Biomedical Engineering Reference
In-Depth Information
measures like renting similar equipment to make up for
the shortage.
alert to the possibility that the product that is recom-
mended to the hospital today will be obsolete in a short
time. CEs do not need to have extrasensory perception to
be able to look into the future. Being well-read and sci-
entifically curious enables CEs to unearth information
that, by itself or in various combinations with other
technologies, can help to paint a picture of what is to
come.
Ensuring efficacy and effectiveness
Specifying medical devices
for cost-effectiveness
Cost-effectiveness means that the product meets all of
the desired specifications at a price that is competitive
with, or even lower than, that of other vendors. CEs must
work closely with the client to prioritize specifications,
listing them as (1) those that are necessary; (2) those that
are desired but that the organization can live without; and
(3) those that are not needed, based on current and an-
ticipated use. It is also best to work closely with the
manufacturers, who can recommend the best devices to
suit the hospital's needs without including unwanted or
nonessential features that would drive up the price.
Evaluating designs for efficiency
and reliability
When assessing efficiency and reliability, the CE should
have the actual device, its user, service manuals, and an
in-service from the manufacturer's representative.
A block of time should be set aside to operate the device,
while becoming acquainted with its various features and
capabilities. This opportunity to learn new technology
is quite often stimulating and enjoyable for the CE.
Assessing a product's efficiency and reliability, long before
it is used, need not be a guessing game. If the product's
design and technology are relatively new and untested in
the market, the CE looks at the manufacturer's reputa-
tion and record of accomplishment for similar products.
The authors prefer devices that have been on the market
for at least one year. Problems occurring in this one-year
introductory period would appear in manufacturers' re-
calls, warning letters, ECRI Hazard Alerts, and the FDA
MAUDE database.
The manufacturer's representatives usually can pro-
vide the CE with a list of user hospitals in the region or in
the entire country. Checking with these users usually
provides one a good insight into what to expect from the
product, especially if one communicates with all levels of
users and maintainers in the hospital. This is where
membership at the local bio-medical engineering society
or any similar professional groups can be of great help.
Anticipating future needs during
selection
Health care is a constantly evolving process, and, at
times, it is even revolutionary. The instrumentation that
is required to deliver current state-of-the-art technolo-
gies could become obsolete in a short time. For example,
robotics is making great strides in the hospital setting.
William Beaumont Hospital's medical laboratories are
major users of robotic systems to perform various tests
efficiently and cost- effectively, utilizing small specimens.
It allowed the hospital laboratory to expand its capacity
and capabilities without increasing skilled and educated
labor. Robotic surgical systems have also revolutionized
the way surgeries are performed in house. A robotic arm
system was quickly superseded by a more sophisticated
one that is a precursor of one enjoying more widespread
use in surgical telemetry.
The CE, with various information sources available, is
becoming an unofficial bio-informatics officer. With our
participation in the institutional review board (IRB)
process in-house; the technology acquisition process;
hands-on familiarity with the standard equipment used
in-house; communication on almost a daily basis with our
clients regarding equipment performance; keeping up
with medical research and current trends; consultations
with clients, manufacturers, and their representatives,
the in-house CE can provide technological guidance to
the future.
An engineering professor's favorite question to his
students is ''When is software considered obsolete?'' The
answer is, ''As soon as it is marketed.'' CEs need to be
Minimizing user errors through
ergonomics in device design
Elegant design often relies upon the KISS (''Keep It
Simple, Sweetheart!'') principle. The design should
make the equipment intuitive, simple, and easy to use.
The fewer controls for staff to manipulate, especially
during procedures, the better. All critical controls should
be on the front panel and not susceptible to fluid spills,
which is a constant risk in the hospital setting. Operating
the equipment should eliminate, as much as possible,
steps that are unnecessary and consolidating those that
are similar and that may require a modified sequence of
operation. Going beyond the equipment itself, make sure
that the supporting infrastructure is available in the areas
