Monitoring & QAQuestion 68 of 100
After a positive biological indicator, the sterilizer is inspected, a probable cause is corrected, and testing resumes. What is generally required before the sterilizer returns to routine service?
a.A single passing chemical indicator in a full production load
b.Three consecutive cycles with negative biological indicators in an empty chamber, and for dynamic-air-removal sterilizers three passing Bowie-Dick tests as well
c.One passing biological indicator run in a fully loaded chamber
d.A signed statement from the operator that the load appeared normal
Explanation
Requalification after a failure or a major repair uses three consecutive empty-chamber cycles with negative biological indicators, with Bowie-Dick testing added for dynamic-air-removal sterilizers, to demonstrate the equipment is reliably performing again. A chemical indicator does not demonstrate microbial lethality, and one biological indicator in a production load is not sufficient evidence of restored performance. Operator observation is not a qualification method.
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