Post-Market Surveillance
The clinical engineering department must be part of the hospital’s hazard-and-recall system.
Some estimate that the percentage of recalled devices is as low as 4% of those in the field.
Inattention to recalls and ignorance of recall and hazard notices may result in defective
devices remaining in use in the hospital (see Chapter 139). The clinical engineer has a duty
to report to the manufacturer and to the FDA medical devices deemed to be hazardous.
User Education
The manufacture is responsible for providing adequate instructional material on the
proper use of the medical device. Most major manufacturers of beds, stretchers and
wheelchairs publish booklets aimed at user, caregiver, and maintainer education (Everest
& Jennings, 1989b). The clinical engineering department should maintain a library and
should have audio-visual equipment to present educational material (e.g., slides and
videotapes) provided by the manufacturer and should play an active role in a hospital’s
in-service education program (Dyro, 1988).
Obsolescence
Clinical engineering should ensure that a plan is in place to retire general medical devices
when their useful lives are over. Well-maintained devices that are retired in favor of newer
technology may be considered for donation (see Chapter 43).