Safety Science 62 (2014) 248256

Contents lists available at ScienceDirect

Safety Science
journal homepage: www.elsevier.com/locate/ssci

Human reliability assessment for medical devices based on failure mode

and effects analysis and fuzzy linguistic theory
Qing-Lian Lin a, Duo-Jin Wang a, Wen-Guang Lin b, Hu-Chen Liu c,d,
a

Department of Human Factors Engineering and Product Ergonomics, Technical University Berlin, Sekr. KWT 1, Fasanenstr. 1, Eingang 1, Berlin D-10623, Germany
School of Mechanical and Automotive Engineering, Xiamen University of Technology, 600 Jimei Ligong Road, Xiamen 361024, PR China
c
School of Management, Hefei University of Technology, 193 Tunxi Road, Hefei 230009, PR China
d
Department of Industrial Engineering and Management, Tokyo Institute of Technology, 1-12-1 Oh okayama Meguro-ku, Tokyo 152-8552, Japan
b

a r t i c l e

i n f o

Article history:
Received 21 December 2012
Received in revised form 18 August 2013
Accepted 26 August 2013
Available online 23 September 2013
Keywords:
Human reliability analysis
SHELL
Medical device safety
Failure modes and effects analysis
Fuzzy linguistic

a b s t r a c t
Medical device systems have become increasingly complex, interconnected, and interoperating. A major
challenge is how to ensure and improve the safety, security, and reliability of medical devices. An efcient
human reliability analysis and assessment for medical devices is essential for improving the quality of
medical treatment and preventing an iatric accident. This paper explores qualitative and quantitative
methods to analyze human reliability for medical devices. First, the SHELL (named after the initial letters
of its components names, Software, Hardware, Environment, Live-ware and Central Live-ware) model is
developed to make a qualitative analysis for human reliability of medical devices. The SHELL model is to
consider human as an integrated and inseparable component of the productive system. After that, failure
modes and effects analysis (FMEA) is proposed to evaluate the potential failures in human reliability of
medical devices. Failure mode and effects analysis (FMEA) is a method to assess a system, design, process
or service for possible ways, in which failures (problems, errors, risks and concerns) can occur. The most
important issue of FMEA is the determination of risk factors like the occurrence, severity, and detection
using the opinions of different experts. This paper applies fuzzy linguistic theory to convert the subjective
cognition of experts into an information entity to obtain the numerical values of risk factors. The aim of
this study is to analyze and build an assessment model for human reliability of medical devices to
improve the safety of medical devices.
2013 Elsevier Ltd. All rights reserved.

1. Introduction
Medical devices are special products that are directly related to
patients health and lives. They are associated with adverse events
which result in death or serious injury, or have malfunctions which
could lead to death/serious injury (Cheng et al., 2011). The design
of medical devices has become more intricate. The designers are
more concerned about the efcacy, safety, and reliability. The users
and patients both want the device to operate as specied, perform
in a safe manner, and continue to perform over a long period of
time without failure (Fries, 2012).
In recent years, the reliability of software and hardware equipment has greatly improved, because of the advances in security
measures. But, along with the increasing complexity of equipment
and the increase in the workload of operators, the number of
accidents caused by the unreliability of the operators behavior
has risen. So the risk of use-error is becoming the main factor in
Corresponding author at: School of Management, Hefei University of Technology, 193 Tunxi Road, Hefei 230009, PR China.
E-mail addresses: qinglian.lin@awb.tu-berlin.de (Q.-L. Lin), wg_lin@yahoo.cn
(W.-G. Lin), huchenliu@foxmaill.com, lisalin685@gmail.com (H.-C. Liu).
0925-7535/$ - see front matter 2013 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.ssci.2013.08.022

