Biomedical Engineering Reference
In-Depth Information
a prerequisite for efficient and safe use of medical
devices.
The operation of complex devices is not easily mas-
tered by typical users. It is, therefore, imperative that
staff members continuously receive in-servicing that
includes theory of operation, device features, and avail-
able resources with the goal of achieving staff familiarity
with, and respect for, devices.
inventory. The various components in this process in-
clude the following:
Identifying the equipment to be purchased based on
(1) clinical need (newer technologies have a way of
rendering some older technologies obsolete);
Planned obsolescence (the device is nearing the end
of its rated useful life);
Maintenance cost (the cost of maintaining a device
exceeds depreciated value).
Conducting pre-purchase evaluation of equipment.
This process consists of two components:
(1) performing engineering evaluations of competing
products, and (2) conducting clinical trials, after
narrowing the field down to a few candidates, to rank
and select the best fit. Where the cost of purchase
exceeds a certain amount, a more formalized
pre-purchase evaluation is conducted, the RFP that
involves the competing vendors and manufacturers
to submit competitive bids that include the desired
hospital specifications.
Justification of the selected product and vendor and
manufacturer is based on results of the pre-purchase
evaluation or the RFP, cost-benefit analysis, life cycle
costing, and the anticipated cost of ownership that
includes, among others, expected cost of
maintenance, depreciation, and obsolescence.
CEs, bridging the communication gap between clinicians
and design engineers, can positively influence product
design. Frequently, the CE explains to the manufacturer
those things that can improve a product's efficiency and
safety. Consider an example that the authors encoun-
tered in which foot supports used on an operating room
(OR) bed repeatedly loosened and fell, but only on one
side. Clinical engineering analysis revealed that the
clamps' unidirectional thread enabled them to tighten
down on the bed rail when a load (the foot) was placed on
it but to loosen on the other side because the load applied
a loosening force. Working with the manufacturer pro-
duced a clamp that works on either the right or the left
side of an OR bed, without loosening.
At some time in the life of a medical device, it is likely
that failure will occur. If the clinical engineering de-
partment provides in-house service, the CEs and BMETs
must be trained at the same level as that of the manu-
facturer's service providers. Based on the manufacturer's
recommended preventive maintenance schedules, the
equipment is included in the scheduled maintenance
program.
Maintaining an up-to-date database is a prerequisite
to being able to predict early on a device's maintenance
schedule. Also, including the projected useful life span
of every device in this database enables the CE to begin
the replacement process before frequent breakdowns
occur, which would force the hospital to take costly
Training the maintainers
Training and in-servicing should be provided to the ser-
vicing department. In particular, the in-house depart-
ment should designate an education specialist, who will
be the department's resource when questions arise.
Surveillance
Monitoring medical device reports
for indicators
Researching the products' safety record can be done from
several sources, including the hospital's medical equip-
ment database; other hospitals; professional colleagues at
local, regional or national conferences; the FDA; and
ECRI. Maintaining a healthy communication line with
every departmental client in-house helps tremendously
because bits and pieces of information gleaned from users
can prove invaluable in fine-tuning requirements to help
keep the device in constant and safe operational condition.
Variance reporting process
Once the device has been purchased, has passed all safety
inspections, and has been deployed in the hospital, sur-
veillance of device performance and safety must occur.
Any variance in device operation must be documented by
means of a variance, incident, or adverse-occurrence
report. (The title of such a report varies from institution
to institution.) Any equipment that malfunctions or fails
while in use on a patient must be investigated, and the
variance, findings, and resolution must be recorded. The
hospital has legal responsibilities under the Safe Medical
Devices Act of 1990 (Alder, 1993; JCAHO, 1993; 21
CFR, 1995).
Cradle-to-grave management
This is a circular process of ensuring the continuity of
making available at all times the necessary patient care
equipment. Key to this process is the collaborative
interaction among the client clinical staff, equipment
maintainers, CEs, and purchasing and financial analysis
departments. Having responsibility for certain steps in
this process and interacting with members of the
project team, the CE stands to achieve a relatively safe,
reliable,
and
cost-effective medical
equipment
