Monitoring & QACâu 76 / 100

A recall is initiated after a sterilization failure. Which action is part of a proper recall procedure?

a.Retrieve only the items still on the sterile storage shelves
b.Notify the affected departments verbally and take no further action
c.Identify every item processed since the last negative biological indicator, retrieve and quarantine them, notify risk management and infection prevention if any were used on patients, and document the investigation and corrective action
d.Reprocess the affected items and release them without documenting the event

Giải thích

An effective recall traces every package from the affected cycles using load records and lot control labels, pulls them from storage and from the procedural areas, and escalates when items have already been used so patient follow-up can be considered. The event, the root cause analysis, and the corrective actions are documented as part of the quality program. Limiting the search to shelf stock or skipping documentation defeats the purpose of traceability.

Trích dẫn luật: AAMI ST79

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