biomedical engineeringasgnmt

8/6/2019 biomedical engineeringasgnmt

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Disciplines within Biomedical Engineering

Clinical engineering

Clinical engineering is a branch of biomedical engineering for professionalsresponsible 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 preventivemaintenance 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,


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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, poweredwheelchairs, 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 themost 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


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[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 andbiological 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 EuropeanUnion. 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.


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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.

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