85%) 68 (11%) 18 (3%) 3 (1%) 618
Wedged beams 484 (85%) 60 (11%) 13 (2%) 13 (2%) 570

496 (87%) 60 (10%) 11 (2%) 3 (1%) 570
Wedge transmission 448 (79%) 82 (14%) 18 (3%) 20 (4%) 568

factor 490 (84%) 75 (12%) 17 (3%) 4 (1%) 568
Note: The values in standard text refer to all deviations observed in the first check, including
the beams with deviations that were not repeated in the second check. The values in bold char-
acters concern only those deviations that have been confirmed in the second check, for which
the number of monitor units has been modified between the first and the second check, or for
which some parameters have been modified between the two checks.
Figure 4 shows the Qm/Qs histograms of the RBO for the X ray and 60Co beams.
The mean value is near 1.000, suggesting that there is no systematic discrepancy in
the dosimetric parameters checked or in the EQUAL TLD measurement procedure.
The largest spread and standard deviation is observed for the WTF (D = 0.88 and SD
= 3.9%), cf. RBO (D =0.24 and SD =1.8%).
3.3. Observed deviations: Electron beams
The values of Qm/Qs are calculated and deviations are shown in Table IV in the
same way as for photon beams. Table IV does not contain the ten deviations observed
in the first check that have not been repeated in the second one, as they seem to be
due to setup errors or to the recalibration of the beam.
For electron beams 86% of the RBO (10 cm ¥ 10 cm) are at the optimal level,
that is deviations below 3%. Compared to the photon dose check for the RBO there
are many more deviations between 3% and 5%.
N
m
SD
Q m /Q s
FIG. 4. Results of the reference beam output check for 60Co and X ray beams expressed as the
ratio of absorbed dose in water Qm measured by the EQUAL laboratory and the absorbed dose
in water Qs stated by the participating centre (Qm/Qs). N is the number of beams, m the mean
of the distribution, SD the standard deviation and D the spread of the results (the difference
between the highest and the lowest values of the ratio Qm/Qs).
TABLE IV. NUMBER OF DEVIATIONS FOR EQUAL ELECTRON BEAM OUT-

PUTS WITH DIFFERENT FIELD SIZES AND SSDs. THE DEVIATIONS
OBSERVED IN THE FIRST CHECK AND NOT IN THE SECOND ONE ARE NOT
INCLUDED
Deviation levels on the ratio Qm/Qs (dQm/Qs) Total No.

Field size TLD used
£3% >3–£5% >5–£10% >10% of beams
10 cm ¥ 10 cm 1 and 2 239 (86%) 35 (13%) 3 (1%) — 277

15 cm ¥ 20 cm 3 212 (81%) 46 (17%) 6 (2%) — 264
7 cm ¥ 7 cm 4 241 (83%) 41 (15%) 4 (2%) — 266
10 cm ¥ 10 cm 5 116 (79%) 29 (20%) 1 (1%) — 146
(SSD ≥105 cm)
Total All TLDs 788 (83%) 151 (16%) 14 (1%) — 953
320 FERREIRA et al.
Eight beams with deviations larger than 5% on one or more parameters have
been remeasured, and for six of these beams there is a good agreement between the
remeasured and stated values: the errors observed in the first check might therefore
be due to problems with one of the geometric parameters during the TLD irradiation,
thus the patients may have been irradiated correctly. For the other two beams the dosi-
metric errors are:
— Leakage in plane parallel ionization chambers,

— High instability of the accelerator during the TLD irradiation so that the dose
of 2 Gy has been delivered in several irradiations.
Figure 5 shows the Qm/Qs histogram of the RBO with the mean value and
standard deviation of Qm/Qs. All values on the RBO histograms are centred on
1.000, which suggests that there is no systematic discrepancy in the electron RBO
or in the EQUAL TLD procedure. The standard deviation for the beam output in
reference conditions (10 cm ¥ 10 cm, at SSD 100) is 2.1%, with a mean value of
1.003, and the spread of the results is 0.11. The beam output for the 15 cm ¥ 20 cm
and 7 cm ¥ 7 cm field sizes have a standard deviation of 2.4% and 2.3%, respec-
tively, with a mean value of 1.001 and a spread of the results of about 0.15.
N
m
SD
Q m /Q s
FIG. 5. Results of 277 reference beam outputs expressed as the ratio Qm/Qs of absorbed dose
in water Qm measured by the EQUAL laboratory and the absorbed dose in water Qs stated by
the participating centre. N is the number of beams, m is the mean of the distribution, SD is the
standard deviation and D is the spread of the results.
4. DISCUSSION
4.1. Photon beams
Among the deviations observed in the first check but not in the second, it is inter-
esting to separate the deviations that might have consequences on patient treatments
from those that could be linked to errors in the conditions of TLD irradiation.
Some deviations could be explained by the physicists, who corrected some of
the parameters before the second check. In some other cases the number of monitor
units were modified between the two checks and the physicists did not give explana-
tions. In those two cases one can assume that the dose delivered to some of the
patients (if not to all of them) irradiated with the beams concerned were in error.
Therefore, these deviations, even if they were corrected later, are linked to real dose
errors in treatments.
The deviations that were not observed during the second check when the num-
ber of monitor units were not modified can have two origins: setup errors or adjust-
ments of the monitors after a new calibration. Setup errors can be due to an incorrect
SSD, an error in the depth of irradiation, an error in the wedge orientation or any other
mistake at the time of phantom setup. Such deviations have no obvious influence on
the quality of treatments and therefore should not be considered as dose errors.
However, there are a relatively large number of such errors that can be shown during
an external audit and for which physicists should be specially careful. It is possible
that a monitor is readjusted between the two checks, either as part of normal quality
assurance or because of the indication of large deviations by EQUAL. In these cases
the doses delivered to patients would have been in error for an unknown time, and
these deviations should be considered as dosimetric errors. However, as it is not
known whether there is a setup error or if a monitor has been readjusted it has been
decided also to include the percentages calculated when taking into account only the
results of the second check.
If one considers all deviations observed in the first check, one might overesti-
mate the rate of deviation, but by not taking into account the deviations that are not
confirmed in the second check there is the probably of an underestimation. Only 1%
of the reference outputs were outside the tolerance level [d(Qm/Qs) >±5%]. These
results were very good compared with recent results published either for the devel-
oping countries checked in the IEAE/WHO network [17], where 19% of RBOs are
outside the tolerance level, or for the USA (the RPC network), where 3.5% of the
checked RBOs have deviations >±5% [2]. Good improvements in dosimetry in
European radiotherapy photons beams were observed, compared with the first
EQUAL results obtained in 1998 when 3% of checked RBOs had deviations >±5%
[4]. The standard deviation of the EQUAL external audit checks is close to the results
obtained by US RPC network (SD of 1.9% for photon beams).
322 FERREIRA et al.
Many deviations >±3% and £±5% can be due to errors in TPS algorithms or
inconsistencies in the beam data used for TPS for the monitor unit calculations.
In Europe some secondary standard laboratories perform calibrations of ion-
ization chambers in terms of absorbed dose to water ND,W while others do so in air
kerma Nk . Table V shows the results of the RBO checks according to the ionization
chamber calibration factors and dosimetry protocols used to calibrate the photon
beams. About 78% of the participating centres calibrate their reference ionization
chambers in terms of air kerma Nk , 20% of the chambers are calibrated in terms of
absorbed dose to water ND,W and only 2% are calibrated in terms of exposure Nx . The
results of the RBO shows a high accuracy when ionization chambers are calibrated in
terms of absorbed dose to water ND,W (mean value on the RBO = 0.997, SD = 1.5%)
compared with ionization chambers calibrated in air kerma (mean value on the RBO
= 0.995, SD = 2.2%); the obsolete calibration factor in terms of exposure gives the
highest SD (3.0 %), see Table V. Further, the beams calibrated according to dosime-
try protocols based on absorbed dose to water ND,W (principally DIN 6800-2 [5], the
IPSM [6] and the NCS [12]) are more accurate (mean value = 0.995, SD = 1.4%) than
the others (mean value = 0.996, SD = 2.1%).
The application in Europe of the new IAEA [7] code of practice based on the
absorbed dose to water and endorsed by ESTRO, the WHO and by the Pan American
Health Organization should improve the accuracy level of beam calibrations.
4.2. Electron beams
Only 1% of deviations were larger than 5%, and no deviation was larger than
10%. However, there were a large number of deviations (13%) outside optimal and
within tolerance levels [d(Qm/Qs)] between ±3% and ±5%. These results can be
explained by the uncertainties in the TPS algorithms for electron radiation, in the
TABLE V. RESULTS OF THE RBO CHECKS ACCORDING TO IONIZATION

CHAMBER CALIBRATION FACTORS AND DOSIMETRY PROTOCOLS USED
BY THE EQUAL PARTICIPATING CENTRES TO CALIBRATE PHOTON
BEAMS
Ionization chamber calibration factor Dosimetry protocol or code of practices
ND,W Nk Nx ND,W based Nk based Nx based

Number 133 521 13 108 548 13
Mean value 0.997 0.995 1.005 0.995 0.996 1.000
SD (%) 1.5 2.2 2.7 1.4 2.1 2.6
manual calculation methods and also in the electron beam calibration methods. In
fact, a large percentage of the low beam energies (£10 MeV) have been calibrated
with cylindrical ionization chambers contrary to the recommendations given in most
dosimetry protocols.
The number of centres with electron beam facilities have increased and a real
improvement in electron beam calibrations and TPS algorithms is urgently needed in
order to increase the accuracy of patients’ treatments.
5. CONCLUSIONS
The aim of the EQUAL project is to check the overall chain of radiotherapy
treatment with photon and electron beams. This should reduce the uncertainty in
dosimetry and therefore improve the possibility to optimize the dose level in radio-
therapy, which ought to result in the better control of a tumour and a constant or
reduced number of complications. For a large number of European centres the
EQUAL project was the first opportunity to take part in an external audit both for pho-
ton and electron beams for both non-reference conditions and in many cases reference
conditions. About 50% of the European radiotherapy centres (394) have applied to
participate in the programme. A total of 6700 parameters have been checked in three
years. An effort has been made to stimulate small centres (those with one or two treat-
ment centres) to participate; this has been successful, as a total of 69% of the appli-
cations are from such centres.
The results from measurements in the reference geometry were very good both
for photon and electron beams (the mean ratio of measured and stated doses was
0.998 and 1.003, respectively, with an SD of 1.9% and 2.1%, respectively).
In 6% (38/654 beams) of photon beams there was at least one parameter with a
proven dosimetric problem. The true number is probably larger as only cases verified
in two investigations were considered.
The results for the 277 electron beam checks were also very good, since 98%
of beam outputs were within the tolerance level [d(Qm/Qs) £5%]. However, the per-
centage of deviations outside the optimal level and within the tolerance level (>3%
and £5%) for the reference beam output was about three times larger than for photon
beams. The large number of deviations observed in non-reference conditions (4%) as
compared to the number of deviations in reference conditions (1%) shows the impor-
tance of checking several parameters.
All beams with dosimetry problems were followed up, and in some cases on-
site visits were undertaken. The EQUAL dosimetry audit on dosimetry in radiother-
apy offers to European radiation oncologists an important tool to improve the quality
of treatments.
324 FERREIRA et al.
ACKNOWLEDGEMENTS
The authors thank the EQUAL team (G. Gobbi, H. Järvinen, C. Kappas, L.N.
Martin, J. Richter, D. Thwaites, G. Heeren and J.-M. d’Hooghe) for their collabora-
tion on the development of the EQUAL programme. They thank especially C.
Dagneaux (the EQUAL technician) for her high precision TLD measurements and for
the organization of the TLD laboratory and A. Mechet (the EQUAL secretary) for her
active help.
They are very grateful to the IAEA for its co-operation to the project, and more
especially to P. Andreo and J. Izewska for the useful discussions on the organization
of the programme. They also thank the physicists of the European centres for their
participation and co-operation.
The present work would not have been possible without the strong support of
the ESTRO Committee for Quality Assurance and the financial help (Grant
Agreements No. 212.146899 (99CVF2-030) and S12.299418 (2000CVG2-019)) of
the European Commission, Directorate General Health and Consumer
Protection–Europe Against Cancer Programme.
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DISCUSSION
C. PÉREZ: It is clearly important to minimize the radiation exposure of persons

who come into close contact with patients, particularly patients undergoing
brachytherapy, for example men with carcinoma of the prostate who have permanent
125I or 103Pd implants. Fortunately, most of the radiation sources used in brachyther-
apy provide a radiation exposure of relatives and medical staff that is very low.
A still more important issue, in my view, is minimizing the radiation exposure
of unintended targets within patients, through blocking and the use of techniques that
enable us to deliver the radiation more precisely to the target volumes. Here, quality
assurance is crucial.
326 FERREIRA et al.
M.P.R. WALIGÓRSKI: I am pleased that C. Pérez and H. Svensson referred to

the proposal, made in paper IAEA-CN-85153,1 that the system and concepts of radi-
ation protection should not be used with reference to radiotherapy patients.
In that context, I am surprised that C. Pérez quoted a limit to the high dose
region of the target volume and to the low dose region in terms of sieverts, or rems,
when International Commission on Radiation Units and Measurements documents
(correctly in my opinion) specify doses in terms of per cent of the dose to the target
volume and do not address numerically any other volumes in patients with regard to
the accuracy of the actual irradiation. I think it is very dangerous to try to introduce
units which bear no relation to the high dose (or call them ‘deterministic’) effects,
which have no relevance for radiation protection. That is why that proposal was made
in paper IAEA-CN-85173.
C. PÉREZ: I take your point.
C. BORRÁS: I am concerned about the standardization of the delineation of
volumes in tumour structures and in radiosensitive structures, especially as we use so
many computerized systems that give a three dimensional outline. It is important to
know exactly where a tumour is, so that one can deliver a higher dose to it and less
radiation to other areas. How does one address this issue from the point of view of
patients’ radiation protection?
C. PÉREZ: In this new era of radiation therapy, with three dimensional confor-
mal and intensity modulated techniques, it will be important for radiation oncologists
to learn radiological anatomy and also to identify normal structures. They will have
to use other imaging methods, including positron emission tomography, in order to
determine the volumes of subclinical disease that they must treat with a given dose.
There are some areas in which a fairly good consensus exists as to what volume
should be treated, for example the prostate. However, there are also areas regarding
where no such consensus exists; I, in the case of the head and neck, for example, have
a good understanding of what the gross disease is (although identifying it radi-
ographically or in imaging studies is not easy), but we do not have a good under-
standing of what the cervical lymph node volume should be and what doses it should
receive, depending on whether one is talking of gross disease, possible microscopic
disease or subclinical disease.
The lung is another area regarding which it is at present difficult to say what the
optimum volume for treatment is. We know that we must treat the target volume, but
there are some centres that, in order to increase the dose to the primary volume, are
not irradiated, such as the regional lymphatics. We shall have to determine, during the
next five to ten years, whether that is a reasonable approach.

However, I agree with you that target volume definition will be critical in the
new radiation therapy era.
Reverting to the question of quality assurance, as there is so much dynamic
treatment we shall have to be even more precise and more vigilant in implementing
quality assurance programmes. Record and verify systems are very helpful, at least in
documenting the way in which patients are treated.
H. SVENSSON: I agree. However, there is a danger that conformal radiother-
apy will miss part of a tumour, especially the subclinical part. We must therefore be
careful and proceed gradually, otherwise there will be problems.
A. ARBABI: In some countries, two or even more hospital patients receiving
large radiation doses in brachytherapy have to share the same room, so that they
receive additional radiation emitted by their roommates. In my view, there should be
some kind of international restriction requiring that each such patient has a room to
himself or herself.
C. PÉREZ: I agree that each such patient should have his or her own room, but
for economic reasons that is not always possible.
The attitude used to be ‘This patient already has a malignant disease, so a little
more radiation is not going to be as harmful in his or her case as in the case of some-
one who has never had a life threatening condition’. However, that attitude is unac-
ceptable today.
L.A. JOVA SED: What, in your opinion, should be the role of the competent
authorities, whoever they may be, with regard to the implementation and control of
radiotherapy quality control programmes?
C. PÉREZ: In my opinion, their role should be to formulate policies regarding
the manner in which radiation sources are used, and to specify the procedures to be
followed and the documentation on compliance with those policies to be submitted.
E. VAÑÓ CARRUANA: What is the situation regarding the need for more
research in the field of intravascular brachytherapy?
H. SVENSSON: My worry is that they give very high doses, often without
knowing how to define the dose — is it at 1 mm from the source, is it at 2 mm?
What is the situation with oxygen? Are there anoxic regions irradiated? Can patients
stand 25 to 50 Gy in one irradiation? I think there needs to be a working party look-
ing into this.
Four papers relating to this session could serve as a reference for what should
be done, but it is too big a field to cover here in a short discussion.
C. PÉREZ: H. Svensson was referring primarily to dosimetry, which is rather
complex.
At present there is no consensus about the best way of prescribing doses for
intravascular brachytherapy, owing to the irregularity of the lumen of the vessel.
Sometimes the presence of calcium will affect the beta particle dose distribution.
Some institutions are trying to carry out intravascular ultrasound based dosimetry,
328 FERREIRA et al.
while others simply prescribe the dose at 2 mm from the axis of the source. I think it
will be a few years before we see the impact of the variations in dosimetry and dose
delivery in relation to the prevention of restenosis.
As a participant in this conference, however, I am more concerned about the
exposures that cardiologists, radiation oncologists and other operators are receiving.
They use aprons and so on, but that does not protect them completely, especially
against the gamma radiation from 192I sources.
I am also concerned about patients. Patients may have a life threatening condi-
tion, such as a coronary disease, but not a malignant disease, so that the impact of
radiation exposure on them is that they survive for a number of years. I think there-
fore we shall have to pay a great deal of attention to radiation protection programmes
in the case of this particular use of ionizing radiation.
H.M. JOHNSON: Like others, we have experienced substantial reductions in
staff doses thanks to the replacement of low dose rate (LDR) by high dose rate (HDR)
brachytherapy, and I have been disappointed to learn that the role of LDR brachyther-
apy may in some countries be greater than that of HDR brachytherapy for both eco-
nomic reasons and because of the practicalities of source life. Would you care to com-
ment on the relative roles of LDR and HDR brachytherapy?
C. PÉREZ: There are two issues here. One is the dose rate and the other is the
method of administration.
One can use remote afterloading in both LDR and HDR brachytherapy, and
with those devices the problems of managing protection are going to be less. The dif-
ference is that many institutions carrying out LDR brachytherapy in developing coun-
tries use the manual afterloading technique, and that is where the exposure of staff
occurs.
With regard to the biological advantages, some people feel that there may be
some antitumour advantages to HDR brachytherapy, while others believe that LDR
brachytherapy may offer some advantages with regard to normal tissue effects.
However, with the linear quadratic equation and some of the new concepts relating to
biological equivalent doses, etc., the people who are carrying out HDR brachytherapy
have come to fairly equivalent doses that give the same tumour control with a com-
parable morbidity. I therefore do not think there is a great difference between the two.
There may be some economic advantages to HDR brachytherapy, especially
with regard to hospitalization — HDR brachytherapy can be performed as an outpa-
tient procedure, whereas LDR brachytherapy involves hospitalization for two to five
days.
L.V. RODRIGUEZ: When is the ideal time to replace a radiation source? After
we have used a source for a period equal to the half-life of the radioisotope in ques-
tion we request funds for the purchase of a replacement, but the funds may take a long
time to materialize, so that we find ourselves still using the source after twice that
period.
H. SVENSSON: That is a difficult question, as it is obviously better to have

some radiation than none at all, but generally I would say that to go below 0.5 Gy/min
is very difficult; not only because of the increase in the irradiation time, but also
owing to the changes in the biological effects, because with all fractionation sched-
ules one assumes a dose rate of 1 to 2 Gy/min and that the irradiation time is less than
ten minutes.
C. PÉREZ: There are three issues here. H. Svensson referred to the biological
one, regarding which I would say that with lower dose rates one undoubtedly needs
to increase the dose in order to have an equal biological equivalent dose.
The second issue is the accuracy of the positioning of patients and the field of
treatment during radiation therapy. We know, from having carried out a lot of studies
using online imaging verification with linear accelerators with exposures of one to
two minutes, that patients do move, and in fact a lot of the effort in the new three
dimensional conformal radiotherapy techniques may be ineffective, because of the
closer margins we use around the target volumes in repositioning and immobilization.
That introduces another area of uncertainty in the treatment of patients.
The third issue relates to the machine itself, in the utilization of the equipment.
How many patients can one treat with this very low output?
I think that ideally one should replace the source every three years. One can
continue using it for another two years, making a total of five years, but after that it
is not practical or, from a biological standpoint, wise.
M. MURPHY: It looks like one of the fundamental problems will always be that
the photons we use in radiotherapy will always scatter. Whatever we do is external, to
try to confine radiation to a tumour, etc., but we do not know where any part of the
radiation will be scattered. In the USA, for example, at the Massachusetts General
Hospital, and in my country, we have a cyclotron with which we are trying to perform
proton therapy, and we know that protons do not scatter. Is there any particular rea-
son why that part of radiotherapy is not represented at this conference?
C. PÉREZ: Before I get to the protons, there is a more practical point that
applies to many more patients and people operating photon devices. It is important to
use the collimation as close as possible to patients in order to reduce scatter. For
example (and I think I read it in one of the papers), if you are using multileaf colli-
mation you should make sure that your primary collimator is as close as possible to
the configuration of your multileaf collimator, and, secondly, blocking with cer-
robend or even lead blocking near — of course more than 20 cm from the patient —
to reduce the possible scatter to the skin, will be beneficial.
Secondly, there is not much that we can do about internal scattering. We know
that it is 1 to 3% of the dose, that it is going to take place depending on the distance
from the area that is being irradiated and that there is little that can be done about it.
With regard to protons, I agree that there are some physical advantages. The
reason why they may not be discussed here is that so few institutions are using them,
330 FERREIRA et al.
and that someone may not have thought about including them. It is something to be
taken up with the scientific secretaries.
Perhaps by the time of the next gathering like this one there will be more pro-
ton units in the world and they will be included in the programme.
L. NORMANDEAU: I should like to make a comment regarding an issue raised
by the introduction of endovascular brachytherapy.
There are other consequences for patients during those procedures — we have
seen that the PTCA (percutaneous transluminal coronary angioplasty) procedures in
cardiology are very long and that the doses are close to deterministic effects and
sometimes go above deterministic effects. What about the increased time of those
procedures brought up by the brachytherapy procedures? After the angioplasty is car-
ried out, you extend the procedure to do the brachytherapy procedure. We may then
see more and more of those deterministic effects. Would you care to comment?
C. PÉREZ: Are you talking about the exposure due to the fluoroscopy, etc., ver-
sus the exposure due to the intracavitary brachytherapy?
L. NORMANDEAU: Because of the prolonged procedure, we shall see more
effects due to the fluoroscopy.
C. PÉREZ: More effects due to the fluoroscopy than due to the brachytherapy?
L. NORMANDEAU: Yes. Obviously, the brachytherapy dose will be only to
the artery, but the fluoroscopy time will be increased.
C. PÉREZ: I agree, and probably the overall exposure will be greater with irid-
ium (gamma) sources than with yttrium (beta) sources. Iridium sources will give
more dose to patients than beta sources.
D.T. SKOURAS: Regarding the implantation of permanent iodine sources for
the treatment of prostate cancer, I should like to hear your opinion regarding the
advantages of this classic brachytherapy technique versus the HDR technique for the
same cancer, especially from the radiation protection and dosimetry points of view.
C. PÉREZ: From the clinical output standpoint, on the basis of the data that I
know (from A. Martínez in Detroit, who made a lot of HDR and LDR studies), I do
not think that there is a significant difference in the outcome. The results are practi-
cally the same whether you use HDR or LDR brachytherapy.
With regard to radiation exposure, obviously there is no radiation exposure
beyond the treatment time to the patient with the high dose rate, as opposed to the low
dose rate doses that are emitted by the permanent implants.
However, one of my associates, using dosimeters, recently carried out a study
on patients, and the dose found was extremely low.
The only advice we can give to patients is not to allow any children near them
and to be careful during the first six weeks with their partners.
IN BIOMEDICAL RESEARCH
(Topical Session 9)
Chairperson
H. AMARAL
Chile
RADIATION PROTECTION OF PATIENTS IN
BIOMEDICAL RESEARCH
J. LINIECKI
Medical Academy of Łódź
Łódź, Poland
E-mail: liniecki@psk2.am.lodz.pl
Abstract
Biomedical research on humans is a necessary step in the development of medicine and
biology. As a result of such studies there is a risk that deleterious effects to the participants may
occur. Various international and national bodies have therefore recommended a set of principal
requirements that should eliminate, or lower as far as possible, the risk to the human
participants of such studies. The specificity of biomedical research involving the exposure of
humans to ionizing radiation results from a postulate that even very low doses of ionizing
radiation may have a possibility, although a very low one, of undesired side effects of a serious
nature, owing to a lack of threshold doses. Therefore, the optimal radiological protection of
subjects participating in biomedical research is a necesary prerequisite. Further basic principles
involve volunteer participation based on well informed consent, the justification of exposure by
a personal and/or societal benefit resulting from the studies and an impartial evaluation of each
project involving human participation by an independent review body prior to the start of
investigations. Special attention in the paper is devoted to the procedures of justification and
optimization of the radiological protection of patients and volunteers.
1. INTRODUCTION
Biomedical research on humans forms a necessary step in a complex process

that aims at understanding biological phenomena as well as establishing new meth-
ods of diagnosis and treatments for diseases, or for their prevention. Human physiol-
ogy, biochemistry, pharmacology and toxicology have pecularities that cannot be ade-
quately studied in other species. Studies on humans have advantages over animal
experiments in that for their interpretation they do not need extrapolations from other
species to the principal object of interest (i.e. humans). Finally, without controlled
research on humans the efficacy of any diagnostic or therapeutic method cannot be
assessed. Thus such studies must be taken as a source of great potential benefit to
society and a necessary and indispensable step in clinical, and frequently also non-
clinical, research.
As a result of such studies, however, some risk of deleterious effects to partic-
ipants may arise. Its nature and magnitude may vary from trivial and negligible to
moderate, although in some cases it can approach being serious. The relationships
333
334 LINIECKI
between the various risks and the intensity or dosage of the studied factors can be
vastly different. Most drugs or physical factors produce biological responses only
after exceeding some threshold value of dosage. Studies below the threshold, for
example of the metabolism of a new drug or the diagnostic use of ultrasound or mag-
netic resonance imaging, carry essentially no risk. However, the current understand-
ing of the biological action of ionizing radiation regarding the induction of most can-
cers and hereditary mutations does not follow the same line. The International
Commission on Radiological Protection (ICRP) and other national and international
expert bodies accept a working hypothesis that the risk of these deleterious effects
should be broadly proportional to the dose [1, 2], with no threshold below which the
probability of their occurrence would equal zero.
This statement means that even at low and very low doses of ionizing radiation
one has to take into consideration that there is some risk, however small, to the indi-
viduals exposed. As the practice of contemporary, advanced medicine without the use
of ionizing radiation in diagnostics and therapy is unthinkable, the conditions for the
acceptance of exposure are that the actual or potential health benefits should outweigh
the expected harm, whatever its magnitude to individuals or society at large. The
same principle must also apply to humans exposed to radiation in the course of bio-
medical research, irrespective of whether they do, or do not, benefit directly from the
exposure.
The scale (i.e. frequency and dosage) of the exposure to ionizing radiation of
humans subjected to biomedical research is not well known. The data given by the
United Nations Scientific Committee on the Effects of Atomic Radiation in its 1993
and 2000 reports [2, 3] are at best fragmentary. From scanning several scientific jour-
nals where research in humans using ionizing radiation is regularly published, one
can only guess that on a global scale the number of people exposed annually in such
studies could reach many thousands.
The expected harm may be understood as a product of two components: the
severity of the effect (in this case cancer) and its expected probability (i.e. the risk
proportional to the dose). For the case of cancer the severity may be assessed as very
high; the probability may lie between very low or even trivial (10–6), through to minor
(10–5), to moderate (>10–3) and sometimes serious (~102) when all the types of pos-
sible harm are added.
This creates, sometimes large, ethical problems, particularly when the benefi-
ciaries are not those who are exposed (i.e. healthy volunteers). In the situation of
exposing healthy volunteers only a minor or intermediate probability of the under-
sired effect could be considered as acceptable (i.e. <10–4) (see below). Such con-
straints should be legally established by individual countries and/or by international
recommendations.
The ethical principles of research on humans were first established by the
Eighteenth World Medical Assembly in Helsinki in 1964 [4] and have been updated
BIOMEDICAL RESEARCH 335
five times; the last ammendment took place in 2000. The first principles and recom-
mendations concerning biomedical experiments on humans with ionizing radiation
were formulated by the World Health Organization in 1977 [5]. The most exhaustive
recommendations devoted to this specific subject were issued by the ICRP in 1991
[6]. They were transferring to a legal framework by experts of the European
Commission in 1998 [1]. The same principles were incorporated into an IAEA docu-
ment [7].
2. BASIC PRINCIPLES
According to the ICRP [6], the basic principles to be observed while planning
and performing research in the course of which humans will be exposed to ionizing
radiation should be that:
— Only well informed volunteers, with their full consent, may take part as sub-
jects of such a study.
— The exposure of volunteers should be justified by their personal and/or by the
societal benefit (i.e. in terms of the scientific gains that aim at the improvement
or protection of health).
— The radiological protection of exposed participants should be optimized.
— The research project, prior to its realization, should be evaluated for its scien-
tific value and conformity with the above principles by an independent, impar-
tial and competent body. In some countries such bodies exist as ethics commit-
tees; in others the same role is played by other designated authorities.
These four principles are examined and specified in a more detailed manner
below.
2.1. Subjects participating in a study
All individuals participating in a project as subjects of biomedical research

should be informed about the aim and methods of the proposed study, including its
nature and the magnitude of the risk involved.
This information must be provided before the start of the study and given using
language and terminology comprehensible to the prospective participants, taking
account of their education. It is not an easy and simple task, particularly when the
common understanding of probabilistic thinking is poor. If necessary, the information
should be formulated in a way understandable to an average layperson, preferably in
a written form. The prospective participants should be given time to consider the mat-
ter, to ask questions and to arrive at a balanced decision.
336 LINIECKI
They should also be informed that they may withdraw from participation at any
stage of the study, and that the results to be obtained are subject to medical discretion.
In other words, they must become convinced that their rights and well being have pri-
ority over the scientific interest of the investigators. Their consent should be
expressed in writing, with a signature. In exceptional situations where there might be
specific reasons for not obtaining the informed consent from a patient, these situa-
tions should be clearly expressed and substantiated when presenting the research plan
to the ethics committee [2].
In situations where the expression of free will is hampered by objective condi-
tions (i.e. age, mental development, lack of conciousness or the rights of others),
those empowered legally for their care may act as substitutes. In most countries in
such situations it is recommended to take the advice of a legal counsellor.
2.2. Design and justification of a study
Justification of a study depends on two conditions: first, its scientific value, and,
second, the ability to demonstrate that the potential benefit, that is the likely scientific
gains to society or/and the diagnostic or therapeutic advantages to the patients under
the study, offset by far the estimated possible harm.
It should be mentioned that there may be different circumstances concerning
the potential benefit. In a clinical study, when the diagnostic applications of ionizing
radiation do not exceed the normal, clinically established routine, justification is only
required of the rationale (aim) of the investigation itself. In a retrospective analysis of
acquired clinical data, based on normally required X rays or nuclear medicine diag-
nostics, the condition of a special justification and of informed consent would not
apply. If the X ray or nuclear medicine procedures planned for a study exceed the
level of those normally used in given clinical conditions, special justification and
informed consent are necessary.
In the case of healthy volunteers who will not gain advantage from a study in
terms of the health benefits, justification has to be based entirely on the expected
potentially positive balance between the scientific gain (to society, future patients,
etc.) of newly established scientific facts and the estimated risk to the participants
themselves.
As the effective doses from various procedures differ by orders of magnitude,
the value of the expected benefits from the study should also vary. The ICRP pro-
posed the scheme for arriving at a sound judgement about the possible justification of
a research project shown in Table I.
From Table I it is apparent that risk has been specified in a semiquantitative way
(i.e. in orders of value). However, as should be expected, the terms in the column
specifying the required benefits are purely qualitative, although a rather lose termi-
nology has been used. The European Commission [1] went further, attributing fea-
TABLE I. CATEGORIES OF RISK AND CORRESPONDING LEVELS OF

POTENTIAL BENEFIT [6]
Risk category Corresponding effective

Level of potential
Level of risk (total risk — see text in dose range (adults)
societal benefit
Ref. [6]) (mSv)a
Trivial Category I <0.1 Minor
(~10–6 or less)
Minor to Category II 0.1–1 Intermediate to
intermediate IIa (~10–5) moderate
IIb (~10–4) 1–10
Moderate Category III >10b Substantial
(~10–3 or more)
a The values for effective dose can be increased by a factor five for those over 50 years, and
should be reduced for children by a factor of two.
b To be kept below the deterministic threshold except for therapeutic experiments.
tures, somewhat better described, to the categories of the expected benefit, therefore
making the judgement easier (Table II).
To put the subject of risk into proper perspective, its presentation in terms of
excess relative risk (ERR) could also be considered. For instance, taking into account
that one in four individuals will die from cancer, an intermediate risk of 10–4 means
an ERR of 0.0004 (0.4%), which is small. This means also that the probability that
the harm will not materialize is 99.99%. However, from a subjective standpoint of
risk perception there will be individuals for whom it will appear significant; this is
their ethical right.
It is easy to see that effective doses above 10 mSv is an open ended category.
Here a particular attention to detail, substantive justification and general prudence
TABLE II. CATEGORIZATION OF THE BENEFIT, AS SPECIFIED BY THE

EUROPEAN COMMISSION
Level of lifetime risk [6] Dose (mSv) Type of benefit expected [1]
Trivial (<106) <0.1 Increase in knowledge only
Minor (~10–5) 0.1–1.0 Increase in knowledge leading to potential
health benefits
Intermediate (~10–4) 1–10 Aimed directly at the diagnosis,
cure or prevention of a disease
Moderate (>10–3) >10 Substantial, directly related to the saving of life
or the prevention or mitigation of serious disease
338 LINIECKI
appear indispensable. For instance, in some procedures of interventional radiology

effective doses may be substantially higher than 10 mSv, but the potential therapeuti-
cal gain in a serious disease, including the avoidance of surgery (a substantial risk in
itself), usually provides full justification. The main issue of radiation management is
that of avoiding the deterministic (cell killing) effects of local irradiation, particularly
radiation induced skin burns.
A special category of justification should be asigned to experimental procedures
in radiotherapy. Each new method of radiotherapy must eventually be tested on well
qualified patients and its efficacy established before considering recommendations for
its wider use. However, even a partial failure of the new procedure may lower the
chances for the participating patients of an effective cure of a life threatning disease or
increase the probability of complications, sometimes quite serious. Therefore, the a
priori justification should be sound and convincing. The theoretical argument in favour
of the new method must be strong and transparent, and the chances of infavourable
results very low indeed. A particular role in this situation must be given, if possible, to
preproject experimental studies, to the theoretical basis of the concept and peer
reviews, and to the assessment by several impartial expert bodies, perhaps even with
international co-operation. Monitoring of patients in the course of the study, and after-
wards for a sufficient lenght of time, must be careful and objective.
2.3. Optimization of protection
Quality assurance is of a paramount importance for medical practice in general;

this is also so for radiological disciplines, and must be a characteristic of the methods
used in research. This is a basic requirement, supported by the literature, and falls out-
side the scope of this paper. One should say only that faulty and imprecise methods
can lead only to conclusions of a similar character, and under such conditions very
limited scientific benefits of the research should be expected.
A related but separate subject is that of the optimization of participants’ pro-
tection against undue or excessive exposure to ionizing radiation. While the condi-
tions for optimization are common to all the specialties considered here, there are
characteristics specific for X ray diagnostics, nuclear medicine and radiotherapy.
In X ray diagnostics an acceptable outcome of a given examination (i.e. an
image) can be obtained at the expense of widely varying values of entrance and effec-
tive doses to patients. Experience has shown, in all countries where this phenomenon
had been studied, that doses for all types of planar X ray examinations vary among
individual X ray machines (units) by a large factor, reaching two orders of magnitude.
It is obvious and commonly accepted that the highest doses cannot be reasonably jus-
tified. To identifity such cases and to correct such situations medical reference levels
(MRLs) or diagnostic reference levels (DRLs) have been recommended [8, 9], situ-
ated usually at the 70th to 80th percentile of frequency distribution, characterizing
specific examinations in a given country or area. In the United Kingdom, for exam-
ple, where this strategy has been consistently followed, it has resulted in a significant
reduction of average doses and in a reduction of the frequency of excessive exposures
[10]. In addition, a set of optimized procedures for most common X ray examinations
has been recommended by the European Commission [11], which, when observed,
should substantially reduce the probability of excessive irradiation (i.e. above the
DRL). A similar methodology has been also developed for computed tomography
(CT) procedures [12].
Such an approach should also be considered as obligatory when undertaking
research projects on humans that include X ray diagnostics. In case of any doubt as to
the full effectiveness of keeping to the recommended procedural standards, measure-
ments of surface entrance doses in planar studies or respective indices in CT applica-
tions should be made to prove that the DRLs are not exceeded in a given installation,
expected for research purposes. When utilizing surface entance doses or dose–area
products in planar X ray exposures, the effective doses can be estimated from the data
in the literature [13]. A similar possibility exists for typical CT examinations on the
basis of CT dose index measurements and the length and position of the scan [14].
However, utilizing the so called typical doses quoted in text books or monographs for
any X ray procedure in the design of a research project can be grossly misleading. It
should be mentioned that the situation of patients’ protection in CT examinations,
where doses are substantially higher than in planar studies of similar parts of the body,
will be considered in detail in a forthcoming ICRP recommendation [15].
In fluoroscopic procedures the parameter to be checked before undertaking a
study is the dose rate in a beam; it is necessary that it conforms to the actual DRL
requirements. In addition, where high doses to patients may be expected to occur occa-
sionally, as for instance in interventional procedures, the equipment should be appro-
priate (i.e. fit for the purpose), the methodology correct and the training as well as the
experience of the staff excellent. In addition, fluoroscopic equipment should be pro-
vided with dose rate, accumulated dose and irradiation time measuring devices, with a
visual display easily accessible to the physician performing the intervention. A new
ICRP report on this very important subject of patients’ protection will appear soon
[16].
In nuclear medicine the effective dose to patients is largely determined by the
nature of the radiopharmaceutical or labelled substance used, and by the administered
activity. The actual information for a standard man, expressed in mSv/MBq for five
categories of age, is available in a recent ICRP publication [17]. Proper corrections
for age and mass of the body of a given patient can be applied [18]. For radioactive
substances (and/or potential radiopharmaceuticals) whose metabolism and organ
doses are as yet unknown in detail, the effective dose should be estimated either from
experiments on animals (with an approximate extrapolation to humans) or assessed in
another way by a qualified expert in the dosimetry of internal irradiation. For all sub-
340 LINIECKI
stances labelled with 99Tcm, the effective dose for a standard man will not exceed a
value of 3 × 10–2 mSv/MBq and for new, not yet investigated 99Tcm compounds this
estimate is conservative, that is it will not underestimate the real value. The activity
in each experiment should be kept as low as it appears compatible with securing a
good, statistically stable result (i.e. an image or numerical result).
In radiotherapy the principle of optimized patients’ protection depends on the
accurate administration of the prescibed absorbed dose to the target (usually a
tumour) while keeping doses to healthy tissues and organs at the lowest attainable
level. This can be secured by the proper individual planning of doses to patients and
an equally rigorous performance of irradiation. The details of this, however, go
beyond the scope of this paper. A forthcoming ICRP report deals with these ques-
tions and with the principal causes of recorded and analysed failures and accidents
[19].
Finally, the number of subjects taking part in a study using ionizing radiation
should be kept as low as compatible with obtaining statistically significant results. The
progress of the results should be monitored to avoid the exposure of unnecessary large
number of individuals when statistically stable results have been already achieved.
2.4. External judgement and oversight
To secure an impartial assessment of the value and compatibility with the rec-
ommended rules of research on humans of a study, the details of it should be pre-
sented before it starts to an external ethics committee or another authoritative body as
required by the national law. The respective administrative and organizational solu-
tions will vary among individual countries. The essential features of such review bod-
ies should include:
— At least a significant part of its membership should be independent of the insti-

tution at which the committee is appointed;
— It should have expertise and competence in matters of science, medicine, ethics
and law;
— It should have access to external experts in many fields of science and disci-
plines of medicine, which in the case discussed here should include medical
physics (dosimetry), radiobiology and radiological protection;
— It should have the authority to accept or reject a study project (of course, for
sound reasons).
The possibility of appeal to a higher level institution should preferably be avail-

able.
In many countries the requirement of a sufficiently high competence in radio-
logical protection matters is not always easy to satisfy, particularly locally (e.g. in the
case of a committee serving just one institution). External expertise (from elsewhere
in the country or abroad) should therefore then be sought.
The ethics committee should be able to obtain the final report of any study for
which it has given approval. Any paper submitted for publication should include a
statement that the project had been approved by such a body. Research made in a pro-
ject not evaluated by an authorized body should not be accepted for publication in any
scientific journal.
The results of biomedical studies on humans should be published in the open
literature, even if their results are negative from the standpoint of the initial working
hypothesis. This should prevent others from duplicating the effort and exposing, most
likely unnecessarily, other human subjects.
However reasonable they may seem, the safequards discussed against undue or
ill-conceived research on humans are not always very easy to implement in practice.
They also sometimes increase the cost of research. The proposed and internationally
accepted system described in this paper is, however, not designed to make research
more difficult and expensive, but to protect people from involuntary, undue, incom-
petent and excessive exposures to radiation. If the conditions and procedures outlined
above are observed, the probability of misjudgement, mistreatment and even overt
damage to health should be radically reduced.
REFERENCES
[1] EUROPEAN COMMISSION, Guidance on Medical Exposures in Medical and

Biomedical Research, Radiation Protection 99, EC, Luxembourg (1998).
[2] UNITED NATIONS, “Medical radiation exposures”, Vol. I, Annex D, Sources and
Effects of Ionizing Radiation, and Annex G, Biological Effects at Low Radiation Doses
(Report to the General Assembly), Scientific Committee on the Effects of Atomic
Radiation (UNSCEAR), UN, New York (2000).
[3] UNITED NATIONS, “Medical radiation exposures”, Annex C, Sources and Effects of
Ionizing Radiation (Report to the General Assembly), Scientific Committee on the
Effects of Atomic Radiation (UNSCEAR), UN, New York (1993).
[4] WORLD MEDICAL ASSOCIATION, Declaration of Helsinki: Recommendations
Guiding Medical Doctors in Biomedical Research Involving Human Subjects,
Eighteenth World Medical Assembly, Helsinki (1964).
[5] WORLD HEALTH ORGANIZATION, Use of Ionizing Radiation and Radionuclides on
Human Beings for Medical Research, Training and Nonmedical Purposes, Report of a
WHO Expert Committee (Meeting Geneva, 1977), Technical Report Series 611, WHO,
Geneva (1977).
Radiological Protection in Biomedical Research, Publication 62, Pergamon Press,
342 LINIECKI