the equipment risk. According to the report To Err Is Human

which was published by the National Institute of Medicine (IOM),
as many as 98,000 inpatients in the United States die each year because of avoidable medical errors (Kohn et al., 1999). In 1999, the
U.S. Food and Drug Administration (FDA) investigated the reasons
for approximately 130,000 medical incidents from 1984 to 1991
and concluded that human error accounts for 60% of all medical
device-related deaths or injuries (Hoelscher et al., 2006).
In order to study the real causes of medical incidents, the
researchers stressed controlling various factors which cause risk
from the design, production and use of medical devices. The standards for medical devices risk management ISO 14971, 2000,
which was issued by the International Standards Association, provides the process and methods of use risk analysis and evaluation
for medical devices (ISO 14971, 2000). In Europe, IEC 60601-1-6
stipulates that the usability engineering must be implemented in
the development process of the medical devices, and the design
principles of humanmachine interface must be followed to ensure
reasonable and reliable design (IEC 60601-1-6, 2004).
Human factor problems are frequently encountered in medical
devices and design-induced errors, in that the use of such devices
can result in patient injuries and deaths (Dhillon, 2003). Cooper

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Q.-L. Lin et al. / Safety Science 62 (2014) 248256

et al. (2006) proposed a human reliability-centered approach to the

development of job aid for reviewers of medical devices, and concluded that an improved understanding of human error, its causes
and contexts, and human reliability analysis is important in the
risk assessment of medical devices.
Human reliability assessment (HRA) is the common name for an
assessment of methods and models that are used to predict the
occurrence of human errors (Hollnagel, 2005). HRA has been
used in high-risk industries (nuclear, aerospace, etc.) to prevent
accidents, the consequences of which would be catastrophic
(Cuschieri, 2000). Moraru et al. (2010) developed and applied
HRA model for mine dispatchers and analyzed the importance of
HRA in system safety. They concluded that human reliability
assessment resulted, primary, from the necessity to reduce the risk
of high-technology production systems.
Failure modes and effects analysis is a risk assessment tool that
mitigates potential failure in system, design, process or service. It is
widely used to dene, identify and eliminate known and potential
failures, problems, and errors (Liu et al., 2011). FMEA has been
used as a powerful tool for safety and reliability analysis of products and processes in a wide range of aerospace, nuclear and automotive industries (Sankar and Prabhu, 2001; Wang et al., 2009). In
recent years, there has been more research about FMEA application
in the healthcare system (Nichols et al., 2004; Capunzo et al.,
2004). Liu et al. (2012) proposed a fuzzy FMEA based on fuzzy
set theory and VIKOR to assess the risk of the general anesthesia
process. Reichert (2004) used FMEA in healthcare, and described
the FMEA project process. Wetterneck et al. (2004) described the
method and challenges of performing a process and design FMEA
to prepare for the implementation of a new intravenous infusion
pump, and they made recommendations for the performance of a
process and design FMEA for new technology implementation in
healthcare organizations. Reiling et al. (2003) used FMEA to create
a replacement facility aimed at reducing errors and promoting patient safety and satisfaction. FMEA is a valuable tool in designing a
healthcare facility that focuses on patient safety, and it will also result in increased architect, owner and contractor awareness.
The research is based on FMEA and fuzzy linguistic to propose
human reliability assessment for medical devices to improve the
quality and safety. This paper is organized as follows: the human
reliability analysis tool, the SHELL model, is introduced in Section 2.
The human reliability assessment model based on FMEA and fuzzy
linguistic is presented in Section 3. A case study is introduced in
Section 4, followed by the conclusion and discussion.

