Some countries regulate the registration of technical personnel,
including supervising personnel, and might further regulate repair and maintenance to the
extent that these activities can be audited to ensure that quality control is maintained. (See
Chapters 19 and 27.) Auditing can extend beyond the country of manufacture such that
all repairs undertaken by the manufacturer or supplier are open to being audited, regardless
of where they are performed (particularly if there is a chance that the device could reenter
the country of manufacture), with penalties if quality standards are breached. (See
Chapter 126.) In such instances, manufacturers will seldom take responsibility for maintenance
and repair performed by unknown personnel. (See Chapter 13.)
In addition, there are various standards (see Chapter 117) that govern medical device
management, and most countries adopt at least one such standard, either as part of the
overall quality process or more rigorously as a legislative requirement. Typically, such
standards define the nature and frequency of safety and performance testing but do not
Ch030-046.qxd 2/6/04 6:12 pm Page 130
define maintenance requirements other than in the most general terms. These standards
seldom if ever define repair quality issues.
The personnel who are responsible for medical device management programs should
be well informed as to the regulatory requirements in their area. Further, they should
know whether there are requirements covering the qualifications of technical personnel
and whether standards exist to cover maintenance and repair procedures. If all requirements
covering device management can be met, then the recipient health care organization
should meet reasonable public expectation for quality health care delivery, given
local circumstances, and should have its capability assured.