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
Recommended Actions
- Develop comprehensive validation protocol for non-traditional cycle parameters
- Validate biological indicators for proposed operating conditions
- Conduct performance testing of process indicator strips
- Evaluate sterilization wrap compatibility
- Perform material compatibility studies
- Select and justify appropriate organic load for simulated-use testing
- Document all limitations and contra-indications in labeling
- Ensure all supporting devices (biological indicators, wraps, strips) have their own substantial equivalency determinations
- Implement simulated-use testing for complex lumened devices
- 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
- Substantial equivalency determination depends on biological indicator, sterilization wrap, and process strip indicator approvals
- Selection of appropriate artificial soil for testing based on actual use conditions
Relevant Guidances
- Regulatory Requirements for Medical Device Washers and Washer-Disinfectors
- Liquid Chemical Sterilants and High Level Disinfectants - Content and Format of 510k Submissions
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Endoscope Washers and Washer/Disinfectors - 510k Review Requirements
- Premarket Notification Requirements for Healthcare Facility Sterilizers
Related references and norms
- 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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