2. Human reliability analysis

Human reliability analysis identies the errors and weaknesses
in the system by examining the systems of work, including those
who work in the system (Lyons et al., 2004). It has been dened
as the application of relevant information about human characteristics and behavior to the design of objects, facilities, and environments that people use (Grandjean, 1980). There is a large number
of methods to analyze human reliability. Here we introduce the
SHELL model.
The SHELL model, introduced by Edwards (1972) and then
developed by Hawkins (1987), describes the behavior of an interactive system with special regard to human factors issues. SHELL
considers humans as an integrated and inseparable component of
the productive system. It emphasizes the interfaces between a person (Center Live-ware) and the other four components, rather than
the components themselves (Reinhart, 1996).
The elements of the SHELL model (Fig. 1) are introduced as follows (Hawkins, 1987):
 Hardware represents any physical and non-human component of the system, such as equipment, vehicles, tools, manuals, signs.
 Software represents all non-physical resources, for
organic operation, like organizational policies/rules, procedures, manuals and placards.
 Environment represents not only the factors which inuence the location where people are working, such as climate, temperature, vibration and noise, but also social
political and economic factors.
 Live-ware represents factors like teamwork, communication, leadership and norms.
 Central Live-ware is regarded as the core of the SHELL
model and other components match with the Live-ware
as the central gure.
The interaction between the Central Live-ware and Hardware
(LH System) is usually named as a manmachine system. Hawkins (1987) argued that the design of controls and displays, which
is subject to the LH interaction, should be matched with human
characteristics in order to minimize the possibility of LH error
occurrences. The second interface is represented as the interaction
between the Central Live-ware and Software. As the Software indicates intangible objects rather than those of the Hardware, it is

Hardware:
Equipment
Tools
Manuals

Environment
Climate
Temperature
Noise

Central Live-ware

Live-ware
Operator
Team
Management

Fig. 1. The SHELL model.

Software:
Norms
Procedures
Practices

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Q.-L. Lin et al. / Safety Science 62 (2014) 248256

Occurrence

Construction
assessment
group

Determine
potential
failure modes,
causes, and
effects

Calculate
RPN

Severity

Human
reliability
assessment

Detection

Based on
SHELL

Rating
scale

Weights

Fuzzy
linguistic

Fig. 2. The structure of the proposed method.

more difcult to solve than the LH interaction. The third interface

is between the Central Live-ware and Environment. Hawkins
(1987) emphasized three environmental factors, noise, heat and
vibration, which can result in the error of LE interaction. The last
interface is between the Central Live-ware and Live-ware. This LL
interface is also related to leadership, cooperation and personality
interaction and human factors. Experts have ascertained that the
problems of LL interaction, such as errors within team-work, have
caused a great deal of accidents (URL1).
3. Human reliability assessment model
In this paper, a human reliability assessment model has been
proposed to analyze the human reliability of medical devices,
based on failure modes and effects analysis (FMEA) and fuzzy linguistic theory. FMEA is a powerful tool for safety and reliability
analysis of products and processes in a wide range of industries,
particularly the aerospace, nuclear and automotive industries
(Braglia, 2000; Liu et al., 2011). Fig. 2 illustrates the steps of the
proposed method to assess the human reliability of medical
devices.
The steps of the proposed methodology are given as follows:
Step 1. Construct assessment group: The occurrence, severity and
detection values are based on the expertise of the constructed
group. Therefore, the group must include experts from a wide variety of expertise. Since each expert has a different inuence on the
results, the weights of the experts must be determined. Using the
100-points moderator to dene the expertise of the experts, the
weights of experts are calculated by Cebi and Kahraman (2010).

