Biomedical Engineering Reference
In-Depth Information
Study of pulmonary fluid dynamics
Study of biomechanics of the human body
Development of material to be used as replacement for human skin
The preceding list is not intended to be all-inclusive. Many other applications use the
talents and skills of the biomedical engineer. In fact, the list of activities of biomedical
engineers depends on the medical environment in which they work. This is especially
true for the clinical engineers—biomedical engineers employed in hospitals or clinical
settings. Clinical engineers are essentially responsible for all the high-technology instru-
ments and systems used in hospitals today, the training of medical personnel in equip-
ment safety, and the design, selection, and use of technology to deliver safe and effective
health care.
Engineers were first encouraged to enter the clinical scene during the late 1960s in
response to concerns about electrical safety of hospital patients. This safety scare reached
its peak when consumer activists, most notably Ralph Nader, claimed, “At the very least,
1,200 Americans are electrocuted annually during routine diagnostic and therapeutic proce-
dures in hospitals.” This concern was based primarily on the supposition that catheterized
patients with a low-resistance conducting pathway from outside the body into blood
vessels near the heart could be electrocuted by voltage differences well below the normal
level of sensation. Despite the lack of statistical evidence to substantiate these claims, this
outcry served to raise the level of consciousness of health care professionals with respect
to the safe use of medical devices.
In response to this concern, a new industry—hospital electrical safety—arose almost
overnight. Organizations such as the National Fire Protection Association (NFPA) wrote
standards addressing electrical safety specifically for hospitals. Electrical safety analyzer
manufacturers and equipment safety consultants became eager to serve the needs of vari-
ous hospitals that wanted to provide a “safety fix” and of some companies, particularly
those specializing in power distribution systems (most notably isolation transformers). To
alleviate these fears, the Joint Commission on the Accreditation of Healthcare Organizations
(then known as the Joint Commission on Accreditation of Hospitals) turned to NFPA codes
as the standard for electrical safety and further specified that hospitals must inspect all
equipment used on or near a patient for electrical safety at least every six months. To meet
this new requirement, hospital administrators considered a number of options, including
(1) paying medical device manufacturers to perform these electrical safety inspections,
(2) contracting for the services of shared-services organizations, or (3) providing these
services with in-house staff. When faced with this decision, most large hospitals opted
for in-house service and created whole departments to provide the technological support
necessary to address these electrical safety concerns.
As a result, a new engineering discipline—clinical engineering—was born. Many hospitals
established centralized clinical engineering departments. Once these departments were in
place, however, it soon became obvious that electrical safety failures represented only a small
part of the overall problem posed by the presence of medical equipment in the clinical envi-
ronment. At the time, this equipment was neither totally understood nor properly main-
tained. Simple visual inspections often revealed broken knobs, frayed wires, and even
evidence of liquid spills. Many devices did not perform in accordance with manufacturers'