HEALTH ORGANIZATION, WORLD HEALTH ORGANIZATION, Radiation
Protection and the Safety of Radiation Sources, Safety Series No. 120, IAEA, Vienna
(1996).
[9] EUROPEAN COMMISSION, Guidance on Diagnostic Reference Levels (DRLs) for
Medical Exposures, Radiation Protection 109, EC, Luxembourg (1999).
Patients from Medical X Ray Examinations in the UK: 1995 Review, NRPB-R289,
National Radiological Protection Board, Didcot (1996).
Radiographic Images, EUR 16260 EN, EC, Luxembourg (1996).
Tomography, EUR 16262 EN, EC, Luxembourg (1998).
[13] JONES, D.G., Calculation of Organ Doses due to Diagnostic X Rays, Memorandum
NRPB-M355, National Radiological Protection Board, Didcot (1992).
[14] SHRIMPTON, P.C., WALL B.F., “Assessment of patient dose from computed tomogra-
phy”, Dosimetry in Diagnostic Radiology, Proc. Seminar Luxembourg, 1991, Rad. Prot.
Dosim. 43 (1992) 205–208.
[15] INTERNATIONAL COMMISSION ON RADIOLGOGICAL PROTECTION,
Managing Patient Dose in Computed Tomography, Pergamon Press, Oxford and New
York (in press).
of Radiation Injuries from Interventional Procedures, Pergamon Press, Oxford and New
York (in press).
[17] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Radiation
Dose to Patients from Radiopharmaceuticals, Addendum 2 to ICRP 53, Publication 80,
Pergamon Press, Oxford and New York (1998).
[18] ADMINISTRATION OF RADIOACTIVE SUBSTANCES ADVISORY COMMIT-
TEE, Notes for Guidance on the Clinical Administration of Radiopharmaceuticals and
Use of Sealed Radioactive Sources, ARSAC, Didcot (1998).
[19] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Prevention
of Accidents to Patients Undergoing Radiation Therapy, Pergamon Press, Oxford and
New York (in press).
DISCUSSION
H. OSTENSEN: An issue to which, in my view, some thought should be given

is the remuneration of volunteers participating in biomedical experiments.
J. LINIECKI: You are right. However, this is a grey area with no clear distinc-
tion between, on one hand, fair compensation for the effort made and the time lost
(and sometimes even for the hardships endured) by the volunteer and, on the other,
what is in effect a bribe designed to induce a person to submit to something to which
he or she would not submit without financial inducement.
H. OSTENSEN: Perhaps an attempt should be made to formulate guidelines.
J. LINIECKI: I agree with you.
R.H. CORBETT: In my opinion, volunteers should not receive any payment
apart from that necessary in order to cover their out of pocket expenses.
F.A. METTLER: I should like to mention the issue of 10 mSv being regarded
as an upper limit. In a great deal of research, especially research where positron emis-
sion tomography scanning is involved, the 10 mSv value is exceeded, and there have
been bitter complaints as a result. Researchers are required to show that doses in
excess of 10 mSv will really save lives, which is a difficult requirement to meet.
J. LINIECKI: I do not think that 10 mSv should be regarded as a strict upper
limit. With volunteers above 50 years of age one can safely employ doses five times
as high, and patients receiving such doses stand to benefit from the examinations in
which the doses are employed.
F.A. METTLER: Another issue that I should like to mention is that of
anonymity; when a volunteer (or patient) insists on remaining anonymous, it is some-
times difficult to determine whether the researcher did the right thing. We try to
resolve the anonymity issue by requesting the volunteer (or patient) to agree, when
giving his or her informed consent, that the research be monitored. A problem in that
connection, however, is the fact that researchers leaving the institution where the
research was carried out often take the informed consent forms with them.
J. LINIECKI: Dealing with the anonymity issue and ensuring that informed
consent forms remain at the institution where the research was carried out are matters
that relate to the administrative backing of ethics committees.
M.K. JANIAK: In your presentation you referred to four basic principles.
Should you not also have mentioned the as low as reasonably achievable (ALARA)
principle?
J. LINIECKI: The third principle to which I referred was that the radiologi-
cal protection of the exposed participants should be optimized. In my view, that is
equivalent to the ALARA principle.
E. VAÑO CARRUANA: In the opinion of some Spanish radiologists the radia-
tion protection of patients participating in research would be greatly improved if the
radiology departments where the research was to be carried out were warned that
344 LINIECKI
those patients were participating in a research project. In Spain, at least, radiology

departments are often not warned.
J. LINIECKI: In my view, the real issue is simply keeping as far as possible
below the medical reference levels, probably by using state of the art techniques.
L.K. HARDING: I should like to hear your views regarding the use of radio-
pharmaceuticals in biomedical research on children.
Most radiopharmaceuticals are not licensed for administration to children, the
reason being that ethics committees will not permit the testing of radiopharmaceuti-
cals on children. This is a major problem.
J. LINIECKI: I do not consider it to be a major problem. If a radiopharmaceu-
tical has been licensed for use generally and has been found to be good, why should
it not be used with children?
The issue is the amount of activity to be employed in the case of a child. The
‘activity per kilogram of mass’ formula does not work with children as the count den-
sity is too low. If you use one of the formulas for correcting for age, however, you
obtain, with most radiopharmaceuticals, effective doses per investigation that are
higher by only a factor of two. The question is then one of justification. If you have
a child with vesical reflux, you should probably use radiopharmaceuticals, as the dose
to the child will be much lower than if you use X rays.
L.K. HARDING: My understanding is that, if there are no data for, for exam-
ple, persons less than 16 years of age, the radiopharmaceutical cannot be approved for
use with such persons.
J. LINIECKI: I have been using various well known radiopharmaceuticals with
children and have not found their metabolic behaviour in children to differ signifi-
cantly from their metabolic behaviour in adults. It is simply a question of reducing the
activity in the case of children.
A. TAYMAZ: One problem with ethics committees is that they take 6 to
12 months to approve research project proposals, by which time there is often no
point in conducting the research in question. What can one do about that?
J. LINIECKI: We have not experienced such delays. This is probably an orga-
nizational issue.
M.M. REHANI: At teaching institutions in some countries, because additional
funding is not involved, many research activities (for example work on a postgradu-
ate thesis) are carried out on an informal basis, without approval by an ethics com-
mittee. What are your views regarding the ethics of such situations.
J. LINIECKI: In my opinion, no biomedical research on humans should be
allowed unless approval has been given by an ethics committee. Institutions that per-
mit such research to proceed without the approval of an ethics committee are simply
acting incorrectly.
INFLUENCE OF STANDARDIZATION
IN THE DESIGN AND DEVELOPMENT
OF MEDICAL RADIOLOGICAL EQUIPMENT
Chairperson
C. LAVOIE
Canada
INFLUENCE OF STANDARDIZATION IN THE
DESIGN AND DEVELOPMENT OF
MEDICAL RADIOLOGICAL EQUIPMENT FOR THE
S.C. LILLICRAP, P. PARAS, H. DUSCHKA
International Electrotechnical Commission,
Erlangen, Germany
E-mail: hartmut.duschka@med.siemens.de
Abstract
The protection of patients against ionizing radiation as laid out in the standards of the
International Electrotechnical Commission (IEC) is addressed; all types of X and gamma ray
equipment are considered. The international standards of the IEC are supported worldwide, and
they are used by regulatory and legislative bodies. The objectives of the IEC are
— To encourage the national adoption of international standards,
— To make the standards applicable and available for voluntary adoption worldwide,
— To set the framework for conformity assessments worldwide.
The key safety elements for the radiological protection of patients are addressed for the
three major fields of radiology: diagnostic X rays, radiation therapy and nuclear medicine.
How to interpret and work with the hierarchical structure of international standards is
explained by taking the safety standard for interventional X ray equipment as an example.
Emphasis is given to facts that:
— It is physicians who decide upon the application of ionizing radiation,
— Compliance of equipment with the IEC standards assures the efficient use of ionizing
radiation, following the principle of as low as reasonably achievable.
1. THE HIERARCHICAL STRUCTURE OF THE INTERNATIONAL

ELECTROTECHNICAL COMMISSION STANDARDS
The International Electrotechnical Commission (IEC) standards developed by

Technical Committee TC62 are structured in several layers. The basic layer is the
General Standard IEC 60601-1. It comprehensively addresses the general areas of
risk that are inherent in all electrical equipment, such as:
— Electric shocks,
— Current leakage,
— Mechanical hazards.
347
348 LILLICRAP et al.
The second layer is the collateral standards. These deal with the risks that are speci-
fic for certain groups of medical equipment, such as:
— Ionizing radiation,
— Electromagnetic fields,
— The coupling of complex systems,
— Human factors (this standard is under preparation).
For the harmonization of the safety requirements concerning ionizing radia-

tion, the collateral standard for radiation safety was developed in this second layer. It
is applicable for all diagnostic X ray equipment using ionizing radiation. All the
requirements given in this standard address the radiological protection of patients.
The third layer defines the safety requirements for specific equipment. As an
example, the requirements for interventional X ray equipment are for:
— The inherent safety of the equipment;

— The safety of patients, especially those elements that enable users to follow the
principle of as low as reasonably achievable (ALARA);
— The safety of users.
For the case of interventional X ray equipment the specific requirements refer to:
— The filtration of X ray beams,

— Collimation,
— Dosimetric indications,
— Zones of occupancy.
To verify these safety elements throughout the life of radiological equipment,

two additional standards have been generated in addition to the safety standard:
— A performance testing standard (or acceptance testing),

— A constancy testing standard.
These performance and constancy testing standards contain the tests and measure-
ments that should be performed when servicing equipment.
It should be kept in mind that when using a specific equipment standard one
should also look at the related collateral and general standards.
MEDICAL RADIOLOGICAL EQUIPMENT 349
2. RADIATION SAFETY AS BASIC SAFETY IN THE COLLATERAL

STANDARD
For diagnostic X ray equipment the general requirements regarding the radio-
logical protection of patients are addressed in Collateral Standard IEC 60601-1-3.
Only selected references are made to the collateral standard for the other two fields,
those for radiation therapy and nuclear medicine.
The collateral standard is relevant for all radiological equipment, and all chap-
ters are related directly to the radiological protection of patients. The contents are
summarized as follows:
— Radiation quality related to radiological applications: X ray tube voltages, half

value layers and filtration.
— Limitations and indications of the extent of X ray beams: confinement of extra-
focal radiation, methods of beam limitation, equipment and light field indica-
tors, and the accuracy of the indicators.
— The relationship between X ray fields and image reception areas: deviation of
the X ray fields related to the image reception areas.
— Radiation leakage.
— Focal spot to skin distance: the minimal permissible values for various radiolo-
gical applications.
— Attenuation of X ray beams: the maximum permissible values for the type and
design of the equipment in use.
— Primary protective shielding for the radiological application in question.
— Protection against stray radiation from the radiological application in question.
These are the essential requirements that directly affect the radiological
The particular standards pertaining to the different radiological disciplines are
presented in the following sections.
3. RADIATION SAFETY IN THE SAFETY STANDARDS
Table I gives an overview on how the standards are grouped according to the
three major radiological fields of diagnostic X rays, nuclear medicine and radiation
therapy.
In the IEC it is the task of a technical committee to maintain the state of the art
in applied technology.
TABLE I. RADIOLOGICAL DISCIPLINES AND RELATED IEC STANDARDS
IEC standards
Radiological discipline
Safety Performance Constancy
Diagnostic X rays
General X rays, including dental 60601-2-7 61223-3-1, -4 61223-2-7, -9, 11
Mammography 60601-2-45 61223-3-2 61223-2-10
Interventional radiology 60601-2-43 61223-3-3 61223-2-9
Computed tomography 60601-2-44 Work in progress 61223-2-6
Components Sixteen IEC standards
Protective means Three IEC standards
Nuclear medicine
Radionuclide calibrators 61303
Radiation counting systems 61948-1 TR
Anger type gamma camera imaging 60789, 61948-2 TR
Gamma camera whole body imaging 61675-3, 61948, 61948-2 TR
Single photon emission tomography 61675-2, 61948-2 TR
Positron emission tomography 61675-1
Radiotherapy
Therapy with electron accelerators 60601-2-1 60976, 60977
Therapeutic X rays 60601-2-8
Gamma beam therapy 60601-2-11, -17
Radiotherapy simulators 60601-2-29 61168, 61170
Treatment planning 62083
3.1. Diagnostic X rays
3.1.1. General X rays, including dental X rays (IEC 60601-2-7:

safety of X ray generators)
General X ray equipment is probably the source of the highest collective expo-
sure to patients. Owing to its widespread availability and the large field of applica-
tions, the majority of the population is affected by it. The dose applied to each indi-
vidual during a general diagnostic procedure is relatively low compared with, for
example, interventional procedures and computed tomography (CT) applications.
The equipment used for general diagnostic radiology comprises a wide variety,
from simple mobile X ray generators to the sophisticated X ray equipment used for
radiography and fluoroscopy.
Additionally for this kind of equipment, it is necessary to use the safety stan-
dard for X ray generators, which contains as key elements the two topics important
for the radiological protection of patients:
— The accuracy of operating data,

— Protection against hazardous outputs.
3.1.2. Mammography (IEC 60601-2-45: safety of mammographic X ray equipment)
The main issues addressed for the radiological protection of patients in

mammography are:
— X radiation generated by mammographic X ray equipment: radiation outputs,

total filtration in tube head assemblies, including collimators, primary protec-
tive shielding and protection against stray radiation.
— Accuracy of operating data: indication of electrical and radiation output, repro-
ducibility, linearity and constancy, accuracy of loading factors and conditions
for measuring air kerma.
Compared with general X ray equipment, in mammography the tolerances for

generating and filtering X rays are much smaller. The same small tolerances need to
be maintained for automatic exposure systems to meet the high sensitivity of
mammographic X ray films and to assure the readability of the radiograms produced.
3.1.3. Interventional radiology (IEC 60601-2-43: safety of interventional X ray

equipment)
Interventional radiology is a fast growing field. Especially in therapeutic inter-

ventional procedures, there is significant exposure to patients and medical staff.
Therefore a particular standard was developed covering the requirements for X ray
equipment dedicated to interventional procedures. The safety elements essential for
the radiological protection of patients and, in this discipline, the radiological protec-
tion of staff can be summarized as follows:
— X radiation: half value layers of X ray equipment and filtration in X ray tube
assemblies. The elements addressed here for interventional procedures are valid
in the same way as for general X ray equipment, especially when used for
paediatric examinations.
As for the X ray field size and image reception, the tolerances defined are
smaller because small fields are often used, especially in cardiovascular examina-
tions.
Isokerma maps in user manuals are addressed to the operators of the equipment.
One should be aware that in interventional radiology operators are more exposed to
radiation than in any other field where ionizing radiation is applied.
The standard also requires control and monitoring features and specific infor-
mation to operators on the doses applied to patients.
3.1.4. CT (IEC 66601-2-44: safety of CT equipment)
The application of CT equipment is spreading fast owing to its advantageous

imaging capabilities and improvements in the speed of examinations. Today’s capa-
bility of presenting near real time imaging allows the application of CT equipment for
interventional procedures. How extensively CT is used today can be estimated from
the fact that about 40% of all X radiation given for diagnostic purposes is generated
by CT equipment. The consequence is the special attention that needs to be given to
the following points for the radiological protection of patients:
— X radiation: dose statements and test equipment, dose information, focal spot
to skin distance control and indication of operating states, radiation quality,
limitation and indication of the extent of X ray beams and protection against
stray radiation.
— Accuracy of operating data: accuracy of recorded examination data.
There are many solutions for dose reduction that can be implemented in CT
systems, for example the modulation of X ray beams during rotation or the use of
multiline detectors — these features, however, cannot be made a requirement in inter-
national standards as they depend upon the type of CT system used. A user of CT
equipment can, however, compare the data produced when compliance with IEC stan-
dards is stated, as the data is derived from standardized measuring conditions and is
hence comparable.
3.1.5. Subsystems intercepting or influencing X ray beams (thirteen standards)
A group of standards addresses the subsystems or components that intercept X

ray beams. These components play an important role in the radiological protection of
patients as they are mandatory for the efficient application of X radiation. These
standards are referred to in all the safety standards for diagnostic X ray equipment,
including for:
— X ray sources: primary filtration, inherent safety, focal spots and extrafocal
radiation.
— X ray grids: selectivity and transparency.
— Image intensifiers: detective quantum efficiency, contrast and conversion
factors.
— X ray cassettes, screens and films.
During recent years the concepts in standardization have moved towards system
oriented standards. This approach leads to a more comprehensive view of X ray
equipment, thus keeping the safety of patients and users in focus. Nevertheless, the
standards for components will retain their importance, primarily for manufacturers.
The properties of the components lead to the minimization of the radiation required
for a safe diagnosis.
3.1.6. Protective means (IEC 61331 series: three standards)
In a series of three standards protective materials and protective items are

addressed, for:
— The determination of the attenuation properties of materials,

— Protective glass plates,
— Protective clothing and protective devices.
The standards give guidance for the attenuation, size and material to be used for
protective items to assure sufficient shielding of patients and medical staff.
3.2. Nuclear medicine (radionuclide imaging)
Diagnostic equipment in nuclear medicine does not expose patients directly

to any particular danger other than the regular electrical or mechanical hazards
that occur when the standards are not satisfied. In standardization the particular
issues are the performance standards for the different modalities used in nuclear
medicine.
There is, however, an indirect danger from the delivery to patients of the radio-
pharmaceuticals necessary for diagnostic procedures. Since an under- or overdose
may result in suboptimum images and misdiagnosis, the exact amount of radioacti-
vity must be measured (using radionuclide calibrators).
In addition, it is important to maintain the performance of equipment adequa-
tely as prescribed in the relevant quality control technical reports.
Standards have been published by the IEC for radionuclide calibrators and for
all imaging nuclear medicine equipment.
3.2.1. Radionuclide calibrators (IEC 61303: radionuclide calibrators)
Methods for describing performance have been laid down. Radiation safety
requirements are mainly given for:
— Protection against incorrect measurements of radionuclide activity,

— The safety of persons other than patients.
3.2.2. Radiation counting systems (IEC 61948-1)
The radiation safety requirements are the same as in Section 3.2.1.
3.2.3. Anger type gamma camera imaging (IEC 60789 and IEC 61948-2 TR:
characteristics and test conditions)
The radiation safety requirements are for:
— Protection against the incorrect delivery of radiopharmaceuticals to patients,

— Protection of patients,
— The safety of persons other than patients.
The safety requirements for anger type gamma cameras are also the require-
ments for all other diagnostic equipment used in nuclear medicine.
3.2.4. Gamma camera whole body imaging systems (IEC 61675-3 and
IEC 61948-2 TR: characteristics and test conditions)
The radiation safety requirements are the same as given in Section 3.2.1.
3.2.5. Single photon emission computed tomographs (IEC 61675-2 and IEC
61948-2 TR: characteristics and test conditions)
3.2.6. Positron emission tomographs (IEC 61675-1: characteristics and test

conditions)
3.3. Radiotherapy
The technical requirements in radiotherapy differ significantly from those

for diagnostic X rays. Radiological protection as defined in the collateral stan-
dard for diagnostic X ray equipment therefore only partly applies. Radio-
therapy treatment equipment (electron accelerators, gamma beams and X ray
units) may also expose patients to danger if the equipment fails to deliver the requi-
red dose or if the equipment does not satisfy the standards of electrical or
mechanical safety.
The standards for radiotherapy equipment address these issues with systems to
protect against incorrect doses being applied to patients, incorrect beam geometry
and excessive radiation leakage. In addition to these safety standards, it is important
to assure that the outcomes are as calculated. There are also functional performance
standards and guidelines setting down acceptable tolerances for the various treat-
ment parameters.
Both radiotherapy simulators and treatment planning systems are important for
ensuring the accurate delivery of doses for radiotherapy. Standards are available for
these two types of equipment.
3.3.1. Therapy with electron accelerators (IEC 60601-2-1: safety of electron

accelerators)
The safety requirements are for:
— Ionizing radiation: protection against incorrectly absorbed doses, stray radia-

tion, radiation in patients, and safety for patients and others.
— Accuracy of operating data: accuracy of recorded examination data, abnormal
operations and fault conditions.
3.3.2. Therapeutic X rays (IEC 60601-2-8: safety of therapeutic X rays,

10 kV to 1 MV)
Although from its technical layout and the technology used the equipment is
similar to diagnostic X ray equipment, the energy levels and the specific applications
make it necessary to have a specific standard, for:
— Ionizing radiation: X radiation generated by the operating X ray equipment,

normal working conditions and the display of data.
— Single fault conditions and the X radiation outputs.
3.3.3. Gamma beam therapy (IEC 60601-2-11 and -17: particular requirements
for safety)
The safety requirements are for:
— Radiation safety requirements: protection against incorrectly absorbed doses in

the treatment volume, stray irradiation in radiation beams and radiation outside
radiation beams.
— Safety for persons others than patients.
3.3.4. Radiotherapy simulators ( IEC 60601-2-29: safety of radiotherapy

simulators)
The safety requirements for radiotherapy simulators in the form of X ray equip-
ment for projection radiography follow the same requirements as given in Section
3.1.1 for general diagnostic X ray equipment and include requirements for protection
against excessive and unwanted outputs.
Radiotherapy simulators in the form of CT equipment are covered by the requi-
rements for CT equipment, as addressed in Section 3.1.4 (IEC 60601-2-44).
3.3.5. Treatment planning (IEC 62083: safety of radiotherapy treatment

planning)
Equipment for treatment planning does not come into contact with patients —
it can, for example, be a computer anywhere fed with data gathered on a radiotherapy
simulator.
The standard establishes the safety requirements for the algorithms used and the
minimum requirements that user manuals need to describe in order to allow the
correct choices to be made during the treatment planning process. The main topics
addressed can be summarized as:
— Radiotherapy treatment equipment and brachytherapy source modelling,

— Treatment planning for solved dose distribution calculations,
— Treatment plan reports.
For the safety of patients this standard also notes the inherent safety of data pro-
cessing and data transfer.
4. CONCLUSIONS
The international standards for medical radiological equipment address safety

in radiological protection and the properties of the equipment for their intended uses:
— By providing designs that are the state of the art that avoid the inappropriate
exposure of patients to radiation,
— By defining the properties of radiation beams that determine their quality and
the quantity required for safe diagnosis or treatment.
Users of medical equipment can be sure that they work with safe equipment
when compliance with the international standards is proven. Patients’ care, however,
is always in the hands of physicians, as:
— Physician decide upon the application of ionizing radiation,

— Equipment compliant with the IEC standards assures the efficient use of the
ionizing radiation applied to patients.
All knowledgeable and competent persons are invited to contribute to the con-
tinuous improvement of the IEC standards.
DISCUSSION
P. ORTIZ LÓPEZ: I know of many cases where imported equipment, although

accompanied by a certificate stating that it complied with IEC standards, was found,
upon being tested, not to comply with them in numerous respects. What can the
importing institution or country do in such cases?
H. DUSCHKA: It can reject the equipment, since such certificates that are
issued by the manufacturer represent a legal liability of the manufacturer.
E. VAÑO CARRUANA: As a user of radiology equipment, I feel that manu-
facturers should be doing more to help improve the radiological protection of
patients, especially with the advent of digital diagnosis equipment. What is your opi-
nion?
H. DUSCHKA: In my opinion, manufacturers and users should engage in an
intensive dialogue regarding the advantages and the still unresolved drawbacks of the
equipment now being developed.
In that connection, I would mention that, in the opinion of manufacturers, the
process of standards formulation by the IEC and the International Organization for
Standardization is too slow. Manufacturers are therefore setting up their own groups
for the purpose of standards formulation, and I believe that a great deal of progress in
that area will be made during the next few years.
G. DREXLER: If one needs a set of IEC standards, one has to buy it. Can IEC
standards not be made available free of charge?
H. DUSCHKA: The IEC finances itself by selling its standards. This is an unsa-
tisfactory procedure, since those who support the formulation of standards by making
experts available for that purpose then have to purchase the standards so formulated.
Manufacturers would be happier if the IEC were financed in some other way, in
accordance with an internationally agreed formula.
G. DREXLER: Most developing countries cannot afford the elaborate infras-
tructure necessary in order to carry out acceptance tests on radiology equipment that
is to be imported. What should they do?
H. DUSCHKA: The acceptance testing of equipment manufactured in accor-
dance with IEC standards, and labelled accordingly, is not such a major operation, it
can be carried out at the site where the equipment, whether new or second hand, has
been installed, and all one needs is a phantom in order to cross-check the data provi-
ded by the manufacturer.
L.A. JOVA SED: When second hand radiology equipment is sold to a develo-
ping country the transaction is often handled not by the manufacturer but by a busi-
nessman who lacks the qualifications necessary to ensure that the equipment will
function properly. That may well have implications for the radiological protection of
patients.
C. LAVOIE: Clearly, developing countries do not wish to import rubbish. At the
same time, manufacturers cannot be expected to guarantee equipment performance
over a period of 10 to 20 years regardless of the kind of maintenance carried out.
This is not a question of standardization, but of regulation, through mechanisms
such as trade agreements and export–import regimes.
G. KLEMPFNER: The rate of technical development in the medical radiology
field is very high. Is the rate of standards development keeping pace with it?
H. DUSCHKA: As far as CT is concerned, it is. The safety standard exists alre-
ady, and development of the performance standard is near completion; I expect that
the performance standard will be available in about two and a half years from now.
Having said that, I still feel that the process of standards development is too
cumbersome. At each stage we have to wait about six months in order to obtain the
inputs of the participating countries, in accordance with the procedures laid down by
the IEC.
DEVELOPMENT IN THE RADIOLOGICAL PROTECTION
OF PATIENTS
Chairperson
S. NAZARENKO
Estonia
EDUCATION, TRAINING AND CONTINUOUS
PROFESSIONAL DEVELOPMENT IN THE
L.K. WAGNER
Houston Medical School, University of Texas,
Houston, Texas, United States of America
Abstract
Education and training in the radiological protection of patients has to face many
challenges. These stem from the interdisciplinary nature of the personnel involved, their varied
backgrounds, the difficult to quantify risk and benefit considerations, concern for quality of the
end product, changing attitudes as knowledge develops in fast growing areas of technology and
the wide complexity of the equipment used. On the one hand there is a need for giving
orientation about the medical exigencies and situations in clinical practice to the radiation
protection regulators and, on the other, more and more clinicians without any training in
radiation protection are getting involved in the use of high levels of radiation through
angiographic procedures. It is hence no wonder that the deterministic effects of radiation have
been observed in patients undergoing angiographic procedures. A review of the state of the art
in education and training and identifying educational challenges is therefore needed. The
medical training of physicians and support personnel in the health care use of ionizing or other
radiation in patients is particularly challenging for many reasons, most of which are unique to
health care. These include those described in the paper.
1. USE OF RADIATION IS A MATTER OF HEALTH BENEFIT VERSUS

HEALTH RISK
1.1. State of the practice
The challenges facing physicians in the care of patients are wide ranging, from
the diagnosis and treatment of a simple fracture to the diagnosis and treatment of life
threatening conditions. During this care they are faced with other challenges, such as
allergic condition, unforeseen complications, the psychological condition of the
patient, etc. The use of radiation as a potential benefit in the diagnosis and treatment
of a patient must take into account the potential benefit of this application of radia-
tion within the milieu of the patient’s situation. Unnecessary diagnostic examinations,
for example, contribute markedly to increased radiation exposure, to increased costs
and make no contribution to benefit. A few medical schools provide mandatory
courses in the diagnostic radiological management of patients, others provide such
training as an elective course.
361
362 WAGNER
1.2. The educational challenge
Physicians, both those responsible for ordering examinations and those

responsible for their performance, must be well trained in the effective use of
radiological studies. In a manner consistent with the technology employed,
radiological physicians (radiologists) must weigh the health benefits anticipated
from the intentional delivery of radiation to patients against the potential radiation
risk.
2. IMPROVING BENEFIT/RISK IN MEDICAL RADIOLOGY IS A MATTER

OF MANAGEMENT
Medical radiation management is the exercise of a controlled deliberate

exposure of the human population to radiation. To achieve the appropriate
benefit/risk, training in the delivery of radiation is essential. Physicians and
support personnel (e.g. radiographers, nurses and medical physicists) must be
sufficiently trained to avoid situations that compromise the safe deployment of
radiation and at the same time must be able to respond to circumstances
within their specialty that may occur as a result of malfunctions or procedural
failures.
Regulators must be sufficiently trained in medical radiation management so as
to be able to design regulations that meet the goals of reducing error in medical
delivery without restricting the proper flexibility of medical personnel to obtain an
adequate diagnosis or therapeutic outcome.
A simple example of regulatory restrictions for public safety versus medical
management for patient care is in the dose limits for exposures to a conceptus.
Radiation safety requires that exposures to non-patients be restricted to less than
some predefined level, usually about 1 to 5 mGy. There are no defined limits for preg-
nant patients. This does not mean that physicians are at liberty to expose a foetus to
arbitrary levels of radiation. Sound medical practice dictates that care be taken to
restrict exposure of a conceptus to as low a level as is necessary for the appropriate
care of a mother and conceptus. That level might be very low or may potentially be
high, requiring alternative medical strategies that depend on the overall condition of
the patient.
An example of co-operative efforts across multiple disciplines is in the
treatment of heart disease, including diagnosis, intervention and intravascular
brachytherapy for the prevention of restenosis. In the United States of America
EDUCATION, TRAINING AND CPD 363
cardiologists, technologists, physicists and radiation therapists are all involved

directly with these types of procedures. Training and co-operation among each con-
tributor are essential.
Education and training of all medical personnel must be designed around meth-
ods of medical radiation management, the principles of which are very different from
traditional radiation safety for non-patients.
3. THE APPROPRIATE MANGEMENT OF RADIATION FOR PATIENTS

MUST GIVE PROPER CONSIDERATION TO THE QUALITY OF
THE END PRODUCT, THAT IS THE DIAGNOSTIC INTERPRETATION
OR THE THERAPEUTIC OUTCOME, TO WHICH A VARIETY OF
PROFESSIONALS CONTRIBUTE
Adequate patient benefit requires that the medical uses of radiation be designed
to achieve the end result satisfactorily. A missed diagnosis owing to an inadequate
study, for example, may result in undue suffering, prolonged health care or even
death. A repeated study owing to inadequate technique or an improperly prepared
patient increases patient exposure.
While the person principally responsible for the delivery of radiation to a
patient is most frequently a physician, many other individuals usually bear some
responsibility for the overall final outcome, including the referring physician, nurses,
technologists (radiographers), physicists, service personnel, manufacturers, adminis-
trators, regulators and even the patient.
— Referring physicians must order the appropriate examinations or treat-

ments.
— Radiological physicians must be well trained in the proper medical techniques
and in the appropriate delivery of radiation specific to their practice and to their
equipment.
— Radiological physicians should know the amount of radiation to which they
expose their patients and be able to place this risk in perspective with the med-
ical risks associated with a patient’s condition.
— Nurses must be instructed to prepare the patient for their study or treatment
properly.
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— Technologists must be trained in the proper delivery of radiation and in the

appropriate performance of a study or procedure to avoid unnecessarily
repeated or corrected work.
— Medical physicists must be well trained in the evaluation of equipment and
recommend servicing or replacement when necessary.
— Medical physicists must be well prepared to design treatment plans, make dose
measurements or consult with physicians on the best techniques for radiation
delivery.
— Service personnel must be well trained to repair or install equipment so that it
works properly.
— Manufacturers must train applications specialists to communicate to users the
proper use of equipment and how radiation delivery is affected under different
conditions of use.
— Administrators must be sufficiently educated in the need for quality to be able
to meet the challenges of judgement about the costs of quality control, mainte-
nance and the replacement of equipment.
— Regulators must learn how to design rules that reduce the potential for the
mismanagement of radiation without restricting or discouraging the proper
delivery of medical care.
— Patients must understand their medical care and be properly instructed on co-
operation in order to achieve the best examination or treatment possible.
Patients cannot be expected to be well educated in matters of radiation risk, are
often biased in their perspective of risk by poorly reviewed publications and
sensational publicity, and must be objectively guided in the benefit versus risk
decision of their physician.
The state of the practice around the globe varies markedly. In many
circumstances, in fact in many rural parts of the world and in some small cities and
suburbs, the number of professionals contributing to radiological health care is very
limited. In some circumstances a nurse or radiographer may be the only person
available. Regardless of the setting training is still essential, perhaps even more so, to
meet the medical goals of managing the benefits against the risks of the
procedures.
Each individual must understand how their responsibilities relate to the

potential benefits of radiation delivery. Education of such individuals must include
information on how their responsibilities impact upon the work of others and,
ultimately, how they impact upon patient care and medical outcome.
4. ATTITUDES TOWARDS RISKS AND BENEFITS CHANGE AS NEW

KNOWLEDGE OF RADIATION EFFECTS DEVELOP
Major advances in our knowledge regarding radiation effects include clarifica-

tions on the sensitivity of children versus adults for radiation induced thyroid cancer
and knowledge regarding the vulnerable developmental stages for the effects on the
embryonic human brain. These factors emphasize the need to focus attention on the
medical management of radiation that is delivered to young people or pregnant
patients. Knowledge of these radiation effects is insufficient by itself. Education and
training that focuses on the application of this knowledge in the radiological diagno-
sis and treatment of ill or potentially ill patients is essential. The performance of sco-
liosis examinations in the posteroanterior projection is an example of a procedure
designed to reduce breast and thyroid cancer risks in young people who will require
multiple examinations in their lifetime.
Educators must convey the relevance of current knowledge about radiation

effects in relation to the specific medical conditions of the patient; these include age,
sex, reproductive status and the nature of the injury or disease.
5. EQUIPMENT IS WIDE RANGING IN COMPLEXITY
A wide variety of equipment specialized for different radiological procedures is

used, and machines appropriate for similar procedures can vary markedly in
complexity. Within the realm of diagnostic imaging the spectrum of techniques con-
sists of the use of fundamental X ray units, fluoroscopy, computed tomography (CT),
scintigraphy, ultrasound and magnetic resonance. Fluoroscopy units can range from
small devices with very simplistic operational features and very low radiation
delivery rates to highly sophisticated biplane units with a wide variety of high dose
rate imaging options.
It has been demonstrated that patients can be severely injured when undergoing
some fluorosocpically guided interventional procedures. The training of a physician
in the efficient completion of a procedure is a primary factor that will dictate how
effectively radiation will be used. Of equal importance is the appropriateness of the
equipment for an application, its proper maintenance and the specific training of
366 WAGNER
physicians in the use of that equipment. For instance, is dose reducing variable pulsed
fluoroscopy available and will the physician use collimation, know the skin dose and
know when to change the beam orientation in order to avoid overirradiation of the
entrance skin site?
Education and training should be structured to meet the variety of conditions

under which radiation can be employed.
6. RADIATION DOSES CAN RANGE FROM TRIVIALLY SMALL TO

POTENTIALLY LETHAL
While the radiation absorbed dose to a patient from a simple, well performed
hand or arm X ray is essentially inconsequential to health, diagnostic and interven-
tional fluoroscopy has the potential to deliver doses that can induce a severe
debilitating disease or injury. Doses from nuclear medicine depend on multiple
factors. Doses are usually low when delivered for diagnostic purposes or they can be
lethal to targeted cells when used for therapeutic purposes. Radiation therapy delivers
tumoricidal doses and doses lethal to some healthy cells. The controlled delivery of a
dose may range from palliative to curative.
When training medical personnel on the safe uses of radiation the range of
doses delivered in a particular specialty must be placed in perspective with the radia-
tion risks and the medical benefits.
7. TECHNOLOGICAL SOPHISTICATION OF EQUIPMENT AND ADVANCES

IN PROCEDURES ARE RAPIDLY PROGRESSING
Prior to the 1980s X ray producing devices and nuclear medicine equipment
were relatively simple compared to today’s technology. Diagnostic X ray tubes were
not capable of extremely prolonged outputs. The collection of images was limited by
mechanical exchanges in film changers and in cine cameras. Delays between
acquisition and film processing limited the number of images acquired. Nuclear
medicine procedures were limited by analogue imaging systems and CT was in its
infancy. Advances in computer technology, however, changed all that. The
calculational power of computers opened the door for medical advances never
before approachable. Following on the heels of advances in computing technolo-
gies was digital image capture technology for rapid sequence imaging with
immediate review. This provided new tools for new procedures and created a
demand for high dose rate X ray tube technology with an extremely prolonged
tube life. This was followed by other demands and advances, such as slip ring
technology for helical CT, multislice helical CT, CT fluoroscopy, single photon
emission computed tomography and positron emission tomography, along with
major advances in magnetic resonance imaging and ultrasound. Advances in
megavoltage therapy and methods for treatment delivery also became possible as
a result of expanding technology. These recent advances in technology have
significantly improved health care, for example through interventional procedures
that reduce the mortality and morbidity associated with conventional surgery. All
these advances in technology pose new challenges associated with the radiation
risks to patients.
With the rapid development of medical radiation related technologies

the challenge is to train physician users and support personnel in radiation
management techniques specific to these developments. Regulators must also be
trained in the evolutionary changes that inevitably occur in medicine so that
old regulations or traditional techniques do not hamper the deployment of supe-
rior techniques and technologies. New regulations to meet the challenges of
the unrestricted use of these devices by unqualified persons may also be
necessary.
8. PHYSICIANS WHO USE RADIATION ARE FREQUENTLY NOT

KNOWLEDGEABLE IN RADIATION PRODUCTION AND DOSIMETRY
While the education of physicians in radiation dosimetry is required in some

countries for some specialties, the truth is that radiation dosimetry is a mysterious
quantity to many physicians who are responsible for the delivery of radiation to
patients. The task of assuring that radiation doses are adequately low for patients is
often considered one of machine calibration rather than applied physics. Radiation is
368 WAGNER
employed by a wide variety of medical disciplines. It is produced in emergency

rooms, operating rooms, recovery rooms, patient wards and in suites specially
designed for certain procedures in, for example, radiology, cardiology, pain manage-
ment and pulmonology.
Of particular concern in today’s high technology world is the expanding
use of high doses of fluoroscopy by physicians in medical disciplines that have
no experience or training in the use of this very sophisticated medical X ray
equipment. With the proliferation of the use of radiation outside the traditionally
high end users of radiotherapy and diagnostic radiology, the medical manage-
ment of radiation delivery must expand as an important component in the training
of specialists such as cardiologists, pain management physicians, urologists,
surgeons, etc.
Designing training so that physicians of multiple disciplines understand the

meaning of radiation dose, its relationship to risk and how it accumulates in patients
under different types of use and with different machines is a daunting task. Training
must be sufficiently comprehensive so that the benefit/risk principles can be applied,
but not so comprehensive that it burdens physicians with impractical and irrelevant
information for his or her discipline and equipment.
9. THE LEVEL OF TRAINING FOR SAFE USE SHOULD BE DEFINED FOR

THE PRACTICE IN WHICH PHYSICIANS AND SUPPORT PERSONNEL
ARE ENGAGED, BUT OFTEN IS NOT
Different specialties use radiation in different ways. It would be inappropriate

to train an orthopaedist in the techniques of brachytherapy, for instance, but should
they be trained in the application of digital serial fluorography? Just what level of
training is necessary to train an orthopaedist as opposed to a cardiologist or pain
management physician? What about technologists (radiographers) or nurses who
work in nuclear medicine rather than those who work in catheterization laboratories?
How should their training be structured? These issues need to be defined if training is
to be accepted as a serious exercise and a valued use of time for physicians and others.
Table 1 in the European Commission publication Radiation Protection 116 [1]
provides some useful hints on the need to specialize training levels for specific
personnel.
Training programmes must be developed specifically for the different special-

ties and the various health care individuals who support those specialties.
10. TRAINING MATERIALS TOO OFTEN FOCUS ON ESOTERIC PHYSICS,

BASIC SCIENCE, REGULATION AND RADIATION SAFETY WITHOUT
DEMONSTRATING PRACTICAL ISSUES RELATED TO SPECIFIC
PROCEDURES AND MEDICAL CARE
While a certain level of basic science and regulatory education is necessary

to meet the goals of safe radiation management adequately, overemphasis on these
areas distracts from the real world safe application of medical radiation. For exam-
ple, does knowledge of the relationship of the speed of light to X ray energy and
wavelength have any bearing on how a physician practices? When using
fluoroscopy is it important that a physician understands what the differences are
when an X ray tube is above a patient rather than below? Should a physician be
able to recognize Compton’s equation relating scattered photon energy to the angle
of scatter? Will a difference of ±20% from a physician’s prescribed activity have
a serious negative impact on a nuclear scintigraphic image? How does such a
difference affect the therapeutic uses of radiation? What does a person need to
know about transformer theory to be a good interventionalist, a good technologist,
a good physicist or a good regulator? What does a nurse need to know about
radiation and its distribution in an operating room? In short, there exist major
differences in the types of knowledge necessary for each professional to do a
good job.
Regulations are a mechanism to establish rules of practice for safety. However,
they constitute a small part of the much broader area of radiation management in
medicine.
Basic science training should be the foundation that supports its practical
application. Regulations are a mechanism to define a limited set of rules
for radiation safety, but the medical applications of radiation are a matter
of educated medical management for a patient, and training must reflect
this.
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11. IN MANY COUNTRIES TRAINING IN THE SAFE USES OF RADIATION

IS NOT REQUIRED FOR PHYSICIANS WHO APPLY DIAGNOSTIC OR
IMAGE GUIDED INTERVENTIONAL RADIATION
In the USA, for example, there are no federal government laws that require a
physician to be trained in the safe uses of radiation before applying radiation to
patients. A doctor of medicine degree is all that is required for a physician to apply
any form of fluoroscopy to patients. The same can be said of brain surgery. Any
physician can legally perform brain surgery, but the medical profession has set suffi-
cient levels of standards on training that such a practice is not acceptable in the USA.
The same is not true for the use of radiation. Physicians with little or no training in
the use of fluoroscopy routinely perform fluoroscopically guided pain management
procedures, interventional neurosurgery, biliary work and vascular surgery. Many
patients have been seriously injured by such procedures performed by ill-trained
fluoroscopists. In all cases the physician was unaware that they could deliver such
injurious doses to patients. Indeed, some physicians did not even recognize the injury
as radiation induced when the patient demonstrated skin changes. In response to this
situation some states in the USA have implemented training requirements for
fluoroscopists. In addition, a few medical professional societies have initiated or
have in place recommendations on training. Accrediting organizations are also
beginning to consider recommendations on mandatory training in the use of
fluoroscopy.
How should training be facilitated? What level of training is required for what
users and what personnel? Who should be responsible for defining educational needs?
What are the roles of medical schools, professional societies, accrediting organiza-
tions and regulators?
12. HEALTH AND MEDICAL PHYSICISTS AND REGULATORS ARE OFTEN

UNFAMILIAR WITH THE SPECIFIC DILEMMAS ASSOCIATED WITH
THE PRACTICAL DELIVERY OF HEALTH CARE
The level of training that a physicist or a regulator has in the delivery of health
care varies greatly around the globe and differs markedly depending on the specialty
of the practice. Therapy physicists typically have a better understanding of health care
delivery than some diagnostic physicists, for example. Many regulators have no
experience with the professional side of health care delivery.
Regulators sometimes ignore medical care issues and apply regulations with a
rigidity that is harmful to good practice. This occurs, for example, when regulations
focus critically on the performance of procedures that are of minimal safety value
when viewed in the perspective of the immediate medical concern.
Health and medical physicists play a significant role in training physicians in

the proper medical application of radiation. To be effective, physicists must demon-
strate an understanding of the health risks posed by medical problems so that the
training exercise can place the risk of radiation into a proper perspective. While teach-
ing for relevance will not ignite interest in every physician, it will give credibility to
the training and, in the long run, muster support within the profession for the need to
bring such training into the mainstream.
13. ACCOUNTABILITY IN TRAINING HAS VALUE AND DETRIMENT
The only valid measure of accountability for education and training is in the
quality of medical care that is delivered to patients. Every other measure of account-
ability is a strategy or attempt to elevate the standard of practice. We are all familiar
with those strategies that have some measure of success. A driver’s licence, a pilot’s
licence, a degree from a fully accredited college or a certification by an accredited
medical board all represent methods of accountability that have degrees of success.
Certification by a medical board means that an individual has passed certain
examinations that measure a level of specific knowledge, but it does not guarantee
that a physician will provide superior health care.
Accountability can be separated into two categories: filters and maintenance.
Filters are accountability events that indicate that a person has completed a course
of training and education and usually has passed a test or series of tests that
indicate an advanced level of performance. Filters separate those who have not
completed or who are unable to complete such training from those who have
completed the training. Degrees from accredited colleges, medical degrees from
accredited medical schools, driver’s licences, completions of medical specialty
residencies and professionally recognized board certifications are examples of
filters.
372 WAGNER
The other form of accountability in training is maintenance. Maintenance

refers to continuing education that demonstrates that an individual is attempting to
maintain her or his skills. Attending a conference, attending a class, watching a
videotape and studying a monograph are all forms of maintenance. Successful
completion of tests is often required.
Credits for completing continuing medical education also demonstrate
maintenance. In the USA the Accreditation Council for Continuing Medical
Education (ACCME) was set up by the American Medical Association to
approve organizations that provide continuing medical education activities for
physicians. Approved organizations can provide a variety of programmes for
ACCME credits, which are required for a physician to maintain recognized
professional expertise. Physicists are also required to have documented records
for continuing education. Credits approved by either the ACCME or the
Commission on Accreditation of Medical Physics Education Programs Inc.
(CAMPEP) are generally acceptable. Technologists (radiographers) are also
required to maintain skills. Courses are approved through the American Society of
Radiological Technologists. Typically 24 hours or units of credit must be
completed every two years for each professional group. Continuing educational
activities are usually categorized according to their level of formal evaluation,
and usually half of the credits must be in courses approved in the highest
category.
The regulatory process for screening mammography in the USA (the Medical
Quality Standards Act) is a good example of the good and bad aspects of account-
ability. Strict requirements are placed on physicians, technologists and physicists
with regard to initial training before they can practice mammography. Once the
initial standards are met, continuing training is required. Both the initial and the
continuing training must be fully documented to assure compliance. The quality of
care for screening mammography has clearly benefited from some of these require-
ments, but it is also clear that the forced documentation, particularly of continuing
education, has not been entirely productive. For example, regulations require
15 hours of continuing education in mammography for physicists every three years,
and this must be certified by the provider of the course. Self-study is usually not
credited. Most medical physicists in the USA must provide services to a wide
variety of modalities, including angiography, CT, digital radiography and more.
Physicists frequently find themselves attending repetitive lectures on the physics
of mammography in order to meet the legal requirements for credits, rather than
making better use of their time attending lectures or seminars on interventional
radiology, digital imaging techniques or advances in multislice CT or CT
fluoroscopy.
One of the major problems facing us today is the expanding use of radia-
tion, particularly fluoroscopy, by physician specialists who are certified in their
profession but have inadequate training in radiation management. When this type
of phenomenon occurs a practical resolution to the issue is necessary, but it is not
straightforward. Radiation is now widely used in radiology, cardiology, neuro-
surgery, urology, pain management, orthopedics, pulmonology and other disci-
plines. Typically the use of radiation precedes training in its safe deployment.
Adjusting training during residency and fellowship programmes to meet the
changing challenges of our technologically advancing world is a significant
priority. In the meantime an interim solution is necessary. In the USA some state
regulatory agencies have required that physicians demonstrate that they have
received adequate training in the use of fluoroscopy. The success or failure of such
programmes is impossible to evaluate. Some hospitals have required that medical
staff who use fluoroscopy be trained in its safe use. The success of this approach
is also impossible to evaluate. Recently in the USA the national accrediting
body for health care facilities has expressed interest in requiring training of
fluoroscopy personnel. By themselves none of these approaches will have a great
impact. However, together they are raising the level of concern about appropriate
training, and the ever growing attention is having an important impact on specialty
societies, which are beginning to require training in their residency and fellowship
programmes.
Resources for training and education are abundant. Training can be a direct
teacher–student experience. It can take place in a classroom or a laboratory. The
virtual world of interactive CD-ROM technology is also a viable tool for expanding
the availability of a teacher and meeting the convenience requirement that is neces-
sary for many physicians who are engaged in busy practices. The internet is another
virtual tool that can bring expert teachers into offices and homes at the convenience
of the student. Videotapes have been proven useful in meeting important educational
objectives. These devices all have their limitations, but all can play a significant role
in meeting the challenge of education and training. The quality of such programmes
should be evaluated by professional bodies to ensure that the educational needs of the
profession are met. Some societies have established accrediting bodies to evaluate
such programmes, and these serve a purpose of assuring a measure of quality in the
product.
Setting reasonable standards for accountability in radiological management

training, providing a wide variety of resources to achieve and maintain that
training, making the process easily accessible and ultimately achieving the appropri-
ate goals for patient care across the wide variety of medical users are the ongoing
challenges.
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14. EDUCATION AND TRAINING REQUIREMENTS ARE VERY

DIFFERENT, DEPENDING ON THE COUNTRY OR EVEN REGION OF A
COUNTRY IN WHICH ONE IS PRACTISING
The practice of medicine around our planet varies greatly. It would certainly be
unrealistic to think that all countries should abide by the same guidelines on
education and training of medical personnel in the use of radiation, given the
differences in types of medical programmes, practices and resources. However, the
implementation of fundamental principles in the safe utilization of radiation to elicit
a favourable health benefit should be widespread. Increasing harmonization in
training among neighbouring countries would serve to increase the regional resources
for training by expanding the population of practitioners skilled in similar circum-
stances. Co-operation among neighbouring countries or among countries with
similar medical programmes will promote the harmonization of training and help
promote patient safety in radiological medicine. In Europe, for example, the
European Union requires member countries to harmonize their requirements.
Guidelines for member countries to promote uniformity in radiation training in the
health professions are published in the European Union document Radiation
Protection 116 [1]. Common requirements on training will promote and facilitate the
free movement of professionals across boundaries, thus also promoting an ongoing
freedom of discussion for improvement.
The harmonization of educational standards across and within borders will

broaden resources and promote continued improvements in medical radiation man-
agement.
15. CONCLUSIONS
To be most effective, education, training and continuous professional develop-

ment in the radiological protection of patients must be a comprehensive approach
focused on all the contributors to the use of radiation in medicine, including physi-
cian users, referring physicians, radiological technologists, nurses, physicists,
engineers, educators, administrators and regulators. Education and training must
rationally place into perspective the health benefits and radiation risks. Training must
target the specialty of the individual’s practice and relate how their activities affect
patient outcomes. Accountability in training must be a filter that discriminates against
unqualified practice while not discouraging quality practitioners. Continuing

education accountability must encourage the full process of education so that the
documentation of activities does not become more important than the educational
process itself.
REFERENCE

DISCUSSION
T. SCHLESINGER: How useful is the background equivalent radiation time

concept in the case of high dose rate irradiation?
L.K. WAGNER: It should really be applied only in diagnostic radiology, where
the doses are normally very low. There it is useful, in my opinion.
P.S. SCHMIDT: As a member of the Conference of Radiation Control Program
Directors, I should like to respond to L.K. Wagner’s comments regarding the need to
educate regulators. In my view, there is a need for a two way process, with the
medical community educating regulators but also with regulators providing informa-
tion to the medical community. Regulators and the medical community should share
their perspectives.
In the USA the Conference of Radiation Control Program Directors is trying to
bring regulators together with medical physicists, radiotherapists, etc., in situations
that are less stressful than those that arise following an incident, when the regulator
must come and investigate.
In my view, the regulatory community should invite medical physicists,
radiologists and so on to participate in the development of regulations. That would be
preferable to the ‘develop and defend’ approach so often adopted by the regulatory
community.
L.K. WAGNER: I should like to see regulators witnessing, on the spot, some of
the problems that we members of the medical community face every day. They might
then stop insisting that we take measures that are unnecessary from the radiation
protection point of view.
I should also like the voice of the medical community to be heard and, what is
more important, heeded, so that bad regulations are changed. We members of the
376 WAGNER
medical community try to communicate with the regulatory community, but the result
is not very satisfactory. A better communication mechanism must be devised.
I.-L.C. LAMM: Obviously, effective communication between the medical
community and the regulatory community, and also among various groups within the
medical community and between the medical community and patients, is crucial, and
it is something that the European Federation of Organisations for Medical Physics (of
which I am currently the President and about which I contributed paper
IAEA-CN-85-1781) is trying to promote.
I am happy to say that in my country most of us medical physicists spend quite
a lot of time in diagnostic radiology, nuclear medicine and radiotherapy departments,
where we provide on the spot advice and also undergo a kind of informal continuing
education.
L.K. WAGNER: I am glad to hear it. Ours is an applied field and, after learning
the fundamentals in the classroom, you need to watch the procedures being applied
and, if possible, to participate in their application.
S. NAZARENKO: Would you care to expand on what you said about the
education of administrators?
L.K. WAGNER: In my view, administrators must, besides being sufficiently
educated in the need for quality so as to be able to meet the challenges of judgement
about the costs of quality control, maintenance and the replacement of equipment, be
sufficiently educated to understand why things should be different from how they
currently are. Much the same applies to government officials, given the great variety
of socioeconomic and political circumstances around the globe.
C.J. HUYSKENS: In agreeing with L.K. Wagner, I should like to say that, in
my view, administrators must be made aware of the need for continuous funding in
support of education, training and continuous professional development.
O.W. LINTON: One problem of education in the radiological protection of
patients is that there are physicians, some of them very good, who are indifferent to
or even scornful of the need to understand what they are doing when they use
ionizing radiation. It is very difficult to educate people who are unwilling to be
educated.