Pei
W ei Pz

i1 P ei

; i 1; 2; 3; . . . ; z

where ei and P symbolize ith expert and expertise point,

respectively.
Step 2. Analyze and determine potential failure modes: In this step,
the SHELL model is used to analyze the human reliability for medical devices and identify what could go wrong. The causes and effects of failures, and those control processes are determined by
using surveys, literature and focus groups.
Step 3. Determine the probability of occurrence (O), severity (S),
and detection rating (D): The O, S, and D can be evaluated using
the 10-point scale described in Tables 13 (Reichert, 2004). Based
on the rating scale, the experts give their opinions of the OSD value
of each failure mode.
The three risk factors (O, S and D) are difcult to precisely determine precisely. In this paper, they are expressed in a linguistic way.
The risk factors are evaluated by experts by using the linguistic
scale given in Fig. 3. The linguistic scale is used for the evaluation,
since people usually use linguistic terms to dene their logical
judgments (Olcer and Odabasi, 2005). The intangible linguistic
terms are dened as very low (VL), low (L), moderate (M), high
(H), very high (VH). The corresponding fuzzy numbers of the ve
linguistic scale are (0, 0, 1.5), (1, 2.5, 4), (3.5, 5, 6.5), (6, 7.5, 9),
(8.5, 10, 10) (Lin et al., 2012).
To weight the importance of each failure mode, it is adapted
with a ve-scale fuzzy linguistic: absolutely unimportant (AU),
unimportant (U), moderately important (MI), important (I), and
very important (VI) (Fig. 4), where the corresponding fuzzy numbers are (0, 0, 0.15), (0.1, 0.25, 0.4), (0.35, 0.5, 0.65), (0.6, 0.75,
0.9), (0.85, 1, 1), respectively (Lin et al., 2012).
m
m
Let Om
jk , Sjk and Djk be the occurrence, severity and detection values. They are evaluated by expert m for interface j and failure mode
m
k, and the membership function of triangular fuzzy number Om
jk ; Sjk
m
and Dm
2
T.
Let
W
be
the
weight
of
importance
which
evaluated
jk
jk

Table 1
Occurrence rating scale.
Rating

Description

Potential failure rate

10
9
8/7
6/5
4/3
2
1

Certain probability of occurrence

Failure is almost inevitable
Very high probability of occurrence
Moderately high probability of occurrence
Moderate probability of occurrence
Low probability of occurrence
Remote probability of occurrence

Failure
Failure
Failure
Failure
Failure
Failure
Failure

occurs at least once a day, or, failure occurs almost every time
occurs predictably, or, failure occurs every 3 or 4 days
occurs frequently, or failure occurs about once per week
occurs about once per month
occurs occasionally, or failure occurs once every 3 months
occurs rarely, or failure occurs about once per year
almost never occurs; no one remembers the last failure

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Table 2
Severity rating scale.
Rating

Description

Denition

10

Extremely
dangerous
Very dangerous
Dangerous

Failure could cause death of a customer or total system breakdown, without any prior warning

9/8
7
6/5
4/3
2

Moderate danger
Low to moderate
danger
Slight danger

No danger

Failure could cause major or permanent or serious system disruption with interruption in service, with prior warning
Failure causes minor to moderate injury with a high degree of customer dissatisfaction or major system problems requiring major
repairs or signicant re-work
Failure causes minor injury with some customer dissatisfaction or major system problems
Failure causes very minor or no injury but annoys customers or results in minor system problems that can be overcome with minor
modications to the system or process
Failure causes no injury and customer is unaware of problem; however, the potential for minor injury exists; little or no effect on
system.
Failure causes no injury and has no impact on system

Table 3
Detection rating scale.
Rating

Description

Denition

10
9/8
7/6
5
4/3
2
1

No chance of detection
Very remote/unreliable
Remote
Moderate chance of detection
High
Very high
Almost certain

There is no known mechanism for detecting the failure

The failure can be detected only with thorough inspection and this is not feasible or cannot be readily done
The error can be detected with manual inspection but no process is in place, so that detection is left to chance
There is a process for double-checks or inspection, but it is not automated or is applied only to a sample or relies on vigilance
There is 100% inspection or review of the process, but it is not automated
There is 100% inspection of the process, and it is automated
There is automatic shut-offs or constraints that prevent failure

Membership
values

Low

Very Low

Moderate

High

Very High

1.0

Performance

10

Fig. 3. Fuzzy linguistic values of performance.

by respondent m for interface j and failure mode k, and the membership function of triangular fuzzy number W m
jk 2 S.

