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
What You Need to Know? 👇
What are the key requirements for 510(k) submissions of sterilizers with non-traditional cycle parameters?
Submissions must include validated biological indicators with D-values at proposed temperatures/pressures, validated process indicator strips, evaluation of sterilization wrap effects, material compatibility testing, and substantial equivalency determinations for all accessories at the new operating conditions.
When is simulated-use testing required for traditional sterilizers in 510(k) submissions?
Simulated-use testing is required when making claims for complex lumened devices (like dental handpieces) or when using new sterilization parameters that differ from traditional temperatures (121°C/132°C for steam, 160°C/190°C for dry heat).
What types of organic loads are acceptable for simulated-use performance testing of sterilizers?
Acceptable organic loads include Hucker’s Soil, Birmingham/Edinburgh Soils, tissue culture media with 10% fetal bovine serum, or red blood cells (≥10%) in saline. The selection must represent the greatest challenge to the sterilization process.
How should biological indicators be validated for non-traditional sterilization cycles?
Biological indicators must be validated with D-values and survival/kill characteristics at the proposed operating temperatures and pressures. Validation methods are described in USP, PDA, ANSI/AAMI/ISO standards, and CDRH checklists for biological indicators.
What material compatibility data is required for sterilizers with higher operating parameters?
Manufacturers must evaluate the effect of repeated exposures to higher temperatures and pressures on material and device functionality. Any limitations or contraindications must be included in the Instructions for Use for the sterilizer.
How should test organisms be prepared for simulated-use testing protocols?
Test organisms should be suspended in artificial soil prior to inoculation onto devices in the most difficult-to-sterilize locations. The effect of artificial soil on organism viability/recovery must be demonstrated, including whether dried or wet inoculum presents greater challenge.
What You Need to Do 👇
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 ID: 6df0561cb319be563b9fa604749faa38