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Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation

This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices and single-use devices initially supplied as non-sterile. It covers devices that require cleaning, disinfection or sterilization before initial use or between uses.

  1. Review device design to optimize cleanability and reprocessing
  2. Develop comprehensive reprocessing instructions addressing:
    • Point-of-use processing
    • Cleaning methods and parameters
    • Disinfection/sterilization requirements
    • Inspection criteria
    • Storage conditions
  3. Validate reprocessing instructions through:
    • Cleaning validation studies
    • Disinfection/sterilization validation
    • Human factors validation
    • Simulated use testing
  4. Document validation results and maintain records
  5. Include appropriate warnings and precautions in labeling
  6. Establish tracking system for reuse life if applicable
  7. Provide user training resources and support contact information
  8. Monitor post-market experience and update instructions as needed

Key Considerations

Non-clinical testing

  • Validate cleaning processes separately from disinfection/sterilization processes
  • Use at least two quantitative test methods to measure clinically relevant soil
  • Conduct simulated-use testing under worst-case conditions
  • Validate extraction methods for recovery of residual soil
  • Validate cleaning endpoints and acceptance criteria

Human Factors

  • Develop consistent reprocessing instructions across product lines
  • Validate that users can understand and follow the instructions
  • Consider use environment and personal protective equipment
  • Observe and document participant behavior during validation
  • Address any known post-market human factors issues

Labelling

  • Provide comprehensive, sequential instructions from initial to terminal processing steps
  • Include diagrams, photos, illustrations where helpful
  • Specify all required equipment, accessories, and parameters
  • Include warnings and precautions
  • Provide contact information for questions

Biocompatibility

  • Validate that residual cleaning agents and disinfectants are reduced to non-toxic levels
  • Consider endotoxin removal requirements for certain devices

Safety

  • Include safety warnings and precautions
  • Specify appropriate personal protective equipment
  • Address chemical exposure risks
  • Include disposal instructions for failed devices

Other considerations

  • AAMI TIR12: Designing, testing and labeling reusable medical devices for reprocessing in health care settings
  • AAMI TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
  • AAMI/ANSI ST81: Sterilization of medical devices - Information to be provided by the manufacturer
  • IEC 62366: Medical devices – Application of usability engineering to medical devices
  • ANSI/AAMI HE75: Human Factors Engineering – Design of Medical Devices

Original guidance

  • Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
  • HTML / PDF
  • Issue date: 2015-03-17
  • Last changed date: 2020-03-02
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket Approval (PMA), 510(k), Premarket, Investigational Device Exemption (IDE)
  • ReguVirta summary file ID: 6a449cb82a0824f81865e80a72de6024
This post is licensed under CC BY 4.0 by the author.