Ojk O1jk  W e1 O2jk  W e2    Om

jk  W em

m
m
m
m
Om
jk LOjk ; MOjk ; UOjk ; Ojk 2 T;

Sjk S1jk  W e1 S2jk  W e2    Sm

jk  W em

Djk D1jk  W e1 D2jk  W e2    Dm

jk  W em

W jk W 1jk  W e1 W 2jk  W e2    W m
jk  W em

6
Sm
jk

UOm
jk

m
where 0 6 LOm
jk 6 MOjk

6 10

m
m
LSm
jk ; MSjk ; USjk ;

USm
jk

2
Sm
jk

2 T;

where 0 6

LSm
jk

MSm
jk

6 10

m
m
m
m
m
m
Dm
jk LDjk ; MDjk ; UDjk ; Djk 2 T; where 0 6 LDjk 6 MDjk

6 UDm
jk 6 10

m
m
m
m
m
m
Wm
jk LW jk ; MW jk ; UW jk ; W jk 2 S; where 0 6 LW jk 6 MW jk

6 UW m
jk 6 1

Eqs. (2)(5) are used to aggregate the expert opinions of the

occurrence, severity and detection values and importance for each
failure mode.

where Ojk , Sjk , and Djk , are occurrence, severity and detection values
of expert opinion for interface j and failure mode k, W jk is importance evaluated by expert for interface j and failure mode kj, and
Wei is the ith expert weight and m is the number of expert,
respectively.
This study adopts FMEA with fuzzy linguistic theory to evaluate
human reliability for medical devices. Since the output of the fuzzy
system is a fuzzy set, the defuzzication procedure is used to convert the fuzzy result into a numerical value in order to represent
the human reliability of medical devices. Braae and Rutherford
(1978), Runkler and Glesner (1993) compared the Mean-of-maxi-

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Q.-L. Lin et al. / Safety Science 62 (2014) 248256

Membership
values

Very
Unimportant

Unimportant

Medium

Very
Important

Important

1.0

Important

0.2

0.6

0.4

0.8

Fig. 4. Fuzzy linguistic values of importance.

mum (MOM) defuzzication and center-of-area (COA) defuzzication methods and concluded that COA yields better results than
MOM (Wu et al., 2010). The COA is a simple and practical method
to defuzzicate the value and the importance of occurrence, severity and detection. Eqs. (10)(13) show the values of fuzzy occurrence, severity and detection and fuzzy weight of importance of
each failure mode, respectively.

DOi

UOi  LOi MOi  LOi 

LOi 8i
3

10

DSi

USi  LSi MSi  LSi 

LSi 8i
3

11

DDi

UDi  LDi MDi  LDi 

LDi 8i
3

12

DW i

UW i  LW i MW i  LW i 
LW i 8i
3

13

Finally, the RPND is calculated with DOi, DSi, DDi, and DWi.

RPND DOi  DSi  DDi  DW i

14

Step 4. Calculate RPN Score: The risk priority number (RPN) is the
product of the occurrence (O), severity (S), and detection (D) of a
failure.

RPN O  S  D

15

where O and S symbolize the frequency and effects of the failure, D

symbolizes the ability to detect the failure before it reaches the customer, respectively.
Step 5. Calculate the total RPN Score for each sub-system: Calculate the total RPN scores for the failure modes of each sub-system
to compare the sub-system risk.

RPNk

m
X
RPNkj ;

j 1; 2; . . . ; m

16

j1

where RPNk is the total RPN score of kth sub-system, RPNkj presents
the RPN score of jth failure mode in kth sub-system, and j symbolizes the number of failure modes in the sub-system, respectively.
Step 6. Output: After step 5, we can nd out which sub-system
has the highest RPN score. The failure modes with higher RPN score
are assumed to be more important and will be given higher priorities for correction.