TOPICS FOR RESEARCH AND DEVELOPMENT
IN THE RADIOLOGICAL PROTECTION OF PATIENTS
Chairperson
G. DREXLER
Brazil
K. FAULKNER
Quality Assurance Reference Centre,
Newcastle General Hospital,
United Kingdom
E-mail: keith2@faulkner54.freeserve.co.uk
Abstract
In recent years there have been numerous developments involving the use of radiation in
medicine. These developments include the introduction of interventional radiology, helical
computed tomography, positron emission tomography and intravascular brachytherapy. Given
the continuing downward pressure on health care budgets these developments continue apace.
In many respects radiation protection research actions have not kept up with the challenges
brought about by these recent developments. In the paper various research topics are described.
At a fundamental level there needs to be research on radiological quantities for patient and staff
dosimetry. Given the importance of the concept of justification, approaches for risk evaluation
must be developed so that optimization studies may be performed to evaluate new technologies
and techniques. Guidance or reference values will need to be developed for various
examinations and procedures. An international consensus on approaches to establishing
reference values will need to be developed. In addition, users will need to develop closer links
with manufacturers and standards organizations such as the International Electrotechnical
Commission. Finally, a broad range of training activities will need to underpin these research
topics.
1. INTRODUCTION
The use of ionizing radiation in medicine is one of a continuing and rapid tech-
nological development. The development, and introduction into clinical practice, of
interventional radiology, helical computed tomography (CT), positron emission
tomography (PET) and intravascular brachytherapy has been driven, in part, by pres-
sures on health care budgets. In many respects radiation protection research actions
have failed to keep up with the challenges brought about by these recent technologi-
cal developments.
In addition, the changes and refinements in approach to radiation protection
introduced by the International Commission on Radiological Protection (ICRP) in
Publication 60 [1] have implications for research and development. Specifically, the
interpretation of justification and optimization have implications for all areas of med-
icine where new technology is being introduced. In addition, changes in dose limits
379
380 FAULKNER
for both occupationally exposed individuals and the general public have numerous
research implications.
At a fundamental level there should be research on the radiological quantities
to be used for patient and staff dosimetry. Both staff and patients request more accu-
rate information on radiation risks for procedures. Specifically, approaches for risk
evaluation must be developed so that the concepts of justification and optimization
can be applied to new techniques and technologies. Occupational and, where relevant,
public exposures must also be evaluated for new procedures.
Guidance or reference values will need to be developed for various examina-
tions and procedures. An international consensus on approaches to establishing refer-
ence values will need to be established.
The increasing technical complexity of new equipment, and the need to evalu-
ate new technology from a radiation protection perspective, demands a closer link to
manufacturers. Closer links to standards organizations such as the International
Electrotechnical Commission (IEC) will also be necessary.
This review will identify and discuss topics for research and development in the
radiological protection of patients in respect of three main areas:
— Fundamental issues,
— Evaluation of new technology,
— Implementation of the ICRP philosophy.
2. RESEARCH AND DEVELOPMENT TOPICS
2.1. Fundamental issues
In order to underpin the implementation of the radiation protection philosophy

introduced by the ICRP, it is necessary to undertake research into the radiological
quantities to be used for patient dosimetry. It is clear when comparing various inter-
national patient dosimetry studies that there is no consensus on quantities and units.
Specifically, there are significant differences between Europe and North America at
almost every level of dose quantity used. At the heart of the problem is the adaptation
of dose quantities derived, in the main, from an occupational/public dosimetry view-
point of medical exposures.
For medical exposures it is important to quantify radiation doses so that the
radiation risk can be estimated. Radiation risk is important, as it is the initial point for
justification studies in medicine. Referring physicians must be made aware of radia-
tion risks in order to make an informed decision on the benefit–risk ratio.
Furthermore, for optimization studies it is generally radiation risks that should be
minimized.
TOPICS FOR RESEARCH AND DEVELOPEMENT 381
For conventional radiography a relatively simple measurement of entrance skin

dose will suffice. However, for examinations involving fluoroscopy, in which the irra-
diated area and technique factors vary during examinations, a more appropriate albeit
controversial quantity is dose–area product. This may be converted into effective
doses using a measured or calculated conversion factor specific for a particular pro-
cedure. There is a need for research studies to address the limitations of the dose–area
product as a unit and to establish conversion factors for a wide range of examinations.
The Basic Safety Standards [2] require that all medical exposures should be jus-
tified. In many examinations the justification process has been poorly addressed, both
from a radiation protection and a clinical perspective. Clinical justification has been
addressed by the United Kingdom’s Royal College of Radiologists [3]. This has
formed the basis for a set of European guidelines. However, there is a large body of
research required to study justification issues in radiation protection terms for clini-
cal examinations.
The United Nations Scientific Committee on the Effects of Atomic Radiations
(UNSCEAR) performs regular surveys of the magnitude of the population dose in dif-
ferent countries. In order to compare practices at an international level there needs to
be a consensus concerning the approach to evaluating population exposures. Research
into methods of sampling practice in a country, measuring doses and agreeing on the
description of common examinations is needed.
In CT both CT dose indexes and multiple slice average doses have been used as
reference values, the latter having the endorsement of the IAEA [2]. The former quan-
tity measured on the central axis free in air is often used as the normalization value
for normalized organ dose compendia [4]. In Europe the quantity dose–length prod-
uct has been proposed in the latest guidance on CT [5]. Consequently, a consensus on
the use of dose quantities for reference values is needed. In addition, if radiation risks
are to be deduced for CT examinations on modern equipment more normalized organ
dose data should be determined for modern machines. Given the high doses from
examinations involving CT, optimization studies are essential.
Measurement of risk related dose quantities in dental radiography is necessary
as part of the process of justification. Estimating effective dose is particularly diffi-
cult as the inclusion of radiosensitive organs in calculating doses to the remainder
organs/tissues is critical. Developing a risk related quantity for dental radiology is a
research priority. This work would also be applicable to partial body occupational
exposures, such as those that occur in fluoroscopy and interventional radiology when
wearing a lead apron.
In interventional radiology the objectives of radiation protection are to mini-
mize the somatic risks and in particular to avoid deterministic effects. This requires
the assessment of a risk related dose quantity (e.g. dose–area products) and the max-
imum skin entrance dose. Given the various reports of deterministic injuries in the
published literature, assessment of maximum skin entrance doses in a reliable and
382 FAULKNER
reproducible manner is a research topic of some urgency. Estimation of doses to iden-

tify the focal point in this respect is essential.
A useful approach to determining organ doses in many areas of radiology is that
of normalized organ dose data. This data converts a dose quantity into organ doses,
from which it is possible to estimate the effective dose. Many national bodies in
Europe and North America have produced normalized organ dose data for a range of
radiographic and CT examinations. The generic approach is particularly useful.
However, little work on intercomparisons and the use of a consistent set of normal-
ization quantities has been undertaken. The advent of new procedures and equipment
inevitably means that further work is necessary.
Various areas of research in radiobiology may have an impact on the radiolog-
ical protection of patients in medicine. Specifically, adapting molecular biology tech-
niques for use in medical imaging and radiotherapy offer exciting prospects. Gene
transfer techniques, tumour specific peptides or single chain antibodies may be used
to improve the number of antigen receptor sites on malignant cells that can be utilized
for both imaging and therapy [6]. It is anticipated that gene therapy will be utilized in
three areas [7]:
— Delivering genes and vector products by minimally invasive intervention tech-

niques;
— Quantitative gene and DNA delivery by nuclear imaging;
— The use of imaging to the levels of transgene expression in vivo, by the
use of PET, nuclear medicine, magnetic resonance imaging or optical
imaging.
The potential of antioxidants for mitigating injuries from ionizing radiation is

widely known [8]. Some antioxidants may work with low dose/low dose rate expo-
sures, whereas others have antimutagenic properties. Consequently, antioxidants may
have a potential role in radiotherapy treatment protocols.
2.2. Evaluation of new technologies
Radiology, nuclear medicine and radiotherapy are all high technology areas of
medicine. Over the years there has been a rapid evolution of imaging technology, with
the aim of producing better, more cost effective medicine. As a consequence, the
capital investment associated with radiation equipment is a major proportion of the
total capital cost of any hospital. Given this large capital investment, it is important
that best use is made of the equipment. From a radiation protection perspective it is
necessary to evaluate the implications of introducing and implementing new equip-
ment. Specifically, there must be optimization and justification studies as well as an
assessment of the impact of equipment on patients, staff and public exposure. In

recent years the following have been introduced:
— Digital imaging,
— Digital fluoroscopy,
— Flat panel detectors,
— Helical CT,
— PET,
— Single position emission computed tomography,
— Interventional radiology,
— Intravascular brachytherapy.
Each of these items of equipment must be evaluated as part of a technology

assessment programme that includes radiation protection aspects.
To reduce radiation doses to patients and/or staff, manufacturers have intro-
duced various modifications and refinements to equipment, particularly imaging
units. The efficacy of these dose reduction devices and techniques should be evalu-
ated. Aspects of imaging equipment which require technical assessment include:
— Increased tube filtration,

— Pulsed fluoroscopy,
— Road mapping in digital imaging,
— Recursive filtration,
— Beam profile filters.
An important aspect of reducing patient (and staff) doses will be the ability to
provide operators with up to date dosimetry information. This may be achieved either
by mounting a suitable dosimeter to each X ray tube or with a software program. It is
likely that this will be required for interventional systems in the forthcoming IEC
standard. These dosimetry systems should be interfaced to a hospital patient admin-
istration system or radiological information system. This linkage will inevitably lead
to a broad range of research topics.
Equipment evaluation includes assessing the impact on clinical examinations,
dosimetry and the development of quality assurance protocols and procedures.
One of the most exciting developments in radiotherapy in recent years has been
intravascular brachytherapy. In this technique radionuclide sources are manoeuvred
into blood vessels in order to widen blocked arteries. It is therefore necessary to per-
form research and development studies to select the most appropriate radionuclide to
be used. Dosimetry studies and an assessment of the radiobiological aspects of the
new technique must be performed. Given the potential for high dose rate exposures
arising from the technique, it will be necessary to avoid the occurrence of radiation
384 FAULKNER
incidents. Quality assurance programmes, including calibration methods, will need to

be developed.
The continuing drive in radiotherapy is the desire to maximize doses to the
planned target volume. This has led to the introduction of conformal radiotherapy and
intensity modulated radiotherapy coupled with three dimensional computer treatment
planning systems. Three dimensional conformal radiotherapy is predicated by accu-
rate three dimensional imaging techniques that can accurately delineate tumour mar-
gins. All aspects of these techniques will require evaluation, from the accuracy of the
imaging, dosimetry and quality control of conformal radiotherapy and intensity mod-
ulated radiotherapy to the accuracy of treatment planning. Radiation protection
research in this area is essential if improved tumour control is to be achieved.
Many of the research and development topics will have implications for inter-
national standards, such as those produced by the IEC. Closer links between radiation
protection research projects and standards organizations are necessary.
PET is a major growth area in nuclear medicine. The drive for new radiophar-
maceuticals will in turn lead to the need for radiation protection research in respect
of uptake and excretion studies. PET is particularly useful in supporting radiotherapy,
by staging tumours and monitoring tumours’ responses to treatment. The efficacy of
the use of PET will need to be evaluated.
2.3. Implementation of the ICRP philosophy
ICRP Publication 60 [1] is an important document that has stimulated interest

in radiation protection philosophy and new concepts. The implication of this new phi-
losophy and the implementation of the ICRP philosophy into national regulations
merit serious scientific study.
Hospital patients and their relatives now demand more information about their
medical problems. They expect to be involved in aspects of the clinical decision mak-
ing process. An implication of informed patient choice is that patients expect to be
made aware of clinical risks, including radiation risks. Thus there is a need to develop
risk related patient dose quantities for use in medicine.
Most regulatory systems expect that all medical exposures should be justified
and optimized. Justification involves comparing risks and benefits. It is an important
question in screening programmes.
Once a procedure has been justified it is important that a process of optimiza-
tion occurs. Very few optimization studies have been undertaken in radiology.
Reference values were introduced in ICRP Publication 60 [1]. They are
intended to be a tool for identifying centres or equipment that have relatively high
doses. They are a very useful radiation protection tool for identifying where opti-
mization studies would have the greatest input. There are numerous radiation protec-
tion research and development opportunities. For example, reference values will need
to be established for each type of examination. In interventional radiology a combi-

nation of different approaches will need to be developed. Questions, such as whether
patient studies, phantom measurements or size corrected patient dose data should be
used as a basis for formulating reference values, need to be asked. Should reference
values be based upon a particular percentile of a dose distribution? What is the sta-
tistical basis for the use of the 75th percentile? Protocols and procedures for measur-
ing reference values will need to be developed and an international consensus
achieved.
The change in radiation protection philosophy and the implementation of this
into practice is a major task. There will need to be a broad range of training activities
to support these initiatives. Improved training activities, including interactive
approaches, will need to be developed.
3. CONCLUSIONS
The use of radiation in medicine is a continuously evolving area that has led to
the introduction of new equipment and procedures, all of which demand a rigorous
technological assessment including the radiation protection aspects. While much
research work has been undertaken on the radiological protection of patients, the
opportunities for radiation protection research are increasing.
REFERENCES

Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of
[3] ROYAL COLLEGE OF RADIOLOGISTS, Making the Best Use of a Department of
Clinical Radiology, Guidelines for Doctors, 4th edn, The Royal College of Radiologists,
London (1998).
[4] JONES, D.G., SHRIMPTON, P.C., Survey of CT Practice in the UK, Part 3: Normalised
Organ Doses Calculated Using Monte Carlo Techniques, Rep. NRPB-R250, National
Radiological Protection Board, Didcot (1991).
Tomography, EUR 16262 EN, EC, Luxembourg (1998).
386 FAULKNER
[6] ROGERS, B.E., ZINN, K.R., BUCHSBAUM, D.J., Gene transfer strategies for improv-
ing radiolabeled peptide imaging and therapy, Q. J. Nucl. Med. 44 (2000) 208–223.
[7] WUNDERBALDINGER, P., BOGDANOV, A., WEISSLEDER, R., New approaches for
imaging in gene therapy, Eur. J. Radiol. 34 (2000) 156–165.
[8] WEISS, J.F., LANDAUER, M.R., Radioprotection by antioxidants, Ann. N. Y. Acad.
Sci. 899 (2000) 44–60.
DISCUSSION
J. ZOETELIEF: In his presentation K. Faulkner said that there is no consensus

on quantities and units. This was recognized a few years ago by the International
Commission on Radiation Units and Measurements (ICRU), which is preparing a
report with the working title Patient Dosimetry for X Rays Used in Medical Imaging.
This report, which will probably appear in about a year’s time, should help in the har-
monization of quantities and units.
G. DREXLER: I suspect that the ICRU report will still leave many issues unre-
solved.
J. ZOETELIEF: A possible area for future research is the use of computer
assisted diagnostic programs, for example in digital mammography to assist radiolo-
gists in recognizing malignant lesions. In a study carried out in the Netherlands on the
detection of microcalcifications, computer analysis was found to be better than the
radiologists were.
K. FAULKNER: I am pleased to hear it. There will have to be a rigorous assess-
ment, however, before the methodology is applied in general screening programmes.
M.M. REHANI: Many problems would be resolved if there were imaging sys-
tems that, after measuring the entrance skin dose and after the thickness factor and
the field size had been fed in, could calculate the effective dose.
K. FAULKNER: There are, at the development stage, systems that calculate the
effective dose from the entrance skin dose using normalized organ dose tables. In the
long term most systems will probably be fitted with mechanisms for predicting the
radiation dose and be linked to patients’ hospital records.
However, we shall need to be able to predict radiation doses for a great variety
of examination types, which is a further research and development topic.
A. BEN-SHLOMO: In cardiac procedures you can protect the patient through
greater X ray filtration. However, staff are then exposed to harder radiation, and the
protection afforded by shielding aprons is limited. Would you care to comment?
K. FAULKNER: Shielding aprons are not sufficient in the case of some exam-
ination types. It is largely a matter of education and training.
L. CARRIZALES: In order to evaluate radiation risks in developing countries,
it is necessary to determine the radiation levels delivered to patients and staff in diag-
nostic radiography. Consequently, I think it would be useful to establish a postal ther-
moluminescent dose programme for mammography, fluoroscopy, interventional radi-
ography and CT — a programme covering both patients and staff. Although there are
guidance/reference dose levels in developing countries, it is very difficult to deter-
mine the dose received by patients as there is not sufficient equipment and often the
X ray machines used are obsolete and/or the staff have not undergone the necessary
training.
K. FAULKNER: Wherever you are in the world, it is important to evaluate radi-
ation risks as well as radiation doses, to identify centres where the doses are higher
than those typical for the region and to focus your dose reduction efforts on those cen-
tres. The IAEA has done work along those lines.
G. DREXLER: There are many developing countries with radiology depart-
ments where almost nothing has changed during the past 40 years. Research and
development programmes that could benefit such countries are very necessary.
E. COTELO: In my view, in some developing countries more can be achieved
through good education and training than by investing heavily in equipment. For
example, in interventional cardiology, of 300 catheter ablation procedures that we
have studied, the 90% that were successful were the ones involving the lowest radia-
tion doses and the 10% that were unsuccessful were the ones involving the highest.
T. SCHLESINGER: More and more money is going to have to be spent on radi-
ation protection in medicine. Perhaps the increase could be stemmed somewhat, how-
ever, if more effort were put into studies, perhaps case control studies, relating to the
question of a threshold for stochastic effects.
K. FAULKNER: In diagnostic radiology the doses and the risk factors are gen-
erally low, so that one would need a very large population in order to carry out a
meaningful epidemiological study.
There is also the problem of finding a control group, since people undergoing
X ray examinations generally have something wrong with them and are therefore not
typical of the population at large. In addition, there are difficulties with the registra-
tion of cancers and therefore with tracking the effects.
In my view, the great difficulty of carrying out a meaningful epidemiological
study is obvious from the fact that so far one has not been carried out.
M.M. REHANI: There is still no way of determining, retrospectively or on-line,
the dose received by a person who has undergone ten minutes of fluoroscopy. Why
can more research effort not be channelled into biological dosimetry?
K. FAULKNER: We need to tackle biological dosimetry at a number of levels,
and we need to think about the estimation of risks almost from first principles.
There are technological solutions available. For example, within the DIMOND
(Digital Imaging: Measures for Optimizing Radiological Information Content and
Dose) group we have access to an instrument that enables one to obtain a real time
readout of radiation dose and radiation risk.
J. PORTE: With the detection of microcalcifications, is there not a danger of
false positives?
388 FAULKNER
K. FAULKNER: Yes, the presence of microcalcifications does not necessarily

mean cancer. A system for detecting microcalcifications should be an aid to radiolo-
gists, prompting them to look more closely at films meriting particular attention.
J. PORTE: What is the lower limit as regards the size of a cancer that can be
removed surgically?
K. FAULKNER: With a stereotactic biopsy unit it is possible to remove very
small cancers surgically.
E. VAÑÓ CARRUANA: With regard to digital radiology, I think the research
community should look more closely into the question of the control of rejected
images in digital systems and into the difficulties of postprocessing images once they
have been stored.
K. FAULKNER: I agree.
R.H. CORBETT: Regarding the question of the lack of consensus on quantities
and units, mentioned by J. Zoetelief, a paper by M. Moores (Moores, M., Reference
Doses and Quality in Medical Imaging, Proc. Workshop, 1997, Radiat. Prot. Dosim.
80 (1998) 351–352) may be helpful.
Regarding the difficulties of carrying out epidemiological studies, described by
K. Faulkner, how do you carry out a double blind trial if you do not have some ‘nor-
mal’ patients? Most people consider themselves to be ‘normal’, but are they ‘normal’
for the purposes of a particular research project?
There is a further difficulty if you wish to carry out prospective research with
CT scanning. A solution might be to consider the various areas of a scan that are
abnormal in some areas and normal in others, although that raises problems of assess-
ment and choice.
K. FAULKNER: I agree that it is difficult to recruit ‘normal’ volunteers for
research projects. It is wrong to approach members of one’s own staff, and nowadays
many patients know what a double blind trial is, and will not volunteer for an exer-
cise during which they may well not receive any treatment.
G. HEEREN: The worst complication in radiotherapy is the failure to cure the
patient, but dead patients who received insufficiently high doses have no advocate.
There is consequently a need for long term patient follow-up on a routine basis.
However, late complications, certainly those of grades 3 and 4, need to be correlated
that clinical outcomes through prospective studies.
G. DREXLER: That is a very important point.
C. BACK: In my country I have noticed that radiologists tend to use higher
doses with digital imaging than with analogue imaging. I think this is a problem that
will arise in digital mammography.
Another problem to which I should like to draw attention relates to cancer
detection using software. Some 70% of cancers are not around microcalcifications.
IMPLEMENTATION OF REGULATIONS
FOR THE RADIOLOGICAL PROTECTION OF PATIENTS
Chairperson
F. VARGAS MARCOS
Spain
IMPLEMENTATION OF REGULATIONS FOR THE
J. CASSAR
Department of Radiology,
St. Luke’s Hospital, G’Mangia, Malta
E-mail: joseph.m.cassar@magnet.mt
Abstract
The implementation of radiation protection regulations in general, and in particular for
the radiological protection of patients, raises challenges for legislators, regulators and users. The
Basic Safety Standards serve as the basis for harmonizing radiation protection programmes
internationally, but it is also important to take into consideration that, although the Basic Safety
Standards are highly structured, allowance has to be made for their adaptation into various forms
of legislation and implementation programmes. The radiation protection principles of
justification and optimization are applicable to the protection of patients, but the principle of
dose limitation is not. The responsibility for radiation protection relies on the licensee or
registrant of a medical facility, but, more specifically, the primary task and obligation to ensure
the overall protection of patients lies with the medical practitioner, who is sometimes not aware
of this responsibility. The regulator, however, while only responsible for monitoring compliance
with and enforcing regulations, should contribute to create awareness by requesting, for
example, quality assurance procedures, and education and training. This overview endeavours to
bring forward for discussion some points related to the implementation in general of radiation
protection regulations with regard to the radiological safety and protection of patients. It
addresses the political issues that need consideration when establishing a regulatory system, as
well as the role of international guidance and intercountry harmonization.
1. POLITICAL ISSUES
For over a century the benefit of radiological exposure in medicine has been
well understood and put to good use. The potential risks from ionizing radiation
applications in medicine have also become evident. Medical radiation exposure con-
tributes the major share of human-made ionizing radiation.
An increase in medical exposures of ionizing radiation is expected as techno-
logical and economic developments change the pattern of health care. Effective med-
ical radiology will be available where at present it is lacking. As life expectancies
increase, the number of cancer cases will also increase and thus the need for more
radiotherapy facilities will grow.
The value of reducing risk through international standards such as the Basic
Safety Standard’s (BSS) [1] “justification of medical exposure” and “optimization of
391
392 CASSAR
medical exposure” is well recognized. This is true for medical radiation exposures,
but the principle of dose limitation is not applicable.
Many countries have incorporated these principles in statutes or laws. Through
safety legislation these countries pave the way for the use of medical exposures,
while controlling the accompanying risk by the safety standards they enact. Other
countries keen on developing the radiological protection of patients look for interna-
tional guidance. They attain varying levels of success owing to inappropriate politi-
cal commitment, their economic and social situation or conflict. Since the radiolog-
ical protection of patients is an activity that needs to be organized, funded and admin-
istered, it competes with the other aspects of safety and protection that seek national
attention. Such issues require adequate resolution before a regulatory framework for
the radiological protection of patients can be conceptually designed and practically
implemented.
2. LEGISLATION IN THE RADIOLOGICAL PROTECTION OF PATIENTS
When the fundamental safety issues for the radiological protection of patients
acquire the necessary consensus, and the appropriate policy is available, administra-
tive mechanisms are needed to materialize the policy, that is to translate the policy ini-
tially into legislation and prepare for its enactment. Typically, these administrative
mechanisms plan or draft national legislation on the subject, create a regulatory body
and provide resources for the infrastructure on which the radiation protection system
can be built.
The human resource component of the radiation protection infrastructure
remains, however, the primary factor of a safety culture, and must be evident at all
levels of planning and subsequently in its operation.
At the preparatory stage of drafting legislation it is common practice in many
countries that administrators, professional bodies, patients and public groups
meet to discuss the essential principles and regulations that should be embodied
in the draft law. This allows for the requisite pooling of opinions to aid in the
design of the legislation itself. Thus the exchange of information properly
conducted in accordance with a country’s culture and customs provides a pathway to
build consensus towards legislation on protection and safety. It should be noted here
that the process of enacting or later amending laws is lengthy. This in itself suggests
that while the law should establish the essential national infrastructure and articulate
the requisite legal elements, the specific and more comprehensive safety require-
ments should be issued by a regulatory body in the form of regulations and guide-
lines. The constituted regulatory body should, therefore, establish regulations
while identifying the main parties responsible for the radiological protection of
patients.
IMPLEMENTATION OF REGULATIONS 393
The international safety standards, in their various guidance and technical doc-
uments, indicate that a regulatory body’s functions include the authorization of prac-
tices, inspections and compliance monitoring, and the dissemination of information
through different methods to the public and different interest groups, while the body
keeps itself well informed of all matters related to radiation safety and protection. A
fundamental concept that should be made evident in legislation is that the primary
responsibility for the radiological protection of patients and the safety of sources
resides with registrants/licensees and employers of occupationally exposed workers,
while medical practitioners should be assigned the primary task and obligation of
ensuring overall patient protection and safety in the prescription of, and during the
delivery of, medical exposures. Qualified experts and manufacturers have subsidiary
responsibilities, notably in radiotherapy; calibration, dosimetry and quality assurance
should be performed by, or under the supervision of, qualified experts in radiotherapy
physics. In the diagnostic use of radiation, imaging and quality assurance require the
advice of qualified experts in either radiodiagnostic physics or nuclear medicine
physics, as appropriate.
Other aspects of the regulations need to refer to the requirements of the users
of the practice and involve the process of justification and optimization of patient pro-
tection, which includes technical measures such as calibration, clinical dosimetry and
quality assurance. Users are also required to keep records, as prescribed, for example,
in the standards, and prepare for and deal with incidents and accidents and appropri-
ately report to the regulatory body significant incidents and radiation doses signifi-
cantly different from those intended.
At various stages of the regulatory process the regulatory body needs to meet the
other responsible parties, advisers and consultants in the field of the radiological pro-
tection of patients, and patients’ advocacy groups. The administrative and operational
detail in a radiation protection system can be extensive, and legislative or administra-
tive provisions and planning are needed in the process of the implementation of its dif-
ferent levels. An additional responsibility of the regulatory body is to require all par-
ties involved to develop a culture of safety in radiation protection. This should include
measures to encourage a questioning and learning attitude to safety.
3. RESOURCES
The implementation of regulations, in particular in the public sector, needs

resources. Regulatory bodies and users of radiation should effectively and efficiently
utilize the resources to meet the requirements of the regulations, even though there is
little or no immediate return on resources spent on safety. Therefore, adequate provi-
sion needs to be budgeted so that funds can be allocated to activate the whole safety
and protection process.
394 CASSAR
The financing of the regulatory body must be secured, and there should be
an effective separation of responsibilities between the functions of the
regulatory body and those of any other party so that the regulators retain their inde-
pendence of judgement. This issue is crucial to the functioning of the regulatory
body.
Owing to their particular responsibilities and functions, the regulatory body and
users require, according to the BSS model, various specialist, such as, for example,
radiation protection officers, administrators, technologists, radiologists, medical
physicists, radiographers, advisory committees and consultants.
These human resources may not all be readily available to work on each
particular radiation protection programme. The mechanism of implementation has
to be very carefully planned over time frames that will allow for the acquisition of
the necessary human resources, otherwise the more elaborate regulatory pro-
grammes that are dependent on specific skills and experts cannot be carried out and
sustained.
Radiation protection programmes should be practicable such that the adequate
allocation of funds and resources will follow. To alleviate the problem of scarce
resources, programmes must be assessed initially for their cost efficiency.
Consequently, the programmes will require development plans to be able, for exam-
ple, to assimilate the benefits of current technology. Programme reviews are also
essential features of radiation protection programmes.
4. STANDARDS
Standards or requirements established by regulatory bodies are rules by which

measures of safety are made and recorded. For example, a regulatory body will
require an application for an authorization to be submitted. In order for a regulatory
body to be able to grant an authorization, sufficient information on the relevant safety
measures has to be provided in the application; for example, details of a quality assur-
ance programme related to a practice’s operation. The regulatory body may then
approve the quality assurance programme, which can be applied in all authorized
medical radiological practices.
Regulations need to involve a balance between two opposite requirements: to
be flexible so as to permit easy adaptation to evolving technology and to include suf-
ficient detail to ease the verification of compliance. The first requirement is achieved
by keeping the regulations general (performance regulations) and the second require-
ment can be achieved by providing more specific regulatory guidance (prescriptive
regulations). As mentioned above, the detailed and specific requirements can be given
in regulatory guidance, which is more amenable to change when needed. As an exam-
ple, a requirement to have a quality assurance programme could be part of the per-
formance oriented regulations, while the details of the programme for specific prac-
tices can be part of the regulatory guidance.
The standards that a regulatory body adopts in terms of the radiological protec-
tion of patients can entail different levels of complexity depending on the local situ-
ation, the technical resources available, the potential of the practice for exposure and
the expected costs of implementation. The BSS itself, if taken as guidance for build-
ing radiation protection programmes, offers in general and in some specific terms a
range of standards applicable to radiological facilities. However, a regulatory body
must also look at the existing national health care regulations to ensure harmoniza-
tion and consistency of its planned regulations with those of the national health care
system where the body’s regulations will be applied.
5. SAFETY STANDARDS AND THE USER
Throughout the design and planning phases for a regulatory programme it is

expected that the necessary consultations with all persons/bodies and organizations
concerned will have occurred, which opens the way for the exchange of ideas on the
structure of the body’s regulations and on how they are likely to effect the users.
Users are likely to encounter radiological protection standards in the identifica-
tion and registration of patients, the selection of equipment and information systems
for patients, and the assessment of patients’ present conditions. Medical practitioners
encounter criteria or standards for patient protection in the safe prescription and deliv-
ery of medical exposures. Registrants or licensees should seek the advice of their eth-
ical review committees on all matters related to medical exposures of research vol-
unteers. Diagnostic reference levels can be initially estimated and then, within a given
time frame, surveyed. Quality assurance programmes should be put into effect and
verified. Systems of notifying incidents and accidents that lead to investigations and
regular reviews of systems are essential. In medical exposures the optimization of
protection is to be understood as giving the necessary dose to achieve the desired
diagnosis or treatment. In general, doses should be maintained as low as reasonably
achievable but high enough to obtain the required diagnostic information or thera-
peutic effect. This means that exposures above clinically acceptable minimum doses
should be avoided.
6. QUALIFICATIONS AND TRAINING OF REGULATORS
The term regulators here refers to those persons in charge of performing the
evaluation of applications for authorizations and monitoring compliance of regula-
tions by means of on-site inspections. Requirements for qualifications and the
396 CASSAR
training of regulators need to be derived from these functions. This also applies to the
regulatory control of medical exposures, for which the fuctions of a regulatory body
are therefore the authorization of practices, inspections and compliance monitoring.
In addition, a regulatory body may enhance safety performance by the dissemination
of information.
The regulatory body that controls radiation protection in medical exposure
activities must be in a position to appreciate, assess and accept or otherwise correct
on a knowledgeable, experienced and skilful basis any issues of radiation protection
that lie in its regulatory domain. This implies that regulators need a wide range of sci-
entific, technological and administrative training to various levels of proficiency in
many areas and an adequate number of staff. A regulatory body may be self-sufficient
or delegate some inspections to governmental or other agencies — an example may
be diagnostic radiology, because of the large number of facilities involved. A regula-
tory body may be self-sufficient in the various specializations or may consult expert
advisers; the contracted skills and consultancy services need to be planned for and
available. An adequate number of administrative and inspection staff should be avail-
able for the adequate functioning of the regulatory body.
It is essential for a regulatory body’s technical knowledge base to be self-suffi-
cient. This knowledge base should be formed by staff who can identify problems,
determine when to seek advice and correctly interpret the advice given. For most sit-
uations an adequate inspection programme can be made by using personnel with a
general education in radiation protection and safety and additional knowledge of ion-
izing radiation practices in the medical field. The use of outside experts can supple-
ment and enhance the skills available to a regulatory body in those cases requiring a
more in-depth inspection, such as accidental medical exposures. Such planned sys-
tems should allow a regulatory body to assume its function in radiation protection
matters fully.
7. ROLE OF INTERNATIONAL GUIDANCE
The guidance given by international organizations such as the IAEA, the World
Health Organization, the Pan American Health Organization and the European Union
can do much to help safety and protection be delivered to patients worldwide. There
are many countries that benefit appreciably from such guidance, because studies and
research, experience and expertise in the radiological protection of patients can be
advantageously pooled.
In the implementation of regulating the radiological protection of patients,
international guidance involves using a large resource of knowledge and expertise and
is a valuable resource for assisting in the design and planning of regulatory frame-
works and programmes in radiation protection. After the actual implementation of
safety and protection programmes start, international organizations can assist in set-
ting the pace for their development. This ultimately produces a programme that pro-
vides appropriate standards of protection for humans in the controlled application of
medical exposures.
8. LEGAL STRUCTURE AND INTERCOUNTRY HARMONIZATION
The main aim of the BSS is the establishment of requirements for protection
against the risks associated with exposures to ionizing radiation and for the safety of
radiation sources that may deliver such exposures. Published as IAEA Safety Series
115, the BSS are intended for implementation through an effective radiation safety
infrastructure that includes support for the enabling legislation and regulations for the
radiological protection of patients among its main themes. The ways in which States
apply and adapt the BSS to local conditions varies, and depends on their legal sys-
tems, technical resources and related factors. It is these systems and resources that
form the infrastructure for the legal and regulatory aspects of radiation protection pro-
grammes.
International standards have developed in a structured way, from general policy
statements and safety requirements to recommendations on how to meet these
requirements. The laws and regulations of many countries are similar as they find
their origins in international standards. Significantly, however, regulatory features
may vary appreciably between countries. For example, as may be expected, the prin-
ciples of justification and optimization as in the BSS are reflected in different coun-
tries’ laws, but some more detailed issues, such as guidance levels for medical expo-
sures, vary considerably.
Intercountry harmonization of legislation, regulations and other aspects of the
BSS is an ongoing process. Properly planned, this process allows for each country’s
progressive assimilation of the BSS. In future, the legal structures of different coun-
tries could be adapted to enable the intercountry harmonization of safety standards,
which will add to their value, their derived benefits and their future development. In
the meantime it must be realized that while legal structures are essential for the con-
trol and maintenance of radiation protection and safety standards, the development of
a safety culture may go a great way towards realizing the benefits of radiation pro-
tection and safety standards for patients within and across countries.
REFERENCE

398 CASSAR

HEALTH ORGANISATION, WORLD HEALTH ORGANIZATION, International
DISCUSSION
L.K. WAGNER: I have often found that regulators do not understand the logis-
tical problems of taking care of patients in a hospital. Without an understanding of
those problems, regulations tend to conflict with the medical management of patients.
Would you care to comment?
J. CASSAR: Clearly regulators need to be properly educated in order that they
understand the environment where the regulations in question are being applied.
C. BACK: As a regulator, I should say that what is missing, in Europe at least,
is a dialogue between regulators, on one hand, and physicians, hospital managers and
other health care professionals, on the other.
Such a dialogue is difficult to bring about, however, in a situation where, as in
my country, some radiologists carry out many unnecessary examinations, purely for
the money.
L.K. WAGNER: I do not know how things are in other countries, but in the
United States of America we have an onerous system that involves citations being
issued for minor violations of the regulations. Quite frequently, regulators carry out a
survey at a hospital and, instead of taking a broad look at the quality of the medical
activities, focus on what is being done wrong. It should be possible to enforce regu-
lations in a constructive manner.
J. CASSAR: I agree. Regulatory bodies need to be persuasive. However, cita-
tions for minor violations of the regulations do underline the importance that should
be attached to a safety culture.
M. VERDEJO SILVA: In my country the regulations take account of the views
of radiologists, medical physicists and other health sector professionals, and also of
private companies that distribute X ray equipment.
With the publication of the regulations, which apply in all of the states consti-
tuting Mexico, we trained the regulators who are responsible for verifying compli-
ance in each state. These regulators invite the owners of radiological equipment to
propose programmes for rectifying situations where non-compliance with particular
requirements has been noted. The response has been very positive.
J. HERNÁNDEZ ARMAS: In some respects the Spanish legislation went
beyond what professionals considered to be necessary. Subsequently, however, most
professionals became very positive regarding the regulations based on the legislation.
That was the result of improved education and training and of the fact that many pro-
fessionals saw how compliance with the regulations led to the better radiological pro-
tection of patients.
I believe that regulators should periodically ascertain the views of those who
are subject to the regulations. The feedback can be very useful.
T.M.L. SIPILÄ: We have been organizing meetings between hospital and regu-
latory body personnel for about 20 years, with very positive results.
F. VARGAS MARCOS: I am surprised that in the USA there appears to be no
dialogue between radiology professionals and regulatory body personnel. We at the
Spanish Ministry of Health maintain very close contact with the relevant scientific
bodies, and Spain’s regulations have strong backing from radiologists, medical physi-
cists and other professionals. I should be interested in learning more about the rea-
sons for L.K. Wagner’s concern.
L.K. WAGNER: In my country there is a history of animosity between physi-
cians, on one hand, and regulators, on the other. Physicians often notice that regulators
do not understand what they are doing, while regulators often feel that physicians do not
care about the regulations and want to be rid of the regulators as quickly as possible.
There is a tradition of negative feedback from regulators, which has got to end.
Only through a great effort on the part both of regulators and of physicians will it be
possible to eliminate the suspicion that exists at present.
A. NIROOMAND-RAD: I agree with L.K. Wagner. At our institution we used
to have cobalt machines that were inspected periodically by the US National
Regulatory Commission. Finally, we decided to get rid of the cobalt machines as we
were tired of receiving citations from the commission because of minor incidents
rather than being given credit for the good things that we were doing.
I think there is a widespread feeling among physicians in the USA that regula-
tors basically do not know what is involved in the day to day work of physicians.
In my opinion, what regulators should do is check whether, at each institution,
the fundamentals of quality assurance are in place, staffing is appropriate and proper
education is being provided. They should not get into the minutiae of what is being
done and how, as they do not have the necessary expertise.
F. VARGAS MARCOS: Clearly there is a need for better communication
between regulators and physicians in the light of the day to day realities.
J. CASSAR: I agree. The implementation of regulations is an ongoing process,
and one ultimate objective should be a safety culture that is recognized by regulators
and physicians alike.
CONTENTS
OPENING SESSION
Opening Address
Opening Address
J.Á. Azuara . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Opening Address
Opening Address
R. Ruiz Cruces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Opening Address
F.A. Mettler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Opening Address
A.J. González . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Opening Address
K. Schnuer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Opening Address
C. Borrás . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Opening Address
H. Ostensen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31


C. Borrás . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
H. Ostensen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
P.C. Shrimpton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
g
F.A. Mettler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
of patients
A. Niroomand-Rad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
G.A.M. Webb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
H. Svensson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
A. Yule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
H. Amaral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
BRIEFING SESSION

P.C. Shrimpton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
F.A. Mettler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
A. Servomaa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
D.J. Goodenough . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
J.-F. Lacronique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
TOPICAL SESSIONS


M.M. Rehani . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
h
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178


J.E. Gray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199


R. Padovani . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223


L.K. Harding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234

(Topical Session 5)

M. Rosenstein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259


C. Streffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275

(Topical Session 7)
i
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285


Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325


J. Liniecki . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 343


Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 357


L.K. Wagner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 361
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 375

j
K. Faulkner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 379
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 386


J. Cassar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 391
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 398
ROUND TABLES

caregivers? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 455

Author Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 587
k
EXPECTATIONS OF PATIENTS’ ADVOCATES
(Round Table 1)
Chairperson
B. BALABAN
ROUND TABLE 1
EXPECTATIONS OF PATIENTS’ ADVOCATES
Summaries
B. Balaban (United States of America)
The issue for patients is that exposure to cancer causing radiation occurs on the
request of the people entrusted to take care of them — their doctors. We suspect that
many deaths from heart disease or lung cancer are really radiation related deaths and
we need both patient and practitioner education to prevent this.
Questions for patients and practitioners:
— What are the side effects of various radiological procedures?

— Are those areas of the body most sensitive to damage from X rays being
shielded?
— I want to know actual doses, not ‘effective dose equivalents’
— Are there any drugs that interact adversely with radiation?
— Does irradiated food have an impact on the total radiation body burden?
— How does sensitivity to radiation damage vary with sex and age?
— How does radiation interact with other carcinogens — PCBs, OCCs, tobacco,
chemotherapeutic agents, prescription drugs, certain heritable mutations?
— How much medical X ray exposure has each patient had? How can we keep
track?
— Are the X rays suggested necessary or just a precaution against the physician
being sued?
Recommendations:
— We need both patient and practitioner education.

