Monitoring & QAQuestion 69 of 100
An implant is processed in a terminal steam cycle with a rapid-readout biological indicator. When may the implant be released?
a.Immediately, if the Class 5 integrating indicator inside the tray has changed
b.At the end of the shift, regardless of the biological indicator result
c.Only after the biological indicator result is available and negative, except in a documented emergency
d.Only after 48 hours of incubation, with no exceptions
Explanation
Implant loads are quarantined until the biological indicator reads negative, because a failure would place a permanently implanted device in a patient. Emergency release before the result is available is permitted only when it is documented and the surgeon is informed, and the result is tracked to completion. A Class 5 indicator supports early release decisions in an emergency but does not by itself satisfy the requirement, and modern rapid-readout indicators give results in far less than 48 hours.
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