Biomedical Engineering Reference
In-Depth Information
(i.e., the hands-on staff members (users)) inform the CE
of changes in a device such as deterioration, inaccurate
measurement, or intermittent operation. When equip-
ment has been identified for obsolescence in at least two
years, work begins on selecting replacements.
At times, if the technology has not changed signifi-
cantly, and the hospital is satisfied with the equipment,
only a financial analysis of the pricing and service quo-
tations from several vendors and manufacturers is
required. Rapid changes in medical technology, however,
dictate that even the most mature, most often used, and
most accepted technologies, despite small generational
improvements, should be compared with newer com-
peting products and technologies through evaluation and,
where necessary, clinical trials. Purchases that exceed
a certain monetary value require a formal bid process
entailing a request for proposal (RFP). The RFP is
addressed later in this chapter.
Amedical device becomes a hospital standard after the
process of engineering evaluation, clinical trials, financial
analysis (based in large part on the responses to the RFP),
and selection as the most cost-effective product.
be on only one page, that the scoring be succinctly
explained, that all terms used be understandable
by the evaluators, that it states where to return
completed forms, and that it contain a space for
the name and mailing address of the evaluator.
Clearly explain and document test methodology to
ensure scientific validity of the study.
Facilitate the monitoring of the devices for proper
operation. This monitoring is usually the responsibility
of the vendor or manufacturer. Because the vendor
cannot be at the hospital at all times, a person in the
department who is properly in-serviced should be
designated as the resource person.
Prepare a schedule lasting over a reasonable time that
covers every possible step needed for the clinical
trial. This is essential to ensure timely completion of
the trial.
Negotiating for safety features
Sometimes certain features that help to improve the
safety of the device are incorporated or are even sold as
options. One should ascertain that the products provided
for the trial have all the desired specifications and that
the competing brands have the same features.
Note the willingness of the manufacturer to provide
training of in-house maintainers to the same level as
that of the manufacturer's field-service technicians.
While in most cases, the manufacturer is quite willing
to provide this level of training, the manufacturer oc-
casionally claims that the proprietary nature of its
technology militates against this. In these cases, one
should relinquish servicing responsibility to the manu-
facturer or should negotiate a plan for utilizing in-house
maintainers. The reasons for this are threefold: (1) im-
mediate response to any equipment problems; (2) con-
trol over the safety, turnaround times, and costs; and (3)
an immediate familiarity with the equipment and user
group.
Clinical trials
Participation in clinical trials is often an enjoyable,
rewarding, and challenging aspect of the CE's work. The
rapid growth in the biomedical engineering and its
application to medical device technology market results
in new and varied devices coming to market. This, in
turn, presents the CE with more devices to evaluate, and
more clinical trials to manage. Clinical trials find CEs
becoming increasingly involved with the clinical and
medical staff. The following is a list of many of the steps
taken by CEs in managing and running a clinical trial:
Obtain user department cooperation. (This tends not
to be a problem because the department usually has
requested the trial.)
Arrange with the vendors and manufacturers for use
of their products on a clinical trial of a duration of
a few days to several weeks. Vendors are generally
quite helpful, even supplying necessary, and often
costly, disposables. Occasionally, the hospital
supplies the disposables, especially if these are
stocked items.
Arrange with the vendors and manufacturers for
in-service training of the staff involved with the
trial. Obtain user and service manuals and make
them readily available to staff. Schedule the trial so
that most staff members have an opportunity to use
and evaluate the product.
Prepare a survey instrument that lists the desired
specifications and evaluation criteria (e.g., ease of
use). It is recommended that the survey instrument
Education
In-servicing of clinical users
The hospital should demand in-servicing for all new
devices, including new standard devices that are upgrades
of the old standard being replaced. Every department has
an assigned education specialist, who will need to be
trained well so that that specialist can train other staff
members, i.e., a train-the-trainer program. (Preferably,
every user should obtain hands-on training initially.) That
department should provide periodic in-servicing to users,
either on demand or on a scheduled basis. Training should
entail the theory of operation. A knowledgeable user is