— Compile a list of recommended radiation doses for various examinations and
treatments, stratified by age.
— Set up demonstration centres to test ways of lowering X ray exposure by pro-
fessional training, reducing dose per exposure and the number of exposures,
redesign of equipment, promulgation of standards for medical practitioners and
legislation.
— Develop informed consent procedures for X ray examinations.
403
404 ROUND TABLE 1
— Develop relevant international standards for the radiological protection of

patients.
— Practitioners other than radiologists who take X rays should be certified (e.g.
dentists, cardiologists, urologists, gastroenterologists, orthopaedic surgeons
and chiropractors).
E. Marshall-Depommier (France)
The patients’ needs are very similar to the practitioners’ good practice stan-
dards, for both of them aim at a good medical outcome. Following quality assurance
procedures ensures the avoidance of accidental overexposures in the radiotherapy and
of unwanted side effects in diagnostic procedures.
Patients understand that when they suffer from potentially fatal illnesses, cura-
tive treatments are heavier, take longer time and have more side effects than those for
benign illnesses. They also understand that highly specialized techniques are
required, which are constantly evolving for they are computer related medical tech-
niques. Radiotherapy and interventional radiology both lead to high doses but the ill-
ness being treated is life threatening. There is no scientific certainty about the bio-
logical effects of diagnostic low doses and there is a high benefit to be expected from
the information provided by the diagnostic procedure. Therefore most patients do not
complain about the treatment nor about the side effects, but about the lack of infor-
mation provided by the medical staff before, during and after the procedure. Medical
staff should be trained to overcome any fear of speaking with patients. By meeting
patients but also healthy persons, on a regular basis, medical staff would learn to lis-
ten to patients’ expectations and anxieties, find together the words to explain radio-
logical procedures, answer patients’ (and families’) questions and establish together
the tools for a fruitful dialogue.
F. Ferraro (Costa Rica)
In November 1996, the health authorities of Costa Rica informed the public of
the radiation accident involving a cobalt therapy unit where 115 persons were over-
exposed, 80 of whom have died to date.
Now, thanks to the efforts of the current administration, we have made major
progress in the equipment area through:
(a) The purchase of:

— One simulator,
— Two planning units,
— One high dose brachytherapy unit.
PATIENTS’ ADVOCATES 405
(b) One surface therapy unit:

— Construction of six bunkers,
— Construction and remodelling of the patient treatment and waiting areas.
(c) As regards staffing:
— Training of five new radiotherapists,
— Training of three new medical physicists,
— Courses for dosimetrists, technicians and engineers in the oncology pro-
gramme.
(d) Setting up of the radiation protection department at the institution.
(e) Purchase of two linear accelerators for 2002.
The current administration views care of cancer patients as a priority and is seri-
ously confronting the challenge of providing high quality services.
More emphasis is now being given to patients’ rights; they are being actively
involved in the decision making process and are being kept informed about their ill-
ness and treatment.
We are committed to giving radiotherapy the place it deserves as a treatment
alternative for our cancer patients, ensuring timely access to real opportunities of a
cure and improvement of their quality of life.
J. Rijlaarsdam (Netherlands)
The merit of the European Medical Exposure Directive (Directive 97/43

Euratom, dated 30 June 1997) is that it initiated not only legislation for radiation, but
also created the necessary platform for further development of a ‘radiation protection
culture’. A true radiation protection culture will only be achieved if the Basic Safety
Standards, justification and optimization are applied in conjunction with other ethical
and legal standards.
The medical–ethical standard is formulated in the Hippocratic oath. This stan-
dard is about ‘doing good and not harm’. By this he meant a serving physician, some-
one who not only possessed the expertise to carry out his profession, but also the
skills, moral qualities and values.
According to legal standard, the physician will only be permitted to expose a
person to ionizing radiation with the permission of the person. The golden rule is:
“No treatment without permission, no permission without information”.
Drawing up a care guideline by and for professionals is the best method to
implement the Basic Safety Standards and, with due regard for other legal require-
ments, to guarantee a person the necessary radiation protection. The care guideline
concerns all phases of the care, including aftercare. To gain recognition it must sat-
isfy the following requirements: the special needs of the person, the latest scientific
406 ROUND TABLE 1
knowledge, transparency, recordability, effectiveness, testability, authoritativeness

and full integration of the ‘patients’ rights’.
In conclusion, one can say that a careful elaboration of the Basic Safety
Standards for radiation protection must take place together with ethical and legal stan-
dards. This needs to be done in close co-operation with all professionals involved in
exposing persons to ionizing radiation.
A. Muñoz (Spain)
First of all, I would like to speak about the information that I, as a radiotherapy
patient, would like to receive. Generally, when you begin a radiotherapy treatment,
you know nothing about it. How much information should you have? Let me give you
an example. When I was receiving my treatment, I heard about the Balkans syndrome
on the news. Some of my doctors had said that sometimes this kind of radiotherapy
treatment can cause leukaemia. I was not afraid because I trusted my doctors, but why
did not anybody tell me about it?
There is another important point that influences the patients’ confidence in their
treatment, and this is the apparent lack of communication between different oncology
departments. Patients often receive chemotherapy treatments in one hospital and
radiotherapy treatments in another one. They have the feeling that they go from one
place to other and nobody is really following their case.
Another important subject that was not discussed with me by my doctors was
the effect of the treatment on my appearance. There was some talk about the investi-
gation, the drugs and the treatments but nothing about how they would affect my
looks. Some patients lose their hair, some have problems with their skin — and they
feel really bad because of these things. Doctors should not forget to discuss all these
issues with patients. If you think that you look bad, you feel ill.
L. Moreno García (Spain)
My experience may be summarized as follows:
Since I was diagnosed with carcinoma of the thyroid in March 2000, I have
been kept informed at all points of the nature of my disorder and the treatment and
follow-up I would receive.
I was to receive a dose of radioactive iodine to eliminate all my thyroid cells.
This meant that I would have to comply with certain recommendations before and
after receiving the dose of radioactive iodine. These recommendations were pharma-
cological, nutritional and hygiene related, and I had to be isolated. The isolation, and
having to comply with these recommendations, have a psychological effect and

impair one’s capacity of adapting to the situation. This, I think, is the main problem.
The staff made a notable effort to keep me properly informed so as to ensure that the
isolation went well.
Discussion
Chairperson: B. Balaban (United States of America)
Round Table members: E. Marshall-Depommier (France)

F. Ferraro (Costa Rica)
J. Rijlaarsdam (Netherlands)
A. Muñoz (Spain)
L. Moreno García (Spain)
F.A. METTLER: From conversations with patients’ advocates I have the impres-
sion that in their opinion there have been improvements. Is this impression correct?
B. BALABAN: In my opinion there have been improvements, but I think a lot
more still needs to be done.
F.A. METTLER: Many patients do not seem to feel the same way towards
chemotherapy as towards radiotherapy, perhaps because in radiotherapy they are sep-
arated from the people who are treating them. Would any of the panellists care to
comment on this point?
A. MUÑOZ: I think there is a lot of truth in this. I underwent chemotherapy for
five months, during which there was no intimidating equipment about and the physi-
cian was able to sit with me while the infusion was taking place and talk with me
about whether I had been suffering from nausea, whether I was afraid, how my part-
ner was reacting to my illness, and so on. When you are feeling rotten, you need to
be able to talk to a physician in this way.
E. MARSHALL-DEPOMMIER: A professor of radiology once said that
patients talk about ‘my doctor’ and physicians talk about ‘my patient’, but radiolo-
gists talk about ‘my equipment’. I cannot help feeling that for many radiologists the
equipment is a kind of screen sheltering them from the patients — at least in the field
of diagnostic radiology. Perhaps that is why they choose to specialize in this field.
Moreover, as we heard from A. Yule of the International Society of Radiographers
and Radiological Technologists, about 90% of diagnostic imaging is carried out by
technicians, not by radiologists — and the patients are usually unaware of the fact.
408 ROUND TABLE 1
B. BALABAN: In radiology there is obviously a need — on radiological pro-

tection grounds — for a screen between the patients, on one hand, and the people
treating them, on the other. However, a way must be found to prevent this screen from
being a psychological barrier.
E. VAÑÓ CARRUANA: I agree with B. Balaban. In my view, the best way of
doing that is to provide patients with enough of the right sort of information.
A. MUÑOZ: I agree with B. Balaban and E. Vañó Carruana. Perhaps I can illus-
trate the situation by means of an analogy. As a journalist, I often interview people,
recording what they say on tape. Sometimes the interviewee becomes nervous when
I switch on my tape recorder. When this happens, I switch off the tape recorder and
explain how I think the interview will proceed and that the tape recorder is simply an
aid to my less than perfect memory. After such an explanation the interviewee is usu-
ally quite relaxed when I switch the tape recorder on again.
In my view, much the same effect could be achieved with patients facing a mass
of radiology equipment.
K.A. SPANSWICK: From comments made here I have the impression that
there is a widespread belief that the interests of patients are represented only by
patients’ advocates. In my country, however, the interests of patients are represented
by independent bodies such as the National Radiation Protection Board and may
therefore be regarded as being indirectly elected by the population at large.
The reason why, say, my mother is not a member of such a body is that the radi-
ological protection of patients is a highly technical subject.
B. BALABAN: It is indeed a highly technical subject, but in my country I know
many present and former breast cancer patients who were never involved in politics
(who were never even involved in, say, the parent/teacher association at their chil-
dren’s school) and are now sitting in committees (for example, at the National Cancer
Institute) where their contributions are greatly appreciated. They are capable of
explaining very clearly to legislators what kind of legislation they consider to be nec-
essary. They tend to speak in very simple terms, but sometimes this is helpful when
one is dealing with a complex subject, and when there is something which they do not
understand they ask for an explanation — and with time they learn. The process
works.
I am not a scientist, but I now feel very comfortable when I talk to scientists and
there are many women in a similar situation. Most people are able to grasp more than
they are given credit for. What has happened in the United States of America in the
field of patients’ advocacy is quite remarkable.
A. RAMÍREZ: Reverting to the question of the difference between radiother-
apy and chemotherapy, I would like to point out that we have a much more accurate
idea of what we are administering in the case of chemotherapy than in the case of
radiotherapy and that, as a rule, we have to wait far longer to see the effects of radio-
therapy than those of chemotherapy.
As regards the first point, we need irradiation equipment with dose recording
systems which give a more accurate idea of what the patient is receiving.
B. BALABAN: As regards A. Ramírez’s second point, I think we need many
more cohort studies in order to better understand what happens to people after they
have received various kinds of radiation treatment. There have not been many such
studies, as they are expensive and do not yield results quickly.
L.K. WAGNER: I should like to ask L. Moreno García whether the instructions
which she received regarding her behaviour after treatment were adequately
explained.
L. MORENO GARCÍA: Yes, the instructions were accompanied by explana-
tions of the underlying reasons. In my view, without such explanations the instruc-
tions would not have made much sense.
L.K. WAGNER: Do you think that simplifying the instructions and relaxing the
isolation conditions would be helpful to patients?
L. MORENO GARCÍA: Yes, I do.
J.H. GÖTHLIN: As someone who works in a hospital department of radiology,
I believe that there is a psychological barrier between patients and radiologists, whose
numbers are declining in many countries where there are understaffed radiology
departments at a large number of hospitals.
In my opinion, it is for the referring physician to judge whether an examination
using radiation is necessary and to explain the risks and benefits to the patient. This
means that referring physicians must be taught what the risks and benefits of radio-
logical procedures are — something which is not done very often.
B. BALABAN: In my view, it would be helpful if each patient carried a chip
card with information about the radiation administered to him or her over the years.
It should be possible for the information to be generated by the irradiation device and
transmitted immediately to the chip card, which would thereby be kept up to date.
R.H. CORBETT: A couple of years ago, I carried out a survey of patients in my
part of Scotland and found that about 90% of the patients covered by the survey had
no interest in knowing what was wrong with them and what was being done to them;
their attitude was ‘The doctor knows best’.
If my findings are valid, there is — in my view — little chance that people will
be interested in accurate records being kept of the radiation administered to them dur-
ing radiological procedures. Moreover, a person with a certain kind of complaint goes
to a physician in the expectation that an X ray examination will be carried out, and if
it is not carried out this person may well go to another physician — one who will
carry out the expected X ray examination. And if the X ray examination does not pro-
vide any answer, this person may well consult another physician and request an X ray
examination without mentioning that one has just been carried out.
I would welcome the ‘chip card solution’ envisaged by B. Balaban and I com-
mend her for her enthusiasm in the cause of patients’ advocacy. I also welcome the
410 ROUND TABLE 1
fact that the Royal College of Radiologists in the United Kingdom now has a patients’
advocacy committee. However, as a radiologist I believe that the real problems can-
not be resolved by patients’ advocacy.
B. BALABAN: I agree that many patients do not wish to know what is wrong
with them and what is being done to them. This is the fault of an educational system
that does not encourage and teach people to ask questions.
There is a great difference, however, between a patient who does not know how
to — or is afraid to — ask the necessary questions and a patient who does not wish
to know whether he or she has cancer. In the case of the latter patient, the physician
should not tell.
M.C. PARADES GARCÍA: I should like to thank A. Muñoz and L. Moreno
García for their Round Table contributions, from which I learned a lot about how we
should deal with patients.
With regard to F. Ferraro’s Round Table contribution, on the accidental overex-
posure of radiotherapy patients in Costa Rica, in my view two radiotherapy physicists
are not sufficient to handle all the work associated with the radiotherapy equipment
now available at the hospital in question.
F. FERRARO: I agree. We still have a long way to go.
D. GOODENOUGH: With regard to the question of keeping track of the radi-
ation doses received by patients, it may be relatively straightforward in the case of
radiotherapy. In the case of radiodiagnosis, however, the doses tend to be much lower,
and factors such as the natural radiation background become important. You might
ultimately have a situation where people, being aware of the total (human made and
natural) radiation doses received by them, become excessively sensitive about the
radiation doses administered for diagnostic purposes.
B. BALABAN: I agree that, because of environmental and other factors, it is
difficult to keep track of radiation doses administered for diagnostic purposes, but
I do not think that it is impossible. And in my view it is something worth trying to
do.
D. GOODENOUGH: Is it something worth trying to do when the necessary
resources could be expended more usefully on, say, a campaign designed to stop par-
ents smoking in the presence of their children?
B. BALABAN: When a legislator asks where the resources needed for an
expansion of research activities at the National Cancer Institute are to come from, I
say ‘That’s your problem. My job is to tell you what needs to be done’.
L.K. WAGNER: I do not believe that, if I were to keep track of the effective
doses from the examinations carried out by me over a period of years, I would know
what to make of the resulting numbers. There are too many confounding factors —
smoking, alcohol consumption, airline flying, and so on.
In my view, the issue is simply whether the likely benefits to be achieved
through the examination justify taking the risks.
B. BALABAN: In the light of what some participants have just been saying, I
am willing to modify my goal and think in terms simply of somehow creating a situ-
ation where patients can give their physicians an idea of the kinds of medical X ray
exposure they have undergone in the past, so that we can prevent incidents such as
those which we have heard about at this conference.
I should like patients to be aware that they can say to their physicians ‘Is this
procedure necessary or only advisable? If it is only advisable, let’s talk about it’. The
busy physician should not have to remember to ask the patient how much medical
radiation exposure he or she has already undergone.
L.K. WAGNER: I would say that the doses — or at least the skin doses —
received in interventional radiology should be kept track of. I am less concerned
about the doses received in diagnostic radiology.
J. LINIECKI: I am afraid that the ‘idealogical’ approach of B. Balaban might
result in situations where the physician, knowing the patient’s radiation exposure his-
tory, would not take necessary measures involving further radiation exposures,
thereby laying himself or herself open to charges of negligence.
I have been a physician for 50 years, and I cannot go along with this approach.
J. RIJLAARSDAM: The physician must, of course, justify a radiation exposure
on the basis of his or her professional knowledge and experience. However, the
patient may — in line with a growing trend — want to have a say in what is to be
done and ask what harmful effects the radiation exposure could have in the light of
previous exposures. Physicians must be prepared to answer such questions, and
patients asking them should be able to say what the previous exposures were.
E. MARSHALL-DEPOMMIER: If the patient can say what previous radiation
exposures he or she has undergone, it may be possible to consult the associated
records and thereby make a further radiation exposure unnecessary.
F.A. METTLER: In my country, the physician asks the patient about his or her
overall medical history, not just his or her radiation exposure history. The physician
wants to know what medicines the patient has been taking, and so on.
Regarding B. Balaban’s comment about a chip card with information on radia-
tion exposures, I would mention that in the USA a chip card for the recording of entire
medical histories has been developed for military personnel, who carry it like a dog
tag.
B. BALABAN: I would welcome the introduction of such a chip card for gen-
eral use.
WHAT SHOULD BE DONE ABOUT
RADIATION SENSITIVE GROUPS?
(Round Table 2)
Chairperson
J. HENDRY
United Kingdom
ROUND TABLE 2
WHAT SHOULD BE DONE ABOUT RADIATION

SENSITIVE GROUPS?
Summaries
J. Hendry (United Kingdom)
There is evidence for variation in susceptibility among individuals regarding

carcinogenesis. This evidence includes the early and enhanced frequency of second
tumours in irradiated individuals with rare syndromes, for example basal cell naevus
syndrome and heritable retinoblastoma. These, and other cases, comprise a few per
cent of people with known mutations predisposed perhaps tenfold to radiogenic
cancer. Also, there is evidence that there are other low penetrant predisposing gene
mutations, for example 40% of breast cancer cases show increased lymphocyte G2
chromosomal radiosensitivity with 60% heritability. All these cases are already
included in current risk estimates, but there is a distribution of risk within the total
population.
Regarding high dose exposures as in radiotherapy (and a few accidents), evi-
dence for heterogeneity in response comes from the steepness of the dose–response
curves for morbidity, the analysis of interpatient versus intrapatient response vari-
ability using data for paired-field irradiations on individual patients, and the severe
reactions in rare radiosensitivity syndromes such as ataxia telangiectasia. The latter
syndromes comprise less than 1% of the population, and the remainder shows a range
of radiosensitivity values around the median.
Detection of radiosensitive individuals for diagnostic and radiotherapeutic pur-
poses includes (a) suggestions from a strong family history of cancer, which can be
confirmed by using molecular tests, (b) indications from pretreatment cellular sensitiv-
ity tests, and (c) severe early reactions during the first part of a radiotherapy schedule.
C. Streffer (Germany)
There is rich clinical experience from cancer therapy with ionizing radiations
that a wide variability exists in humans with respect to individual radiosensitivity. In
a number of cases it has been possible to show that this variability is due to a genetic
predisposition and several genetic syndromes could be defined such as
415
416 ROUND TABLE 2
— ataxia telangiectasia,
— Bloom’s syndrome,
— Fanconi anaemia,
— Li Fraumeni syndrome,
— Nijmegen breakage syndrome,
— retinoblastoma.
In several of these syndromes it was possible to identify the responsible genes

and to show that mutations in these genes cause the increased radiosensitivity [1].
Many cellular and molecular studies have been performed with cells (mainly fibrob-
lasts or blood lymphocytes) from these patients. Frequently, impairment or defi-
ciencies of DNA repair pathways and changes in the regulation of the cell prolifer-
ation cycle are connected with these syndromes. In patients with hypersensitivity,
frequently an increased genomic instability is observed which increases cancer risk
[1, 2]. The increased radiosensitivity is of significance for the development of radi-
ation risk and for the success of radiotherapy.
Animal experiments have demonstrated that an enormous increase of cancer
risk occurs in p53 knock-out mice (patients with Li Fraumeni syndrome have a germ
line mutation in the tumour suppressor gene p53) and that this effect is highly
enhanced by irradiation. Clinical studies have proven that the risk for secondary
tumours is strongly increased after radiotherapy in children who have been treated for
retinoblastomas and who have a predisposition for this tumour through a mutation in
one of the Rb alleles. In these studies mainly osteosarcomas and soft tissue sarcomas
are increased in the irradiated tissue.
Cancer is a multistep process, and in some radiosensitive syndromes mutations
in tumour suppressor genes reduce the number of necessary steps for cancer devel-
opment and through this mechanism cancer rates are enhanced. Such a mechanism
apparently operates in the development of retinoblastomas and colon cancers. This
increase has been shown up to now only after high radiation doses in radiotherapy.
Studies with low radiation doses are missing.
To recognize patients with increased radiosensitivity, cellular or molecular tests
have to be developed. Mainly chromosomal aberrations or simple assays measuring
DNA repair (comet assay) have been studied in this connection. Thus it has been
observed with breast cancer patients that the rate of chromosomal aberrations has a
wide spectrum with familial correlation [3]. With the comet assay it has been
observed that the DNA repair capacity is reduced in those patients who show severe
side effects during radiotherapy [4].
In general, the variability of individual radiosensensitivity in human popula-
tions is appreciable. Frequently, a genetic predisposition is responsible for such situ-
ations. It is necessary to develop better assays in order to recognize hypersensitive
patients.
RADIATION SENSITIVE GROUPS 417
REFERENCES
[1] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Genetic

Susceptibility to Cancer, Publication 79, Pergamon Press, Oxford and New York (1998).
[2] STREFFER, C., “Genomic instability induced by ionizing radiation” (Proc. 10th Int.
Congr. IRPA, Hiroshima, 2000), Jap. Health Phys. Soc., Tokyo (2000) 1–5.
[3] SCOTT, D., Chromosomal radiosensitivity, cancer predisposition and response to radio-
therapy, Strahlenther. Onkol. 176 (2000) 229–234.
[4] MÜLLER, W.-U., BAUCH, T., STÜBEN, G., SACK H., STREFFER C., Radiation sen-
sitivity of lymphocytes from healthy individuals and cancer patients as measured by the
comet assay, Radiat. Environ. Biophys. 40 (2001) 83–89.
L.V. Pinillos-Aston (Peru)
There are two special situations: those where we know, historically, that
radiosensitivity is increased, such as ataxia telangiectasia or retinoblastoma, inter
alia; and those where we do not know whether this is the case but where this does
occur in medical practice. Such cases oblige us to be mindful of this possibility and
to monitor the patient closely when he or she is exposed to radiation. This means eval-
uating any history of photosensitivity, allergies, prior and concomitant infections, and
medication which might increase the effects of radiation such as some chemotherapy
preparations; during therapy, this means performing careful monitoring at least every
five fractions.
As regards the use of radiation for diagnostic purposes, protection can be
achieved by using alternative procedures such as ultrasound scanning or nuclear
magnetic resonance techniques. When radiation is used, there must be adequate jus-
tification for this, and the procedure must be implemented with sufficient quality in
order to avoid further exposure from the repetition of badly performed examina-
tions.
With regard to therapy, we must look at alternative treatments such as surgery
or chemotherapy, or plan combined treatments which allow the dose or the irradiated
volume to be reduced. As regards actual radiotherapy, we must attempt to reduce the
irradiated volume by employing external conformation therapy or brachytherapy,
using shielding plates for blood vessels, the rectum, the bladder and other vulnerable
organs, and performing oophoropexy where this seems advisable. The dose must be
reduced: either by reducing the total dose, or the dose must be modified by fraction
using hyperfractionation, ultrafractionation, continuous hyperfractionation or an
interrupted course of treatment. The use of radioprotective agents such as amifostine,
colony stimulating factors, cortisone and ACE, and the use of genetic therapy to
418 ROUND TABLE 2
improve repair, are a good strategy for alleviating early reactions and the effects of
delayed reactions.
A series of laboratory tests for cell sensitivity are currently available which can
help us to identify radiosensitive patients before they receive treatment. The above
mentioned measures can then be used on such patients. However, these tests could
also help us to identify patients with lower levels of radiosensitivity for whom we
could programme a scaling of the dose which would enhance control of the disorder.
We hope that these tests will soon be available in regular clinical practice.
E.H. Kamal (Sudan)
This presentation is mainly based on clinical observation, as advanced tests of

fibroblast or lymphocyte culture are not available in Sudan. In Sudan there are two
radiotherapy hospitals: the main one in Khartoum, the Radiation and Isotopes Centre
of Khartoum (RICK), and the second centre has started two years ago at Medani, the
second city of Sudan.
Breast cancer is the most common cancer in Sudanese women. It forms
34.5% of all women cancers, 85% present with stage 3 and 4 disease. In 1999 and
2000, 78 patients had breast conservation treatment for early stages followed by
external radiation with a total dose of 45 Gy delivered in 20 fractions over four
weeks by cobalt-60. Eight of them had severe skin reactions, most desquamation
and hyperpigmentation. None of them had neoadjuvant chemotherapy, their treat-
ments were stopped, and BRCA gene tests were not performed for them.
Retinoblastoma is the second most common cancer in Sudanese children, form-
ing about 14% of all paediatric cancers. In 1999 and 2000, 94 cases were treated at
the RICK. Nearly all of them presented with ulcerated tumours, and enoculation was
performed, first followed by external irradiation of the orbit by one field or two
wedged fields giving doses ranging between 4000 and 4500 cGy. Four out of 94
patients (5%) developed severe acute reaction during the third week of treatment, and
treatment had to be terminated. It is not our policy to give routine adjuvant
chemotherapy to retinoblastoma patients.
During 1999 to 2000, we saw seven patients with xeroderma pigmentosa x.p.
They presented with squamous cell carcinomas, all of them with advanced ulcerated
tumours, so surgery was not offered to them and palliative radiotherapy was given.
Two of them developed severe skin reaction.
There is a chance for collaborative studies especially in retinoblastomas, given
the high prevalence of this tumour in Sudanese children. In our situation there is a
need for close follow-up of patients during radiotherapy, to be aware of hypersensi-
tive patients, stop treatment earlier and try alternative therapies. Our observations
suggest that about 5 to 10% of patients are hypersensitive to irradiation.
Discussion
Chairperson: J. Hendry (United Kingdom)
Round Table members: C. Perez (United States of America)

C. Streffer (Germany)
L.V. Pinillos-Aston (Peru)
E.H. Kamal (Sudan)
L.K. WAGNER: There is speculation — and data to suggest — that people

with diabetes mellitus, lupus erythrematosus, connective tissue disease and even
thyroid disease are hypersensitve to ionizing radiation. Would C. Streffer care to
comment?
C. STREFFER: This is an important issue, particularly for interventional radi-
ology.
There are a number of known genetic syndromes — and probably many
unknown ones — involving higher radiosensitivity. In the case of such syndromes, it
is necessary to find out, through cellular and molecular studies, what the mechanism
is and then to identify the responsible genes.
With most genetic syndromes involving higher radiosensitivity there are reces-
sive genetic traits. This means that only homozygotes are hypersensitive. You will rec-
ognize most homozygotes from their phenotype — an experienced physician faced
with a patient suffering from ataxia will recognize that something is wrong and per-
form the corresponding tests.
The main problem is with heterozygotes, whom you will not recognize.
Although they are less radiosensitive than homozygotes, it helps to perform the cor-
responding tests in order to help identify them.
F.A. METTLER: Besides people who are hypersensitive all over the body, there
are people who are hypersensitive only in some parts of the body — for example,
children, whose thyroids and breasts are hypersensitive. I gather from the literature
that if, say, you treat a teenager for Hodgkin’s disease with mediastinal radiation, the
risk of breast cancer later in life is very high. What should one do with children? In
particular, should one shield the hypersensitive parts of the body?
C. PEREZ: The general radiation management philosophy today in the case of
children is to eliminate radiotherapy as far as possible. Children now undergo radio-
therapy only when it is strictly necessary — for Wilms’ tumours, some neuroblas-
tomas and brain tumours, and a few lymphomas.
F.A. METTLER: This is fine if chemotherapy is available as an alternative, but
what does one do in a developing country where there is no such alternative?
420 ROUND TABLE 2
C. STREFFER: With regard to the point about people who are hypersensitive
only in some parts of the body, if there is a genetic predisposition it will exist in all
cells — there will be no radical difference between organs and tissues.
However, there are many open questions — for example, with regard to
retinoblastomas. The retinoblastoma gene is a tumour suppressor gene involved in the
regulation of the cell cycle. Thus if you have a germ line mutation in this gene, you
will have cell cycle disturbances.
Cancer in the eye apparently manifests itself only as a retinoblastoma, and at
present we do not know why other tissues are not involved in the spontaneous mani-
festation. If we irradiate a person in whom there has been a germ line mutation in the
retinoblastoma gene, however, other tissues are found to be more vulnerable than
those tissues in normal persons.
With regard to the thyroid, we know from the aftermath of the Chernobyl acci-
dent that rearrangements in the RET gene lead to the development of cancers. We also
know that there is sometimes a mutation which makes the patient more vulnerable —
the higher sensitivity manifesting itself only as carcinogenesis in the thyroid.
These are the types of issue about which we need to learn more. Homozygotes
are rare, but heterozygotes account for several per cent of the population.
K. FAULKNER: With regard to breast cancer and genetic hypersensitivity,
what advice would you give about screening for breast cancer?
C. STREFFER: The only thing one can say at the moment is ‘If you have an
indication of increased sensitivity, carry out biological tests with a view to detecting
DNA repair and cytogenetic damage’. That is the easiest thing to do.
Various groups have found quite a number of patients with high radiosensitiv-
ity, but with some patients we do not know which genes are involved. We can there-
fore only look for biological and molecular systems.
J. HENDRY: I suppose that, at present, the techniques which we have available
— assaying DNA repair, chromosome damage or cell killing in in vitro systems —
are not robust and reliable enough to distinguish clearly among patients in the middle
range of radiosensitivity. We can detect the extremes, but this accounts for only a few
per cent at the most.
By using various of the present assay techniques in combination it may be pos-
sible to make progress, and with the next generation of techniques, where we shall be
looking at hundreds — if not thousands — of genes in a patient, we shall have the
gene expression profile and may be able to make overall assessments which are bet-
ter than what we can achieve now. However, nothing will happen automatically; a
great deal of development effort and of work with patients will be necessary.
L.V. PINILLOS-ASHTON: There is research under way which, in a few years’
time, may result in our being able to distinguish those breast cancer patients who are
highly radiosensitive from those who would benefit from radiotherapy as a comple-
ment to surgery — and in our being able to say ‘This woman should have radiother-
apy, that one should not’.
H. TATSUZAKI: When one sees hypersensitivity with regard to cell killing,
should one always expect to see hypersensitivity also with regard to mutations and
carcinogenesis? In other words, can one always see changes in deterministic effects
as well as in stochastic effects?
C. STREFFER: Not always, but in quite a number of cases. For example, AT
patients are very sensitive with regard to cell killing and also have increased cancer
rates.
So far, we do not have enough evidence either way. However, if you observe a
phenomenon such as a decrease in DNA repair, you can expect it to coincide with
increased cell killing and carcinogenesis.
J. HENDRY: There is a correlation for some genes and syndromes but not for
others. With basal cell naevus syndrome, there are increased secondary cancers after
radiotherapy, but the cells from the individuals in question are not generally more
radiosensitive with regard to cell killing. That is a case where there is no consistent
correlation between endpoints.
ESTABLISHING PRIORITIES IN RADIOLOGICAL PROTECTION
(Round Table 3)
Chairperson
J.P. OLIVA GONZÁLEZ

Cuba
ROUND TABLE 3
ESTABLISHING PRIORITIES IN
Summaries
J.P. Oliva González (Cuba)
As is well known, in medical practice, education and research, the use of radi-
ation is widespread and increasing. The IAEA has played and continues to play a very
important role in the widespread use of ionizing radiation in diagnostic and interven-
tional radiology, nuclear medicine and radiation therapy. It is also well known that in
certain circumstances, however, safety mechanisms and procedures have been
ignored or deliberately bypassed, resulting in significant radiation exposure of
patients, as well as occupational exposure of personnel, which has led to serious
injuries and, in some cases, even to fatalities. The IAEA has investigated the more
serious of these incidents and published comprehensive reports so that all can benefit
from the lessons learned.
Worldwide, diagnostic medical exposures provide 0.3 mSv per year of average
dose per caput. In 1988 to 1993, these exposures represented 12.5% of the average
effective dose from natural sources and around 97% of all human-made ionizing radi-
ation exposures. In some industrialized countries, medical exposures represent 99%
of all human-made exposures, while in some developing countries they amount to
only 77% or less. The increasing proportion of older people in industrialized nations
and the increasing access to health care services in developing nations will inevitably
lead to a more widespread use of ionizing radiation for medical purposes. The bene-
fits associated with this expected increase in medical radiation exposure should out-
weigh the risks, but only if adequate safety measures are implemented.
Radiation protection of patients has, as its first aim, to provide an appropriate
standard of protection for human beings against the harmful effects of ionizing radi-
ation, without unduly limiting the benefits of such exposures. Protection of patients
is particularly important as many people are exposed to ionizing radiation from med-
ical practices, and individual doses may be higher than from any other artificial
sources. The elimination of unnecessary exposures, those not justified or resulting in
doses that are inappropriate (either too high or too low) for the attainment of the clin-
ical objective, has become an important task in medical practice.
The aim of this Round Table is to establish priorities in the radiological protec-
tion of patients. These priorities should be flexible enough to permit easy adaptation
425
426 ROUND TABLE 3
to evolving technology or changing conditions in medical procedures and practice.

They should certainly not hinder the delivery of medical care. For example, some
radiology, radiotherapy or nuclear medicine equipment that is no longer in use in
many industrialized countries is often still used in other nations, for economic rea-
sons. In this situation it should be recommended that the regulatory authorities or the
legal persons in charge of this duty in these countries establish safety rules for the
clinical use of ionizing radiation in order to avoid dangerous exposures of patients
who are undergoing medical studies with this older technology.
S. Grgic (Croatia)
The justification and optimization of diagnostic medical exposures and meth-

ods for patient dose reduction are the subjects of main concern. Firstly, consultation
between the radiologist and the referring physician is desirable, to establish justifica-
tion of exposures and the concepts of benefit–risk analysis.
In diagnostic X ray examinations not all methods for reduction of the entrance
skin dose influence the effective dose in the same proportion. From this point of view,
the methods can be classified into two categories:
— Methods leading to a pure reduction of the milliampere seconds without modi-

fication of the beam quality, for instance: improving the film developing condi-
tions or reducing the optical density of the film.
— Methods leading to modification of the dose distribution within the patient by
modifying the beam quality.
To avoid unnecessary skin exposure due to low energy components of the X ray
spectrum, additional filtration is needed. The quality of the image and the radiation
dose depend on the characteristics and upkeep of the film intensifying screen used.
Analysis of rejected films is also important for the evaluation of image quality.
Periodic surveys of all diagnostic X ray equipment should be conducted as part of the
quality assurance programme of the diagnostic X ray facility. Shielding of specific
areas may be of additional value.
The dose to the patient can be limited by the following technical means:
— Keeping the size of the X ray field to a minimum and shielding specific organs
(gonads, eyes);
— Using additional filtration;
— Using low attenuation (e.g. carbon fibre) materials between the patient and the
image receptor;
ESTABLISHING PRIORITIES 427
— Recording the irradiation time during fluoroscopy;

— Using fast intensifying screens;
— Controlling scattered radiation;
— Reduction of repeat exposures;
— Quality assurance, particularly with regard to film processing.
In nuclear medicine, reduction of the absorbed dose to the patient from a given
administered activity of a radiopharmaceutical can often be achieved by the follow-
ing simple measures:
— Oral or intravenous hydration;

— Use of thyroid blocking agents such as KI;
— Laxatives to increase the elimination of radiopharmaceuticals from the gas-
trointestinal tract;
— Diuretics or gall bladder stimulants.
To conclude, it is possible to achieve significant dose reductions to the patient

with simple and low cost methods, without loss of diagnostic information. It seems
possible to choose reference or guidance levels of dose that are valid worldwide for
common examinations and to use them as investigation levels to be implemented in
national legislation. Quality control of all stages of diagnostic and treatment proce-
dures, as well intercomparison of all issues in processing the diagnostic and treatment
outcome, are the key points.
F. Giczi (Hungary)
The International Commission on Radiological Protection, the IAEA, the

European Commission and the other international organizations give a comprehen-
sive system of priorities, recommendations and regulations connecting to the radio-
logical protection of patients in diagnostic and interventional radiology, nuclear med-
icine and radiotherapy.
However, different countries may stand on different levels regarding patient
protection. This situation may cause problems if our goal is to carry out a full scale
implementation of these recommendations and to create conditions for meeting the
requirements on a national and/or regional level. The reasons are as follows:
— Some countries have already brought into force the necessary laws, regulations
and administrative provisions, but other countries have not yet done so;
— Some countries can create the financial conditions to meet the requirements, but
others cannot or do not do so on a full scale;
428 ROUND TABLE 3
— The protocols for the standard radiological practices may be different from
country to country;
— The technical level of radiological equipment may be different in the different
countries;
— The educational levels of practitioners and others involved in medical expo-
sures may be different regarding quality assurance/quality control and radiation
protection issues, etc.
As a conclusion, I think it would be very useful if global priorities for imple-

menting these recommendations at the national or regional level could be established,
taking into consideration the special circumstances, characteristic of the given coun-
try or region. Contributions from the international organizations to promote this
process would be appreciated.
As an example, it can be mentioned that in 1999 the IAEA initiated a co-ordi-
nated research programme in our region. The aim of the programme is to define a
methodology for the implementation of the European Quality Assurance/Quality
Control Protocol for Mammography in the East European countries. This co-ordi-
nated research programme is an outstandingly valuable help offered by the IAEA in
the determination of local priorities in the special field of mammography.
Jun Zheng Zheng (China)
Medical uses of ionizing radiation such as in diagnostic and interventional radi-

ology, clinical nuclear medicine and radiotherapy constitute an important part of
modern medicine. With the continuous development of medical uses of ionizing radi-
ation, this area has become one of the most important branches in the field of radia-
tion protection.
The priorities in radiological protection for medical uses of ionizing radiation
are mainly as follows:
— To strengthen the supervision and management of radiological protection in

diagnostic and interventional radiology, nuclear medicine and radiotherapy, by
the country’s general infrastructure (e.g. by licensing and registration).
— To establish and perfect a standard system for radiological protection in med-
ical exposures; this is the key task. The radiological protection standards should
include:
• Management requirements,
• Responsibilities of each responsible party,
• Justification of medical exposures,
• Optimization of protection for medical exposures,

• Guidance levels for common diagnostic procedures,
• Quality control of medical radiological equipment and its operation,
• Quality assurance of medical exposures,
• Guidance on the prevention and investigation of accidental medical exposures.
— To enhance the capability and quality of medical radiological equipment in

radiological protection and safety.
— To establish and maintain a system of installation, acceptance, status and con-
stancy tests for medical radiological equipment.
— To monitor the radiation exposure of patients, workers and the workplace.
— To provide appropriate education, training and continuous professional devel-
opment in the radiological protection of patients.
— To encourage the manufacture and use of all kinds of radiological protection
products for patients.
— To conduct surveys of medical radiation usage and exposures and to analyse
trends.
— To foster the exchange of information on the radiological protection of patients
and international co-operation in medical exposures.
J.E. Ngaile (United Republic of Tanzania)
To establish a national infrastructure in the radiological protection of patients,

one must provide a national legal framework and regulations governing medical
exposures; a regulatory authority for the enforcement of regulations and standards
governing radiological protection; adequate education and training programmes for
regulatory staff and professionals in radiation protection and safety measures; the
capability to perform patient dosimetry, calibration and to implement quality control
and quality assurance programmes of radiation devices and techniques for medical
uses of radiation; and the capability to implement maintenance programmes of radi-
ation equipment.
In the United Republic of Tanzania, we are facing difficulties in enforcing radi-
ation protection of patients because there are no specific regulations governing med-
ical exposure; there is no in-house quality control and quality assurance programme
for almost all diagnostic facilities; there is no appreciation, on the part of registrants
and licensees, of adhering to radiation safety standards; and inadequate resources
force the majority of hospitals to use expired films, exhausted film chemicals and
poor processing conditions.
To create a good national infrastructure for the radiological protection of
patients, the government should have a national legal framework, carefully designed
430 ROUND TABLE 3
regulations and adequate enforcement of the regulations. It should provide adequate

resources and arrangements for the education and training of professionals and
regulatory staff. Governments should also establish regulations that specify the neces-
sity of comprehensive quality assurance and quality control programmes including
calibration of therapy equipment, maintenance of radiological equipment and accep-
tance testing of instruments following their installation.
Discussion
Chairperson: J.P. Oliva González (Cuba)
Round Table members: Jun Zheng Zheng (China)

S. Grgic (Croatia)
F. Giczi (Hungary)
H.B. Wang (Malaysia)
J.E. Ngaile (United Republic of Tanzania)
A. DÍAZ APONTE: In many countries, especially Latin American ones, the

ministries of health are run by physicians, who tend to attach great importance to the
quality of diagnostic images without worrying very much about the radiation expo-
sures involved in obtaining the images. How can one make ministries of health more
aware of the risks associated with such radiation exposures?
J.P. OLIVA GONZÁLEZ: The problem is a worldwide one although it does not
exist in my country, and international organizations such as the IAEA, the World
Health Organization and the Pan American Health Organization (PAHO) are trying to
bring it to the attention of governments. We who are working in radiology and related
fields should do what we can in our own countries to complement the efforts of these
organizations.
I. OTHMAN: In the field of radiological protection of patients there are devel-
oped countries and developing countries. The difference is not due to a shortage of
radiologists, technicians and equipment in developing countries; most radiology
departments in such countries have sufficient resources of this kind. It is, however,
due to the poor safety culture in developing countries. If you carry out a survey of a
radiology department in a developing country and make recommendations for
improving its procedures, you are unlikely to find any changes for the better during
your follow-up visit. Thanks to organizations such as the IAEA, it is easy to establish
the necessary regulations; the difficult thing is to enforce them.
J.P. OLIVA GONZÁLEZ: I agree with you.
Where safety culture is poor, it must be improved because we should not accept
a situation where there is one level of radiological protection for those who are afflu-
ent and another level for those who are not.
The question is very much one of education and training, which must be such
as to ensure, for example, that the radiologist, before allowing a female of child bear-
ing age to be exposed to radiation, asks her whether she is pregnant — an elementary
precaution that is often forgotten.
However, even the best education and training in a developed country will not
help if the persons sent there by developing countries to be educated and trained are
not prepared to work hard and, on returning home, to share with their colleagues the
knowledge and experience which they have gained.
A. PIÑERO: When I hear that for 60% of the examinations carried out in a radi-
ology department the results are normal and that the examination has revealed that
nothing is wrong with the patient, I suspect that something is wrong in the radiology
department. Especially in developing countries, physicians are often under great pres-
sure to prescribe expensive examinations even if these are unnecessary. Such pressure
may be due to fear of overlooking something or be exerted by the patient or his or her
relatives; it may be exerted by people who have invested heavily in radiology equip-
ment and wish to see a return on their investment.
Matters would be improved if there were proper planning of health care —
planning designed to ensure, inter alia, a better distribution of equipment and other
resources.
J.P. OLIVA GONZÁLEZ: The proper planning of health care is something
which organizations such as the IAEA and PAHO could promote, but the real effort
would have to be made at the national level.
F.A. METTLER: I would be interested in knowing the opinion of participants
in this conference regarding what percentage of national budgets for public health
should be spent on radiological protection.
J.E. NGAILE: In a developing country such as mine, where diseases such as
malaria and AIDS constitute an enormous problem, very little of the public health
budget is likely to be spent on radiological protection.
L.A. JOVA SED: In developing countries, the percentages of public health bud-
gets spent on radiological protection should be significantly larger than the percent-
ages currently being spent on it. In many developing countries, the radiological pro-
tection of patients is an issue which has been sadly neglected and, besides the harm
which may be done to patients as a result, one must bear in mind the impact which
serious radiation accidents in medicine can have on public opinion.
RISKS AND BENEFITS: CAN THEY BE ASSESSED? HOW?
(Round Table 4)
Chairperson
M. VERDEJO SILVA
Mexico
ROUND TABLE 4
RISKS AND BENEFITS:

CAN THEY BE ASSESSED? HOW?
Summaries
M. Verdejo Silva (Mexico)
Evaluation of benefit has been mentioned on several occasions during this con-
ference. Is this done in line with specific measures? Does one identify what exposure
to radiation can lead to, for research workers, radiologists, radiotherapists and nuclear
medicine staff?
Does one link this to patients requiring diagnosis or treatment?
Does one link it to occupationally exposed staff or to the general public, who
are exposed through living in a society where the environment is probably affected by
non-natural radiation?
The various opinions of experts in the research area, in utilization and govern-
mental regulation, including doctors, medical physicists and legislators, could all
make a contribution to risk evaluation, looking at non-natural radiation sources from
their point of origin to their final destination.
Finally, the existence of quality assurance programmes for protection of public
health would have to be justified, where the staff involved need to have the necessary
knowledge and training.
J.L. Ramirez Arias (Mexico)
The aim of my presentation was to evaluate the benefits rather than the risks of
using ionizing radiation on patients. Emphasis was placed on the as low as reasonably
achievable (ALARA) terminology and the principle that, if an imaging study has no
impact on patient treatment, it should not be performed. It was recognized that radi-
ation can cause damage; however, in practice such damaging effects are generally
extraordinarily rare.
Radiographic images of the thorax were shown of patients with tuberculosis
and abnormalities which could only be revealed using by such studies or computed
tomography. It was pointed out that treatment cannot be initiated on the basis of
bacteriology alone when there are atypical localizations or complications such as
pleurisy and bullae. The fact was also mentioned that false negatives are produced in
435
436 ROUND TABLE 4
the case of some forms of tuberculosis such as miliary tuberculosis. Masses in the
mammary glands of pregnant patients were shown, demonstrating the need to differ-
entiate between galactoceles and real developing tumours, for which purpose ultra-
sound scanning is not specific enough. Mastography must therefore be performed.
Computed tomography and magnetic resonance studies in pregnant patients
with cerebral problems of vascular or tumoral origin were evaluated. It was found that
magnetic resonance studies are suitable; however, it must be borne in mind there is a
shortage of equipment in developing countries and these studies may be very costly
so that it is justified to perform computed tomography.
The same was found for patients with other disorders of abdominal origin
who are viewed as medical surgical emergencies. In closing, emphasis was placed
on the extensive communication which must take place between clinicians, radiol-
ogists and patients in order to justify the risk of diagnostic studies involving the use
of radiation.
M. Waligórski (Poland)
Let us make an attempt at assessing the risk and benefit to the patient in four
types of medical procedures involving ionizing radiation: (1) diagnostic radiology, (2)
diagnostic nuclear medicine, (3) interventional radiology and (4) radiotherapy. A
quantitative assessment of risk for the first two of these types of procedure could in
principle be made via risk factors supplied by the International Commission on
Radiological Protection (ICRP) Publication 60 [1] and the Medical Internal Radiation
Dose Committee [2], as they apply over the dose levels involved. The radiation dose
incurred by the patient in interventional radiology may be considerably higher and, if
exceeding the threshold, even involve early effects, such as skin desquamation. This
has to be accepted against the life saving circumstances of interventional radiology.
As to diagnostic radiology and diagnostic nuclear medicine, the benefit is clearly in
the correct diagnosis of the patient’s condition, and the patient is protected by obser-
vation of guidance levels relating to patient dose, as introduced in the Basic Safety
Standards. F. Mettler and other colleagues have pointed out during this meeting that
when prescribing and performing diagnostic radiology, nuclear medicine or interven-
tional radiology, the medical doctors will be guided by their own ‘gut’ judgement of
the benefit to the patient, and not by any quantitative rules suggested by a radiation
safety officer. However, the medical practitioner should be made well aware of the
potential radiation hazard to the patient and of any relevant threshold dose values for
early radiation effects.
We encounter a totally different situation in radiotherapy. Here, radiation is
the curing agent and, according to the principles of this discipline, a dose as high
as reasonably achievable (AHARA), limited only by the likelihood of concurrent
ASSESSING RISKS AND BENEFITS 437
complications, should be administered to the treated volume. Again, it is the life sav-
ing circumstances or the severity of the patient’s condition that justify the radiother-
apy treatment procedure, on medical grounds. No limitation of dose for reasons other
than strictly medical should be proposed in this case. The patient undergoing radio-
therapy procedures, as prescribed by the medical practitioner, is protected by the
quality assurance system legally required for medical exposures.
REFERENCES

[2] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Limits for
Intakes of Radionuclides by Workers, Publication 30, Pergamon Press, Oxford and New
York (1979).
S. Koga (Japan)
Patients exposed to ionizing radiation for medical purposes run the risk of pos-
sible stochastic effects, even if the dose is well below the threshold for deterministic
effects. In diagnostic radiology, when the dose is too high or too low the radiation
exposure may well be of no diagnostic value and is essentially useless.
Complications, and even fatal anaphylactic events, can also occur from the use (and
misuse) of contrast agents. For diagnostic procedures, obtaining information is the
benefit. In therapeutic radiology, cure of disease and palliation of painful symptoms
are the therapeutic fruits.
In diagnostic radiology, measurement of the dose from individual examinations
is the first step towards an assessment of the risk. Measured doses should be compared
with national guidance/reference levels if available, or the guidance levels indicated by
the Basic Safety Standards [1] of the IAEA. In radiation oncology, complication rates
after treatment might be the measure for assessing the risk. In interventional radiology,
the dose to the patient should be measured and recorded. The occurrence of any deter-
ministic damage to the patient’s skin should also be recorded. In nuclear medicine, the
dose for particular examinations can be estimated from the activity of the radionuclide
administered to the patient. Doses to the family and members of the public from
radioactive patients and contaminated materials are usually very small.
There are so many different terms, quantities and units used to express doses to
patients. This makes consistent and accurate information on the dose to the patients
very difficult. The establishment of a standard terminology for expressing doses to
438 ROUND TABLE 4
patients and standardized methods to measure them should be encouraged. The edu-
cation of personnel, patients and the general public is essential. Psychological prob-
lems associated with the perception of radiation risks were also discussed.
REFERENCE