Table 4
Experts weights.
Experts

E1

E2

E3

E4

E5

Weights

0.1

0.15

0.2

0.3

0.25

4. Case study
The application of the human reliability assessment method
was undertaken for a medical device in a medical devices design
company. The application steps of the human reliability assessment methods are given in this section.
Step 1. Construct assessment group: The human reliability assessment group was constructed from multidisciplinary experts, which
includes designers, users of medical devices, and human reliability
researchers. There are ve experts in the assessment group, one is
a researcher, two are designer experts, and two are users. The
weights of each expert (as shown in Table 4) are assigned based
on the experts individual background and calculated by using
Eq. (1).
Step 2. Analyze and determine potential failure modes: According
to the introduction of the SHELL model, the four interfaces of the
human reliability of medical devices SHELL model are dened.
The users of medical devices are the most important part in the
medical device design. They operate the devices directly. So the
users of the medical devices are dened as the Central Live-ware.
Following the review of literature and multidisciplinary experts,
we got the failures of the four interfaces: LH, LS, LE and LL.
The SHELL model for human reliability of medical devices is given
in Fig. 5. In the LH sub-system, we must consider the interface,
instruments and work space components. In the LS sub-system,
we consider the training, organizational rules and procedures. In
the LE sub-system, we study the thermal environment, acoustic
environment, luminous environment, and environment pressure
components. In the LL sub-system, we consider the leadership,
communication and cooperation components. Based on these components, we analyze the potential failure modes of each
component.
The potential failure modes are determined by the SHELL model. After analysis of the four sub-systems, LH, LS, LE, and LL,
we found the failure modes of each sub-system, as Fig. 6 shows.
There are seven failure modes in the LH sub-system, ve failure

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Q.-L. Lin et al. / Safety Science 62 (2014) 248256

Standard

Identify

Consistency

Space size

Interface size

Thermal
environment

Information display

Interface

Low
temperature

Instrument

Work space

High
temperature

Information capacity

Operation
training

Hardware

Training

Thermal
radiation
Environment

Acoustic
environment

Noise

Central Live-ware

Knowledge
training

Software

Organizational
rules

Live-ware

Planning

Luminous
environment

Too bright

Environment
pressure

Leadership

Communication

Cooperation

Too dark

Allocation
Procedures
Work flow

Too many
related person
Leadership
challenge

Communication
between
operators and
designers

Communication
among operators

Individual
different

Cognitive
difference

Fig. 5. The SHELL model for human reliability of medical devices.

modes in the LS sub-system, six failure modes in the LE sub-system, and ve failure modes in the LL sub-system.
Step 3. Determine the probability of occurrence (O), severity (S),
and detection rating (D): The fuzzy numbers of the ve linguistic
scales for O, S, and D values are VL, L, M, H, and VH. The weight
of importance of each failure mode fuzzy linguistic are AU, U, M,
I, and VI. The ve experts give their O, S, and D fuzzy evaluation
for each failure mode according to their own understanding. Based
on the experts opinions, the O, S, and D values of failure modes and

the weight of importance of each failure mode are shown in Tables

5 and 6.
According to Eqs. (6)(14), we can get the RPND value of each
failure mode (Table 7)
Step 4. Calculate RPN Score and the total RPN Score for each subsystem: Based on Eq. (16), we can get the total RPN score of LH,
LS, LE, and LL system (Table 8).
Step 5. Output: From Table 8, it was discovered that, the highest
RPN score is the LL system. The LL system is the most important

Human reliability of medical devices

L-H

Interface

L-S

Work
space

Instrument

Training

Organizational
rules

L-E

Procedures

Thermal
environment

L-L

Acoustic
environment

Luminous
environment

Environment
pressure

Communication

Cooperation

Cognitive problem

Individual problem

Communication
problem among
operators

Communication
problem between
designer and operators

Low leadership

Too many related

person

Too dark

Too bright

Noise

Radiation

Too cold

Too hot

Non-standard work
flow

Unsuitable allocation

Lack knowledge
planning

Lack knowledge
training

Lack operation
training

Wrong space size

Non-consistency

Non-identity

Non-standard

Wrong information
capacity

Wrong information
display

Wrong size

Fig. 6. The failure modes of human reliability for medical devices.

