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साइन इन
स्वास्थ्य सुविधा अनुपालन 12 आइटम

Single-Use Device Reprocessing Policy Audit

यह चेकलिस्ट अंग्रेज़ी में है।

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

मुफ़्त PDF या Word · डाउनलोड करने के लिए अपना ईमेल दर्ज करें।

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?

पूरी Single-Use Device Reprocessing Policy Audit चेकलिस्ट डाउनलोड करें

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