P. Schmidt (United States of America)
In the United States of America, minimizing the risk to patients while maxi-
mizing clinical benefit from radiological procedures is a subject of great interest. It is
also a very difficult area to address. On the one hand, the medical community is pri-
marily focused on clinical outcome and wants minimal interference from government
with the practice of medicine. On the other hand, government regulators want to
reduce the levels of unnecessary radiation exposure to patients while not interfering
with the practice of medicine. A very delicate balancing act.
Issues to consider with risk and benefit include:
— We need an objective measure to determine the cost (i.e. patient risk) versus the
benefit of radiological procedures.
— Medical diagnosis and treatment decisions are primarily based on clinical out-
come, quality of life and legal and other more subjective measures that cannot
readily be quantified.
— The impact of activities that reduce unnecessary exposure to patients can be
quantified and provide an objective measure of reduced patient risk.
Radiation exposure of patients can be reduced by using a variety of processes,

including regulation, individual certification, facility accreditation and education. In the
USA, organizations, such as the Conference of Radiation Control Program Directors,
associations and government agencies can have a role in education. Exposure reduc-
tions can then be quantified (i.e. assessed) by using some simple tools such as the
Nationwide Evaluation of X ray Trends (NEXT) that is available in the USA.
To conclude:
— We should be concerned about the use of administrative X rays, the number of

diagnostic radiological examinations ordered, how they are performed, who is
performing them and the amount of radiation received by patients. Regarding
administrative X rays, we should discourage use of routine/automatic X rays,
such as admission X rays for everyone entering a hospital, or automatic post-par-
tum X rays. There is little clinical benefit to justify the risk from the exposure.
— We should not attempt to regulate the ordering or medical use of diagnostic
radiation procedures based upon a risk–benefit analysis.
— The combined focus of the medical and the regulatory communities should be
on reducing the number of unnecessary radiation procedures and the dose
received per procedure. If there are alternatives to specific radiation examina-
tions that reduce patient risk and produce the same clinical outcome, regulatory
agencies should encourage, and work with, the medical community to pursue
these alternatives.
Discussion
Chairperson: M. Verdejo Silva (Mexico)
Round Table members: J.L. Ramirez Arias (Mexico)

M. Waligórski (Poland)
S. Koga (Japan)
P. Schmidt (United States of America)
P. ORTIZ LÓPEZ: M. Waligórski spoke just now about the administration of a

dose as high as reasonably achievable (AHARA) to the volume being treated. To me,
this seems to suggest some kind of conflict between radiotherapy and radiation pro-
tection, commonly described as being based on the ALARA (as low as reasonably
achievable) principle. This conflict does not exist and is therefore, in my view, a non-
issue. AHARA refers to the tumour (dose as high as possible) and ALARA refers to
normal tissue (dose as low as possible).
Moreover, Appendix II of the Basic Safety Standards [1], on medical exposure,
refers to optimization of protection in radiotherapy by establishing that “the exposure
to normal tissue be kept as low as reasonably achievable consistent with delivering
the required dose to the target volume”, with no reference to ALARA. There is no
conflict between radiotherapy and radiation protection, and the pretended differences
are artificial.
440 ROUND TABLE 4
M. WALIGÓRSKI: In my view, there is a fundamental difference between

radiotherapy and radiation protection when radiation is being used as a kind of med-
icine. In the field of radiation protection, one is trying to minimize exposure to radi-
ation, whereas the underexposure of a tumour is something to be avoided. My coin-
ing of the AHARA concept was by way of being a joke, and I certainly would not
fight for its inclusion in the Basic Safety Standards.
I think it is important to realize that quality assurance is the only safety mea-
sure in the case of radiotherapy patients. For example, in the case of the prostate we
used to be able to deliver only about 50 Gy, owing to the sensitive healthy tissues
within the target volume, whereas now, with conformal radiotherapy, we can deliver
much higher doses because our techniques are better; but the quality assurance must
therefore now also be better.
A.J. GONZÁLEZ: I do not doubt the sincerity of M. Waligórski in stating that
there is a fundamental difference between radiotherapy and radiation protection.
However, such statements can be misinterpreted. If radiation protection of patients
were not an issue which the IAEA should take up, because of the alleged contradic-
tion between radiotherapy and radiation protection, then this conference would not
have taken place.
In my opinion, acronyms like ALARA — and now possibly AHARA — can
produce a lot of confusion, which is why we in the IAEA’s Secretariat do not use
them. We stick to the concept of ‘optimization of protection’, which is in the Basic
Safety Standards. Optimization of protection simply means the best radiation protec-
tion under the prevailing circumstances: sometimes circumstances permit a large
reduction in doses, which must then be achieved; sometimes they do not.
M. WALIGÓRSKI: The ALARA concept has indeed caused a lot of unneces-
sary concern in the field of radiation protection, and I would not attach very much
importance to it — or to the AHARA concept. Perhaps we can agree that the differ-
ence between radiation protection and radiotherapy lies in the subject — the subject
of radiation protection is the entire body, whereas the subject of radiotherapy is the
tumour.
C.J. HUYSKENS: When talking about optimization and the ALARA principle,
we should never forget that the R in ALARA stands for ‘reasonably’.
M. TSCHURLOVITS: One problem in assessing risks is that the word ‘risk’ is
used in different ways, depending on, for example, whether one is thinking of deter-
ministic or stochastic effects. With deterministic effects, the situation with regard to
the individual is fairly clear. With stochastic effects, however, concepts such as
’decrease in life expectancy’ only give an impression of the risk for the individual.
Nevertheless, quite a lot of useful work has been done, and, in my view, things are not
as bad as some people seem to think.
The assessment of benefits, which is associated with the issue of education and
training, is clearly a future challenge for people working with ionizing radiation.
L. ARRANZ: I understood P. Schmidt to say that the evolution of risk–benefit

should not be regulated, as such regulation might inhibit the prescribing physician. In
my view, the first criterion in radiological protection is justification, and it must be
included in quality assurance protocols for a correct diagnostic strategy — among
other things, in order to avoid the abuse of unnecessary radiological techniques,
which is unfortunately more common than many people think.
P.S. SCHMIDT: Basically, what I was saying is that the justification of a cer-
tain medical procedure rests with the physician. I do not believe that, from a regula-
tory standpoint, the implementation of regulations can be based on risk–benefit; in the
development of regulations there are many things besides risk–benefit which have to
be taken into account — for example, trends over time and cost–benefit.
My main point was, however, that regulations should not be so restrictive as to
interfere with the practice of medicine.
A. DÍAZ APONTE: Ionizing radiation used in medicine has been likened to a
pharmaceutical. If we all received the same amount of a given pharmaceutical from
the same receptacle, we would probably all be running the same risk. However, if
some of us received the pharmaceutical under appropriate conditions and others
received it under inappropriate conditions, we would not all be running the same risk.
In the third world, people are being irradiated with equipment which has often been
discarded in advanced countries, so that in addition to the risk associated with the
dose there is the risk associated with the technology being used.
C. BORRÁS: As a representative of an organization which co-sponsored the
Basic Safety Standards and is mainly concerned with developing countries, I feel
compelled to respond to this comment.
Risks are risks, and benefits are benefits. We are all equal, and the Basic Safety
Standards apply to everyone. The strategy for implementing the Basic Safety
Standards may have to be prioritized in the light of the available technology, but the
end result should be the same, in accordance with World Health Organization’s
‘health for all’ concept.
When we talk about technology, we do not simply mean equipment, but equip-
ment in use, and, as P. Ortiz López of the IAEA will tell you, most of the mishaps which
have been reported have been due to human error — not to inadequate equipment.
I.-L.C. LAMM: To assess risks and benefits, we need good documentation of
what has been and is being done. The documentation is generally more extensive in
radiotherapy than in radiodiagnostics and nuclear medicine. What is needed interna-
tionally in this connection is a common terminology for reporting, whatever termi-
nology we use for reporting within our own countries.
When considering the risks for the patient, we must bear in mind not only the
major risks associated with radiotherapy but also the minor risks, for we should be
aiming at a high quality of life for the patient once he or she has been cured. You may
cure the patient by using a certain technique, but with a different technique you might
442 ROUND TABLE 4
have cured him or her and at the same time have delivered smaller doses to sensitive
critical organs — with a resulting higher quality of life.
M. WALIGÓRSKI: It is interesting that the only unit used by radiotherapists is
the gray. This illustrates the appropriateness of using the right unit for recording clin-
ical procedures — and it is an argument against using, in some cases, dose or dose
equivalent rather than measurable quantities such as milliampere seconds.
J. LINIECKI: As a physician, I am surprised that we are talking here about the
risk–benefit situation in radiotherapy — something which, in my view, is obvious.
Some 50% of those who undergo radiotherapy do so in order that their lives may be
saved, and in such cases there is no question of whether to use radiation but of how.
The fine points which we have been discussing here are, in my view, marginal to the
real issue. A patient may end up with skin burns due to the inexperience of a physi-
cian employing a very difficult procedure, but if his or her life was saved?
In the case of radiodiagnostics, the benefits associated with screening normally
exceed the risks by orders of magnitude; screening for gastric or mammary cancer has
demonstrated this. With normal diagnosis, it is not always possible to demonstrate the
benefit, and then it is a question of the physician’s education, training and experience.
There is no substitute for an experienced physician who has been well educated and
trained. In an emergency, with a seriously injured patient, no one is going to argue
with such a physician when he or she acts immediately without an elaborate assess-
ment of the risks and benefits. If the physician does not act immediately, he or she
may be accused of malpractice — of neglecting to do what was necessary.
Physicians may do things that are unnecessary. There are countries where about
half of the X ray examinations performed are performed in response to complaints of
lower back pains. Unless there are neurological indications, those examinations do
not help. However, this is very basic medical knowledge.
It would be nice to have risk–benefit expressed as a quantity, such as years of
enhanced quality of life, but things are not so simple.
REFERENCE

REGULATIONS: TOO MUCH OR NOT ENOUGH?
(Round Table 5)
Chairperson
N.J. DÍAZ
ROUND TABLE 5
REGULATIONS: TOO MUCH OR NOT ENOUGH?
Summaries
N.J. Díaz (United States of America)
I think that the answer to the question of whether there are too many or not
enough regulations is that we have both too many and not enough. The key ques-
tion is ‘What is the role of regulations?’ This is a delicate question given the sen-
sitive interface between regulators, whose primary responsibility is public health
and safety, and physicians, whose primary responsibility is the medical care of
patients.
The real issue is how regulators and physicians can work together to best fulfill
their individual responsibilities. The bottom line is not who wins, who has the last
word, but the standard of patient care — how we can both make things work for the
benefit of patients.
I am a commissioner of the United States Nuclear Regulatory Commission
(NRC), but what I am saying now represents my own personal view, which is not nec-
essarily the view of the commission.
Regulation in the United States of America has been changing. The month I
joined the NRC’s regulations for medical uses of byproduct material in 10 CFR Part
35 had just been revised. Two months later I concluded that they were already obso-
lete, incomplete and inadequate. Therefore, the commission initiated another revision
of Part 35, as we realized that the requirements were not proportional to the risk. That
was the beginning of risk informed regulation for the medical uses of radiation, which
we now engage in more and more.
Regulation is an important component of society’s infrastructure. However, reg-
ulation must result in a benefit or it will result in a loss. It follows that the medical
uses of radiation, or, better, humankind’s uses of radiation, must result in a benefit or
they will result in a loss. Therefore, the minimum amount of regulation that achieves
the primary objective is best for our society, and in the context of this conference the
primary objective is a reasonable assurance of the adequate protection of patients’
health and safety from the medical use of radiation, which means neither zero nor
unlimited risk, but risk that is bounded.
In the medical field we have to distinguish between regulations for the ‘radia-
tion protection’ of patients versus regulations for the ‘protection of patients’, as the
doses involved in therapeutic medical procedures can be very large compared with the
445
446 ROUND TABLE 5
doses that a member of the public receives from background or diagnostic uses of
radiation. Consequently, there is a need for balance and reasonableness in developing
any regulation for the protection of patients. I am sure that almost everyone here
would agree on what ‘radiation protection’ means. On the other hand, we need to have
a better understanding and to make better use of regulations for the ‘protection of
patients’. For example, regulations are supposed to help to prevent scenarios where a
patient receives the wrong dose or radiopharmaceutical or is treated at the wrong site.
It has been said that regulators are responsible for ensuring that risk is under-
stood, that it is managed and that it is low. As medical practitioners or radiation pro-
tection specialists, you are also responsible for ensuring that risk is understood, that
it is managed and that it is low. There must be a partnership between practitioners and
radiation protection specialists. If the medical practitioner ignores the regulations or
the regulator tries to go beyond them, things will not work. Eventually, somebody
must deliver the radiation, and it will not be the regulator who does that, but the med-
ical practitioner.
We now know, at least in the USA and some other countries, how to mix and
match deterministic and probabilistic regulations; we are getting better at risk analy-
sis. We now know how to add requirements based on risk. We also know how to
reduce unnecessary requirements. In the recent revision of the commission’s medical
regulations one of the main things we did was to develop regulations for the diag-
nostic and therapeutic uses of radiation that are commensurate with their risk. For
example, the regulations for the diagnostic use of radionuclides in nuclear medicine
were reduced proportional to the risk.
I believe we have significantly simplified the use of what one might call ‘report-
ing controls’, maybe not as much as the medical profession would like, but signifi-
cantly. Somebody has complained at this conference about the number of citations
issued by regulators. In fact, the number of minor violations has decreased by 90% in
the past two years (a fact that is probably not well known). On the other hand, at times
we are accused of ignoring our responsibility to protect patients.
I believe that regulators should not try to scrutinize the benefits of the medical
uses of radiation — that is not their job. That is the job of medical practitioners and
the other people who deliver the medical care. They are the ones who should deter-
mine the benefit. It was recently stated by the US Nuclear Regulatory Commission
that regulations for the radiological protection of patients should not intrude into
medical judgements affecting the patients. As regulators we should be involved in
assessing the radiation risks from medical uses, and in clearly regulating the use in
such a way as not to interfere with medical care, thus providing protection of patients
in a manner that will benefit society.
All regulations restrict, for example those governing the issuing of drivers’
licences, but they should not deter from the beneficial activities that they regulate;
they should not be detrimental to them, but frame and guide them. Medical regulations
REGULATIONS 447
should allow for the timely approval and use of emergent technology, and they should
be based on facts and supported by the best available knowledge regarding research
and clinical experience. They should be technically, socially and economically sound,
but not necessarily in equal proportions.
How does the US NRC address the needs of patients? One example is when one
particular hospital petitioned the NRC for a change in the medical use regulations, as
it said that it had to isolate its patients, who were getting frustrated because they could
not be visited. The commission looked into the matter and said ‘You are absolutely
right’. Therefore, the NRC’s revised medical regulations allow licensees the discre-
tion to allow visitors to receive up to 5 mSv in a year, essentially five times the gen-
eral public dose, from exposure to hospitalized patients.
Another issue that needs to be taken into account is that increased costs due to
more stringent regulations could result in more limited availability of certain diag-
nostic and therapeutic procedures, and that might not be acceptable to society.
I believe it is fair to say that in most places there is currently no shortage of
regulations. The regulations may not be the right ones, and they might not be prop-
erly applied, but that is another matter. Regulators may be tempted to do a little
more, to be more protective, to add a further ounce of conservatism. However, I am
convinced that the right goal for our society should be fewer and better regulations,
ones based on the balance between protecting patients and providing medical bene-
fit to patients.
I conclude with this observation: nothing developed by humankind can
replace simplicity as the most effective and efficient way of doing things.
Simplicity, in the good sense of the word, is underestimated, so I would urge you to
pursue simplicity as you try to optimize the delivery and control of the medical uses
of radiation.
O.W. Linton (United States of America)
The general purpose of regulations applicable to the medical uses of ionizing

radiation is to assure the safe and efficacious use of radiation in diagnostic and ther-
apeutic medical procedures. The same regulations also should assure the safety of
those who work in medical radiation facilities. To meet these ends, regulations may
be contrived by public agencies to cover the following areas:
— Radiation emitting equipment.

— Radiation sources, such as radioisotopes.
— Personnel, that is physicians, technologists, radiographers, physicists,
dosimetrists, etc.
— Procedures, for example
448 ROUND TABLE 5
• Which procedures are to be authorized in regulated facilities.

• The age, gender or other qualifications for patient groups.
• The periodicity for screening procedures.
— Standards: these may be state of the art or otherwise, but should be reasonably
flexible, with the ability to revise them at appropriate intervals. They should
include requirements for record keeping.
The wide range of resources for health care in different nations makes it
impossible to create one set of regulations that embody technical and personnel
specifications and that would be feasible for implementation in all jurisdictions.
However, it should be possible to state a series of elements that should be incorpo-
rated in any effective regulation.
I. Lequerica (Spain)
The regulatory framework in Spain concerning the radiological protection of

medical installations and the corresponding regulatory authorities assigns the
responsibility for regulation and control to different safety bodies depending on the
subjects to be protected. The radiation protection of workers, the public and the
environment is assigned to the Nuclear Safety Council. The radiation protection of
patients is assigned to the Ministry of Health and the autonomous authorities of
health.
The radiation protection of patients is basically regulated through quality con-
trol measures established in specific decrees of the Ministry of Health regarding diag-
nostic radiology, nuclear medicine and radiotherapy. Inspection is performed through
audits made by the autonomous authorities of health. Organizational arrangements
are required in medical centres to discharge their responsibilities in these matters.
These include licences for appropriate personnel and the assignment of specific roles
in the radiological protection of patients to radiation physicists.
In the development of regulations one should pursue a balance between the
risks associated with these medical exposures and the evident benefits derived, and
properly take into account the knowledge of the professionals involved. Key aspects
in this development process include:
— Subjecting draft regulations to comments by most interested parties;

— Reviewing on a continuous base the adequacy of existing regulations;
— Co-ordinating the activities of the involved regulatory authorities;
— Creating and maintain forums with professionals and other stakeholders;
— Recognition of protocols produced by professional or licensees’ associations
and endorsed by the regulators.
REGULATIONS 449
R. Pardo (Costa Rica)
(These remarks were presented by L. Bermúdez (Costa Rica))
The following important matters must be taken into account in the activities of
national radiation protection authorities in order to ensure that the doses received by
patients and staff are kept as low as is reasonably possible, and to limit the probabil-
ity of radiological accidents occurring.
— National authorities must be completely independent of users in order to avoid

the influence of other authorities and prevent a conflict of interests where they
are both judge and defendant.
— There must be a legal framework for establishing the necessary requirements
for workers, equipment, sources and the facility in general. These standards
must be easy to understand for users, and easy to apply and monitor. They may
give the national authority the powers to establish requirements, perform
inspections and grant authorizations.
— Accidents occur in both rich and poor countries, those with or without controls
and with very strict or less strict legal frameworks. We may therefore ask: what
is missing? Our answer is: a safety culture is missing. Proper attention is not
being given to the practices that are being implemented, and activities are often
being left to habit; there is a lack of ongoing and adequate training.
— The technical sphere of authorities must possess excellent standards of training,
adequate equipment and sufficient economic resources to be able to perform
their functions, without losing sight of the overriding need for reliance on and
direct access to higher level political spheres, such as ministers or presidential
offices.
— The political sphere is supremely important since, in developing countries, it is
a simple fact that decisions are taken there; hence the importance of the inter-
action of both spheres: an authority that is not directly reliant on the political
sphere will have very few opportunities to act.
— The influence and presence of international organizations, and the technical and
political pressures that they can exert on Member States, is highly important
and has a major impact on the policies adopted in those States for promoting a
safety culture.
J.P. Bares (Panama)
Cancer is the primary cause of illness and death in Panama. The most common
tumours (e.g. of the cervix, prostate, breast, head and neck, etc.) can be cured or
450 ROUND TABLE 5
alleviated using radiotherapy alone, or together with other therapies such as surgery
and chemotherapy. The National Oncology Institute is the main cancer centre in the
country and is involved in cancer treatment, early detection and prevention pro-
grammes. It takes care of 40% of those suffering from cancer, on average, and meets
80% of the demand in the country for radiotherapy. There are 4000 new cases of can-
cer every year. The National Oncology Institute has two cobalt therapy units, only one
of which is currently functioning. This meets 20% of the total radiotherapy demand.
We have to purchase services for the remaining 80% from the private sector.
Radiotherapy in Panama needs global investment in both equipment and human
resources. The National Oncology Institute has short and medium term plans for
improving its services through a new project involving investment in infrastructure
and equipment (two Linacs and two cobalt units), training of human resources (radi-
ation oncologists, medical physicists, dosimetrists, technicians) and installing quality
control programmes.
In August 1999 the National Oncology Institute moved from its premises in an
old hospital, where it had two adequately shielded cobalt therapy rooms, to another
older hospital that had been remodelled. This hospital had a bunker for a cobalt unit,
but it did not meet modern radiological protection requirements. In Panama there are
nine sets of regulations or standards relating to radiological protection instituted by
ministerial resolutions or decrees. However, the resources of the State are limited and,
consequently, so is our budget. An attempt is being made to adapt existing national
legislation, in line with international recommendations in the radiological protection
field, to the socioeconomic situation of the country. We need more communication
with the competent authority to implement standards, and these must be implemented
with the participation of all involved in order to ensure that obstacles are not placed
in the way of health care services for patients.
K. Ketiku (Nigeria)
The existing regulations covering the protection of patients during medical

exposures are considered to be sufficient. What are required, however, to ensure com-
pliance with existing guidelines and regulations, are appropriate monitoring or audit
teams. At the national level there should be a strong and autonomous national radia-
tion use and protection agency empowered to accredit and monitor all centres using
ionizing radiation for medical purposes.
In this regard, sufficient attention should be given to the standardization and
good design of equipment to comply with national and international safety standards.
All equipment should include the necessary accessories and instruction manuals, and
spare parts should be readily available. Local staff should be fully trained in the use
and maintenance of all equipment, especially that which has been newly acquired.
REGULATIONS 451
Medical imaging and radiotherapy centres should be updated periodically on new

equipment developments and designs and should be upgraded to improve perfor-
mance and safety as soon as possible.
Each centre must have a local quality control unit, which should form part of a
regional or national audit centre. Governments in developing countries should pro-
vide the adequate financial assistance necessary to maintain and optimize the opera-
tion of radiotherapy centres. Regional or international research activities should be
encouraged so as to improve the performance of staff and equipment and the quality
of the service that they provide.
Discussion
Chairperson: N.J. Díaz (United States of America)
Round Table members: O.W. Linton (United States of America)

J.I. Lequerica Pérez (Spain)
R. Pardo (Costa Rica)
J.P. Bares (Panama)
L. CARRIZALES: In my country, where we have adopted regulations for

radiodiagnostics and are developing regulations for radiotherapy and nuclear medi-
cine, we have realized that regulations are not very helpful without a high level of
awareness. That is what we are now trying to achieve at all institutions, through the
education not only of medical physicists but also of physicians in the establishment
of quality assurance programmes.
N. DÍAZ: We all need to be educated in such things, both physicians and every-
one else involved in the radiological protection of patients.
Fortunately, suitable educational modules are now accessible in various forms,
so that it is no longer necessary to, for example, go to a major university in another
country.
L.A. JOVA SED: With regard to the title of this Round Table, ‘Regulations: Too
Much or Not Enough?’, I would say that a country can have the best regulations in
the world but, unless its regulators have the authority necessary for enforcing com-
pliance, the regulations will not achieve their objective, which is the radiological pro-
tection of patients.
N. DÍAZ: Undoubtedly, the authority of the regulators is a matter of great
importance. In my country, however, we are moving towards a situation where less
authority is vested in the regulators and more in those who carry out the medical pro-
cedures. This is a dramatic switch that is involving a major education and training
452 ROUND TABLE 5
effort and will take several years to complete, but we believe that regulators cannot
keep abreast of everything and check everywhere.
We believe that what is necessary is a regulatory infrastructure sufficiently
strong to ensure that major incidents do not occur and that is sufficiently flexible to
accommodate change.
J.I. LEQUERICA PÉREZ: The authority of the regulators derives from their
knowledge, and they can acquire the knowledge necessary for regulating in detail
only through dialogue with the health care professionals. That should not be impos-
sible, as both groups have the same objective, that is the health of patients.
A. NIROOMAND-RAD: In the United States of America there are areas, for
example the calibration and operation of radiation producing equipment, that are
without adequate regulations and areas, for example brachytherapy, that are overreg-
ulated, and in that connection I was glad to hear what N. Díaz just said; attitudes
within the United States Nuclear Regulatory Commission seem to be changing in a
positive manner.
N. DÍAZ: The United States Nuclear Regulatory Commission regards the
development of regulations as a form of participatory rule making and tries to involve
the community that is being or is to be regulated. The medical community is a diverse
one, however, and the commission often receives very differing signals from cardiol-
ogists, radiologists, medical physicists and so on. It listens to all groups, and the pro-
cedure, although not perfect, is better than we had three years ago and, I hope, will
have improved still further in three years’ time, when risk informed regulation is
firmly established.
About four years ago I proposed that medical procedures involving annual
doses of less than 100 mrem be regulated at the discretion of the hospital or the physi-
cian involved, that medical procedures involving annual doses of 100 to 5000 mrem
be subject to a justification requirement and to some degree of mandatory regulation,
and that medical procedures involving higher annual doses be subject to strict regu-
lation. That would account for about 99% of all medical procedures, and it would not
require much in the way of legislation or regulation drafting, just the application of
common radiological protection rules in the treatment of patients. And I think that is
the way we shall ultimately go.
WHAT IS THE ACCEPTABLE (NON-OCCUPATIONAL)
EXPOSURE OF CAREGIVERS?
(Round Table 6)
Chairperson
A. HEFNER
Austria/Holy See
ROUND TABLE 6
WHAT IS THE ACCEPTABLE (NON-OCCUPATIONAL)

EXPOSURE OF CAREGIVERS?
Summaries
A. Hefner (Austria/Holy See)
Caregivers discussed in this Round Table were only non-occupationally

exposed people (individuals who are knowingly and willingly helping, rather than
doing this as part of their occupation), such as family and friends, but also third per-
sons giving care to the patient such as nurses or even Red Cross people. This fact
should be clearly kept in mind.
Before looking, however, at the acceptable exposure of these caregivers, we
should first clearly answer the following questions:
— What kind of medical treatment or diagnostics is most likely to generate rele-

vant doses to caregivers and how large are the doses likely to occur in the dif-
ferent situations?
— Pathways of exposure of these individuals and their relative importance in dif-
ferent exposure situations.
— Classification of the individuals close to the patients in order to differentiate for
possible dose constraints
— Who is giving really exact information on doses and risks and how is this to be
done?
— The ethical problem is the most important one and should be discussed and
treated henceforth in a working group within the IAEA.
H. Olerud (Norway)
The European BSS state that the dose limits for members of the public do not
apply to “exposures of individuals, who are knowingly and willingly helping, other
than as a part of their occupation, in the support and comfort of in-patients or out-
patients undergoing medical diagnostics or treatment” (Article 6.4(b)). The justifica-
tion and optimization for these kinds of exposure is therefore emphasized, and, in the
context of optimization, the establishment of dose constraints is recommended
455
456 ROUND TABLE 6
(Article 7.2). The BSS also states that “In case of a patient undergoing a treatment
with radionuclides Member States shall ensure that the practitioner provides the
patient or legal guardian, before leaving the hospital or clinic, with written instruc-
tions, on the reduction of doses to persons in contact with the patient and with infor-
mation on the risk associated with ionising radiation” (Article 4).
An important issue for discussion is the question what kinds of medical expo-
sures of patients are most likely to give rise to significant doses to caregivers, and how
large are the doses likely to be? A related question is: What are the pathways for expo-
sures to caregivers and which are the important ones? The ethical and cost–benefit
arguments for allowing caregivers to receive higher doses than the public need to be
considered as well as the most effective methods of informing them on these benefits
and risks.
Some suggestions for dose constraints for different categories of caregivers are
shown in Table I, which is taken from the EC booklet Radiation Protection Following
Iodine-131 Therapy [1].
TABLE I. SUGGESTED DOSE CONSTRAINTS FOR DIFFERENT CATEGORIES

OF CAREGIVERS
Type of caregiver Reason for suggested dose constraint Dose constraint

(risks, habits) (mSv)
Third person A fraction of the dose limit for the public 0.3
Family and close friends:

Pregnant women Protection of the unborn child 1
Children up to
2 years old Close physical contact with their parents 1
Children between 3 and Same risk as the unborn child 1

10 years old
Adults up to 60 years old Two to three times lower risk than for 3
younger children
Certain recommendations for partners
Not to be applied when comforting very

ill in-patients, for example parents taking
care of hospitalized children
Adults older than Three to ten times lower risk than for the
60 years old average population 15
EXPOSURE OF CAREGIVERS 457
For persons comforting nuclear medicine patients, special arrangements

should be made for dealing with incontinent or nauseous patients where the risks of
contamination from urine or vomit may be significant. There are ethical problems
regarding the point of time when such patients were sent home, particularly if one
reason is to save money for the hospital. The psychological pressure on the relatives
may be significant.
Regarding the protection of caregivers in diagnostic radiology, we need to con-
sider in what situations we should allow parents to hold and comfort their children dur-
ing X ray examinations and how we should protect them from the scattered radiation?
REFERENCE
[1] EUROPEAN COMMISSION, Radiation Protection Following Iodine-131, EC,

Luxembourg (1998).
A.A. Miranda Cuados (Bolivia)
One type of ‘caregiver’ that is generally not given enough attention is the per-
son providing support and comfort to a patient who has received radioisotope treat-
ment.
A harmonized radiological protection system must be in place, allowing us to
deal with such situations in a coherent manner. If the persons involved are not
informed about what is going on, it is impossible to maintain adequate radiological
safety conditions. Usually, they must obtain this information from the patient who, in
the majority of cases, is not accurately and exhaustively informed on the treatment he
or she is receiving, including the risks and benefits, consequences and results. If, as
is often the case, the patient is not informed, we can be sure that family members are
not either, which prompts the thought that the family member, through his or her
affection and concern, which, owing to the psychological aspect, is sometimes more
important than the treatment itself, may commit a series of irregularities leading to
unnecessary exposure. And it is not only family members who must be kept informed:
other categories of visitors must be too, such as friends or priests. Another important
consideration is when children are involved (as patients or visitors), who require
affection and support from family members, particularly younger children.
We must also bear in mind something that happens on a routine and regular
basis: patients leaving the health care centre, which means that they cannot be moni-
tored. These patients, who continue their treatment at home, cannot be isolated, and
therefore we have to think about what will be done. It is this situation, among many
others, that makes us suggest that it is not practical to impose any kind of limit or
restriction on the exposure of caregivers. Rather, simple mechanisms should be put in
458 ROUND TABLE 6
place which help us achieve better control of persons caring for, visiting, or interact-
ing with, patients who are undergoing radioisotope treatment. In essence, these mech-
anisms imply that these persons monitor themselves, and they are more likely to do
this if the information provided or received on the risks and safety is accurate and in
sufficient detail. The doctor treating the patient should provide this information.
R.H. Corbett (United Kingdom)
We should remember that caregivers are going to receive some radiation dose
because of a sense of duty or perhaps love for a friend or relative. They are also very
unlikely to know much about radiation risks and radiation protection. It is important
that these risks should be fully explained to both the patient and the caregivers and
this should normally be done first by the patient’s doctor and perhaps later by a nurse
(especially in breast cancer units) or a radiographer. Whoever it is, they will have to
try to assess the knowledge and the understanding of the patient and caregivers before
they can start to explain the risks.
At the first meeting with the patient and the caregivers they can be given an
information leaflet. This must be written in very simple terms and must be available
in all the common languages spoken in the locality. It must describe the X ray proce-
dure, the reasons for doing it and the risks. At the second meeting the doctor will be
able to find out just how much they have taken in from the leaflet and go over it again
with them, if necessary. Before he or she starts to explain what the risks might be, it
is very important to understand what the patient or the caregiver understands by
‘risks’. There is no point in saying that it is only as dangerous to get this radiation
exposure as driving down the road if the person you are talking to happens to be a rac-
ing driver. Or, it is as dangerous as smoking two to three cigarettes if the person hap-
pens to be a heavy smoker. The risks must be put into perspective in a way that the
patient will understand. I am a sailor and I think nothing of sailing across the seas but
I would never risk diving under the water. But there are many people, quite possibly
some here, that would have quite the reverse attitude to these risks.
To conclude, I have a personal view, which is somewhat contentious, that no
dose that a caregiver receives is too high. However, it is the job of the operator or the
medical practitioner, whoever you like, to fully explain the risks to the caregiver and
to make sure that the procedures are fully optimized and that the caregiver is fully pro-
tected. So, is it really appropriate that we have a dose constraint for caregivers? I
believe the figure of 5 mSv has been postulated. A provisional study in Glasgow has
shown that the total dose to relatives caring for children having brachytherapy, over the
whole period of the treatment, was less then 3 mSv. This dose was shared between a
number of caregivers (e.g. mother, father, grandmother or grandfather) so the dose to
each one is well under the constraint of 5 mSv. So, perhaps, the constraint is all right.
EXPOSURE OF CAREGIVERS 459
E. Fernández Vicioso (United States of America)
I have carefully reviewed the current literature and analysed regulations in the
United States of America on the basis of BEIR V (Biologic Effects of Ionizing
Radiation). It must be pointed our that, in the last two decades, the exposure of care-
givers to ionizing radiation has decreased significantly, owing, in part, to strict regu-
lations and improvement in equipment, policies and procedures. As a radiation oncol-
ogist I can say that, with current technology, exposure to personnel is minimal, with
the use of linear accelerators and remote afterloading devices for brachytherapy.
Since doses to personnel have been minimized, the only possible detrimental
effects are stochastic or non-deterministic in nature. The threshold doses for deter-
ministic effects are so high that occupational doses to the staff in a department of radi-
ation oncology never approach them if radiation protection standards are observed,
and they cannot occur, unless an accident strikes. The possibility of mutagenesis and
radiation induced cancers cannot entirely be ruled out because there is no threshold
for their induction; nevertheless, their incidence can be minimized following the ‘as
low as reasonably achievable’ principle as well as observing the dose limits recom-
mended by the International Commission on Radiological Protection ( ICRP).
According to the linear quadratic (LQ) model, at low doses, the linear compo-
nent (aD) is responsible for the effects. The two ‘sub-lesions’ needed must be induced
in a single event in time (double strand break, etc.), so that these stochastic effects are
independent of time factors of dose deposition such as elapsed time, dose rate or frac-
tionation since the two lesions will be induced simultaneously. Obviously, the total
dose is important, so lifetime exposure is considered a sum of multiple small expo-
sures. It is also important to remember that when the risk or excess incidence of a sto-
chastic effect is plotted against dose, using the linear model versus the LQ model,
there is overestimation of risk; this is equivalent to the statement that the linear
approach is much more conservative that the LQ.
For all these reasons, I believe that the current occupational dose limit for staff
working in health care situations involving ionizing radiation (50 mSv/a) should not
be modified.
Note: In this contribution the term ‘caregivers’ seems to have been taken as
meaning the professional staff working in health care rather than those helping in the
comfort and support of patients
460 ROUND TABLE 6
Discussion
Chairperson: A. Hefner (Austria/Holy See)
Round Table members: H. Olerud (Norway)

A.A. Miranda Cuadros (Bolivia)
R.H. Corbett (United Kingdom)
E. Fernández Vicioso (United States of America)
G. ARBABI: With regard to patients being treated with iodine-131, different

countries have different upper limits for the activity level at the time of discharge
from hospital. I think it would be better to have one internationally agreed upper limit.
A. HEFNER: This is an interesting point. The upper limit seems to vary from
as low as 50 MBq to as high as 800 MBq.
L.V. PINILLOS-ASHTON: A question to which, in my view, thought should be
given is what happens when patients with iodine or palladium implants in the prostate
die and are cremated.
E. FERNÁNDEZ VICIOSO: We reckon that, after a post-implantation period
equal to 1.44 times the half-life of the implanted radioisotope, the patient may be con-
sidered to be no longer radioactive. Iodine-125 has a half-life of about 60 days, so that
a patient with an 125I implant may be considered to be no longer radioactive after
about 90 days.
C. STREFFER: When discharging a patient with a radioactive implant, one
should bear in mind that, while the thyroid cancer risk increases by only 4% for every
additional sievert in the case of adults, it increases by 1000% for every additional
sievert in the case of children under ten years of age.
A. HEFNER: I understand that ICRP’s subgroup No. 3 is working on a docu-
ment about dose constraints in the case of caregivers and that this document will be
issued in about one and a half years’ time.
CHAIRPERSONS OF SESSIONS
Background Session F. METTLER United States of America

Background Session J. HERNÁNDEZ ARMAS Spain
Briefing Session H.M. OLERUD Norway
Topical Session 1 C.G. STANDERTSKJÖLD-
NORDENSTAM Finland
Topical Session 2 G. KLEMPFNER Australia
Topical Session 3 V. SINITSYN Russian Federation
Topical Session 4 J. KONISHI Japan
Topical Session 5 E. VAÑÓ Spain
Topical Session 6 W. LEITZ Sweden
Topical Session 7 P. CORR South Africa
Topical Session 8 C. PÉREZ United States of America
Topical Session 9 H. AMARAL Chile
Topical Session 10 C. LAVOIE Canada
Topical Session 11 S. NAZARENKO Estonia
Topical Session 12 G. DREXLER Brazil
Topical Session 13 F. VARGAS MARCOS Spain
Round Table 1 B. BALABAN United States of America
Round Table 2 J. HENDRY United Kingdom
Round Table 3 J.P. OLIVA GONZÁLEZ Cuba
Round Table 4 M. VERDEJO SILVA Mexico
Round Table 5 N.J. DÍAZ United States of America
Round Table 6 A. HEFNER Austria/Holy See
PRESIDENT OF THE CONFERENCE
C. VILLALOBOS TALERO (Minister of Health and Consumer Affairs, Spain)
VICE-PRESIDENTS OF THE CONFERENCE (Spain)
J.M. KINDELÁN GÓMEZ DE BONILLA

F. VALLEJO SERRANO
A. DÍEZ DE LOS RÍOS DELGADO
461
462
SCIENTIFIC CONFERENCE PROGRAMME COMMITTEE
F. METTLER (Chairperson) United States of America

C.E. ALMEIDA Brazil
J. COSSET France
M. MAGNUSSON Iceland
Y. SASAKI Japan
E. VAÑÓ (Vice-Chairperson) Spain
L. WAGNER United States of America
P. ORTIZ LÓPEZ International Atomic Energy Agency
A.J. GONZÁLEZ International Atomic Energy Agency
S. GROTH International Atomic Energy Agency
A. MEGHZIFENE International Atomic Energy Agency
H. OSTENSEN World Health Organization
C. BORRÁS Pan American Health Organization
K. SCHNUER European Commission
SPANISH CONFERENCE ORGANIZING COMMITTEE
R. RUIZ CRUCES (Chairperson)

M. FERNÁNDEZ BORDES (Vice-Chairperson)
F. VARGAS MARCOS (Liaison)
M. PÉREZ MARTÍNEZ (Secretary)
I. TORT AUSINA (Secretary)
Members
R. AGUILAR CUEVAS
L.A. ARRANZ Y CARRILLO
F. CARRERA MAGARIÑO
P. GALÁN MONTENEGRO
J.M. JIMÉNEZ-HOYUELA
A. MARTÍN PALANCA
O. QUINTANA TRÍAS
A. REBOLLO AGUIRRE
M. TORRES TABANERA
J.A. VILLALOBOS MARTÍN
463
SPANISH SCIENTIFIC COMMITTEE
J. HERNÁNDEZ ARMAS (Chairperson)

C. ÁLVAREZ (Vice-Chairperson)
M. BEZARES (Vice-Chairperson)
J.C. CASTRO (Vice-Chairperson)
C. BODINEAU GIL (Secretary)
Members
F. ÁLVAREZ
J. ESTARRIAGA ANSÓ
J. FERNÁNDEZ CRUZ
B. FERNÁNDEZ GONZÁLEZ
J.M. FREIRE
A. HERNÁNDEZ LEZANA
A. HERNÁNDEZ VITORIA
I. HERNANDO
M. MARTÍNEZ MORILLO
C. MORIS DE LA TASSA
J. PARDO MASFERRER
J.J. PEÑA BERNAL
C. SERRANO
A. UGARTE PALLARÉS
HOST GOVERNMENT LIAISON
F. VARGAS MARCOS
464
SECRETARIAT OF THE CONFERENCE
Scientific Secretaries
A.J. GONZÁLEZ International Atomic Energy Agency

S. GROTH International Atomic Energy Agency
A. MEGHZIFENE International Atomic Energy Agency
P. ORTIZ LÓPEZ International Atomic Energy Agency
A.D. WRIXON International Atomic Energy Agency
H. OSTENSEN World Health Organization
C. BORRÁS Pan American Health Organization
K. SCHNUER European Commission
International Atomic Energy Agency Staff
C. COOLBAUGH Conference Services

H. SCHMID Conference Services
K. MORRISON Conference Services
A. RODRIGUEZ GOMEZ Secretarial Co-ordinator
M. DAVIES Records Officer
J. DENTON-MacLENNAN Proceedings Editor
G. RAMESH Proceedings Editor
M. SPAK Proceedings Editor
LIST OF PARTICIPANTS
ALBANIA
Qafmolla, L. Institute of Nuclear Physics,

Aleksander Moisiu Street 80,
P.O. Box 85,
Tirana,
ALBANIA
Fax: +3554363241
E-mail: anura@icc.al.eu.org
ARGENTINA
Arias, E. Asociación de Técnicos Radiólogos Rosario,

La Broca 2164 (2000),
Rosario 2000, Santa Fé,
ARGENTINA
E-mail: quiquerx@satlink.com
Baldini, Y. Centro Imágines Médicas,

Calle 40e/4y5 no. 465,
La Plata C.P. 1900,
ARGENTINA
Fax: +542214231112/13
E-mail: cimed@netuerk.com.ar
Caspani, C.E. Radiofísica Sanitaria de la Provincia de Santa Fé,

Obispo Gelabert 3586,
3000 Santa Fé,
ARGENTINA
Fax: +543424522933
E-mail: ccaspani@figus.unl.edu.ar
Piñero, A. Avda. 53 y 12 P.14,

1900 La Plata,
ARGENTINA
Fax: +542214510530
E-mail: dpma@ms.gba.gov.ar
465
466 LIST OF PARTICIPANTS
Rojo, A.M. Autoridad Regulatoria Nuclear (ARN),

Avenida del Libertador 8250,
1429 Buenos Aires,
ARGENTINA
Fax: +541143798960
E-mail: arojo@cae.arn.gov.ar
Saraví, M. Centro Regional Referencia Dosimetría,

Comisión Nacional de Energía Atómica,
Avenida del Libertador 8250,
1429 Buenos Aires,
ARGENTINA
Fax: +541143798228
E-mail: saravi@cae.cnea.gov.ar
Valloud, R.S. Bionics S.A.,

Ramallo 2410,
1429 Buenos Aires,
ARGENTINA
Fax: +541147011017
E-mail: bionics@elsitio.net
Veneroni, J. Asociación de Técnicos Radiólogos Rosario,

La Broca 2164 (2000),
Rosario 2000, Santa Fé,
ARGENTINA
E-mail: Jveneroni@hotmail.com
ARMENIA
Hovhannisyan, N.M. Research Centre of Radiation Medicine and Burns,

P.O. Box 25, Davidashen,
Yerevan 375108,
ARMENIA
Fax: +3741340800
E-mail: ncrmio@lx2 yerphi.am
LIST OF PARTICIPANTS 467
AUSTRALIA
Thomson, J.E. Australian Radiation Protection and

Nuclear Safety Agency,
Lower Plenty Road,
Yallambie, Vic. 3085,
AUSTRALIA
Fax: +61394321835
E-mail: julian.thomson@health.gov.au
Towson, J.E. Royal Prince Alfred Hospital,

Department of PET and Nuclear Medicine,
Camperdown, NSW 2050,
AUSTRALIA
Fax: +6129515 6381
E-mail: jtowson@nucmed.rpa.es.nsw.gov.au
Warren-Forward, H.M. Discipline of Medical Radiation Science,

University of Newcastle,
Box 16, Hunter Building,
Newcastle, NSW 2308,
AUSTRALIA
Fax: +61249217053
E-mail: hwf@mail.newcastle.edu.au
AUSTRIA
Granegger, S. Department of Nuclear Medicine,

University of Vienna,
Währinger Gürtel 18–20,
A-1090 Vienna,
AUSTRIA
Fax: +431404005532
Mandl, H. St. Johanns-Spital Salzburg,

Müllner Hauptstrasse 48,
A-5020 Salzburg,
AUSTRIA
Fax: +4366244823929
E-mail: h.mandl@lks.at
Nowotny, R. Institut für Biomedizinische Technik und Physik,

Universität Wien, AKH-4L,
A-1090 Vienna,
AUSTRIA
Fax: +431404003988
E-mail: r.nowotny@bmtp.akh-wien.ac.at
Oberladstaetter, M.G. University Clinic for Nuclear Medicine,

Anichstrasse 35,
A-6020 Innsbruck,
AUSTRIA
Fax: +43 512 504 2683
E-mail: michael.oberladstaetter@uklibk.ac.at
Pärtan, G. Radiology Department, SMZO/Danube Hospital,

Langobardenstrasse 122,
A-1220 Vienna,
AUSTRIA
Fax: +431288024980
E-mail: gerald.paertan@smz.magwien.gv.at
Pichler, R. Allg. Öff. Krankenhaus der Stadt Linz,

Institut für Nuklearmedizin und Endokrinologie,
Krankenhausstrasse 9,
A-4020 Linz,
AUSTRIA
E-mail: robert.pichler@akh.linz.at
Sinzinger, H.F. Department of Nuclear Medicine,

University of Vienna,
A-1090 Vienna,
AUSTRIA
Fax: +431404005532
E-mail: Helmut.Sinzinger@akh-wien.ac.at
Tschurlovits, M. Atominstitut der Österreichischen Universitäten,

Technische Universität Wien,
Stadionallee 2,
A-1020 Vienna,
AUSTRIA
Fax: +4315880114199
E-mail: tschurlo@ati.ac.at
Ziervogel, J. Arbeitsmedizinisches Zentrum der Voest-Alpine Schienen,

Vordernbergerstrasse 112,
A-8700 Leoben,
AUSTRIA
Fax: +4338422022478
E-mail: arbeitmedizin@va.schienen.at
BAHAMAS
Fielding, M.N.S. X-Ray Department, Princess Margaret Hospital,