Leadership

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Q.-L. Lin et al. / Safety Science 62 (2014) 248256

Table 5
The OSD value of each failure mode.
Sub-system

Expert

E1 (0.1)

E2 (0.15)

E3 (0.2)

E4 (0.3)

E5 (0.25)

Value

LH

M11
M12
M13
M14
M15
M16
M17

L
M
M
M
M
H
M

M
H
H
H
M
H
M

L
M
L
M
M
M
VH

L
M
M
M
M
M
M

M
H
H
H
M
H
M

L
L
L
M
M
L
H

L
M
M
M
M
M
M

H
M
H
H
M
M
M

L
L
L
M
L
L
H

L
M
M
M
L
M
L

M
M
M
H
M
M
M

VL
M
L
M
M
L
H

M
M
M
M
L
H
L

M
M
M
H
M
M
M

L
L
L
M
M
L
H

LS

M21
M22
M23
M24
M25

M
M
M
M
H

H
M
H
H
H

L
H
M
M
M

M
H
M
M
H

H
M
H
H
H

M
M
M
M
M

M
H
L
L
H

H
H
H
H
H

M
M
M
M
M

M
H
M
M
H

H
M
M
M
H

M
M
M
M
M

M
H
M
M
VH

H
H
M
M
M

L
M
M
M
M

LE

M31
M32
M33
M34
M35
M36
M37

M
M
M
M
M
M
L

M
M
M
M
M
M
M

L
L
H
L
L
L
L

L
L
M
M
M
M
L

M
M
M
M
M
M
L

L
L
M
L
VL
L
L

M
M
M
M
M
L
M

M
M
H
M
M
M
L

L
L
H
L
L
L
M

M
M
M
M
M
M
L

M
M
M
M
M
M
M

L
L
M
L
L
L
M

M
L
M
M
M
L
H

L
M
M
M
M
M
L

M
L
H
L
L
L
M

LL

M41
M42
M43
M44
M45

H
M
M
H
M

H
M
M
H
H

H
M
M
M
M

H
M
M
H
M

H
H
M
H
H

H
M
M
M
M

H
M
M
H
M

M
M
M
H
H

H
M
L
M
M

H
M
M
H
M

M
M
M
H
H

H
M
M
M
M

H
M
M
M
M

M
M
M
H
H

H
H
M
H
M

Table 6
The weight of importance of each failure mode.

Table 7
The PRND value of each failure mode.

Sub-system

Expert

E1 (0.1)

E2 (0.15)

E3 (0.2)

E4 (0.3)

E5 (0.25)

LH

M11
M12
M13
M14
M15
M16
M17

M
VI
I
I
M
I
I

M
I
I
M
M
I
M

I
VI
M
I
I
M
I

U
I
I
I
U
M
I

I
VI
M
I
I
I
I

M21
M22
M23
M24
M25

VI
I
M
M
U

VI
I
U
M
U

I
M
M
M
M

VI
I
M
I
U

VI
I
I
M
U

M31
M32
M33
M34
M35
M36
M37

M
M
I
U
M
M
M

M
I
I
U
M
M
M

I
M
M
U
I
I
M

U
M
I
M
M
M
M

M
M
I
M
I
I
M

M41
M42
M43
M44
M45

M
VI
I
M
I

M
VI
I
U
I

I
I
M
M
I

M
VI
I
M
M

I
I
I
I
I

LS

LE

LL

system in human reliability analysis for medical devices. So the designer must pay more attention to the LL system (Leadership,
Communication and Cooperation) and develop an action plan.

5. Results and discussion

The human reliability assessment model, introduced in this
study, is based on the SHELL method to analyze the potential failures in the four interfaces systems (LH, LS, LE, and LL), and
using FMEA and fuzzy linguistic theory to calculate the risk priority
number (RPN) for each interface system.

