Sterilization of Convenience Kits: Component Compatibility and Validation Requirements
This guidance addresses concerns about finished device components that are assembled into clinical or surgical convenience kits and then sterilized. It focuses on ensuring that the sterilization process does not adversely affect the finished components in these kits.
Recommended Actions
- Assess and document the impact of sterilization process on kit components
- Measure and evaluate sterilant residuals
- Develop and validate appropriate labeling including storage instructions and expiration dating
- Determine regulatory pathway requirements (510(k) or PMA)
- Implement quality system requirements including:
- Manufacturing controls
- Labeling controls
- Post-market surveillance
- Adverse event reporting
- Corrections and removals procedures
- Maintain documentation of all validation studies and controls
- Ensure shortest component expiration date is used for overall kit
- Verify package integrity post-sterilization
- Consult with device component manufacturers regarding sterilization compatibility
Key Considerations
Non-clinical testing
- Validate stability data to support expiration dating
- Conduct process validation studies for devices
- Evaluate effects of storage conditions (e.g., one year at room temperature at 30 degrees centigrade)
Labelling
- Provide instructions for appropriate storage conditions
- Include expiration date supported by stability data
- Ensure expiration date is not longer than the shortest expiration date of any component
- Validate storage instructions
Safety
- Evaluate effects of sterilization process on material degradation
- Assess impact of sterilization on form, fit, and function of device components
- Verify package integrity remains intact after sterilization
- Determine sterilant residuals
Other considerations
- Comply with general controls (manufacturing, labeling controls, postmarket reporting)
- Determine if 510(k) or PMA is needed for the kit
- Document that device components are not adversely affected by further processing
- Follow Good Manufacturing Practices (GMPs)
Relevant Guidances
- Medical Device Convenience Kits - Premarket Notification and Compliance Requirements
- Unique Device Identification Requirements for Convenience Kits
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms
- ICH Q1A: Stability Testing of New Substances and Products
- 21 CFR Part 820: Quality System Regulation
- 21 CFR Part 803: Medical Device Reporting
- 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals
Original guidance
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