P.O. Box CB-13789,
Nassau,
BAHAMAS
Fax: +2423564359
E-mail: fielding@batelnet.bs
BANGLADESH
Roy, S. Health Physics Radiation Monitoring Laboratory,

Centre Campus, P.O. Box 164,
Dhaka 1000,
BANGLADESH
Fax: +88028613051
E-mail: aecd@citechco.net
BARBADOS
Porte, J. Queen Elizabeth Hospital,

Martindale’s Road,
St. Michael, West Indies,
BARBADOS
Fax: +2464295374
BELGIUM
Buls, N. Department of Radiology and Medical Imaging,

Free University Hospital Brussels (AZ-VUB),
Laarbeeklaan 101,
B-1090 Brussels,
BELGIUM
Fax: +3224775800
E-mail: Nico.Buls@az.vub.ac.be
Clapuyt, P.R.M. Cliniques Universitaires Saint Luc,

10, Avenue Hippocrate,
B-1200 Brussels,
BELGIUM
E-mail: clapuyt@rdgn.ucl.ac.be
Deprez, T. Radiology Department, University Hospitals,

Herestraat 49,
B-3000 Leuven,
BELGIUM
Fax: +3216343765
E-mail: tom.deprez@uz.kuleuven.ac.be
Ortmanns, P.M.A.A. Liersestw 341,

B-2547 Lint,
BELGIUM
Fax: 3234886484
Pages, J.M. Academisch Ziekenhuis Vrije Universiteit (AZ-VUB),

Laarbeeklaan 101,
B-1090 Brussels,
BELGIUM
Fax: +3224775800
E-mail: jessica.ica.pages@hotmail.com
Schibilla, H. Rue de la Cambre, 148 Bte 8,

B-1200 Brussels,
BELGIUM
Fax: +3227704573
E-mail: schibillaha@skynet.be
Smeesters, P. Service de protection contre les rayonnements ionisants,

36, rue Ravenstein,
B-1000 Brussels,
BELGIUM
Fax: +32 2 2892112
E-mail: patrick.smeesters@fanc.fgov.be
Sonck, M.P.G. Association Vincotte Nuclear (AVN),

Koningslaan 157,
B-1190 Brussels,
BELGIUM
Fax: +3225368585
E-mail: msk@avn.be
Struelens, L. SCK-CEN, Belgian Nuclear Research Centre,

Boeretang 200,
B-2400 Mol,
BELGIUM
Fax: +3214321049
E-mail: lstruele@sckcen.be
Van Bladel, L.A.K. Federal Agency for Nuclear Control,

Ravensteinstraat 36,
B-1000 Brussels,
BELGIUM
Fax: +3222892195
E-mail: lodewijk.vanbladel@fanc.fgov.be
Van de Putte, S. Universiteit Gent,

Proeftuinstraat 86,
B-9000 Ghent,
BELGIUM
Fax: +32 9 2646699
E-mail: sasha.vandeputte@rug.ac.be
Vanhavere, F. SCK-CEN, Belgian Nuclear Research Centre,

Boeretang 200,
B-2400 Mol,
BELGIUM
Wulfrank, D.A.K. Nuclear Medicine,

Kortrijkse Steenweg 1026,
B-9000 Ghent,
BELGIUM
Fax: +3292417074
E-mail: denis.wulfrank@a2mmsj.be
BOLIVIA
Miranda Cuadros, A.A. Instituto Boliviano de Ciencia y Tecnología Nuclear

(IBTEN),
C.P. 4821,
Avenida 6 de Agosto 2905,
La Paz,
BOLIVIA
Fax: +5912433063
E-mail: ibten@caoba.entelnet.bo
BRAZIL
Aldred, M.A. Secretaria de Estado de Saúde de São Paulo,

Av. São Luis 99, 6 andar,
01046-000 São Paulo SP,
BRAZIL
Fax: +55 11 259 9920
E-mail: maldred@usp.br
Bernardo-Filho, M. Departamento de Biofísica,

Universidade do Estado do Rio de Janeiro,
Av. 28 de Setembro 87,
20551-030 Rio de Janeiro RJ,
BRAZIL
Fax: +55 21 2543532
E-mail: bernardo@uerj.br
Canevaro, L.V. Universidade do Estado do Rio de Janeiro,

Rua Rogério Karp 101/205,
CEP 202795-210 Rio de Janeiro RJ,
BRAZIL
Fax: +55214376007
E-mail: luciacanevaro@zipmail.com
Cunha, P.G. Instituto de Radioproteção e Dosimetria, IRD/CNEN,

Av. Salvador Allende s/n,
BRAZIL
Fax: +55214421950
E-mail: pcunha@ird.gov.br
de Almeida, C. Universdade de Ribeirão Preto Escola de Medicina,

Rua Tamoios 262, Ap. 154,
14020-700 Ribeirão Preto,
BRAZIL
Fax: +55215685923
E-mail: cea@uerj.br
Drexler, G. Laboratório de Ciências Radiológicas,

Rua São Francisco Xavier 524,
Maracanã, CEP 2055-013 Rio de Janeiro RJ,
BRAZIL
Fax: +55 21 256 8932
E-mail: drexler@Icr.uerj.br
Hazin, C. Departamento de Energia Nuclear, UFPE,

Av. Prof. Luiz Freire 1000,
CEP 50740-540 Recife PE,
BRAZIL
Fax: +558132718250
E-mail: hazin@npd.ufre.br
Khoury, H.J. Departamento de Energia Nuclear, UFPE,

Av. Prof. Luiz Freire 1000,
CEP 50740-540 Recife PE,
BRAZIL
E-mail: khoury@elogica.com.br
Kuwabara, M.T. Instituto Dante Pazzanese de Cardiologia,

Av. Dante Pazzanese 500,
BRAZIL
Fax: +551155712279
E-mail: kuwabara@lee.dante.br
Lassance, A. Secretaria de Estado de Saúde,

Governo de Estado de Rio de Janeiro,
Rua México 128, Centro Sala 513,
CEP 20030-142 Rio de Janeiro RJ,
BRAZIL
Fax: +55212209918
E-mail: lassance@provide.psi.br
Moreira, F. Colégio Brasileiro de Radiología,

Av. Paulista 491,
01311 909 São Paulo SP,
BRAZIL
Fax: +55112851690
E-mail: cbradiol@cbr.org.br
Mota, H.C. Instituto de Radioproteção e Dosimetria, IRD/CNEN,

BRAZIL
Fax: +55214421950, 4422325
E-mail: helvecio@ird.gov.br
Pedrosa de Azevedo, A.C. Department of Radiology, Faculty of Medicine,

Federal University of Rio de Janeiro,
21941 590 Rio de Janeiro RJ,
BRAZIL
Fax: +55215622394
E-mail: anacecilia@hucff.ufrj.br
Peixoto, J.G.P. Instituto de Radioproteção e Dosimetria, IRD/CNEN,

BRAZIL
Fax: +55214429651
E-mail: guilherm@ird.gov
Rezende Avila, A. Instituto de Biología,

Av. 28 de Setembro 87,
20551 030 Rio de Janeiro RJ,
BRAZIL
Fax: +55212543532
E-mail: asra@uerj.br
Ribeiro de Freitas, L. Instituto de Radioproteção e Dosimetria, IRD/CNEN,

BRAZIL
Fax: +55214421950
E-mail: lribeiro@ird.gov.br
Soares, A. Colégio Brasileiro de Radiología,

Av. Paulista 491,
BRAZIL
Fax: +55112851690
E-mail: cbradiol@cbr.org.br
Tavares Campos, D.M. National Nuclear Energy Commission,

Rua General Severiano 90,
Botafogo, 22294-900 Rio de Janeiro RJ,
BRAZIL
Fax: (55 21) 295 86
E-mail: dmcampos@cnen.gov.br
Viterbo de Oliveira, B.G. Faculdade de Medicina de Botucatu, UNESP,

Hospital das Clínicas de Botucatu,
CP 530 Rubião Jr.,
Botacatu, CEP 18618-970,
BRAZIL
Fax: +55 14 68215497
E-mail: beatrizviterbo@uol.com.br
BULGARIA
Apostolova, D.B. Center of Occupational Diseases,

Medical University,
Blvd. D. Nestorov 15,
BG-1431 Sofia,
BULGARIA
Fax: +359 2 595106
Paskalev, Z.D. National Center of Radiobiology and Radiation

Protection,
132 Kliment Ohridski Blvd.,
BG-1756 Sofia,
BULGARIA
Fax: +359 2 621059
E-mail: ncrrp@medicalnet-bg.org
CAMEROON
Dong, A. Zok Hôpital Général,

B.P. 5408,
Yaounde,
CAMEROON
Fax: +237213181
E-mail: dongazok@uycdc.Uninet.com
Essomba, B.M. Hôpital Général,

B.P. 4856,
Douala,
CAMEROON
Fax: +237370146
E-mail: essobim@yahoo.fr
Gonsu Fotsin, J. Central Hospital,

P.O. Box 13765,
Yaounde,
CAMEROON
Fax: +237235261
E-mail: gonsufj@camnet.cm
Mouelle, S. Hôpital Général,

P.O. Box 4856,
Douala,
CAMEROON
Fax: +237370146
E-mail: hgd@camnet.cm
Nko’o Anvene, S. Centre hospitalier et universitaire,

Yaounde,
CAMEROON
Fax: +237237541
E-mail: nkoo-an@yahoo.com
Ongolo Zogo, P. Central Hospital,

B.P. 5604,
Yaounde,
CAMEROON
E-mail: Pongolo@uycdc.ininet.cm
CANADA
Aldrich, J.E. Department of Radiology,

Vancouver General Hospital,
899 West 12th Avenue,
Vancouver, British Columbia, V5Z 1M9,
CANADA
Fax: +16048755498
E-mail: aldrich@interchange.ubc.ca
Gagnon, G. Ordre des technologues en radiologie du Québec,

7400 Boul. les Galéries d’Anjou, Bureau 420,
Anjou, Quebec, H1M 3M2,
CANADA
Fax: +15143552396
E-mail: ggagnon@otrg.gc.ca
Johnson, H.M. Department of Medical Physics,

Cancer Care Manitoba,
675 McDermot Avenue,
Winnipeg, Manitoba, R3E 0V9,
CANADA
Fax: +12047751684
E-mail: harry.johnson@cancercare.mb.ca,
Lavoie, C. Radiation Protection Bureau,

A.L. 6301A, 775 Brookfield Road,
Ottawa, Ontario, K1A 1C1,
CANADA
Fax: +16139411734
E-mail: christian_lavoie@hc-sc.gc.ca
Normandeau, L. Centre hospitalier de l’Université de Montréal,

1560 rue Sherbrooke Est,
Montreal, Quebec, H2L 4M1,
CANADA
Fax: +15148964712
E-mail: lysanne.normandeau.chum@sss.gouv.qc.ca
CHILE
Astudillo Gómez, S. Pontificia Universidad Católica de Chile,

Hospital Clínico de Medicina Nuclear,
Marcoleta 367,
Casilla Postal 114-D Santiago,
CHILE
Fax: +5626333266
E-mail: satudil@puc.cl
Ramirez, A. Hospital Clínico de la Universidad de Chile,

Santos Dumoutt 999,
Santiago,
CHILE
Fax: +5627320683
E-mail: aramirezn@entelchile.net
CHINA
Luo, Qingliang Beijing Institute of Radiation Medicine,

27 Taiping Road,
Beijing 100850,
CHINA
Fax: +861068214653
E-mail: haoj@nic.bmi.ac.cn
Wei, Kedao Laboratory of Industrial Hygiene, Ministry of Health,

2 Xinkang Street, Deshengmenwai,
Beijing 100088,
CHINA
Fax: +86 10 62012501
E-mail: mphlihzj@public3.bta.net.cn
Yang, Guoshan Beijing Institute of Radiation Medicine,

27 Taiping Road,
Beijing 100850,
CHINA
Fax: +861068214653
E-mail: yanggs@nic.bmi.ac.cn
Zheng, Jun Zheng Laboratory of Industrial Hygiene, Ministry of Health,

P.O. Box 8018,
Beijing 100088,
CHINA
Fax: +861-62012501
E-mail: zheng jun zheng@sina.com
Zhu, Zhi Xian Shenzhen Hygiene and Anti-epidemic Station,

Shenzhen 518020,
CHINA
Fax: +86755 5508427
E-mail: zhu zhi xia_2@163.net
COLOMBIA
Natera Hoyos, J. Hospital Militar Central,

Avenida 42 No. 15-71 (202),
Bogotá,
COLOMBIA
Fax: +5712876270
E-mail: jnate72@latinmail.com
Plazas, M.C. Departamento de Física-Médica,

Universidad Nacional de Colombia,
Avenida Primera 9, 85,
Bogotá,
COLOMBIA
Fax: +5713165135
E-mail: mcplazas@andinet.com
COSTA RICA
Bermúdez Jiménez, L. Ministerio de Salud,
Apartado Postal 10123-1000,
San José,
COSTA RICA
Fax: +5062221748
E-mail: luisbermudez@hotmail.com
Carmona Roblero, S.A. Caja Costarricense de Seguro Social,

Gerencia Divisiva Operaciones,
San José,
COSTA RICA
Fax: +5062554547
E-mail: scarmona@ccss.sa.cr
Castrillo, L.F. Caja Costarricense de Seguro Social,

Apartado Postal 10105,
San José,
COSTA RICA
Fax: +5062335682
E-mail: drcastrillo@racsa.co.cr
Ferraro, F. Caja Costarricense de Seguro Social,

San José,
COSTA RICA
Fax: +5062335682 or 2952829
E-mail: fferraro@ccss.sa.cr
Pardo Evans, R. Ministerio de Salud,

Avenida 8, Calle 16,
San José,
COSTA RICA
Fax: +5062552594
E-mail: ministro@netsalud.sa.cr
Ramirez Guillén, F. Caja Costarricense de Seguro Social,

San José,
COSTA RICA
Fax: +5062554547
E-mail: framirez@ccss.sa.cr
CROATIA
Grgic, S. Ministry of Health,

Ksaver 200a,
Zagreb,
CROATIA
Fax: +38514607566
E-mail: srecko.grgic@mzrh.tel.hr
Novakovic, M. EKOTEH Radiation Protection,

V. Ruzdjaka 21,
10 000 Zagreb,
CROATIA
Fax: +38516043882
E-mail: ekoteh@zg.tel.hr
CUBA
Alonso González, I. Centro Nacional de Seguridad Nuclear (CNSN),

Calle 28, No. 504 e/5ta y 7ma,
Miramar, Playa,
C.P. 11300 Habana,
CUBA
Fax: +537231664
de Fleitas Estévez, I. Centro de Control Estatal de Equipos Médicos,

Calle 4, No. 455 e/19 y 21 Vedado,
C.P. 10400 Habana,
CUBA
Fax: +537551030
E-mail: ileana@cceem.sld.cu
Domínguez Hung, L. Centro de Control Estatal de Equipos Médicos,

Calle 4, No. 455 e/19 y 21 Vedado,
C.P. 10400 Habana,
CUBA
Fax: +537551930
Fernández Gómez, U. Centro Nacional de Seguridad Nuclear (CNSN),

Habana,
CUBA
Jova Sed, L.A. Centro de Protección e Higiene de las Radiaciones,

Calle 20, No. 4109 e/41 y 47,
Miramar, Playa,
P.O. Box 6195,
10600 Habana 6,
CUBA
Fax: +537241188
E-mail: jova@cphr.edu.cu
López Bejerano, G.M. Centro de Estudios Aplicados al Desarrollo Nuclear,

Calle 30, No. 502 e/61 y 22,
C.P. 10600 Habana,
CUBA
Fax: +537241188
E-mail: gladys@cphr.edu.cu
Martínez González, A. Centro de Protección e Higiene de las Radiaciones,

Calle 20, No. 4109 e/41 y 47,
Miramar,
C.P. 10600 Habana 6,
CUBA
Fax: +537241188
E-mail: alina@cphr.edu.cu
Oliva González, J. Instituto Nacional de Oncología y Radiobiología,

Calle 29 y E Vedado,
Habana,
CUBA
Fax: +53 7 55 2587
E-mail: Imagamma@infomed.sld.cu
Vilaragut Llanes, J.J. Centro Nacional de Seguridad Nuclear (CNSN),

Miramar, Playa,
C.P. 11300 Habana,
CUBA
Fax: +537231664
E-mail: cnsn@isctn.edu.cu
CYPRUS
Kaplanis, P.A. Medical Physics Department,

Nicosia General Hospital,
1450 Nicosia,
CYPRUS
Fax: +357 2 801773
E-mail: p.a.kaplanis@cytanet.com.cy
CZECH REPUBLIC
Heribanová, A. Prague Regional Centre, State Office for Nuclear Safety,

Senovázné námestí 9,
CZ-110-00 Prague 1,
CZECH REPUBLIC
Fax: +420 2 2162 4710
E-mail: Alena.Heribanova@subj.cz
Hyka, J. Czech Society of Radiographers and Radiological

Assistants,
Jindricha Plachty 28,
CZ-370-04 Ceské Budejovice,
CZECH REPUBLIC
Fax: +420387314389
E-mail: hyka@jcu.cz
Paskova, Z. Prague Regional Centre, State Office for Nuclear Safety,

Senovázné námestí 9,
CZ-110-00 Prague 1,
CZECH REPUBLIC
Fax: +420 2 2162 4760
E-mail: zuzana.paskova@subj.cz
DENMARK
Andersen, E. Kas Herlev University Hospital,

Herlev Ringvej 75,
DK-2730 Herlev,
DENMARK
Fax: +45 44 88 30 65
E-mail: eran@herlevhosp.kbhamt.dk
Grøn, P. National Institute of Radiation Hygiene,

Knapholm 7,
DK-2730 Herlev,
DENMARK
Fax: +4544543450
E-mail: sis@sis.dk.
Hjarbaek, J. Department of Radiology, Vejle Hospital,

DK-7100 Vejle,
DENMARK
Fax: +4579406873
E-mail: j.hjarbaek@dadlnet.dk
Stougaard, K.E. Department of Radiology, Vejle Hospital,

DK-7100 Vejle
DENMARK
Fax: +4579406873
E-mail: stougaard@privat.dk
EL SALVADOR
Martínez Pérez, J.L. Hospital Nacional Niños Benjamin Bloore,

25 Norte,
San Salvador,
EL SALVADOR
Fax: +5032261684
ESTONIA
Filippova, I. Estonian Radiation Protection Centre,

Kopli 76,
10416 Tallinn,
ESTONIA
Fax: +3726603352
E-mail: irinaf@kopli.envir.ee
Nazarenko, S. Clinic of Radiology,

Tallinn Central Hospital,
Ravi 18,
10001 Tallinn,
ESTONIA
Fax: +3726207002
E-mail: sn@kristel.sps.ee
FIJI
Ajibulu, O.O. Department of Radiography,

Fiji School of Medicine,
P.M.B. Suva,
FIJI
Fax: +679303469
E-mail: olusegunatfsm.ac.fj
FINLAND
Havukainen, R.T.I. STUK, Radiation and Nuclear Safety Authority,

P.O. Box 14,
FIN-00881 Helsinki,
FINLAND
Fax: + 358 9 7598 8248
E-mail: ritva.havukainen@stuk.fi
Järvinen, H.E.J. STUK, Radiation and Nuclear Safety Authority,

P.O. Box 14,
FIN-00881 Helsinki,
FINLAND
Fax: +358 9 7598 8450
E-mail: hannu.jarvinen@stuk.fi
Kormano, M.J. Department of Diagnostic Radiology,

University of Turku,
FIN-20521 Turku,
FINLAND
Fax: +35822612950
E-mail: martti.kormano@utu-fi
Korpela, T.H. STUK, Radiation and Nuclear Safety Authority,

P.O. Box 14,
FIN-00881 Helsinki,
FINLAND
Fax: +358 9 7598 8248
E-mail: helina.korpela@stuk.fi
Paunio, M.K. Ministry of Social Affairs and Health,

P.O. Box 33,
FIN-00023 Helsinki,
FINLAND
E-mail: mikko.paunio@stm.un.fi
Pukkila, O.K. STUK, Radiation and Nuclear Safety Authority,

P.O. Box 14,
FIN-00881 Helsinki,
FINLAND
Fax: +358 9 7598 8248
E-mail: olavi.pukkila@stuk.fi
Servomaa, A.J. Laboratory for Diagnostic X-ray Research,

STUK, Radiation and Nuclear Safety Authority,
FIN-0881Helsinki,
FINLAND
Fax: +358 9 7598 8589
E-mail: antti.servomaa@stuk.fi
Sipilä, P.M.V. STUK, Radiation and Nuclear Safety Authority,

P.O. Box 14,
FIN-00881 Helsinki,
FINLAND
Fax: +358 9 7598 8450
E-mail: petri.sipila@stuk.fi
Sipilä, T.M.L. Orton Hospital,

Tenholantie 10,
FIN-00280 Helsinki,
FINLAND
Fax: +358 9 4748 2401
E-mail: tiina.sipila@invalidisaatio.fi
Standertskjöld-Nordenstam, C.-G. Department of Radiology,

Helsinki University Hospital,
Meilahti Clinics,
FIN-00290 Helsinki,
FINLAND
Fax: +358947174404
E-mail: carl-gustaf.standertskjold@hus.fi
FRANCE
Beauvais-March, H. Office de protection contre les rayonnements ionisants

(OPRI),
31, rue de l’Ecluse, B.P. 35,
F-78116 Le Vesinet Cedex,
FRANCE
Fax: +33139760896
E-mail: helene.beauvais@opri.fr
Garcier, Y. Electricité de France,

Site Cap Ampère,
1, Place Pleyel,
F-93282 Saint-Denis Cedex,
FRANCE
Fax: +33143693495
E-mail: yves.garcier@edf.fr
Lacronique, J.F.M. Office de protection contre les rayonnements ionisants

(OPRI),
FRANCE
Fax: +33139760896
E-mail: jflacronique@ofri.fr
Maccia, C. Centre d’assurance de qualité des applications

technologiques dans le domaine de la santé (CAATS),
43 Bd. du Maréchal Joffre,
F-92340 Bourg-La-Reine,
FRANCE
Fax: +33 01 40913031
E-mail: mcarlo@compuserve.com
Marinello, G. Unité de radiophysique et radioprotection,

Hôpital Henri Mondor,
51, avenue Maréchal de Lattre de Tassigny,
F-94010 Créteil,
FRANCE
Fax: +33149812589
E-mail: ginette.marinello@hmn.ap.hop.paris.fr
Marshall-Depommier, E. Société française de radiology (SFR),

20, avenue Rapp,
F-75007 Paris,
FRANCE
E-mail: edepomm@club.internet.fr
Nénot, J.-C. Service d’hygiène radiologique,

Institut de protection et de sûreté nucléaire,
B.P. 6,
F-92265 Fontenay-aux-Roses
FRANCE
Fax: +33 1 46544610
E-mail: jean-claude.nenot@ipsn.fr
Valero, M. Office de protection contre les rayonnements ionisants

(OPRI),
FRANCE
Fax: +33138155224
E-mail: marc.valero@opri.fr
GERMANY
Attwood-Wood, D. Institute of Clinical Radiology,

Albert-Schweitzer Strasse 33,
D-48129 Münster,
GERMANY
Fax: +492518347312
E-mail: wood@uni-muenster.de
Duschka, H. Siemens Medical Referat TC 62 and SC62B,

Henkestrasse 127,
D-91052 Erlangen,
GERMANY
Fax: +49 91 31 84 89 04
E-mail: hartmut.duschka@med.siemens.de
Kemmer, W. Bundesministerium für Umwelt,

D-53048 Bonn,
GERMANY
Fax: +492283052828
E-mail: kemmer.wolfgang@bum.de
Knopp, R. Sulzbachstrasse 24,

D-79282 Ballrechten-Dottingen,
GERMANY
Fax: +497634591922
E-mail: rknopp@mailer.meb.mni-bonn.de
Lauk, R. PTW Freiburg,

Lorracher Strasse 7,
D-79115 Freiburg,
GERMANY
Roskewitsh, H. Erlenweg 13,

D-55578 Wallertheim,
GERMANY
Fax: +4967328060
Streffer, C. Radiologisches Zentrum, Universitätsklinikum Essen,

Hufelandstrasse 55,
D-45122 Essen,
GERMANY
Fax: +49201723/3808
E-mail: streffer.essen@t.online.de
GHANA
Nani, K.E. National Centre for Radiotherapy and Nuclear Medicine,

P.O. Box KB 369,
Korle-Bu, Accra,
GHANA
Fax: +23321400807
E-mail: kwakunani@yahoo.com
Vanderpuye, V.D.N.K. National Centre for Radiotherapy and Nuclear Medicine,

P.O. Box KB 369,
Korle-Bu, Accra,
GHANA
E-mail: vvanderpuye@hotmail.com
GREECE
Kottou, S. Medical Physics Department,

Athens University Medical School,
M. Asias 75,
GR-11527 Athens,
GREECE
Fax: +3017793273
E-mail: skottou@cc.uoa.gr
Molfetas, M.G. Medical Physics Department, Evangelismos Hospital,

Ipsilandou 43–47,
GR-10676 Athens,
GREECE
Fax: +3017258328
E-mail: Molfetas@mail.kapatel.gr
Neofotistou, V. Medical Physics Department, Athens General Hospital,

15 Solonos Street,
GR-14576 Dionysos, Athens,
GREECE
Fax: +3018150054
E-mail: evaneof@otenet.gr
Papadimitriou, D. Medical Physics Department,

Athens University Medical School,
M. Asias 75,
GR-11527 Athens,
GREECE
Fax: +3017793273
Skouras, D.T. Department of Medical Physics,

University Hospital Patras,
GR-26500 Patras,
GREECE
Fax: +361999861
E-mail: skouras@med.upatras.gr
Tsapaki, V. Onassis Cardiac Surgery Center,

356 Syngru Avenue,
GR-17674 Kallithea, Athens,
GREECE
Fax: +3019493363
E-mail: vtsapaki@hotmail.com
HAITI
Joachim, M.G. Ministère de la santé publique et de la population,

Complexe medical Marguerite Liautaud,
52, angle Chemin des Dalles et Avenue Magny,
Port-au-Prince,
HAITI
E-mail: ginajoachim@yahoo.fr
HOLY SEE
Hefner, A. Österreichisches Forschungs-Zentrum Seibersdorf GmbH,

A-2444 Seibersdorf,
AUSTRIA
Fax: +430505502502
E-mail: alfred.hefner@arcs.ac.at
Kirisits, C. Department of Radiotherapy and Radiobiology,

University of Vienna Medical School,
AUSTRIA
Fax: +430140400-2695
E-mail: christian.kirisits@str.akh.magwien.gv.at
HONDURAS
Amaya Fonseca, A.G. Centro de Cáncer Emma Romero de Callejas,

Colonia Lomas del Guijarro,
II Etapa, Calle Atenas,
Tegucigalpa,
HONDURAS
Fax: +504 2399481
E-mail: fisicamedical@optinet.hn
HUNGARY
Giczi, F. Györ-Moson-Sopron County Health and Medical Office,

National Institute for Radiobiology and Radiohygiene,
P.O. Box 66,
H-9002 Györ,
HUNGARY
Fax: +3696 418068
E-mail: antszgy@mail.datanet.hu
Pellet, S. National Research Institute for Radiobiology and

Radiohygiene,
Anna Street 5,
H-1221 Budapest,
HUNGARY
Fax: +3612291931
E-mail: pellet@hp.osski.hu
Szilvási, I. Semmelweis University,

Szabolcs u. 35, Pf.112,
H-1389 Budapest,
HUNGARY
Fax: +3613208066
E-mail: szilvasi@mail.hu
ICELAND
Elnarsson, G. Icelandic Radiation Protection Institute,

Raudarárstigur 10,
150 Reykjavik,
ICELAND
Fax: +35455228202
E-mail: ge@gr.ls
INDIA
Rehani, M.M. Institute Rotary Cancer Hospital,

All India Institute of Medical Sciences,
Ansari Nagar,
New Delhi 110 029,
INDIA
Fax: +91116523661
E-mail: mmrehani@vsnl.com
Sawant, S.G. Radiological Physics and Advisory Division,

Bhabha Atomic Research Centre,
Anushaktinagar,
Mumbai 400094,
INDIA
Fax: +91 22 5505151 or 5519209
E-mail: sgsawant@hotmail.com
INDONESIA
Azhar, A. BAPETEN, Nuclear Energy Control Board,

Jl. MH Thamrin 55,
Jakarta 10350,
INDONESIA
Fax: +62212301253
Badri, C. Indonesian Radiological Society,

Instalasi Radioterapi RSCM,
Jl. Diponegoro 71,
Jakarta Pusat 10430,
INDONESIA
Fax: +6221331867
E-mail: chbadri@yahoo.com
Nasukha, N. Clinical Dosimetry Group, BATAN,

P.O. Box 7043 JKSKL,
Jakarta 12070,
INDONESIA
Fax: +62217657950
E-mail: aljabar2@hotmail.com
IRAN, ISLAMIC REPUBLIC OF
Arbabi, G. Medical Phsyics Department, Jorjani Medical Centre,

Shaheed Beheshti Medical Sciences University,
P.O. Box 17115-137,
Tehran,
ISLAMIC REPUBLIC OF IRAN
Fax: +98218717894
E-mail: aarbabi@hotmail.com
IRELAND
Casey, M. Medical Physics Department,

St. Vincent’s University Hospital,
Elm Park,
Dublin 4,
IRELAND
Fax: +35312094961
E-mail: m.casey@st-vincents.ie
Corridan, M.-P. St. Vincent’s University Hospital,

Elm Park,
Dublin 4,
IRELAND
E-mail: mp.corridan@circom.net
Dowling, A.R. Department of Medical Physics and Bioengineering,

St. James Hospital,
Dublin 8,
IRELAND
Fax: +353 1 410 3478
E-mail: adowling@stjames.ie
MacCoy, C. St. Vincent’s University Hospital,

Elm Park,
Dublin 4,
IRELAND
Fax: +35312602347
E-mail: mccoy@esatclear.ie
Malone, J.F. Department of Medical Physics and Bioengineering,

St. James Hospital,
Dublin 8,
IRELAND
Fax: +3531 410 34 78
E-mail: jfmalone@haughton-institute.ie
McGarry, A.T. Radiological Protection Institute of Ireland,

3 Clonskeagh Square,
Clonskeagh Road,
Dublin 14,
IRELAND
Fax: +353 1 2697437
E-mail: amcgarry@rpii.ie
ISRAEL
Ben-Shlomo, A. Radiation Safety Division,

Soreq Nuclear Research Center,
81800 Yavne,
ISRAEL
Fax: +972 8 9434696
E-mail: avi@ndc,soreq.gov.il
Faermann, S. Soroka University Medical Center,

P.O. Box 151,
84101 Beer-Sheva,
ISRAEL
Fax: +972 7 623236
Freud, A. Radiochemistry Department,

Israel Atomic Energy Commission (NRCN),
P.O. Box 9001,
84190 Beer-Sheva,
ISRAEL
Fax: +97276567015
E-mail: freud@netvision.net.il
Kadosh, S. Noshe Saret 12/28,

Akko,
ISRAEL
Melloul, M. Hasharon Hospital,

44/4 Arlozorv Street,
Petah-Tikva,
ISRAEL
Fax: +97239372661
E-mail: moshem2@clatit.org.il
Schlesinger, T. Radiation Safety Division,

Soreq Nuclear Research Center,
81800 Yavne,
ISRAEL
Fax: +97289434696
E-mail: tuvia@ndc.soreq.gov.il
Shokron, M. Hasharon Hospital,

Gold Street 6,
Petah Tikva,
ISRAEL
Fax: +97239372740
E-mail: moshem2@clalit.orig.il
ITALY
Corlaita, S. Sant’ Orsola-Malpighi Hospital,

Radiologia Venturoli,
Via Massarenti, 9,
I-40138 Bologna,
ITALY
E-mail: stefradio@katamail.com
Giussani, A.M. Università degli Studi di Milano,

Dipartimento di Fisica,
Via Celorca 16,
I-20133 Milan,
ITALY
Fax: +3902 58357630
E-mail: augusto.giussani@unimi.it
Malisan, M.-R. Ospedale S. Maria della Misericordia,

Istituto di Fisica Sanitaria,
I-33100 Udine,
ITALY
Fax: +432552548
E-mail: fissan2@aoud.sanita.fvg.it
Padovani, R. Ospedale S. Maria della Misericordia,

Istituto di Fisica Sanitaria,
I-33100 Udine,
ITALY
Fax: +390432552
E-mail: padovani.renato@aoud.sanita.fvg.it
Pollastri, P. Istituti Ortopedici Rizzoli, IRCCS,

C. Pupilli 1,
I-40137 Bologna,
ITALY
Fax: +39051580453
Roma, L. Instituto di Fisica Sanitaria,

Università di Bologna,
Via Massarenti 9,
I-40138 Bologna,
ITALY
Fax: +39051393306
E-mail: fisan@med.unibo.it
JAPAN
Iwanami, S. Faculty of Medical Engineering,

School of Allied Health Sciences, Kitasako University,
1-15-1 Kitasako, Sagamihara-shi,
Kanagawa-ken 288-8555,
JAPAN
Fax: +81 427789628
E-mail: iwanami@medcc.kitasato-u-ac.jp
Koga, S. Fujita Health University School of Medicine,

1-98 Dengaku-ga-kubo,
Kutsukake-cho, Toyoake-shi,
Aichi-ken 470-1192,
JAPAN
Fax: +81 562952253
E-mail: skoga@fujita-hu.ac.jp
Konishi, J. Department of Nuclear Medicine,

Kyoto University School of Medicine and Hospital,
54 Seigoin Kawara-machi,
Sakyo-ku, Kyoto-shi,
Kyoto 606-8507,
JAPAN
Fax: +81 75 771 9709
Muroi, M. Toshiba Medical Systems Europe,

Zilverstraat 1,
NL-2718 RP Zoetermeer,
NETHERLANDS
Nishizawa, K. National Institute of Radiological Sciences,

4-9-1, Anagawa, Inage-ku,
Chiba, 263-8555,
JAPAN
Fax: +81432841769
E-mail: nisizawa@nirs.go.jp
KENYA
Karigi, A.W. Radiation Protection Board,

P.O. Box 63055,
Nairobi,
KENYA
Fax: +254 2 714 383
E-mail: rpbkenya@nbnet.co.ke
Mwangi, M. X Ray Department, Kenyatta National Hospital,

P.O. Box 19323,
Nairobi,
KENYA
Fax: +25402725272
E-mail: faogall@hotmail.com
KUWAIT
Almedaires, J. Ministry of Health,

P.O. Box 38024 Dahaiyt,
Abdalla Al Salem,
KUWAIT
Fax: +9652437691
E-mail: jasem33@hotmail
Gupta, R. Radiology Department, Faculty of Medicine,

Kuwait University,
P.O. Box 24923,
Safat 13110,
KUWAIT
Fax: +9655330473
E-mail: renu@hsc.kuniv.edu.kw
LATVIA
Pakers, E. P. Stradinj Clinical Hospital,

13, Pilsonu Street,
LV-1002 Riga,
LATVIA
Fax: +3717611169
LITHUANIA
Jonaitiene, E. Clinic of Radiology,

Kaunas Medical Universersity Hospital,
Eivenu 2,
LT-3007 Kaunas,
LITHUANIA
Fax: +3707 733607
Morkünas, G. Radiation Protection Centre,

Kalvariju 153,
LT-2042, Vilnius,
LITHUANIA
Fax: +370 2 754692
E-mail: genmo@takas.lt
LUXEMBOURG
Back, C. Division de la Radioprotection, Direction de la Santé,

Villa Louvigny,
L-2120 Luxembourg,
LUXEMBOURG
Fax: +352 467522
E-mail: carlo.back@ms.etat.lu
MALAYSIA
Ng, K.H. Department of Radiology, Faculty of Medicine,

University of Malaya,
59100 Kuala Lumpur,
MALAYSIA
Fax: + 603 758 1973
E-mail: ngkh@medicine.med.um.edu.my
Sathyamoorthy, P. Diagnostic Imaging Department, Kuala Lumpur Hospital,

Jalan Pahang,
50586 Kuala Lumpur,
MALAYSIA
Fax: +60 3 2984035
E-mail: sathya@hkl.gov.my
Wang, H.B. Engeenering Department, Ministry of Health,

4th and 6th Floor, Wisma Sime,
Darby-Jalan Raja Laut,
50590 Kuala Lumpur,
MALAYSIA
Fax: +603 2949317 / 2949327
E-mail: wanghb@cmis.com.my
MALI
Sidibe, S. Department of Radiology and Nuclear Medicine,

Hôpital National du Point G,
B.P. 333,
Bamako,
MALI
Fax: +223229790
E-mail: sidibes@hotmail.com
MALTA
Cassar, J. Radiography Services, Department of Radiology,

St. Luke’s Hospital,
G’ Mangia,
MALTA
Fax: +356 240247 / 25951491
E-mail: Joseph.M.Cassar@magnet.mt
MEXICO
Alvarez García, J. Instituto Mexicano del Seguro Social,

Calle 38, No. 65 Col. Santa Rosa,
Delegación Gustavo A. Madero,
C.P. 07620 Mexico, D.F.,
MEXICO
Fax: +52864154
Arroyo Pérez, A.I. Instituto Mexicano del Seguro Social,

Sindicalismo 77 Bis 302,
Delegación Miguel Hidalgo,
MEXICO
Fax: +52864154
Carreon Bautista, G. Instituto Mexicano del Seguro Social,

Manuel M. López 101, Edif. 3 H 204,
Col. Santiago Zapotitlán,
Delegación Tláhuac,
MEXICO
Fax: +52864154
Escamilla Cuevas, J. Servicio de Salud,

Mexico D.F.,
MEXICO
Massillon, Guerda J.L. Instituto de Ciencias Nucleares,

Universidad Nacional Autónoma de Mexico,
A. Postal 70-543,
04510 Mexico, D.F.,
MEXICO
Fax: +5256162233
E-mail: massillo@nuclecu.unam.mx
Moreno Díaz, San G. Instituto Mexicano del Seguro Social,

Primaveras No. 172,
Parque Residencial Coacalco,
55720 Mexico, D.F.,
MEXICO
Fax: +52864154
Ramírez Arias, J.L. Hospital General de México,

Av. México Coyoacán 346, Col. General Anaya,
003340 Mexico, D.F.,
MEXICO
Fax: +5256056388
E-mail: iramirez@datasys.com.mx
Ruíz-Trejo, C.G. Instituto de Física, UNAM,

A.P. 20–364
01000 Mexico, D.F.,
MEXICO
Fax: +525 6161535
E-mail: cesar@fenix.ifisicacu.unam.mx
Sánchez Menéndez, S. Instituto Mexicano del Seguro Social,

Calle Pablo García 245, Edif. A, Apto. 402,
Col. Juan Escutia,
Delegación Iztapalapa,
Mexico, D.F.,
MEXICO
Fax: +52864154
Tokunaga, J. Sociedad Mexicana de Radioterapeutas,

Calle Gral. Ferreira 2236, Col. Juárez,
22150 Tijuana, B.C.,
MEXICO
Fax: +526848159
E-mail: tokunaga@omnitec.com
Verdejo Silva, M. Riesgos Radiológicos, Secretaría de Salud,

Topilejo 70,
11000 Mexico, D.F.,
MEXICO
Fax: +5252504558
E-mail: mverdejo@intersky.com
Villegas Méndez, R. Instituto Mexicano del Seguro Social,

Calle Recreo 28, Esquina Emiliano Zapata,
Delegación Iztacalco,
08300 Mexico, D.F.,
MEXICO
Fax: +52864154
MOROCCO
Charif, Y. Centre national de radioprotection,

Avenue Al Massira Al khadra,
Bettana, Salé,
MOROCCO
Fax: +21237813184
Zaoui, F. Centre national de l’énergie, des sciences et des

techniques nucléaires
65, rue Tansift. Agdal,
Rabat,
MOROCCO
Fax: +21237711846
E-mail: zaoui@cnesten.org.ma
NETHERLANDS
Eastick, R. Toshiba Medical Systems Europe,

Zilverstraat 1,
NL-2718 RP Zoetermeer,
NETHERLANDS
Fax: +31793689444
Hummel, W.A. Klinisch Chemisch Laboratorium,

Borniastraat 34,
NL-8934 AD Leeuwarden,
NETHERLANDS
Fax: +31 58 2882227
E-mail: willyhummel@kcl.znb.nl
Huyskens, C.J. Eindhoven University of Technology,

P.O. Box 513,
NL-5600 MB Eindhoven,
NETHERLANDS
Fax: +31402435020
E-mail: C.J.Huyskens@tue.nl
Kop, J.M.M. Department of Safety and Environment,

University of Maastricht,
P.O. Box 616,
NL-6200 MD, Maastricht,
NETHERLANDS
Fax: +433884119
E-mail: j.kop@vm.unimaas.nl
Meinders, L.W. Inspectorate of Health Care,

Parnassusplein 5,
P.O. Box 16119,
NL-2500 EB The Hague,
NETHERLANDS
Fax: +31703407159
E-mail: medtech.higz@igz.nl
Rijlaarsdam, J. Ministry of Health, Welfare and Sports,

P.O. Box 20350,
NL-2500 EJ The Hague,
NETHERLANDS
Fax: +31073407103
E-mail: j.rijlaarsdam@minvws.nl
Spoelstra, F.M. Department of Radiology,

Leiden University Medical Centre,
Albinus Dreef 2,
NL-2333 ZA Leiden,
NETHERLANDS
Fax: +31 071 5248256
E-mail: f.m.spoelstra@lumc.nl
Termorshuizen, W. Department VSM, Leiden University Medical Centre

P.O. Box 9600,
NL-2300 RC Leiden,
NETHERLANDS
Fax: +31 71 524 81111
E-mail: w.termorshuizen@lumc.nl
Van der Giessen, P.H. Dr. Bernard Verbeeten Instituut,

Brugstraat 10,
NL-5042 SB Tilburg,
NETHERLANDS
Fax: +31135947683
E-mail: giessen.ph@bvi.nl
Wemmenhove, B.L. Academy Medical Centre,

Meibergdreef 9,
NL-1105 A2 Amsterdam,
NETHERLANDS
Fax: +31206976508
E-mail: B.L.Wemmenhove@amc.uva.nl
Zoetelief, J. Delft University of Technology,

Mekelweg 15,
NL-2629 JB Delft,
NETHERLANDS
Fax: +311527889011
E-mail: j.zoetelief@iri.tudelft.nl
Zuur, C. Ministry of Housing, Spatial Planning and Environment,

P.O. Box 30945,
NL-5600 GX The Hague,
NETHERLANDS
Fax: +31703391314
E-mail: ciska.zuur@minvrom.nl
Zwigt, A. Academic Hospital Maastricht,

P.O. Box 5800,
NL-6202 AZ Maastricht,
NETHERLANDS
Fax: +31 43 3874746
E-mail: azw@nug.azm.nl
NEW ZEALAND
Evans, D.L. Alert Medical Research,

P.O. Box 34054,
Christchurch,
NEW ZEALAND
E-mail: alertmedicalresearch@consultant.com
Le Heron, J.C. National Radiation Laboratory,

P.O. Box 25099,
Christchurch,
NEW ZEALAND
Fax: +6433661156
E-mail: john_le_heron@nrl.moh.govt.nz
NIGERIA
Ketiku, K.K. Lagos University Teaching Hospital,

P.M.B. 12003,
Lagos,
NIGERIA
Fax: +23415851432
E-mail: cmul@rcl.nig.com
NORWAY
Bjorklund, E.G. Norwegian Radiation Protection Authority,

Grini Naeringspark 13,
P.O. Box 55,
N-1332 Østerås,
NORWAY
Fax: +4767147407
E-mail: eva.bjorklund@nrpa.no
Olerud, H.M. Norwegian Radiation Protection Authority,

P.O. Box 55,
N-1332 Østerås ,
NORWAY
Fax: +4767147407
E-mail: hilde.olerud@nrpa.no
Torp, C. Norwegian Radiation Protection Authority,

P.O. Box 55,
N-1332 Østerås,
NORWAY
Fax: +4767147407
Tynes, T. Norwegian Radiation Protection Authority,

P.O. Box 55,
N-1332 Østerås,
NORWAY
Fax: +4722461304
E-mail: tore.tynes@nrpa.no
Widmark, A. Norwegian Radiation Protection Authority,

P.O. Box 55,
N-1332 Østerås,
NORWAY
Fax: +4767147407
E-mail: anders.widmark@nrpa.no
OMAN
Derweesh, A. Department of Radiology,

Royal Hospital Muscat,
P.O. Box 1331, P. Code 111,
Seeb Airport,
Muscat,
OMAN
Fax: +968592930
E-mail: assim@omantel.net.om
PANAMA
Bares, J.P. Instituto Oncológico Nacional Calle Gorgas,

Esquina con Juan de Arco Galindo,
Ancon,
PANAMA
Fax: +5072629733
PERU
Medina Gironzini, E. Instituto Peruano de Energía Nuclear,

Avda. Canaval Moreyra 425, Of. 92,
Lima 27,
PERU
Fax: +5114422330
E-mail: medina@ancalxx.org.pe
Paucar Jauregui, R. Complejo Hospitalario San Pablo,

San Salvador 120,
Huaquillay Lima 7,
PERU
Fax: +5114372355
E-mail: jpaucar@hotmail.com
Pinillos-Ashton, L.V. Insituto de Enfermedades Neoplásicas,

Avda. Angamos Este 2520,
Surquillo, Lima 34,
PERU
PHILIPPINES
Rodriguez, L.V. Department of Radiotherapy,

José R. Reyes Memorial Medical Center,
Rizal Ave., Sta. Cruz, 1003,
Manila,
PHILIPPINES
Fax: +6327321077
E-mail: lilianvr@philonline.com
POLAND
Bulski, W. Department of Medical Physics,

Centre of Oncology,
Roentgen Street 5,
PL-02-781 Warsaw,
POLAND
Fax: +48 22 6449182
E-mail: w.bulski@rth.cci.waw.pl
Dziuk, E.J. Central Clinical Hospital,

Military Medical University,
Szaserów 128,
PL-00-909 Warsaw,
POLAND
Fax: 48226816743
Gwiazdowska, A. Department of Medical Physics,

Centre of Oncology,
Roentgen Street 5,
PL-02-781 Warsaw,
POLAND
Janiak, M.K. Military Institute of Hygiene and Epidemiology,

4 Kozielska Street,
PL-01-163 Warsaw,
POLAND
Fax: +48228104391
E-mail: zorwihe@warman.com.pl
Jankowski, J. Nofer Institute of Occupational Medicine,

St. Teresy Street 8,
P.O. Box 199,
PL-90-950 Łódź,
POLAND
Fax: +48426314548
E-mail: jjan@parta.imp.todz.pl
Lesiak, J. Centrum Onkologii Oddzial w Krakowie,

ul. Garncarska 11,
PL-31-115 Kraków,
POLAND
Fax: +48124226680
E-mail: z5lesiak@cyf-kr.edu.pl
Liniecki, J. Department of Nuclear Medicine,