Subsystem

Failure mode

RPND

LH

Wrong interface size

Wrong information display
Wrong information capacity
Non-standard
Non-identity
Non-consistency
Wrong space size

17.55273
84.65625
48.80859
133.5938
43.83984
56.79932
99.43828

LS

Lack operation training

Lack knowledge training
Unsuitable planning
Unsuitable allocation
Non-standard work ow

140.7656
163.193
72.35156
79.24219
82.5

LE

Too hot
Too cold
Radiation
Noise
Too bright
Too dark
Too many related person

30.0354
26.875
122.7188
24.21875
33.6875
29.66797
32.539

LL

Low leadership
Communication problem between designer and
operator
Communication problem among operators
Individual problem
Cognitive problem

193.7988
130.0078
78.75
152.2705
126.5625

As a result of this study, we learn that the most important interface system on the human reliability of medical devices is the LL
system, i.e. the interaction between the Live-ware and Central
Live-ware. The problems in the LL system (Leadership, Communication, and Cooperation) could cause a great number of accidents.
The medical devices designer must analyze the LL system in
greater detail. The leadership, communication, and cooperation
in the LL system are complicated to analyze. It requires a multidisciplinary approach for a fully comprehensive analysis. The next
step following this research is to focus on the application of the

Q.-L. Lin et al. / Safety Science 62 (2014) 248256

Table 8
The total RPN score of each sub-system.
Sub-systems

LH

LS

LE

LL

RPN score

484.69

538.05

299.739

681.39

multidisciplinary approach to the analysis of the LL system of

medical devices.
From the study, we also found out that the least two important systems are LE and LH. In the last two decades, there has been research
to consider the reliability prediction, related to the hardware and
environment, and to medical systems at the design and development
stage (Fries, 2012; Dhillon, 2000). Hence, the RPN scores of LH and L
E are lower in the human reliability assessment of medical devices.
Failures in products can be classied into two broad categories:
soft and hard failures. Currently, designers are focused on the hard
failures of the medical devices. Hard failures are easy to notice as
soon as they occur. They inuence directly the functioning of the
device or they are self-announcing. However, the soft failures are
minor defects that have little inuence on the functioning of a device. Therefore, there is a time delay between the occurrence of a
soft failure and its detection (Taghipour et al., 2010). The human
reliability analysis is concerned with analyzing the soft failures
of products. Medical devices are used to diagnose, prevent, or treat
disease. They have great inuence on a patients life. Therefore,
there is an urgent need to analyze the human reliability in medical
devices design.

6. Conclusion
Human reliability assessment (HRA) involves the use of qualitative and quantitative methods to assess the human contribution to
risk. A great number of tools are used for HRA. Such as the second
generation HRA methods like ATHEANA has been developed to
evaluate the probability of a human error occurring throughout
the completion of specic task (NUREG, 2000). But most of the
tools fail to consider such things as the impact of context, organizational factors and errors of commission (Bell and Holroyd, 2009).
As a result, known potential failures are difcult to identify in HRA
research. Failure mode and effects analysis are tools for evaluating
a system, design, process or service for possible ways in which failures can occur. It is a structured approach that starts with known
potential failure modes at one level, and investigates the effects at
the next level. After that, a complete analysis is obtained of the system spanning all levels. Therefore, FMEA is a suitable approach to
solve difculties in HRA research.
The design of medical devices has become more complex. It requires greater efcacy, safety, and reliability. A human reliability
assessment model has been developed for this purpose in this paper. The strengths of the developed model are:
 The use of the SHELL model to analyze the human reliability of medical devices from four interface systems, LH, L
S, LE, and LL. This provides a comprehensive analysis.
 The FMEA is a bottom-up approach to analyze the failure
modes in a system. It can look at the whole system for
potential failure modes of the system.
 In the FMEA procedure, the RPN value is based on experts
fuzzy linguistic evaluation. As the human reliability
assessment of medical devices involves many qualitative
assessment factors, there is not sufcient data for the
qualitative factors. Hence, the experts fuzzy judgement,
based on their professional knowledge, is a more efcient
method.

255

For future studies, the following topics can be considered: (i)

the relative importance of failure modes in each sub-system when
calculating the RPN score; (ii) to generalize, the failure modes of
medical devices must be determined after the application of the
model in a different medical devices design; and (iii) social and culture factors should be considered for the users of medical devices
within different areas.

Acknowledgments
The writers of this thesis would like to thank the authors of all
references mentioned. Their work has contributed greatly to the
completion of this thesis. The authors also wish to thank the editor
and reviewers for their constructive suggestions.

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