Disciplines within Biomedical Engineering

Clinical engineering

Clinical engineering is a branch of biomedical engineering for professionals

responsible for the management of medical equipment in a hospital. The tasks of a
clinical engineer are typically the acquisition and management of medical device
inventory, supervising biomedical engineering technicians (BMETs), ensuring that
safety and regulatory issues are taken into consideration and serving as a
technological consultant for any issues in a hospital where medical devices are
concerned. Clinical engineers work closely with the IT department and medical
physicists.

A typical biomedical engineering department does the corrective and preventive

maintenance on the medical devices used by the hospital, except for those covered
by a warantee or maintenance agreement with an external company. All newly
acquired equipment is also fully tested. That is, every line of software is executed,
or every possible setting is exercised and verified. Most devices are intentionally
simplified in some way to make the testing process less expensive, yet accurate.
Many biomedical devices need to be sterilized. This creates a unique set of
problems, since most sterilization techniques can cause damage to machinery and
materials. Most medical devices are either inherently safe, or have added devices
and systems so that they can sense their failure and shut down into an unusable,
thus very safe state. A typical, basic requirement is that no single failure should
cause the therapy to become unsafe at any point during its life-cycle. See safety
engineering for a discussion of the procedures used to design safe systems.

Medical devices

A medical device is intended for use in:

the diagnosis of disease or other conditions, or

in the cure, mitigation, treatment, or prevention of disease,

intended to affect the structure or any function of the body of man or other animals,
and which does not achieve any of its primary intended purposes through chemical
action and which is not dependent upon being metabolized for the achievement of
any of its primary intended purposes.

Some examples include pacemakers, infusion pumps, the heart-lung machine,

dialysis machines, artificial organs, implants, artificial limbs, corrective lenses,
cochlear implants, ocular prosthetics, facial prosthetics, somato prosthetics, and
dental implants.

Medical devices can be regulated and classified (in the US) as shown below:

Class I devices present minimal potential for harm to the user and are often simpler
in design than Class II or Class III devices. Devices in this category include tongue
depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical
instruments and other similar types of common equipment.

Class II devices are subject to special controls in addition to the general controls of
Class I devices. Special controls may include special labelling requirements,
mandatory performance standards, and post market surveillance. Devices in this
class are typically non-invasive and include x-ray machines, PACS, powered
wheelchairs, infusion pumps, and surgical drapes.

Class III devices require premarket approval, a scientific review to ensure the
device's safety and effectiveness, in addition to the general controls of Class I.
Examples include replacement heart valves, silicone gel-filled breast implants,
implanted cerebellar simulators, implantable pacemaker pulse generators and
endosseous (intra-bone) implants.

Medical Imaging

Imaging technologies are often essential to medical diagnosis, and are typically the
most complex equipment found in a hospital including:

Fluoroscopy

Magnetic resonance imaging (MRI)

Nuclear Medicine

Positron Emission Tomography (PET) PET scansPET-CT scans

Projection Radiography such as X-rays and CT scans

Tomography

Ultrasound

Electron Microscopy
[edit] Tissue engineering

One of the goals of tissue engineering is to create artificial organs for patients that
need organ transplants. Biomedical engineers are currently researching methods of
creating such organs. In one case bladders have been grown in lab and transplanted
successfully into patients[1]. Bioartificial organs, which utilize both synthetic and
biological components, are also a focus area in research, such as with hepatic assist
devices that utilize liver cells within an artificial bioreactor construct[2].

[edit] Regulatory Issues

Regulatory issues are never far from the mind of a biomedical engineer. To satisfy
safety regulations, most biomedical systems must have documentation to show that
they were managed, designed, built, tested, delivered, and used according to a
planned, approved process. This is thought to increase the quality and safety of
diagnostics and therapies by reducing the likelihood that needed steps can be
accidentally omitted again.

In the United States, biomedical engineers may operate under two different
regulatory frameworks. Clinical devices and technologies are generally governed by
the Food and Drug Administration (FDA) in a similar fashion to pharmaceuticals.
Biomedical engineers may also develop devices and technologies for consumer use,
such as physical therapy devices, which may be governed by the Consumer Product
Safety Commission. See US FDA 510(k) documentation process for the US
government registry of biomedical devices.

Other countries typically have their own mechanisms for regulation. In Europe, for
example, the actual decision about whether a device is suitable is made by the
prescribing doctor, and the regulations are to assure that the device operates as
expected. Thus in Europe, the governments license certifying agencies, which are
for-profit. Technical committees of leading engineers write recommendations which
incorporate public comments and are adopted as regulations by the European
Union. These recommendations vary by the type of device, and specify tests for
safety and efficacy. Once a prototype has passed the tests at a certification lab, and
that model is being constructed under the control of a certified quality system, the
device is entitled to bear a CE mark, indicating that the device is believed to be safe
and reliable when used as directed.
The different regulatory arrangements sometimes result in technologies being
developed first for either the U.S. or in Europe depending on the more favourable
form of regulation. Most safety-certification systems give equivalent results when
applied diligently. Frequently, once one such system is satisfied, satisfying the other
requires only paperwork.

Training

Biomedical engineers combine sound knowledge of engineering and biological

science, and therefore tend to have a bachelors of science and advanced degrees
from major universities, who are now improving their biomedical engineering
curriculum because interest in the field is increasing. Many colleges of engineering
now have a biomedical engineering program or department from the undergraduate
to the doctoral level. Traditionally, biomedical engineering has been an
interdisciplinary field to specialize in after completing an undergraduate degree in a
more traditional discipline of engineering or science, the reason for this being the
requirement for biomedical engineers to be equally knowledgeable in engineering
and the biological sciences. However, undergraduate programs of study combining
these two fields of knowledge are becoming more widespread. As such, many
students also pursue an undergraduate degree in biomedical engineering as a
foundation for a continuing education in medical school.