Medical University of Łódź,
Czechoslowacka 8/10,
PL-922-16 Łódź,
POLAND
Fax: +48426791780
E-mail: liniecki@psk2.am.todz.pl
Stanszewska, A.M. Nofer Institute of Occupational Medicine,

St. Teresy Street 8,
P.O. Box 199,
PL-90-950 Łódź,
POLAND
Fax: +48426314548
E-mail: hastan@imp.lodz.pl
Tolwinski, J. Department of Medical Physics,

Centre of Oncology,
Roentgen Street 5,
PL-02-781 Warsaw,
POLAND
Waligórski, M. Centrum Onkologii Oddzial w Krakowie,

ul. Garnearska 11,
PL-31-115 Kraków,
POLAND
Fax: +48124226680
E-mail: Michal.Waligorski@ifj.edu.pl
PORTUGAL
Afonso, J.M.R. Instituto Português de Oncologia,

Rua Prof. Lima Basto,
P-1099-023 Lisbon,
PORTUGAL
Fax: +351217229858
E-mail: jmrafonso@mail.telepac.pt
Assuncao de Jesus, J.S. Departamento de Protecção Radiológica,

Instituto Tecnologico e Nuclear,
Estrada Nacional 10,
P-2686-953 Sacavem,
PORTUGAL
Fax: +351219941995
E-mail: sebast@itn.pt
Lopes, M.C. CROC-IPOFG,

Avda. Bissaya Barreto,
P-3000-075 Coimbra,
PORTUGAL
Fax: +351239 484317
E-mail: mclopes@croc.min-saude.pt
Matos, A. CROC-IPOFG,
Avda. Bissaya Barreto,
P-3000-075 Coimbra,
PORTUGAL
Fax: +351239 484317
E-mail: amatos@croc.min-saude.pt
Nogueira, A.R. Department of Nuclear Medicine,

Instituto Português de Oncologia de Francisco Gentil,
P-1070-213 Lisbon,
PORTUGAL
E-mail: anogueira@ipotisboa.min-sauda.pt
Sevilla Miguelez, A.J. Instituto Português de Oncologia de Francisco Gentil,

P-1070-213 Lisbon,
PORTUGAL
Fax: +351217229873
E-mail: mrvnuclear@mail.telepac.pt
ROMANIA
Iacob, O. Institute of Public Health and Medical Research,

14, V. Babes Str.,
RO-6600 Iasy,
ROMANIA
Fax: +4032210399
E-mail: olga.iacob@usa.net
Milu, C. Institute of Public Health,

Radiation Hygiene Laboratory,
Str. Dr. Leonte No. 1–3,
RO-76256 Bucharest 35,
ROMANIA
Fax: +4013123426
E-mail: cmilu@pcnet.ro
Popescu, F.S. Radiopathololgy Centre,

Radiation Hygiene Laboratory,
Str. Dr. Leonte No. 1–3,
RO-76256 Bucharest 35,
ROMANIA
Fax: +4013123426
E-mail: cmilu@pcnet.ro
RUSSIAN FEDERATION
Kalnitsky, S.A. Institute of Radiation Hygiene,

Mira Street 8,
RU-197101 St. Petersburg,
RUSSIAN FEDERATION
Fax: +78122332612
E-mail: seckal@sk7613.spb.edu
Sinitsyn, V. Radiology Department, Cardiology Research Centre,

Moscow Medical Academy,
3d Cherepkovskaya ul. 15a,
RU-121552 Moscow,
RUSSIAN FEDERATION
Fax: +70954146699
E-mail: vsin@glasnet.ru
SAUDI ARABIA
Al-Haj, A.N. Biomedical Physics Department,

King Faisal Specialist Hospital and Research Centre,
P.O. Box 3354,
Riyadh 11211,
SAUDI ARABIA
Fax: +96614424777
E-mail: abdel@kfshrc.edu.sa
Al-Sakhri, H. Military Hospital Alhada,

Riyadh,
SAUDI ARABIA
Fax: +96627541238
Al-Thaqafi, M.b.Y. Military Hospital,

Riyadh,
SAUDI ARABIA
Almesned, A. Riyadh Medical Complex,

P.O. Box 88735,
Riyadh 11672,
SAUDI ARABIA
Fax: +96614922114
E-mail: alialmesned@yahoo.com
Azaya, F. King Fahad Armed Forces Hospital,

Radiology–Medicial Physics Section,
P.O. Box 9862,
Jeddah 21159,
SAUDI ARABIA
SLOVAKIA
Furiová, E. St. Elisabeth Cancer Institute,

Heydukova 10,
SK-81250 Bratislava,
SLOVAKIA
Fax: +4212592449473
E-mail: afuriova@ousa.sk
Horváthová, M. Institute of Preventive and Clinical Medicine,

Limbova 14,
SLOVAKIA,
Fax: +421259369338
E-mail: mnorvath@truni.sk
Laginová, V. St. Elisabeth Cancer Institute,

Heydukova 10,
SLOVAKIA
Fax: +421752923711
E-mail: vlaginov@ousa.st
SLOVENIA
Fras, A.P. Institute of Oncology,

Zaloska cesta 2,
SI-1000 Ljubljana,
SLOVENIA
Fax: +38614314180
E-mail: pfras@onko-i.si
Grmek, M. Department of Nuclear Medicine,

University Medical Centre,
Zaloska 7,
SI-1525 Ljubljana,
SLOVENIA
Fax: +38614327272
E-mail: marko.grmek@guest.arnes.si
Omahen, G. Institution of Occupational Safety,

Bohoriceva 22a,
SI-1000 Ljubljana,
SLOVENIA
Fax: +38612312562
E-mail: gregor.omahen@zvd.si
Petrovic, Z. Slovenian Nuclear Safety Administration,

Vojkova 59,
SI-1000 Ljubljana,
SLOVENIA
Fax: +38614721199
E-mail: zoran.petrovic@gov.si
Skrk, D. Health Inspectorate,

Ministry of Health,
Parmova 33,
SI-1000 Ljubljana,
SLOVENIA
Fax: 38614363351
E-mail: damijan.skrk@gov.si
Zdesar, U. Institution of Occupational Safety,

Bohoriceva 22a,
SI-1000 Ljubljana,
SLOVENIA
Fax: +38661312562
E-mail: urban.zdesar@zvd.si
SOUTH AFRICA
Corr, P. Department of Radiology,

Faculty of Medicine,
University of Natal,
Private Bag 7, Congella,
4013 Durban,
SOUTH AFRICA
Fax: +27312604408
E-mail: corr@nu.ac.za
Murphy, M. National Accelerator Centre,

Old Cape Road,
7131 Faure, Western Cape,
P.O. Box 72
SOUTH AFRICA
Fax: +27218433525
E-mail: moja@nac.ac.za
SPAIN
Abreu-Luis, J. Laboratorio de Física Médica,

Hospital Universitario de Canarias,
Ctra. Ofra–La Cuesta s/n,
E-38320 La Laguna,Tenerife,
SPAIN
Fax: +34 922 319279
Aguado, L. Facultad de Medicina de la Universidad de Málaga,

c/Manuel de Falla 1,
E-29000 Málaga,
SPAIN
Aguilar Arjona, J.A. Hospital Clínico Universitario,

c/Corregidor Francisco Molina 11,
E-29006 Málaga,
SPAIN
E-mail: tunasanto@hotmail.com
Aguilar Cuevas, R. Facultad de Medicina,

Camino del Pilar 72,
E-29140 Málaga,
SPAIN
E-mail: racuevas@teleline.es
Alcaide Aguilar, S. Hospital Carlos Haya,

c/Abogado Federico de Orellana Toledano 8-6-4,
E-29002 Málaga,
SPAIN
Fax: +34 952 64 58 51
E-mail:
Alcaraz, M. Departamento de Radiología, Facultad de Medicina,

Universidad de Murcia,
E-30100 Murcia,
SPAIN
Fax: +34 968363602
E-mail: mab@um.es
Alcazar Ortega, F. Paseo Reding 47-3-2,

E-29016 Málaga,
SPAIN
E-mail: falcazary@aeds.org
Alegre Bayo, N. Hospital Clínico Universitario,

c/Eugenio Selles 3,
E-29017 Málaga,
SPAIN
Alejandro Ugarte, P. ENRESA,

Apartado de Correos 2,
E-14200 Peñarroya–Pueblonuevo,
SPAIN
Fax: +34957575130
E-mail: augp@enresa.es
Algarra García, J. Hospital Clínico Universitario,

c/Geranios 11, Rincón de la Victoria,
E-29730 Málaga,
SPAIN
Alguacil Gan, M.C. Clínica El Angel,

Enrique de las Morenas 7 Bajo,
E-14940 Cabra-Cordoba,
SPAIN
Alguacil Gan, S. Clínica El Angel,

Enrique de las Morenas 7 Bajo,
E-14940 Cabra-Cordoba,
SPAIN
Alonso Hernandez, D. Servicio de Acreditación y Evaluación,

Consejería de Sanidad de la Comunidad de Madrid,
Avda. Filipinas 50,
E-28003 Madrid,
SPAIN
Alonso Hernandez, O.R. TECNO Medical Systems,

c/Esteban Salazar Chapela 16, Porton 5, Nave 131,
Poligono Guadalhorce,
E-29004 Málaga,
SPAIN
Fax: +34952244459
E-mail: tec-med@arrakis.es
Alvarez Garcia, C. Consejo de Seguridad Nuclear,

Justo Dorado 11,
E-28040 Madrid,
SPAIN
Fax: +34913460588
E-mail: cag@csn.es
Alvarez, P. Fundación Española para la Investigación del Cáncer,

Poligono de Elorz, Edif. Cein. Lab A-1,
E-31110 Noain, Navarra,
SPAIN
Fax: +34948428904
E-mail: president@oncologia.org
Angulo, A. Facultad de Medicina de la Universidad de Málaga,

c/Calderona 13,
E-29120 Alhaurin El Grande, Málaga,
SPAIN
Fax: +34654823477
Antúnez, J. Hospital San Antonio,

Avda. Pinta Soiolla 2,
E-29000 Málaga,
SPAIN
Aquado, L. Facultad de Medicina de la Universidad de Málaga,

E-29000 Málaga,
SPAIN
Arias Isaac, R. Hospital General Universitario Gregorio Marañon,

c/Doctor Esquerdo 46,
E-28028 Madrid,
SPAIN
Armisen, J. AGFA,
Provenza 392,
E-08025 Barcelona,
SPAIN
Fax: +34934767680
Arranz, L. Servicio de Radiofísica y Protección Radiológica,

Hospital Ramón y Cajal,
Ctra. de Colmenar, km 9,
E-28034 Madrid,
SPAIN
Fax: +34 913368453
E-mail: larranz@hrc.insalud.es
Arribas de Rodrigo, L. Hospital Clínico Universitario,

c/Hulera 8, B7, 3A,
E-29007 Málaga,
SPAIN
Arteaga Artiz, M.E. Avda. del Ayuntamiento, 1-2 Dcha.,

Barañain, Navarra,
SPAIN
Fax: +34 948277852
Aviles Alcarria, F. Materno Infantil,

Marcos de Obregon 6, 1D,
E-29016 Málaga,
SPAIN
E-mail: falcarri@teleline.es
Azuara, J.A. Consejo de Seguridad Nuclear,

Justo Dorado 11,
E-28040 Madrid,
SPAIN
Fax: +34913460575
Ballester Moll, B. Hospital Universitario de San Juan,

E-03550 San Juan, Alicante,
SPAIN
Fax: +965938652
E-mail: ballester-bar@gva.es
Banderas Bravo, M.E. Facultad de Medicina de la Universidad de Málaga,

c/Mendoza 6, 4,
E-29002 Málaga,
SPAIN
E-mail: esther@banderos.net
Barco Moreno, E. Facultad de Medicina de la Universidad de Málaga,

c/Retama 4, Urbanización Puertosol, Puerto de la Torre,
E-29190 Málaga,
SPAIN
Baro, J. ACPRO,
c/Rafael Batalle 24,
E-08017 Barcelona,
SPAIN
Fax: +34932041680
E-mail: josep.baro@acpro.es
Barquero, R. Hospital Universitario Del Rio Hortega,

Avda. Cardenal Torquemada s/n,
E-47010 Valladolid,
SPAIN
Fax: +34 9833274420
E-mail: rbarquero@hurh.insalud.es
Bazan Vicchez, A. Clínica Parone San Antonio,

c/Pintor Sorolla 2,
E-29000 Málaga,
SPAIN
Fax: +34952601669
Becerra Mayor, M.M. Hospital Clínico Universitario,

c/Robinson Crusoe BIQ 7,
E-29006 Málaga,
SPAIN
Bejar Navarro, M.J. Servicio de Radiofísica, Hospital Universitario,

Paseo de San Vicente s/n,
E-37007 Salamanca,
SPAIN
Fax: +34 923291459
Benitez de la Poza, A. Facultad de Medicina de la Universidad de Málaga,

c/Fernando El Católico 64 3A,
E-29000 Málaga,
SPAIN
E-mail: aguaoft@mixmail.com
Benslimane Adanero, M. Facultad de Medicina de la Universidad de Málaga,

Avda. Miramar 80 7-9-2C,
E-29000 Málaga,
SPAIN
Berenger Serrano, R. Servicio de Radiofísica, Hospital Universitario,

E-37007 Salamanca,
SPAIN
Fax: +34 923291459
Berrocal Postigo, E. Facultad de Medicina de la Universidad de Málaga,

Avda. Juan XXIII 61 4b,
E-29006 Málaga,
SPAIN
Bertrán, S. Hospital Universitario Son Dureta,

c/Andrea Doria 55,
E-07014 Palma de Mallorca,
SPAIN
Fax: +34 971175500
E-mail: sbertran@hsd.es
Bezares Gonzalez, M. Ministerio de Sanidad,

Subdirección General de Sanidad Ambiental,
Paseo del Prado 18,
E-28071 Madrid,
SPAIN
Fax: +34 913601341
E-mail: mbezares@msc.es
Bodineau Gil, C. Complejo Hospitalario Carlos Haya,

Avda. Carlos Haya s/n,
E-29010 Málaga,
SPAIN
Fax: +34952645851
E-mail: bodineau@hch.sas.cica.es
Bolaños García, P. Servicio de Protección Radiológica,

Hospital de Gran Canaria Dr. Negrín,
Barranco de la Ballena s/n,
Las Palmas de Gran Canaria,
SPAIN
Fax: +34 928449789
E-mail: rmartin@correo.hpino.rcanaria.es
Bolivar Girón, F. Facultad de Medicina de la Universidad de Málaga,

Sofocles 3, Aticos,
E-29000 Málaga,
SPAIN
E-mail: pacolobo@eresmas.com
Borrego Ruiz, P. Sociedad Española de Radiología,

Goya 38-3,
E-28001 Madrid,
SPAIN
Fax: +915763279
E-mail: secretaria@seram.es
Caballero Lucena, E.M. Hospital Carlos Haya,

c/Lona de los Riscos 85, Pta 15,
E-29620 Torremolinos,
SPAIN
Fax: +34 952645851
E-mail: fypr@hch.sas.cica.es
Calero Chamero, J.A. Dextro Medica S.L.,

c/Ciudad de Liria 75,
E-46988 Paterna, Valencia,
SPAIN
Fax: +34961325833
E-mail: jcadero@dextromedica.com
Calzado, A. Departamento de Radiología,

Universidad Complutense de Madrid (Física Médica),
E-28040 Madrid,
SPAIN
Fax: +34913941675
E-mail: calzado@eucmax.sim.ucm.es
Campayo, J.M. UTPR, Logística y Acondicionamientos Industriales S.A.,

c/E1 Palleter 13,
E-46008 Valencia,
SPAIN
Fax: +34963840409
Campos, P. Toshiba Medical Systems S.A.,

Ctra. Fuencarral 46,
E-28108 Alcobendas, Madrid,
SPAIN
E-mail: pcamposo@tmse.nl
Cañadillas Perdomo, B. Laboratorio de Física Médica,

SPAIN
Fax: +34922 319279
Cañamero, A. JUSTE, SAQF,

Pasaje Esperanto 1,
E-29007 Málaga,
SPAIN
Fax: +34952399127
E-mail: albertoca@juste.es
Cantera, C. Nucletron S.A.,

c/Berlin 5 Dpdo.,
E-28028 Madrid,
SPAIN
Fax: +34917242061
E-mail: carloscantera@nucletron.es
Capote Martínez, M. Facultad de Medicina de la Universidad de Málaga,

Avda. Arroyo de los Angeles,
E-29009 Málaga,
SPAIN
Carrajo Rodriguez, J.L. Hospital Universitario Virgen de la Victoria,

E-29013 Málaga
SPAIN
Carrasco Campos, J. Facultad de Medicina,

c/Alcade Joaquin Quiles 7, 8-4,
E-29014 Málaga,
SPAIN
E-mail: spr@hvv.sas.cic.es
Carrasco López, P.R. Facultad de Medicina de la Universidad de Málaga,

San Bartolomé 7-6C,
E-29013 Málaga,
SPAIN
Carrasco Rodríguez, J. Unidad de Radiofísica,

Hospital Universitario Virgen de la Victoria,
Campus Universitario Teatinos,
E-29010 Málaga,
SPAIN
E-mail: spr@huv.sas.cica.es
Carrera Magariño, F. Servicio de Física Médica y Pr.,

Hospital Juan Ramón Jiménez,
Ronda Norte s/n,
E-21005 Huelva,
SPAIN
Fax: +34 952 201118
E-mail: fcarrera@hjrj.sas.cica.es
Carril, J.M. Servicio de Proteccíon Radiológica,

Hospital Universitario Marqués de Valdecilla,
Avda. de Valdecilla s/n,
E-39008 Santander,
SPAIN
Fax: +34942323840
Castañeda Arronte, M.J. Servicio de Proteccíon Radiológica,

E-39008 Santander,
SPAIN
E-mail: pracaj@humv.es
Castedo, A. Toshiba Medical Systems S.A.,

SPAIN
E-mail: acostedo@tmse.nl
Castillo Benzo, M.A. Facultad de Medicina de la Universidad de Málaga,

c/Juan de Ortega 5, 7o. 4,
E-29190 Málaga,
SPAIN
Catalan Acosta, A. Laboratorio de Física Médica,

SPAIN
Fax: +34922319279
E-mail: acatalan@ull.es
Cepuera, M. Facultad de Medicina de la Universidad de Málaga,

Paseo de Reding,
E-29000 Málaga,
SPAIN
Chevalier, M. Departamento de Radiología,

E-28040 Madrid,
SPAIN
Fax: +34913941675
E-mail: chevalier@eucmax.sim.ucm.es
Cobos Cortés, A. Finca los Catalanes 9,

Rincón de la Victoria,
E-29000 Málaga,
SPAIN
Fax: +34657325663
Cobos Díaz, A. Facultad de Medicina de la Universidad de Málaga,

c/Mendoza 8, P6, 4a,
E-29002 Málaga,
SPAIN
Contreras, C. Facultad de Medicina de la Universidad de Málaga,

Campus de Teatinos s/n,
E-29071 Málaga,
SPAIN
Fax: +34952600840
Cortés Blanco, A. Nuclear Medicine,

Domingo Ram 32, 3F,
E-50017 Zaragoza,
SPAIN
E-mail: anabelcortes@iname.com
Cortés Toro, J.A. Facultad de Medicina de la Universidad de Málaga,

Avda. Capuchinos 8 5o. A,
E-29014 Málaga,
SPAIN
Cristofol Alcaraz, J.E. Grupo PRUMA,

Facultad de Medicina de la Universidad de Málaga,
E-29071 Málaga,
SPAIN
E-mail: jcca@inicia.es
De Hoyos, J.J. Facultad de Medicina de la Universidad de Málaga,

c/Las Palmeras 50,
E-29720 La Cala del Moral, Málaga,
SPAIN
De la Peña Fernández, L. Facultad de Medicina de la Universidad de Málaga,

E-29071 Málaga,
SPAIN
E-mail: lpf@uma.es
De Sena Espinel, E. Servicio de Radiofísica, Hospital Universitario,

E-37007 Salamanca,
SPAIN
Fax: +34923291459
Deblas Sandoval, A. Facultad de Medicina de la Universidad de Málaga,

Avda. Pio Baroja 16, 3A,
E-29017 Málaga,
SPAIN
E-mail: C092128@medicina.ahmos.uma.es
Del Mar, S.C. Servicio de Física y Protección Radiológica,

Hospital Universitaria Reina Sofia,
Avda. Menéndez Pidal s/n,
E-14004 Córdoba,
SPAIN
Fax: +34957011607
E-mail: msoler@sofia.hrs.sas.cic.es
Delgado Mactas, M.T. Departamento de Ciencas Médicas y Quirurgicas,

Facultad de Medicina, Universidad de Cantabria,
Cardenal Herrera Oria s/n,
E-39011 Santander,
SPAIN
Fax: +34942201991
E-mail: delgadot@unican.es
Díaz Romero, F. Servicio de Radiodiagnóstico,

E-38320 La Laguna, Tenerife,
SPAIN
Díez de los Ríos Delgado, A. Grupo de Investigación en Protección Radiológica,

E-29071 Málaga,
SPAIN
Fax: +34 952 134231
E-mail: rector@uma.es
Díez de los Ríos González, A.M. Facultad de Medicina de la Universidad de Málaga,

c/Conde Ureña 89,
E-29013 Málaga,
SPAIN
Díez Gonzalez, R. Hospital Universitario La Fé,

c/Taquigrafo Marti 14,
E-46005 Valencia,
SPAIN
Fax: 96 374 93 38
E-mail: rdiezg@mixmail.com
Doménech Carreras, J. Hospital de Sant Pau i La Santa Creu,

c/Sant Antoni M. Claret 167,
E-08025 Barcelona,
SPAIN
Dominguez Mayoral, A. Hospital Carlos Haya,

Avda. Pinto Sorella 99,
E-29018 Málaga,
SPAIN
Fax: +34 952645851
Dominguez Pinos, M.D. Facultad de Medicina de la Universidad de Málaga,

c/Maria Teresa León 36,
E-29011 Málaga,
SPAIN
E-mail: nesteve@clientes.unicaja.es
Dominguez Sobrino, M.P. S.A.S., D.S. Camas,

c/Santa Maria de Gracia 54,
Camas, Seville,
SPAIN
Fax: +34955019422
Dominguez, D.A.M. Institu Catala d’Oncologia,

Montserrat Dominguez I Arseda,
c/Robrenyo 23, ATIC,
E-08014 Barcelona,
SPAIN
Fax: +932607980
Doña Díaz, A.J. Facultad de Medicina de la Universidad de Málaga,

Ruta de las Migas 7,
E-29740 Torre del Mar, Málaga,
SPAIN
E-mail: alvdona@teleline.es
Dueñas Buey, M.C. Facultad de Ciencias, Universidad de Málaga,

c/Mayoral 2, p. 6, 4,
Finca La Albahaca,
E-29016 Málaga,
SPAIN
E-mail: mcduenas@uma.es
Escalera Castillo, S. Complejo Hospitalario Carlos Haya,

E-29010 Málaga,
SPAIN
Fax: +34 952 645851
Escalona Peña, M. Facultad de Medicina de la Universidad de Málaga,

c/Nuestra Señora de las Clamines 6, B2,
E-29000 Málaga,
SPAIN
Espada Muñoz, J.F. Facultad de Medicina de la Universidad de Málaga,

Plaza González Badia Torre 10,
E-29600 Marbella, Málaga,
SPAIN
E-mail: frauespada@yahoo.com
España Lopez, M.L. Hospital Universitario de la Princesa,

c/Diego de León 62,
E-28006 Madrid,
SPAIN
Fax: +34 914021169
E-mail: mespana@hlpr.insalud.es
Espila Navarro, A.M. Facultad de Medicina de la Universidad de Málaga,

c/Lanuza 46, 1,
E-29009 Málaga,
SPAIN
E-mail: anaespila@hotmail.com
Espínola Moreno, M. Facultad de Medicina de la Universidad de Málaga,

c/Pinosol 7, 3A,
E-29012 Málaga,
SPAIN
Espinosa Navarrete, C. Facultad de Medicina de la Universidad de Málaga,

c/Manuel Torres 6-7D,
E-29000 Málaga,
SPAIN
Estarriaga Anso, J. Dr. Reparaz 4-5A,

E-31012 Pamplona,
SPAIN
Fax: +34948277852
E-mail: jeanso@telelines.es
Fernández Artillo, J. Hospital Universitario,

E-29000 Málaga,
SPAIN
E-mail: javier.artillo@havegalia.com
Fernández Bonilla, D. Facultad de Medicina de la Universidad de Málaga,

c/ Montes de Oca 11, 4o. B,
E-29007 Málaga,
SPAIN
E-mail: dfbonilla@mixmail.com
Fernández Bordes, M. Hospital Universitario,

E-37007 Salamanca,
SPAIN
Fax: +34 923291459
Fernández Cañadillas, M.J. Hospital Carlos Haya,

c/Abegado Federico de Orellana Toledano 8-6-4,
E-29002 Málaga,
SPAIN
Fax: +34 952 645851
E-mail: fypr@hch.sas.cia.es
Fernández García, F. Facultad de Medicina de la Universidad de Málaga,

c/Robinson Crusoe 24, 5-4,
E- 29000 Málaga,
SPAIN
Fernández González, B. Hospital Central de Asturias,

c/ Julián Claveria s/n,
Edificio Antigua Escuela de Enfermeras 3,
E-33006 Oviedo,
SPAIN
Fax: +34 985106142
E-mail: bfernandezg@meditex.es
Fernández Martín, M.C. Facultad de Medicina de la Universidad de Málaga,

c/Oropéndola 8, 3o. D,
Arroyo de la Miel,
E-29000 Benalmádena, Málaga,
SPAIN
Fernández Orta, E.M. Facultad de Medicina de la Universidad de Málaga,

Avda. Isaac Peral 1, 9, 2,
E-29004 Málaga,
SPAIN
Fernández Vargas, D. Facultad de Medicina de la Universidad de Málaga,

c/Miravioletas 2-3F,
E-29011 Málaga,
SPAIN
E-mail: hades.ju@wanzdos.es
Fernández Vázquez, I. Centro de Salud Capuchinos,

Servicio Andaluz de Salud,
Cañizares 25, 6D,
E-29002 Málaga,
SPAIN
E-mail: mabelfv@jumpy.es
Field Galan, C.A. U.M.A.,

Paseo de Reding 47-9-4,
E-29016 Málaga,
SPAIN
Fisac Noblejas, E. Despacho Fisac, Asensio y Asociados,

Paseo de La Habana 80,
E-28036 Madrid,
SPAIN
Fax: +34 914574976
Flo Gongors Souzo, F.G.A. Centro Radiológico Andaluz S.A.,

c/Hilera 6,
E-29016 Málaga,
SPAIN
E-mail: radiologica@sousa.com
Florentino Lozano, M. Basico de Baza de Granada,

c/Cadiz 2, 3A,
E-18800 Baza Granada,
SPAIN
Fax: +958 863177
Freire, J.M. Spanish Society of Nuclear Medicine,

Capitán Haya 60,
E-28020 Madrid,
SPAIN
Fax: +34 7499503
E-mail: freirejm@teleline.es
Fuentes Capparrós, R. Facultad de Medicina de la Universidad de Málaga,

c/Enrique Scholtz 4, 3F,
E-29007 Málaga,
SPAIN
Gaitan Fernández, M. Hospital Costa del Sol,

Ctra. 340, km 187,
Marbella, Málaga,
SPAIN
E-mail: gaitanfernandez@yahoo
Galán Montenegro, P. Complejo Hospitalario Carlos Haya,

E-29010 Málaga,
SPAIN
E-mail: pgalan@hch.sas.cica.es
Galan Zafra, M. Milagrosa, Bloque 2-4A,

E-29010 Málaga,
SPAIN
Gallar, P. Hospital General Universitario Gregorio Marañon,

E-28007 Madrid,
SPAIN
Fax: +3491 58 66630
Galván Bermejo, C. Hospital Clínico de San Carlos,

Plaza Cristo Rey,
E-28040 Madrid,
SPAIN
Fax: +34913303911
E-mail: cgalvan@hscs.insalud.es
Gálvez Delgado, M. Física Médica y Protección Radiológica,

Facultad de Medicina, Universidad de Córdoba,
Avda. Menendez Pidal s/n,
E-14004 Córdoba,
SPAIN
Fax: +34957218274
E-mail: fa1gadem@uco.es
García Algarra, J. Hospital Clínico Universitario,

Geranios 11, Rincón de la Victoria,
E-29730 Málaga,
SPAIN
García Bueno, J.M. Hospital Parque San Antonio,

c/Pintor Sorolla 2,
E- 29000 Málaga,
SPAIN
García Casares, N. Facultad de Medicina de la Universidad de Málaga,

Avda. Salvador Allende 9-11B,
E-29017 Málaga,
SPAIN
E-mail: natachacasares@yahoo.es
García Granados, J. Servicio de Física Médica,

E-35020 Las Palmas de Gran Canaria,
SPAIN
Fax: +34 928 49789
García Infante, D. Facultad de Medicina de la Universidad de Málaga,

c/Vélez Málaga 4, 3C,
E-29600 San Pedro de Alcántara, Málaga,
SPAIN
García Jimenez, R. Servicio de Radiofísica,

Hospital Universitario Virgen del Rocío,
Avda. Manuel Siurot s/n,
E-41013 Seville,
SPAIN
García Madueño, J.M. Servicio de Radiofísica,

E-41013 Seville,
SPAIN
Fax: +34955013473
E-mail: mherrador@hvr.sas.cica.es
García Martos, A. Clínica Parque San Antonio,

c/Ronda baja de Benyamina 22,
E-29000 Málaga (Torremolinos),
SPAIN
Fax: +34952614422
García Miguel, A. Servicio de Radiofísica, Hospital Universitario,

E-37007 Salamanca,
SPAIN
Fax: +34 923291459
García Román, M.J. Laboratorio de Física Médica,

SPAIN
Fax: +34922 319279
E-mail: chechegr@iname.com
García Romero, A. Hospital Clínico Universitario Lozano Blesa de Zaragoza,

Avda. San Juan Bosco 15,
E-50009 Zaragoza,
SPAIN
Fax: +34 97656995
E-mail: fpro@heu.lblesa.es
Garralda Pascual, M.Y. Los Olimos 6,

E-31180 Zizur Mayor, Navarra,
SPAIN
Fax: +948277852
Gil Agudo, A. Servicio de Radiofísica, Hospital de la Ribera,

c/Carretera de Corbera,
E-46600 Alzira,
SPAIN
Fax: +34 962458156
E-mail: angil@hospital-ribera.com
Gimeno-Benitez, V. Consejeria de Sanidad y Consumo,

Ronda del Pilar 22,
E-06002 Badajoz,
SPAIN
Fax: +34924215397
Ginjaume, M. Universitat Politécnica de Catalunya,

Diagonal 647,
E-08028 Barcelona,
SPAIN
Fax: +34 934017149
E-mail: merce.ginjaume@upc.es
Gómez Fernández, B.M. Servicio de Protección Radiológica,

Avda. de Valdecilla s/n, Pab. 20,
E-39008 Santander,
SPAIN
E-mail: pracaj@humv.es
Gomez Llorente, P.L. Servicio de Radiofísica, Hospital Universitario,

E-37007 Salamanca,
SPAIN
Fax: +34 923291459
Gomez Martinez, J.M. Servicio de Medicina Nuclear,

Gran Capitan 20,
E-14008 Cordoba,
SPAIN
Fax: +34957475399
Gómez Puerto, A. Servicio de Radiofísica,

E-41013 Seville,
SPAIN
Fax: +34955013473
Gomez Robles, C. Facultad de Medicina de la Universidad de Málaga,

c/Armenqual de la Mota 37, D,
E-29007 Málaga,
SPAIN
E-mail: celiagr@mixmail.com
Gómez Rodriguez, L. Facultad de Medicina de la Universidad de Málaga,

Audo/Manuel Gorria 32-9,
E-29013 Málaga,
SPAIN
Gongora, F. C.N.O.J.S.J.,
c/La Ena 6,
E-29026 Málaga,
SPAIN
Fax: +34952607989
E-mail: gongore@santande-superetion
González Alvarez, P. Servicio de Evaluación y Accreditación Sanitaria,

Dirección General Sanidad,
Avda. Filipinas 50,1,
E-28003 Madrid,
SPAIN
Fax: +34 915541597
E-mail: UEI0630578100@eurociber.es
González Galán, M.S. Facultad de Medicina de la Universidad de Málaga,

c/Septimo Miau 5-3C,
E-29006 Málaga,
SPAIN
E-mail: 7161095@medicina.dumnos.uma.es
González Iradiel, M.J. Hospital de Navarra,

c/Irnularrea,
E-31008 Pamplona,
SPAIN
Fax: +34 948422303
González Llergo, I. Facultad de Medicina, Hospital Universitario,

c/Avda. Doufour 4,
E-14012 Córdoba,
SPAIN
González Vila, V. Servicio de Radiofísica,

E-41013 Seville,
SPAIN
Fax: +34955013473
González-Jorge, M.C. Servicio de Protección Radiológica,

SPAIN
Fax: +34 928 449789
Guerrero Alcade, R. Servicio de Física y Protección Radiológica,

Hospital Virgen de las Nieves,
Avda. de las Fuerzas Armadas 2,
E-18014 Granada,
SPAIN
Fax: +34958241245
E-mail: rir@hvn.sas.cica.es
Guibelalde del Castillo, E. Universidad Complutense de Madrid,

Avda. Complutense,
E-28040 Madrid,
SPAIN
Fax: +34 91 3941675
E-mail: egc@eucmax.sion.ucn.es
Guirado Llorente, D. Servicio de Protección Radiológica y Física Médica,

Hospital Universitario San Cecilio,
Avda. Dr. Oloriz 16,
E-18012 Granada,
SPAIN
E-mail: dguirado@hsc.sas.cica.es
Gutierrez Chacon, P. Hospital Clínico Universitario Nuestra Señora

de la Victoria,
Avda. Teatinos,
E-29000 Málaga,
SPAIN
Gutierrez, M. Facultad de Medicina de la Universidad de Málaga,

Avda. Málaga Oloroso B28, 6-9,
Cortijillo Bazan, Cuidad Jardin,
E-29014 Málaga,
SPAIN
Haro Madero, G. Servicio de Diagnóstico por Imagen,

E-41013 Seville,
SPAIN
Fax: +34955013473
E-mail: gharom41@smail2.ocenf.org
Heredia Escamez, A. Hospital Salud,

Avda. Clemente Diaz, Edificio Puebla Lucia,
E-29620 Fuenginola, Málaga,
SPAIN
Fax: +34952581007
E-mail: anes@terra.com
Hernández Armas, J. Servicio de Física Médica,

38320 La Laguna, Tenerife,
SPAIN
Fax: +34922 319422
E-mail: jharmas@ull.es
Hernandez Barreto, P. Servicio Protección Radiológica,

Hospital Universitario Reina Sofia,
E-14004 Córdoba,
SPAIN
Fax: +34957011607
E-mail: fisica@sofia.hrs.sas.cica.es
Hernando Gonzalez, I. Hospital Universitario Rio Hortega,

E-47010 Valladolid,
SPAIN
Fax: +34983274420
E-mail: ihernando@hurh.insalud.es
Hernando Ruiz, I. Facultad de Medicina de la Universidad de Málaga,

c/Rio Guadalhorce, E. Sevilla 2B,
E-29700 Vélez-Málaga,
SPAIN
Herrador Córdoba, M. Servicio de Radiofísica,

E-41013 Seville,
SPAIN
Fax: +34955013473
Herrera Pozo, P.D. Facultad de Medicina de la Universidad de Málaga,

c/Real 11, 2B,
E-29320 Campillos, Málaga,
SPAIN
E-mail: pedrodavid.herrera@wanadoo.es
Herrero Alonso, E. Hospital Universitario Gregorio Marañón,

E-28007 Madrid,
SPAIN
Fax: +34915868588
E-mail: eugenio.abuso@comadid.es
Honero Martinez, F. Facultad de Medicina de la Universidad de Málaga,

Paseo Maritimo, Pablo Ruiz Piccaso 15-1B,
E-29000 Málaga,
SPAIN
Irigoyen Oyarzabal, J. Hospital Universitario,

E-29000 Málaga,
SPAIN
Irujo Asurmendi, K. Hospital de Navarra,

c/Irnularrea,
E-31008 Pamplona,
SPAIN
Fax: +34 948422303
Ivanova Maguerova, A. c/Madrid 7,

Urbanizacion Torremar,
E-29639 Benalmadena,
SPAIN
E-mail: amagerova@hotmail.com
Jérez Sainz, I. Hospital Universitario de la Princesa,

E-28006 Madrid,
SPAIN
Fax: +34 914021169
E-mail: inma-jerez@hotmail.com
Jiménez Alarcón, J.I. Servicio de Protección Radiológica,

Hospital Nuestra Señora de Candelaria,
Carretera del Rosario s/n,
E-38010 Santa Cruz de Tenerife,
SPAIN
Fax: +34 922 602382
E-mail: mchapel@hcan.rcanaria.es
Jimenez Cebrian, F.J. Facultad de Medicina de la Universidad

de Málaga,
Hospital Universatorio,
c/Francisco Pacheco 9, 6, A3,
E-29004 Málaga,
SPAIN
Jiménez González, J.M. Servicio de Protección Radiológica,

Fundación Jiménez Díaz Hospital,
Avda. Reyes Católicos 2,
E-28040 Madrid,
SPAIN
Fax: +34 91 5494764
E-mail: jmjimenez@fjd.es
Jimenez Ruiz, A. Facultad de Medicina de la Universidad

de Málaga,
c/Brahms 6-1B,
E-29000 Málaga,
SPAIN
E-mail: nebulosa@de.com
Jiménez-Hoyuela Garcia, J.M. Hospital Clínico Universitario,

Paseo de Reding 53, 1A,
E-29016 Málaga
SPAIN
E-mail: hoyuela@airtel.net
Jodar Porlan, S. Department of Radiology, University of Murcia,

E-30100 Espinardo, Murcia,
SPAIN
Fax: +34 968363602
Laqué Rupérez, E. Universidad de Málaga,

c/Monte Sancha 36, B1.2.3-4,
E-29016 Málaga,
SPAIN
Fax: +34958833780
E-mail: estichu@hotmail.com
Leiva Aranda, I. Facultad de Medicina de la Universidad de Málaga,

Camino Suárez 74, Ed. Jilena, Bloque 1, 5o. B,
E-29010 Málaga,
SPAIN
E-mail: isatake@teleline.es
Llamas Llamas, P. Complejo Hospitalario Carlos Haya,

E-29010 Málaga,
SPAIN
Llorente, M. Hospital Universitario Rio Hortega,

E-47010 Valladolid,
SPAIN
Fax: +34 983274420
E-mail: ihernando@hurh.insalud.es
Lobato Bancalero, L. Hospital Clínico Universitario,

c/Ancha del Carmen 1,
E-29754 Competa,
SPAIN
Lope, R. Hospital Clínico Universitario Lozano Blesa de Zaragoza,

E-50009 Zaragoza,
SPAIN
Fax: +34976565995
López Berruezo, P.L. Hospital de Navarra,

Los Olmos 6-3,
E-31180 Zizur Nagusia, Navarra,
SPAIN
Fax: +948 277852
López Carrillo, I. Facultad de Medicina de la Universidad de Málaga,

c/ Babel 2, 5D,
E-29006 Málaga,
SPAIN
López Franco, M.P. Hospital Universitario de la Princesa,

E-28006 Madrid,
SPAIN
Fax: +34 914021169
E-mail: plopez@hlpr.insalud.es
López Marin, B.B. Hospital Costa del Sol,

c/Viego de Vélez No. 65, 7-1A,
E-29738 Rincón de la Victoria, Málaga,
SPAIN
E-mail: b-b@navegalia.com
López Medina, A. Hospital Meixoeiro,

E-36200 Vigo, Pontevedra,
SPAIN
Fax: +34986811713
López Muñoz, M.J. Facultad de Medicina de la Universidad de Málaga,

c/Magistrado Salvador,
Barbera 18, pta 1 2, 7B,
E-29010 Málaga,
SPAIN
Luis Simón, J. Servicio de Radiofísica,

E-41013 Seville,
SPAIN
Fax: +34955013473
Macias Benitez, M. Hospital Básico de Antequera,

Bernardo Lopez Garcia 8,
E-29017 Málaga,
SPAIN
Macías Jaén, J. Hospital Clínico Universitario Lozano Blesa de Zaragoza,

E- 50009 Zaragoza,
SPAIN
Fax: +34 952 645851
E-mail: jmacias@hch.as.cica.es
Manzanas Artigas, J. Hospital Universitario Doce de Octubre,

Carreteria de Andalucía 5, 4,
E-28041 Madrid,
SPAIN
Fax: +34 913908278
E-mail: manzanas@hdoc.insalu.es
Marco Gálve, I. Facultad de Medicina de la Universidad de Málaga,

c/Capitán Marcos Garcia 2-1D,
E-29007 Málaga,
SPAIN
E-mail: isabelmarco@mixmail.com
Marquez Moreno, A. Hospital Clínico Universitario,

E-29000 Málaga,
SPAIN
Martín Hurtado, A. Facultad de Medicina de la Universidad de Málaga,

c/Maestro Lecuona 13-3C,
E-29006 Málaga,
SPAIN
E-mail: 009446x@medicina.alumnos.uma.es
Martin Ortega, J.A. Hospital Clínico Universitario,

c/Camino de Archez 3,
E-29754 Competa,
SPAIN
E-mail: jamartin@medinet.com
Martín Palanca, A. Radiología Intervencionista,

Hospital Clínico Universitario,
c/Federico Fellini 58,
E-29018 Málaga,
SPAIN
Martin Sanchez, E. Hospital Carlos Haya,

c/México, Edif. México 2-1C,
E-29010 Málaga,
SPAIN
Martin-Garcia, J.J. c/Rodrigo de Triana 1-3B,

Edificio Sto. Angel-I,
E-52005 Melilla,
SPAIN
Martín-Oliva, R. Hospital de Gran Canaria Dr. Negrín,

SPAIN
Fax: +34928449789
E-mail: rmartin@corres.pino.rcanaria.es
Martinez Beneyto, Y. Department of Radiology, University of Murcia,

SPAIN
Fax: +34 968363602
Martinez Gómez, L.C. Hospital Universitario Doce de Octubre,

Carretera de Andalucía, km 5, 400,
E-28041 Madrid,
SPAIN
Fax: +34 913908278
E-mail: mmanzanas@hdoc.insalud.es
Martinez Mezo, G.L. Facultad de Medicina de la Universidad de Málaga,

Boulevard Louis Pasteur,
E-29007 Málaga,
SPAIN
E-mail: glmm@gmx.net
Martínez Morillo, M. Facultad de Medicina de la Universidad de Málaga,

E-29071 Málaga,
SPAIN
Fax: +34 952 131630
E-mail: morillo@uma.es
Martos Cerezuela, I. Complejo Hospitalario Carlos Haya,

c/México, Edif. Villa México 2, 1C,
E-29010 Málaga,
SPAIN
Mata, F. Hospital Universitario Son Dureta,

c/Andrea Doria 55,
SPAIN
Fax: +34 971 175500
E-mail: fmata@hsd.es
Mateos Ortigosa, R. Associación Española Técnicos Radiología,

Boulevard San José 23,
E-18005 Bajo Granada,
SPAIN
Fax: +34958265382
Melgarez Accoba, D. Parque San Antonio,

c/Pintor Sorolla 2,
E-29000 Málaga
SPAIN
Fax: +34552601669
Melian Díaz, J. Hospital General de Fuerteventura,

c/Murillo 2, 2E,
E-35600 Puerto del Rosario,
SPAIN
Miranda Barera, A.R. Universidad de Málaga,

c/Pico de Las Palomas 20, 3,
E-29004 Málaga,
SPAIN
E-mail: amirabar@ole.com
Molero Savall, J. Hospital Universitario Germans Trias i Pujol,

Ctra. del Canyet s/n,
E-08916 Badalona, Barcelona,
SPAIN
Fax: +34934978843
E-mail: jmolero@ns.hugtip.scs.es
Molina Gonzalez, E. Clínica de Podología,

c/Eugenio Gross 9-1,
Málaga,
SPAIN
Molina Gonzalez, F.J. Hospital Costa del Sol,

Ctra. 340, km 187,
Marbella, Málaga,
SPAIN
Molina Martin, V. Clínica de Podología,

c/Eugenio Gross 9-1,
Málaga,
SPAIN
Moreno Bonilla, M. Facultad de Medicina de la Universidad de Málaga,

c/Alcade Joaquin Alonso 6, 9-8,
E-29003 Málaga,
SPAIN
Moreno García, L. Avda. de la Estación 32,

Codigo Postal 18230,
Atarse, Granada,
SPAIN
Moreno Gómez, E.M. Universidad de Málaga,

c/Fernandez Fermina 4, 2-8,
E-29006 Málaga,
SPAIN
Moreno Moreno, R. Facultad de Medicina de la Universidad de Málaga,

c/Anita Adamuz 21,
E-29011 Málaga,
SPAIN
Morillas Pérez, M.D. Servicio de Radiofísica,

E-41013 Seville,
SPAIN
Fax: +34955013473
Muñoz Monplet, C. Hospital Universitario Doce de Octubre,

Carreteria de Andalucia,
E-28041 Madrid,
SPAIN
Fax: +34 913908278
Muñoz Quintero, B. Hospital Urba. La Marina,

c/Tingentera 4B,
E-11009 Cadiz,
SPAIN
Muñoz Sanchez, V. Radiología Intervencionista,

Hospital Clínico Universitario,
c/Federico Fellini 58,
E-29018 Málaga,
SPAIN
Muñoz, A. ABC Salud,

Juan Ignacio Luca de Tena 7,
E-28027 Madrid,
SPAIN
E-mail: abcsalud@abc.es
Muro de Zaro, C. Consejo de Seguridad Nuclear,

Calle Justo Dorado 11,
E-28040 Madrid,
SPAIN
Fax: +34913460558
E-mail: cmz@csn.es
Nava Baro, E. ETSI Telecomunicación, Universidad de Málaga,

Campus Teatinos,
E-29013 Málaga,
SPAIN
Fax: +34952132077
E-mail: en@uma.es
Navarro Gallego, M.I. Facultad de Medicina de la Universidad de Málaga,

c/Miguel Moreno Masson 2, 3o. 10,
E-29007 Alameda, Málaga,
SPAIN
E-mail: misabeln2000@yahoo.es
Navarro, E.L. Hospital Costa del Sol,

Avda. San Sebastian 6-11D,
E-29010 Málaga,
SPAIN
E-mail: eugenion@navegalia.com
Nuñez de Villavicencio de, C. Servicio de Protección Radiológica,

