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Reprocessing of Single-Use Medical Devices: Requirements for Third-Party and Hospital Reprocessors

This guidance provides clarification on the requirements for third-party and hospital reprocessors of single-use devices (SUDs), addressing their responsibilities as manufacturers under FDA regulations. It covers aspects from facility registration to quality systems, sterilization processes, and adverse event reporting.

  1. Register facility as a manufacturer with FDA using form FDA 2891
  2. Implement Quality System regulation requirements
  3. Establish and validate sterilization processes
  4. Develop documentation system for process controls and validation
  5. Set up adverse event reporting procedures
  6. Train staff on quality system requirements and procedures
  7. Establish management oversight of quality system
  8. Create procedures for device release after reprocessing
  9. Maintain records of all reprocessing activities
  10. Consider implementing relevant consensus standards for sterilization processes

Key Considerations

Non-clinical testing

  • Validation studies must demonstrate that sterilization processes achieve a sterility assurance level (SAL) of 10-6 for devices used in normally sterile areas
  • Evidence must show that sterilization process does not adversely impact materials or device functioning

Safety

  • Hospitals must comply with Medical Device Reporting (MDR) requirements for adverse events
  • Process controls must ensure specifications for sterilization parameters are always met
  • Documentation of sterility validation and routine processing must be maintained

Other considerations

  • ISO 11135: Industrial EO sterilization
  • ISO 11134: Industrial moist heat sterilization
  • ANSI/AAMI ST 41: Healthcare facility EO sterilization
  • ANSI/AAMI ST 46: Healthcare facility moist heat sterilization

Original guidance

  • Reprocessing of Single-Use Medical Devices: Requirements for Third-Party and Hospital Reprocessors
  • HTML / PDF
  • Issue date: 2001-07-06
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 39237eb20dbdd778944d1a5944c52ec0
This post is licensed under CC BY 4.0 by the author.