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Single-Use Device Reprocessing Policy Audit
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Audit of policies governing the reprocessing of single-use devices, ensuring reprocessing is performed only by FDA-cleared reprocessors and tracked.
FDA SUD Reprocessing GuidanceCMS 42 CFR 482.42AAMI ST58
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Policy & Regulatory Basis
- Does the facility have a written policy defining whether and how single-use devices may be reprocessed? *
- Is reprocessing of single-use devices performed only by an FDA-cleared/registered third-party or original-equipment reprocessor? *
- Is unauthorized in-house cleaning and reuse of critical/semicritical single-use devices prohibited? *
Device Eligibility & Handling
- Is only the specific list of devices cleared by the reprocessor for reprocessing sent for reprocessing? *
- Are devices collected, protected from damage, and not exceeding the cleared maximum number of reprocessing cycles? *
- Are reprocessed devices labeled to identify the reprocessor as the manufacturer? *
Tracking & Oversight
- Is reprocessed single-use device use tracked and included in device recall and adverse-event processes? *
- Are adverse events associated with reprocessed devices reported per MedWatch requirements? *
- Is the reprocessing program reviewed by infection prevention and sterile processing leadership?
Cost, Consent & Records
- Are records maintained that allow reprocessed devices to be traced to specific patients and reprocessing cycles? *
- Is the reprocessor's regulatory status (registration and clearances) verified before contracting? *
- Are cost savings from SUD reprocessing balanced against documented safety and functional performance?
Single-Use Device Reprocessing Policy Audit 체크리스트 전체 다운로드
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