Fundación Jimenez Diaz,
Avda. Reyes Católicos 2,
E-28040 Madrid,
SPAIN
Fax: +34915494764
E-mail: cnvillavicencio@fjd.es
O’Donnell, P. Consjeo de Seguridad Nuclear,

Justo Dorado 11,
E-28040 Madrid,
SPAIN
Fax: +3413460377
E-mail: pot@csn.es
Ojeda Restituto, M.C. Servicio de Física Médica y Pr.,

Hospital Juan Ramón Jiménez,
Ronda Norte s/n,
E-21005 Huelva,
SPAIN
Fax: +34-952 201118
E-mail: cojeda@hjrj.sas.cica.es
Olivares Menol, P. Hospital General Universitario Gregorio Marañon,

E-28028 Madrid,
SPAIN
Fax: +34915866630
Ortega Belmonte, M.J. Facultad de Medicina de la Universidad de Málaga,

c/Goya 12-11-3,
E-29002 Málaga,
SPAIN
E-mail: 0088132@medicina.alumnos.uma.es
Ortega Cantos, E.M. Hospital Carlos Haya,

c/Juan Cortés Cortes, Bloque 5-2F,
E-29010 Málaga,
SPAIN
Fax: +34 952 645851
Ortega Casanueva, C. Facultad de Medicina de Salamanca,

Plaza del Ejercito 4-6,
E-37005 Salamanca,
SPAIN
E-mail: kerryabbess@terra.es
Ortiz de Zárate Vivanco, R. Servicio de Proteccíon Radiológica,

E-39008 Santander,
SPAIN
E-mail: wences@teleline.es; pracaj@humv.es
Orts, S. Facultad de Medicina de la Universidad de Málaga,

Avda. Santiago Ramon y Cajal 100,
E-29014 Málaga,
SPAIN
E-mail: josajo@hotmail.com
Ossola, G. Centro PET Complutense,

c/Bartolome Cossio10,
E-28040 Madrid,
SPAIN
Fax: +34915530845
E-mail: asesor@petmadrid.com
Padilla Arenas, M. Ministerio de Sanidad,

E-29004 Málaga,
SPAIN
Padron Pérez, C. Hospital Costa del Sol,

c/José Barrera 2G, C.P. 29620,
E-29000 Torremolinos, Málaga,
SPAIN
Fax: +34952823219
E-mail: juandea@terra.es
Palomo Rosado, A.M. Facultad de Medicina de la Universidad de Málaga,

Paseo de la Sancha 16, A2,
E-29000 Málaga,
SPAIN
Pardo Susacasa, E. MIR, Hospital Clínico Universitario,

E-29000 Málaga,
SPAIN
E-mail: susacpac@teleline.es
Pardo, J. Hospital Universitario Son Dureta,

c/Andrea Doria 55,
SPAIN
Fax: +34 971 175500
E-mail: insardt@hsd.es
Paredes García, M.C. Clínica Puerta de Hierro,

Hospital Universitario INSALUD,
c/San Martin de Porres 4,
E-28035 Madrid,
SPAIN
Fax: +34 91 3730535
E-mail: mparedes@hpth.insalud.es
Pastor Vega, J.M. Facultad de Medicina de la Universidad de Málaga,

E-29071 Málaga,
SPAIN
E-mail: josepastor@uma.es
Pedrosa, C. Hospital Clínico de San Carlos,

Plaza Cristo Rey,
E-28040 Madrid,
SPAIN
Fax: +34913303580
E-mail: cpedrosa@hotmail.com
Peinado, M.A. Hospital Universitario Rio Hortega,

E-47010 Valladolid,
SPAIN
Fax: +34 983274420
E-mail: rtorres@hurh.insalud.es
Peña Bernal, J.J. Facultad de Medicina, Universidad de Extremadura,

Avda. de Elvas s/n,
E-06080 Badajoz,
SPAIN
Fax: +34 92418010
E-mail: juanjop@ctv.es
Peña Ventura, V. Hospital General de Fuerteventura,

c/Toboso 2,
E-35600 Puerto del Rosario,
SPAIN
Perdices Acero, C. CRTRA,

Pozuelo a Majadamonda, km 3,5,
E-28220 Majadamonda, Madrid,
SPAIN
Fax: +34916392607
E-mail: concha_perdices@fremap.es
Pérez Dueñas, V. Facultad de Medicina de la Universidad de Málaga,

c/Mayoral 2, p6-4, Finca La Albahaca,
E-29071 Málaga,
SPAIN
Pérez Martín, C. Servicio de Ingeniería Biomédica,

E-38320 La Laguna, Tenerife,
SPAIN
Pérez Martin, F.J. Servicio de Radiología, Hospital Clínico Universitario,

Meridiana, Bloque 2 Bajo B-Z,
E-29000 Málaga,
SPAIN
Pérez Martinez, M. Departamento de Radiología y Física Médica,

E-29071 Málaga,
SPAIN
Fax: +34 952 134231
E-mail: mperezm@uma.es
Pérez San Emeterio, C. Universidad de Málaga,

E-29000 Málaga,
SPAIN
Planes Meseguer, D. Servicio de Radiofísica, Clínica Puerta de Hierro,

Hospital Universitario INSALUD,
c/San Martin de Porres 4,
E-28035 Madrid,
SPAIN
Fax: +34913730535
Portillo, J.C. Departamento de Radiología,

E-28040 Madrid,
SPAIN
E-mail: correo@lander.es
Pozo Arteseros, A. Clínica El Angel,

Avda. Pardo Santallana 61, Collado Villalba,
E-28400 Madrid,
SPAIN
Pujol, P.F.M. Ciudad Sanitaria y Universitaria de Bellvitge,

Manuel Pujol I Ferris,
c/Robrenyo 23, Sat/1a,
E-08014 Barcelona,
SPAIN
Fax: +932607980
E-mail: pujolferris@csub.scs.es
Quesada Clavijo, E. Hospital de Gran Canaria Dr. Negrín,

SPAIN
Fax: +34928449789
E-mail: rmartin2correo.hpino.rcanaria.es
Quesada, P. Facultad de Medicina de la Universidad de Málaga,

c/Rio Durcal 2,
E-29650 Mijas-Costa, Málaga,
SPAIN
E-mail: pilifree2001@terra.es
Quintana, O. Ministerio de Asuntos Exteriores,

Plaza de la Provincia 1E,
E-28012 Madrid,
SPAIN
Ramirez Vera, M.L. Consejo de Seguridad Nuclear,

Justo Dorado 11,
E-28040 Madrid,
SPAIN
Fax: +34913460588
E-mail: mir@csn.es
Ramos Garcia, L.I. Servicio de Radiofísica,

E-41013 Seville,
SPAIN
Fax: +34955013473
Rastrollo Peña, D. Facultad de Medicina de la Universidad de Málaga,

c/Carraca,
E-29011 Málaga,
SPAIN
Rebollo Aguirre, A.C. Medicina Nuclear, Hospital Clínico Universitario Málaga,

E-21080 Huelva,
SPAIN
Reina Aniza, E. Facultad de Medicina de la Universidad de Málaga,

c/Luchana 11,
E-29000 Málaga,
SPAIN
Ríos Ruiz, M. Facultad de Medicina de la Universidad de Málaga,

c/Montes de Oca 18, 4, 1,
E-29007 Málaga,
SPAIN
Ristori-Bogajo, E. Departamento de Radiología y Física Médica,

E-29071 Málaga,
SPAIN
Fax: +34952131630
E-mail: ristori@uma.es
Robayna Duque, B. Servicio de Física Médica,

SPAIN
Fax: +34922319279
E-mail: brobayna@ull.es
Robles Dominguez, F.J. Facultad de Medicina,

Camino de Suarez 6, 2C,
E-29010 Malága,
SPAIN
E-mail: 009210x@medicina.aluminos.cica.es
Rodriguez Castillo, M.F. Servicio de Radiofísica,

Hospital Universitario de Valme,
Carretera de Cadiz s/n,
E-41014 Seville,
SPAIN
Fax: +34955015062
E-mail: fimmrc@valme.sas.cica.es
Rodriguez Escalera, J. c/Jonas 5, 4B,

E-29013 Málaga,
SPAIN
Rodriguez Gonzalez, A. Hospital Clínico Universitario,

C/Avda. Finlandia No. 6,
E-29640 Fuengirola,
SPAIN
E-mail: argrojo@hotmail.com
Rodríguez Romero, R. Laboratorio de Física Médica,

SPAIN
Fax: +34922319279
E-mail: ruthrad@fnmail.com
Rodriguez San Pedro, J.M. Aplicaciones Tecnológicas S.A.,

Berlin 4, Pozuelo de Alarcon,
E-28224 Madrid,
SPAIN
Fax: +34913524685
E-mail: atsa@arrakis.es
Rodriguez, M.M. Consejo de Seguridad Nuclear,

Justo Dorado 11,
E- 28020 Madrid,
SPAIN
Fax: +34913460588
E-mail: mrm@csn.es
Roman Collado, J.R. Servicio de Radiofísica, Hospital de Valme,

Ctra. de Cadiz s/n,
E-41014 Seville,
SPAIN
Fax: +34955015062
E-mail: fimmre@valme.sosicica.es
Romero Romero, M. Servicio de Radiología, Hospital Clínico Universitaria,

El Correo Andalucia 7, Bl. 9-3,
E-29000 Málaga,
SPAIN
Rubio Lamia, L. Facultad de Medicina de la Universidad de Málaga,

Pasaje del Dracma 3, Piso 11A,
E-29006 Málaga,
SPAIN
Ruiz Cruces, R. Departamento de Radiología y Física Médica,

E-29071 Málaga,
SPAIN
Fax: +34 952 134231
E-mail: rrcmf@uma.es
Ruiz del Pino, M.F. Grupo de Investigación en Protección Radiológica,

Departamento de Radiología y Física Médica,
E-29071 Málaga,
SPAIN
Ruiz Díaz, M. Complejo Hospitalario Carlos Haya,

E-29010 Málaga,
SPAIN
Ruiz Gómez, M.J. Universidad de Málaga,

c/Jaén 18,
E-29700 Vélez, Málaga,
SPAIN
Fax: +34 95 2131630
E-mail: mjrg@uma.es
Ruiz Manzano, P. Hospital Clínico Universitario Lozano Blesa de Zaragoza,

E-50009 Zaragoza,
SPAIN
Fax: +34 976565995
Ruiz Torrecillas, F.J. Facultad de Medicina de la Universidad de Málaga,

c/Sacinto Benavente 27,
E-29530 Alameda, Málaga,
SPAIN
Saenz Moreno, J. Dextro-Medica, S.L.,

c/Ciudad de Liria 75,
E-46988 Paterna, Málaga,
SPAIN
Fax: +34961325833
Saez Gómez, A. Facultad de Medicina,

Urb. Huerta Belon,
c/Bergantin1,
E-29600 Marbella,
SPAIN
Sanchez Bueno, J.S.B. Universidad de Málaga,
c/Corregidor Francisco Molina 15-3A,
E-29006 Málaga,
SPAIN
Sánchez Hidalgo, M. Complejo Hospitalario Carlos Haya,
E-29010 Málaga,
SPAIN
Sánchez Rodríguez, M.D. Facultad de Medicina de Salamanca,
c/San Justo 27,
E-37001 Salamanca,
SPAIN
E-mail: mdcsr@mixmail.com
Sanz Carretero, R. Facultad de Medicina de la Universidad de Málaga,
Plaza Miraflores 3, 8o. 2A,
E-29011 Málaga,
SPAIN
E-mail: www.webrsanznet@mixmail.com
Sanz Sánchez, J.L. Toshiba Medical Systems S.A.,
SPAIN
E-mail: jsanz@tmse.nl
Saura-Iniesta, A.D. Department of Radiology, University of Murcia,
SPAIN
Fax: +34 968363602
E-mail: mab@um.es
Sendra-Portero, F. Departamento de Radiología y Física Médica,
E-29071 Málaga,
SPAIN
Fax: +34952131630
E-mail: sendra@uma.es
Serrano Cabrera, A. Facultad de Medicina de la Universidad de Málaga,
PT 1-1 C,
E-29008 Málaga,
SPAIN
Sierra Diaz, F. Hospital General Universitario Gregorio Marañon,

E-28028 Madrid,
SPAIN
Fax: +34915866630
E-mail: polivares@radonc.hggm.es
Simó, A. Hospital General Universitario Gregorio Marañon,

E-28028 Madrid,
SPAIN
Fax: +34915866630
E-mail: polivacy@radiogic.hggm.es
Soler Cantos, M. Servicios Protección Radiológica,

Hospital Universitario Reina Sofia,
E-14004 Córdoba,
SPAIN
Fax: +34957011607
E-mail: msoler@sofia.hrs.sas.cica.es
Taboada Martín, X. Servicio de Radioterapia,

c/Campoamor 5-4A,
E-38006 Santa Cruz de Tenerife,
SPAIN
Teijeiro Vidal, J. Escuela Universitaria de Terapia Ocupacional de la

Universidad de A. Coruña,
Campus de Oza s/n,
E-15006 A Coruña
SPAIN
E-mail: jtv@udc.es
Tellez de Cepeda, M. Radioprotección, Hospital Universitario La Paz,

Paseo de la Castellana 261,
E-28046 Madrid,
SPAIN
Fax: +34917277103
E-mail: mteller@hulp.insalud.es
Terron Franco, I. Hospital Carlos Haya,

c/Jerez Perchet 47-3D, Hacienda de los Montes,
E-29002 Málaga,
SPAIN
Thomson Luque, R. Facultad de Medicina de la Universidad de Málaga,

c/ Blanco Coris 7, 1o. Izq.,
E-29007 Málaga,
SPAIN
E-mail: rhth_2000@yahoo.com
Tobarra, B. Servicio de Protección Radiológica,

Hospital Universitario Virgen de la Arrixaca,
Carretera Madrid–Cartagena,
E-30120 El Palmar, Murcia,
SPAIN
Fax: +34968369678
E-mail: btobarra@arrixaca.huva.es
Torales, C. Universidad de Málaga,

Paseo del Limonar 14, 2D,
E-29016 Málaga,
SPAIN
E-mail: oet@unet.es
Torres Sousa, Y. c/Rodrigo de Triana 1-3B,

Edificio Sto. Angel 1,
E-52005 Melilla,
SPAIN
Torres Tabanera, M. Departamento de Radiología y Física Médica,

E-29071 Málaga,
SPAIN
Torres, R. Hospital Universitario Rio Hortega,

E-47010 Valladolid,
SPAIN
Fax: +34 983274420
E-mail: rtorres@hurh.insalud.es
Tort Ausina, I. Departamento de Radiología y Física Médica,

E-29071 Málaga,
SPAIN
Fax: +34 952 134231
E-mail: tort@uma.es
Ugarte Palares, A. ENRESA,

E-14200 Peñarroya–Pueblonuevo,
SPAIN
Fax: +34 957575130
E-mail: augp@enresa.es
Urbono Bravo, M.A. Hospital Carlos Haya,

c/México, Edif. México 2-1C,
E-29010 Málaga,
SPAIN
Valverde Morán, J. Consejeria de Sanidad, Comunidad de Madrid,

Avda. de Filianas 50,
E-28003 Madrid,
SPAIN
Fax: +34 915541597
Van Veen, P. Toshiba Medical Systems S.A.,

SPAIN
E-mail: pvveen@tnse.nl
Vañó, E. Departamento de Radiología, Facultad de Medicina,

Universidad Complutense de Madrid,
Ciudad Universitaria,
E-28040 Madrid,
SPAIN
Fax: +3413941675
E-mail: eliseo@eucmax.sim.ucm.es
Vargas Marcos, F. Ministerio de Sanidad,

Subdirección General de Sanidad Ambiental,
Paseo del Prado 18,
E-28071 Madrid,
SPAIN
Fax: +34913601341
E-mail: fvargas@msc.es
Vazquez Mesa, J.I. c/San Cristobal 5,

E-29000 Málaga,
SPAIN
Vega Beltran, A. Facultad de Medicina de la Universidad de Málaga,

Sofocles 3, Aticos,
E-29000 Málaga,
SPAIN
E-mail: pacolobo@eresmas.com
Velasco Roman, J. Centro Radiológico Andaluz S.A.,

c/Pintor Sorolla 2,
E-29016 Málaga,
SPAIN
Fax: +34 952 121134
E-mail: jaimevr@hotmail.com
Vélez Vásquez, R. Facultad de Medicina de la Universidad de Málaga,

Avenida de Andalucía 19-9D,
E-29002 Málaga,
SPAIN
Ventosa de la Cruz, T. Consejo de Seguridad Nuclear,

Calle Justo Dorado 11,
E-28040 Madrid,
SPAIN
Fax: +34913460558
E-mail: tvc@csn.es
Vieito, J.M. Hospital Xeral de Vigo,

c/Pizarro 21,
E-36204 Vigo,
SPAIN
Fax: +34986816029
E-mail: jvieito@unicies.cesga.es
Vilches Cruz, N. Facultad de Medicina de la Universidad de Málaga,

Ferrocarril Del Puerto 6-3C,
E-29002 Málaga,
SPAIN
Villa Bastias, E. Departamento de Radiología y Física Médica,

E-29071 Málaga,
SPAIN
Villaescusa, J.I. Protección Radiológica, Hospital Universitario La Fé,

Avda. Campanar 21,
E-46009 Valencia,
SPAIN
Fax: +34963862770
E-mail: villaescusa-ign@.gra.es
Villaescusa, J.I. Hospital Universatorio La Fé,

Avda. de Campanar 21,
E-46009 Valencia,
SPAIN
Fax: +34963862770
E-mail: villaescusa-ign@gra.es
Villalobos Martin, J.A. Hospital Universitario Clínico Málaga,

Avda. San Antón 110,
E-29018 Málaga,
SPAIN
Villarroel Gonzalez, R. Consejo de Seguridad Nuclear,

Justo Dorado 11,
E-28040 Madrid,
SPAIN
Fax: +34913460588
E-mail: rvge@csn.es
Wolczak, D.F. Casa Terraza,

c/de Jatar,
E-29254 Competa, Málaga,
SPAIN
Fax: +34952553777
E-mail: internationalconsultant@yahoo.com
Yahyaoui Macias, R. Facultad de Medicina de la Universidad de Málaga,

c/Cañada de Mejias 43, 1D,
E-29003 Málaga
SPAIN
E-mail: yahyaoui@teleline.es
SUDAN
Abuelhia, E. Institute of Nuclear Medicine and Molecular Biology,

University of Gezira,
P.O. Box 20,
Wadmedani,
SUDAN
E-mail: elfatih_a@yahoo.com
Kamal, E.H.M. Faculty of Medicine,

University of Khartoum,
P.O. Box 102,
Khartoum,
SUDAN
Fax: +24911785381/7753 51
E-mail: tsrc@sudanmail.net
SWEDEN
Englund, A. Department of Medical Physics,

Uppsala University Hospital,
Akademiski Sjukhuset,
S-751 85 Uppsala,
SWEDEN
E-mail: alexander.englund@asf.uas.se
Göthlin, J.H. Department of Radiology,

Sahlgrenska University Hospital,
S-413 45 Gothenburg,
SWEDEN
Fax: +4634697227
E-mail: jan.gothlin@zeta.telenordia.se
Lamm, I.-L.C. Radiation Physics,

Lund University Hospital,
S-221 85 Lund,
SWEDEN
Fax: +4646136156
E-mail: inger-lena.lamm@skane.se
Leitz, W.K. Swedish Radiation Protection Institute,

S-171 16 Stockholm,
SWEDEN
Fax: +4687297152
E-mail: wolfram.leitz@ssi.se
Ringertz, H. Department of Diagnostic Radiology,

Karolinska Institute,
S-171 76 Stockholm,
SWEDEN
Fax: +46851776000
E-mail: hari@adr.ks.se
Unfors, T. Unfors Instruments AB,

Uggledalsv 27,
S-427 40 Billdal,
SWEDEN
Fax: +4631910950
E-mail: unfors_tomas@unfors.se
SWITZERLAND
Aroua, A. Institut universitaire de radiophysique appliquée,

Grand-Pré 1,
CH-1007 Lausanne,
SWITZERLAND
Fax: +41216233435
E-mail: abbas.aroua@inst.hospvd.ch
Flükiger Meylan, U. SVMTRA,

Nelkenweg 7,
CH-3006 Bern,
SWITZERLAND
Fax: +41319707730
E-mail: ursula.fluekiger@zieglerspital.ch
Gonzalez, G. SVMTRA,
Viktoriastrasse 8, 7,
CH-3013 Bern,
SWITZERLAND
Fax: +41313313808
E-mail: gisela.gonzalez@azi.insel.ch
Trueb, P.R. Radiation Protection,

Swiss Federal Office of Public Health,
CH-3003 Bern,
SWITZERLAND
Fax: +41 313228383
E-mail: philipp.trueb@bag.admin.ch
Verdun, F. Institut universitaire de radiophysique appliquée,

Grand-Pré 1,
CH-1007 Lausanne,
SWITZERLAND
Fax: +41216233435
E-mail: francis.verdun@inst.hospvd.ch
SYRIAN ARAB REPUBLIC
Othman, I. Atomic Energy Commission of Syria,

P.O. Box 6091,
Damascus,
Fax: +963116112289
E-mail: aecs@mail.sy
Sadiyyah, A.K. Nuclear Medicine Center,

P.O. Box 3905,
Damascus,
E-mail: saddiyyah@scs-net.com
Shannan, A. Radiology Department,

Tashreen Hospital,
Damascus,
Fax: +963113318567
E-mail: a.shannan@net.sy
THAILAND
Krisanachinda, A. Department of Radiology,

Faculty of Medicine,
Chulalongkorn University,
Rama IV Road,
Bangkok 10330,
THAILAND
Fax: +6622564162
E-mail: kanchali@yahoo.com
Manatrakul, N. Division of Radiation and Medical Devices,

Department of Medical Sciences,
Ministry of Health,
Tiwanon Road,
Nonthaburi 11000,
THAILAND
Fax: +6629511028
E-mail: nisakorn@health.moph.go.th
Pataramontree, J. Department of Radiology,

Chulalongkorn Hospital,
Bangkok 10330,
THAILAND
Fax: +6622541931
E-mail: jongjinp@yahoo.com
THE FORMER YUGOSLAV REPUBLIC OF MACEDONIA
Mitreska, N. Institute of Radiology,

Ozumajska 43,
Skopje,
THE FORMER YUGOSLAV REPUBLIC OF
MACEDONIA
TUNISIA
Mtimet, S., Centre national de radioprotection,

Hôpital d’enfants,
Place Bab Saadoun,
1006 Tunis,
TUNISIA
Fax: +2161571697
E-mail: sadok.mtimet@rns.tn
TURKEY
Okyar, H.B. Turkish Atomic Energy Authority,

Radiation Health and Safety Department — Licensing
Division,
Eskisehir Yolu – Lodumlu,
06530 Ankara,
TURKEY
Fax: +903122854284
E-mail: burcin.okyar@taek.gov.tr
Pala, F.S. Radiobiology Department,

Çekmece Nuclear Research and Training Center,
P.O. Box 1,
Atatürk Airport,
34800 Istanbul,
TURKEY
Fax: +902125482230
E-mail: palaf@nukleer.gov.tr
Pirnar, T. Dokuz Eylul Tip Fakultesi,

Hastahanesi,
Balcova,
Izmir,
TURKEY
Fax: +902322780655
E-mail: tugpir2@superonline.com
Taymaz, A. Nuclear Physics Department,

Physics Division,
Science Faculty,
Vezneciler Campus,
Istanbul University,
34459 Istanbul,
TURKEY
Fax: +902125190834
E-mail: taymaza@istanbul.edu.tr
UKRAINE
Kornyeyeva, V.V. Grigoriev Institute for Medical Radiology,

Pushkinska Street 82,
Kharkov 61024,
UKRAINE
Fax: +380572431125 or 437120
E-mail: imr@online.kharkiv.net
UNITED ARAB EMIRATES
Janeczek, J. Tawam Hospital,

P.O. Box 15258,
Al Ain, Abu Dhabi,
UNITED ARAB EMIRATES
Fax: +97137075803
E-mail: jacek@tawam.gov.ae
UNITED KINGDOM
Almari, A.F. James Paget Hospital,

Lowestoft Road,
Gorleston NR31 6LA,
UNITED KINGDOM
Fax: +441493452405
E-mail: ahmed.almari@jpaget.nhs.uk
Armpilia, C.I Medical Physics Department,

Royal Free Hospital,
Pond Street,
London NW3 2QG,
UNITED KINGDOM
E-mail: carmpilia@hotmail.com
Barlow, S. College of Radiographers,

207 Providence Square,
London SE1 2EW,
UNITED KINGDOM
Fax: +441392402926
Batty, V.B. Department of Nuclear Medicine,

Southampton General Hospital,
Tremona Road,
Southampton SO16 6YD,
UNITED KINGDOM
Fax: +442380796927
E-mail: vincentbaty@dial.pipex.com
Clewer, P. Department of Medical Physics,

Southampton General Hospital,
Tremona Road,
Southampton SO16 6YD
UNITED KINGDOM
Fax: +442380794117
E-mail: prc@soton.ac.uk
Corbett, R.H. Hairmyres Hospital,

East Kilbride G75 8RG,
UNITED KINGDOM
Fax: +441355234064
E-mail: r_h_corbett@hotmail.com
Crossley, C.A. Radiation Protection Service,

Velindre Hospital,
Velindre Road,
Cardiff CF4 7XL,
UNITED KINGDOM
Fax: +442920322694
E-mail: cathy.crossley@velindre.tr.wales.nhs.uk
Ebdon-Jackson, S. Department of Health,

Wellington House,
133–155 Waterloo Road,
London SE1 8UG,
UNITED KINGDOM
E-mail: Steve.Ebdon-Jackson@doh.gsi.gov.uk
Faulkner, K. QA Reference Centre,

Newcastle General Hospital,
Westgate Road,
Newcastle Upon Tyne NE45 6BE,
UNITED KINGDOM
Fax: +441912195034
Fitzgerald, M. Radiological Protection Centre,

St. George’s Hospital,
London SW17 0QT,
UNITED KINGDOM
Fax: +442087251052
E-mail: mikef@sghrpc.demon.co.uk
Harding, L.K. Department of Nuclear Medicine,

City Hospital,
Birmingham B18 7QH,
UNITED KINGDOM
Fax: +441215075223
E-mail: l.k.harding@bham.ac.uk
Honey, I.D. Radiation Protection Service,

King’s College Hospital,
London SE5 9RS,
UNITED KINGDOM
Fax: +442073466482
E-mail: iar.honey@kel.gc.uk
Horrocks, J.A. Clinical Physics Department,

St. Bartholomew’s Hospital,
London EC1A 7BE,
UNITED KINGDOM
Fax: +442076018299
E-mail: j.a.horrocks@mds.qmw.ac.uk
Jefferies, A.L. Radiation Protection Service,

King’s College Hospital,
London SE5 9RS,
UNITED KINGDOM
Fax: +44 207 346 6482
E-mail: anita.jefferies@kingsho.nhs.uk
Jones, J.R. Department of Medical Physics,

Royal Free Hospital,
Pond Street,
London NW3 2QG,
UNITED KINGDOM
Fax: +442078302469
E-mail: jeffriones@yahoo.com
Kadera, N. Department of Medical Physics and Bioengineering,

University College London Hospital,
11–20 Capper Street,
London WC1E 6JA,
UNITED KINGDOM
E-mail: nkadera@medphys.ucl.ac.uk
Kyriou, J. Radiological Protection Centre,

St. George’s Hospital,
London SW17 0QT,
UNITED KINGDOM
Fax: +442087251052
E-mail: johnokyriou@sghrpl.co.uk
Monaghan, N.C. Radiation Consultancy Services Ltd,

8 Second Cross Road,
Twickenham,
Middlesex TW2 5RF,
UNITED KINGDOM
Fax: +442088934092
E-mail: niall@rcs-ltd.demon.co.uk
Myers, M.J. Radiological Sciences Unit,

Hammersmith Hospital,
Ducane Road,
London W12 0HS,
UNITED KINGDOM
Fax: +442083832400
E-mail: mmyers@ic.ac.uk
Pemberton, J. Diagnostic Radiology Department,

Guy’s and St. Thomas’ Hospital,
London SE1 7EH,
UNITED KINGDOM
Fax: +442072610405
E-mail: james.pemberton@gstt.sthames.nhs.uk
Ramsdale, M.L. Regional Radiation Protection Service,

Royal Surrey Country Hospital,
Guildford BU2 7XX,
UNITED KINGDOM
Fax: +441483406742
E-mail: mramsdale@royalsurrey.nhs.uk
Richards, A.R. Medical Physics and Clinical Engineering Department,

University Hospital of Wales,
Cardiff CF14 4XW,
UNITED KINGDOM
Fax: +4429207402012
E-mail: richards@cf.ac.uk
Rogers, A.T. Medical Physics Department,

Nottingham City Hospital,
Hucknall Road,
Nottingham NG5 1PB,
UNITED KINGDOM
Fax: +441159627784
E-mail: arogers@ncht.org.uk
Ryan, E.A. Clinical Physics Department,

London EC1A 7BE,
UNITED KINGDOM
Fax: +442076018290
E-mail: elaineryan785@netscape.net
Shrimpton, P.C. Medical Deparment,

Didcot, OX11 0RQ
UNITED KINGDOM
Fax: +441235833 891
Slack, K.A. Department of Health,

Wellington House,
133–155 Waterloo Road,
London SE1 8UG,
UNITED KINGDOM
Fax: +442079724800
E-mail: kthlin.slack@doh.gsi.gov.uk
Spanswick, K.A. KAS and Associates,

20 Milton Drive,
Ravenshead NG1 5HE,
UNITED KINGDOM
E-mail: keith@spanswick.co.uk
Spring, J.L. Southampton University Hospitals,

Tromand Road,
Southampton SO16 6YD,
UNITED KINGDOM
Fax: +442380794038
Theodorakou, C. Clinical Physics Department,

London EC1A 7BE,
UNITED KINGDOM
Fax: +442076018294
E-mail: c.theodorakou@mds.qmw.ac.uk
Wall, B.F. National Radiological Protection Board,

Didcot OX11 0RQ,
UNITED KINGDOM
Fax: +441235533891
E-mail: barry.wall@nrpb.org.uk
Webb, G.A.M. International Radiation Protection Association,

‘Brunswick’,
Cornwall Garden,
Brighton BN1 6RJ,
UNITED KINGDOM
Fax: +441273565509
E-mail: Geoffrey.Webb@physics.org
Webster, C.M. 80 Peak Hill,

London SE26 4LQ,
UNITED KINGDOM
Fax: +442076018402
UNITED REPUBLIC OF TANZANIA
Ngaile, J.E. National Radiation Commission,

P.O. Box 743,
Arusha,
UNITED REPUBLIC OF TANZANIA
Fax: +255272548554
E-mail: jngaile@hotmail.com
UNITED STATES OF AMERICA
Balaban, B. 310B Heritage Hills,

Somers, NY 10589,
USA
Fax: +19142776994
E-mail: bbalaban@bestweb.net
Díaz, N.J. United States Nuclear Regulatory Commission (USNRC),

Washington, DC 20555,
USA
Fax: +13014153504
E-mail: jb11@nrc.gov
Fernández Vicioso, E. Department of Radiation Oncology,

Aventura Comprehensive Cancer Center,
20950 NE 27th Court,
Aventura, FL 33180,
USA
Fax: +13057925851
E-mail: efernandez@rtsx.com
Goodenough, D. Medical Imaging Department,

George Washington University,
901 23rd Street, NW,
USA
E-mail: goodenou@gwu.edu
Grant, D.C. Washington Hospital Center,

2131 Yorktown Road, NW,
USA
Fax: +12027265968
E-mail: _huttohi@aol.com
Huda, W. Radiation Physics, University Hospital,

SUNY Upstate Medical University,
750 East Adams Street,
Syracuse, NY 13210,
USA
Fax: +13154647068
E-mail: hudaw@mail.upstate.edu
Koenig, T.R. Department of Radiology, Houston Medical School,

University of Texas,
6431 Fannin, MSB 2.100,
Houston, TX 77030,
USA
Fax: +17135007676
E-mail: titus.r.koenig@uth.tmc.edu
McGinley, P.H. Department of Radiation Oncology, Emory Clinic,

1365 Clifton Road,
Atlanta, GA 30322,
USA
Fax: +14047784139
E-mail: patton@radonc.emory.org
Mettler, F.A. Department of Radiology, School of Medicine,

University of New Mexico,
915 Camino Salud NE,
Albuquerque, NM 87131-5336,
USA
Fax: +15052775821
E-mail: fmett@unm.edu
Nikolic, B. 2500 Wisconsin Avenue, Apt. 554,

USA
E-mail: _nikolib@Georgetown.edu
Pérez, C. Radiation Center, Mallinckrodt Institute of Radiology,

Washington University,
510 S. Kings Highway,
St. Louis, MO 63110,
USA
Fax: +13143628521
E-mail: perez@radonc.wustl.edu
Rosenstein, M. 9433 Bethany Place,

Montgomery Village, MD 20886,
USA
Fax: +13018405949
E-mail: smrmr@msn.com
Sollod, H. 4770 East Iliff Avenue,

Denver, CO 80222,
USA
Fax: +3033206040
E-mail: hsollod@aol.com
Wagner, L.K. Department of Radiology, Houston Medical School,

University of Texas,
6431 Fannin, MSB 2.100,
Houston, TX 77030,
USA
Fax: +17135007676
E-mail: Louis.k.wagner@uth.tmc.edu
URUGUAY
Cotelo, E. Facultad de Medicina,

Hospital Universitario Dr. Manuel Quintela,
Avda. Italia, Piso 3er,
Montevideo,
URUGUAY
Fax: +59824871323
E-mail: elecote@adinter.com.ug
Estevan Collazo, M.A. Ministerio de Salud Pùblica del Uruguay,

Sandiago Gadea 3192,
C.P. 11600 Montevideo,
URUGUAY
Fax: 59829027652
E-mail: miganges@adinet.com.uy or
UZBEKISTAN
Kazimova, G. Institute of Immunology,

9 Progressiv Street,
Tashkent City 700007,
UZBEKISTAN
E-mail: damir@medik.silk.org
Zaredinov, D. Second Tashkent State Medical Institute,

2 Farobiy Street,
Tashkent City 700109,
UZBEKISTAN
Fax: +998711361425
E-mail: damir@medik.silk.org
VENEZUELA
Canete, M.C. Instituto Venezolano de Investigaciones Científicas,

SSDL,
Carretera Panamericana km 11,
P.O. Box 21827,
Caracas 1020-A,
VENEZUELA
Fax: +5825041577
E-mail: mpadilla@pion.ivic.ve
Carrizales Lila, C.L. Instituto Venezolano de Investigaciones Científicas,

Carretera Panamericana km 11,
Altos de Pipe,
Caracas 21827,
VENEZUELA
Fax: +5825041577
E-mail: lcarriza@pion.ivic.ve
Díaz Aponte, A. Facultad de Medicina, Escuela de Medicina Luis Razetti,

Universidad Central de Venezuela,
Apartado de Correo 47924,
Caracas 1041-A,
VENEZUELA
Fax: +5826053518
E-mail: diaza@camelot.rect.ucv.ve
Pérez de Díaz, F. Universidad Central de Venezuela,

Ciudad Universitaria,
Caracas 1070-A,
VENEZUELA
E-mail: diazz@camelot.sect.ucv.ve
VIETNAM
Dang, Thanh Luong Viet Nam Atomic Energy Commission,

59 Ly Thuong Kiet,
Hanoi,
VIET NAM
Fax: +8449424133
E-mail: hq.vaec@hn.vnn.vn or
ZIMBABWE
Makoni, T.E. Department of Radiation Therapy,

Mpilo Central Hospital,
P.O. Box 2096,
Bulawayo,
ZIMBABWE
Fax: +263970080
E-mail: rjowo@healthnet.zw
EUROPEAN COMMISSION
Jehenson, P. HFR Unit, JRC Petten,

P.O. Box 2,
NL-1755 ZG Petten,
NETHERLANDS
Fax: +31224561449
E-mail: jehenson@jrc.nl
Moss, R.L. Institute for Advanced Materials, JRC Petten,

Postbus 2,
NL-1755 ZG Petten,
NETHERLANDS
Fax: +31224561449
E-mail: mossa@jre.nl
Nikula, T. Institute for Transuranium Elements, JRC-ITE,

P.O. Box 2340,
D-76125 Karlsruhe,
GERMANY
Sarro-Vaquero, M. Directorate General for Environment,

Bât. Wagner C/325,
Rue Alcide de Gasperi,
L-2920 Luxembourg,
LUXEMBOURG
Fax: ++352 430 1 34646
E-mail: Mercedes.Sarro-Vaquero@cec.eu.int
Schnuer, K. Directorate General for Environment,

Plateau de Kirchberg, Bât. C3/331,
L-2920 Luxembourg,
LUXEMBOURG
Fax: +352430134646/3628
E-mail: klaus.schnuer@dg11.cec.be
Teunen, D. Directorate General for Research,

L-2920 Luxembourg,
LUXEMBOURG
Fax: +3222966256
INTERNATIONAL ATOMIC ENERGY AGENCY (IAEA)
González, A.J. Division of Radiation and Waste Safety,

Department of Nuclear Safety,
Wagramer Strasse 5, P.O. Box 100,
A-1400 Vienna
AUSTRIA
Fax: +43126007
E-mail: A.J.Gonzalez@iaea.org
Groth, S. Division of Human Health,

Department of Nuclear Sciences and Applications,
A-1400 Vienna
AUSTRIA
Fax: +43126007
E-mail: S.Groth@iaea.org
Meghzifene, A. Division of Human Health,

A-1400 Vienna
AUSTRIA
Fax: +43126007
E-mail: A.Meghzifene@iaea.org
Ortiz López, P. Division of Radiation and Waste Safety,

A-1400 Vienna
AUSTRIA
Fax: +43126007
E-mail: P.Ortiz-Lopez@iaea.org
Tatsuzaki, H. Division of Human Health,

A-1400 Vienna
AUSTRIA
Fax: +43126007
E-mail: H.Tatsuzaki@iaea.org
Wrixon, A.D. Division of Radiation and Waste Safety,

A-1400 Vienna
AUSTRIA
Fax: +43126007
E-mail: A.Wrixon@iaea.org
INTERNATIONAL ORGANIZATION OF MEDICAL PHYSICS (IOMP)
Niroomand-Rad, A. Department of Radiation Medicine,

L.L. Bles Building,
3800 Reservoir Road, NW,
USA
Fax: (202) 7843323
E-mail: nirooma@gunet.georgetown.edu
INTERNATIONAL SOCIETY FOR RADIATION ONCOLOGY/EUROPEAN

SOCIETY FOR THERAPEUTIC RADIOLOGY AND ONCOLOGY (ISRO/ESTRO)
D’Hooge, J.M. European Society for Therapeutic Radiology

and Oncology
Avenue Mounierlaan 83,
B-1200 Brussels,
BELGIUM
Fax: +32 2 7795494
E-mail: Germaine.heeren@estro.bee
Heeren, G. European Society for Therapeutic Radiology

and Oncology
Avenue Mounierlaan 83,
B-1200 Brussels,
BELGIUM
Fax: +3227795470
E-mail: Germaine.heeren@estro.be
Hendry, J. Paterson Institute for Cancer Research,

Christie Hospital NHS Trust,
Manchester M20 4BX,
United Kingdom
Fax: +44 161 446 3109
E-mail: JHendry@picr.man.ac.uk
Lartigau, E. Avenue Mounierlaan 83,

B-1200 Brussels,
BELGIUM
Fax: 3227795494
E-mail: frederique.artus@estro.be
Svensson, H. Radiation Physics Department,

University Hospital,
S-90185 Umea,
SWEDEN
Fax: +4690781588
E-mail: hans.svensson@radfys.umu.se
INTERNATIONAL SOCIETY OF RADIOGRAPHERS AND RADIOLOGICAL

TECHNOLOGISTS (ISRRT)
Yule, A. University Hospital of Wales,

Heath Park,
Cardiff, Wales CF4 4XW,
United Kingdom
Fax: +442929742128
E-mail: Sandy.Yule@UHW-TR.wales.nhs.uk
INTERNATIONAL SOCIETY OF RADIOLOGY (ISR)
Klempfner, G. Department of Radiology, St. Frances Cabrini Hospital,

183 Wattletree Road,
Malvern, Victoria 3144,
AUSTRALIA
Fax: +61398274739
E-mail: georgklem@bigpond.com.au
Linton, O.W. International Society of Radiology,

Suite 800, 7910 Woodmont Avenue,
Bethesda, MD 20814,
USA
Fax: +3019078768
E-mail: isr@isradiology.org
Schmidt, P.S. Radiation Protection Section,

Department of Health and Family Services,
P.O. Box 2659,
Madison, WI 53701-2659,
USA
Fax: +16082673695
E-mail: schmips@dhfs.wi.us
PAN AMERICAN HEALTH ORGANIZATION (PAHO)
Borrás, C. Pan American Health Organization,

Regional Office of the World Health Organization,
525 23rd Street, NW,
USA
Fax: +12029743610
E-mail: borrasc@paho.org
WORLD FEDERATION OF NUCLEAR MEDICINE AND BIOLOGY (WFNMB)
Amaral, H. Medicina Nuclear, Clinica Alemana,

Avda. Vitacura 5951,
Santiago 6681922,
CHILE
Fax: +5622124380
E-mail: hamaral@alemana.cl
WORLD HEALTH ORGANIZATION (WHO)
Ostensen, H. Diagnostic Imaging and Laboratory Technology,

World Health Organizaton,
20, Avenue Appia,
CH-1211 Geneva 27,
SWITZERLAND
Fax: +41227910746
E-mail: Ostensenh@who.ch
587
AUTHOR INDEX
Amaral, H.: 103 Ortiz López, P.: 35

Azuara, J.Á.: 7 Ostensen, H.: 31, 67
Borrás, C.: 27, 55 Padovani, R.: 203
Bremmer, S.: 281 Paras, P.: 347
Bridier, A.: 309 Pérez, C.A.: 291
Cassar, J.: 391 Purdy, J.A.: 291
Chavaudra, J.: 309 Rehani, M.M.: 169
Díez de los Ríos Delgado, A.: 11 Ringertz, H.G.: 281
Duschka, H.: 347 Rosenstein, M.: 241
Dutreix, A.: 309 Ruiz Cruces, R.: 13
Faulkner, K.: 379 Sarró Vaquero, M.: 47
Ferreira, I.H.: 309 Schnuer, K.: 23
González, A.J.: 17 Servomaa, A.: 129
Goodenough, D.J.: 145 Shrimpton, P.C.: 71, 109
Gray, J.E.: 183 Standertskjöld-Nordenstam,
Harding, L.K.: 227 C.G.: 95
Izewska, J.: 35 Streffer, C.: 267
Lacronique, J.-F.: 157 Svensson, H.: 97, 291, 309
Lillicrap, S.C.: 347 Teunen, D.: 47
Liniecki, J.: 333 Villalobos Talero, C.: 3
Marre, D.: 309 Wagner, L.K.: 361
Meghzifene, A.: 35 Webb, G.A.M.: 91
Mettler, F.A.: 15, 77, 119 Wrixon, A.D.: 35
Niroomand-Rad, A.: 79 Yule, A.: 99

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Radiological Protection of

Patients in Diagnostic and

Proceedings of an international conference held in Málaga,

PROCEEDINGS OF AN INTERNATIONAL CONFERENCE HELD

INTERNATIONAL ATOMIC ENERGY AGENCY

VIC Library Cataloguing in Publication Data

Printed by the IAEA in Austria

— Radiological interventional procedures, which are increasingly being used to

In diagnosis, the radiological protection objective is to keep doses as low as

GLOBAL VIEW ON THE RADIOLOGICAL PROTECTION OF

Role of the IAEA in the radiological protection of patients

The current uses of radiation in medicine

RADIOLOGICAL PROTECTION OF PATIENTS IN GENERAL

Protection of patients in general radiography

RADIOLOGICAL PROTECTION ISSUES IN SPECIFIC USES OF

Radiological protection issues in mammography and computed tomography

RADIOLOGICAL PROTECTION IN INTERVENTIONAL

Radiological protection in interventional radiology

RADIOLOGICAL PROTECTION OF PATIENTS IN NUCLEAR

Radiological protection of patients in nuclear medicine

DEVELOPING AND USING GUIDANCE (REFERENCE) LEVELS IN

Diagnostic reference levels in medical imaging

RADIOLOGICAL PROTECTION OF THE EMBRYO AND FOETUS

Effects after prenatal radiation exposures

RADIOLOGICAL PROTECTION OF PAEDIATRIC PATIENTS

RADIOLOGICAL PROTECTION OF PATIENTS IN

Radiation protection in patients treated with radiation therapy

RADIOLOGICAL PROTECTION OF PATIENTS IN BIOMEDICAL

Radiation protection of patients in biomedical research

INFLUENCE OF STANDARDIZATION IN THE DESIGN AND

Influence of standardization in the design and development of medical

EDUCATION, TRAINING AND CONTINUOUS PROFESSIONAL

Education, training and continuous professional development in the

TOPICS FOR RESEARCH AND DEVELOPMENT IN THE

IMPLEMENTATION OF REGULATIONS FOR THE RADIOLOGICAL

Implementation of regulations for the radiological protection of patients

Round Table 1: Expectations of patients’ advocates . . . . . . . . . . . . . . . . . . . . 403

Chairpersons of Sessions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 461

The International Conference on the Radiological Protection of Patients in

The officers of the conference were as follows:

President: Celia Villalobos Talero, Minister of Health and Consumer Affairs,

Vice-Presidents: Juan M. Kindelán Gómez de Bonilla, President of the Nuclear

Chairperson of the Progamme Committee: F. Mettler, School of Medicine of

Chairperson of the Organizing Committee: R. Ruiz Cruces, University of

Chairperson of the Spanish Scientific Committee: J. Hernández Armas,

Membership of the Programme Committee: C.E. de Almeida, Universidad do

Radiological Sciences, Japan; E. Vañó (Vice-Chairperson), Universidad Complutense

Chairpersons of Technical Sessions and Round Tables: C.G. Standertskjöld-

The topics covered in the conference were:

• Current uses of radiation in medicine

• Radiological protection of patients in general diagnostic radiology

impact of digital techniques)

• Expectations of patients’ advocates

FINDINGS, CONCLUSIONS AND RECOMMENDATIONS

1. Medical practice involving the use of ionizing radiation (hereinafter referred

1 Accidental exposure is referred to in the International Basic Safety Standards for

Findings of the topical sessions

Radiological protection of patients in general diagnostic radiology

4. The conference identified a number of important means of reducing doses to

• appropriate quality control is exercised over the processing of films;

Radiological protection issues in specific uses of diagnostic radiology, such

5. The conference noted that mammography is the procedure in diagnostic radiol-

screen-film mammography, e.g. 2 to 4 times higher or more. In fact, these