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Testing Requirements for Healthcare Facility Sterilizers with Non-Traditional Cycle Parameters

This guidance serves as an addendum to clarify requirements for sterilizers intended for use in healthcare facilities, specifically addressing: - Test data requirements for steam and dry-heat sterilizers with non-traditional cycle parameters - Simulated-use and in-use testing requirements for traditional sterilizers - Acceptable types of organic loads for simulated use performance testing

  1. Develop comprehensive validation protocol for non-traditional cycle parameters
  2. Validate biological indicators for proposed operating conditions
  3. Conduct performance testing of process indicator strips
  4. Evaluate sterilization wrap compatibility
  5. Perform material compatibility studies
  6. Select and justify appropriate organic load for simulated-use testing
  7. Document all limitations and contra-indications in labeling
  8. Ensure all supporting devices (biological indicators, wraps, strips) have their own substantial equivalency determinations
  9. Implement simulated-use testing for complex lumened devices
  10. Validate the effect of artificial soil on test organism viability and recovery

Key Considerations

Non-clinical testing

  • Validation of biological indicators must include D-values and survival/kill characteristics at proposed operating temperatures and pressures
  • Performance testing of process indicator strips at proposed cycle parameters
  • Evaluation of sterilization wraps performance with new cycles
  • Material compatibility and device functionality testing after repeated exposures
  • Simulated-use testing required for complex lumened devices or new sterilization parameters
  • Organic load testing must represent a significant challenge to the sterilization process

Labelling

  • Include limitations or contra-indications regarding sterilization wraps in Instructions for Use
  • Include any material compatibility limitations in Instructions for Use

Safety

  • Validation of biological indicators for new/non-traditional cycles
  • Performance validation of process indicator strips
  • Effect evaluation of higher temperatures and pressures on materials

Other considerations

  • ANSI/AAMI/ISO: Standards for biological indicators validation
  • AAMI TIR No. 12-1994: Designing, Testing, & Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities

Original guidance

  • Testing Requirements for Healthcare Facility Sterilizers with Non-Traditional Cycle Parameters
  • HTML
  • Issue date: 1995-09-18
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 6df0561cb319be563b9fa604749faa38
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