Biomedical Engineering Reference
In-Depth Information
By describing clinical engineering experiences in this
chapter, the authors provide practicing and prospective
CEs with a window into the clinical environment,
showing ways in which CEs can help the hospital and
patients and can advance health care. Engineers are never
satisfied with the status quo. They constantly explore
various solutions to a problem, seeking the optimal
outcome.
The following anecdote captures the sense of the
engineer's fervent desire to seek engineering solutions to
a problem. A long time ago, three folks were about to lose
their heads on the guillotine. The first to go, a peasant,
was asked by the executioner whether he wanted to have
his head cut off while facing the sky, or downwards. He
chose to look downwards. The blade was released but
stopped just short of his head. Everyone took it as
a miracle, and the peasant, to his extreme joy, was par-
doned of his crime and was set free. The same thing
happened to the second person, a lawyer, who chose to
face the sky. The last person, an engineer, also choosing to
face the sky, saw a knot in the rope and, just before the
guillotine was released, cried out, ''Hold everything
the CE to facilitate communication among medical,
nonmedical, and technical people. In addition to a work-
ing knowledge of the engineering process and specifica-
tions, the CE must be able to translate this information to
such diverse professionals as doctors, nurses, financial
managers, administrators, and technicians. At the same
time, the CE needs to be able to transmit the clients'
feedback on a medical product to the manufacturer in
a constructive fashion in order to resolve product prob-
lems in a timely fashion. Such feedback often results in
product improvements as well.
Ensuring medical device safety
by clinical engineering
Various tools are available to the CE in the hospital set-
ting to ensure the safety of medical devices. These tools,
tried and tested by the authors, are listed below.
Equipment selection and evaluations
d
I
see the problem!''
CEs conduct short equipment evaluations in-house to
provide an educated estimation of the product's useful-
ness, safety, and effectiveness. The focus at this stage is
on the product's suitability as a hospital standard. Such
factors that must be considered include the manu-
facturer's financial health, which could determine
whether the company will even exist in 10 years to
support its products, and the product's record of
performance.
The manufacturer's financial health can be assessed by
analyzing information gleaned from annual reports, the
Internet, and information services such as ECRI and the
MDE Group. Purchasing and finance departments, by
the nature of work that they do, are excellent resources.
A product or a technology's track record, i.e., perfor-
mance history, can be assessed through various sources,
like interviewing user hospitals (vendors should be able
to provide you with a list of hospitals and specific de-
partments using their products), researching websites
such as the FDA's Manufacturers And User Device Ex-
perience (MAUDE) database at www.fda.gov/, and ECRI
at
www.ecri.org
.
Hospital technology management requires the moni-
toring of the life cycles of medical devices and systems
(see Chapter 5.3). Systems comprise not merely the
device, but also the support group of equipment and
services that ensure its proper functioning and the
competency of the user group. As a device approaches
the end of its rated life expectancy, or if it has required
inordinately high maintenance, this information must be
conveyed to the user group. However, as experience
shows, through constant communication, the clients
Design and modification of medical
devices in the hospital
CEs thrive on change. They must, because medical
technology is constantly evolving and changing. What
seems to work well today could be superseded by
something better tomorrow. Keeping up with the tech-
nology, and managing current and future needs are two
services that CEs can provide adequately. This goes well
with the hospital's goals of customer satisfaction by
providing a holistic approach to medical care in a timely
and effective manner. By helping to ensure an environ-
ment of safe and effective medical devices through good
technology management, CEs enable clinicians to have
the armamentarium that is needed to treat patients
effectively.
Managing medical technology requires that both the
medical device and the human factor component be
understood. Ensuring that a medical device is safe and
effective requires consideration of a host of factors, such
as device design, construction materials, performance
history in the clinical setting, the time in the market,
FDA allowances and approvals, the manufacturer's rep-
utation, parts availability, and the vendor's responsiveness
to its clients' needs. The human factor component of
technology management looks at the human interface,
which includes the patient, the clinician, the clinical/
biomedical engineer, the service provider(s), and the
manufacturer's representatives. The hospital relies on
