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.