Liquid Chemical Sterilants and High Level Disinfectants - Content and Format of 510k Submissions
This guidance provides recommendations for the content and format of 510(k) submissions for liquid chemical sterilants/high level disinfectants intended for sterilization and/or high level disinfection of reusable heat-sensitive critical and semicritical medical devices.
Recommended Actions
- Conduct complete AOAC Sporicidal Testing with three product lots
- Perform simulated-use and in-use testing under worst-case conditions
- Complete comprehensive biocompatibility assessment
- Validate material compatibility claims with appropriate testing
- Develop clear and complete labeling per guidance requirements
- Establish chemical indicator system for reusable products
- Generate stability data supporting shelf life claims
- Document cleaning validation and residue removal
- Create comprehensive training materials for users
- Prepare complete 510(k) submission addressing all guidance elements
Key Considerations
Non-clinical testing
- Must pass AOAC Sporicidal Test for sterilant claim
- Must demonstrate efficacy against mycobacteria for high-level disinfection claim
- Must conduct simulated-use testing with appropriate microbial challenges
- Must conduct in-use testing in clinical settings
- Must demonstrate effectiveness under worst-case conditions
Human Factors
- Users must be adequately trained in device reprocessing and handling toxic substances
- Clear instructions must be provided for proper use and monitoring
Labelling
- Must include essential information on bottle label (ingredients, intended use, warnings, precautions, etc.)
- Must include comprehensive information in package insert
- Must refer users to reusable device labeling
- Must clearly state contact conditions and limitations
Biocompatibility
- Must evaluate toxicity of germicide solution and residues
- Must conduct appropriate biocompatibility testing (skin irritation, sensitization, cytotoxicity, etc.)
- Must demonstrate safe residue levels after processing
Safety
- Must include appropriate warnings and precautions
- Must provide emergency contact information
- Must include disposal instructions
- Must address user safety during handling
Other considerations
- Must demonstrate material/device compatibility
- Must provide stability data supporting shelf life claims
- Must provide chemical indicator system for reusable products
- Must validate cleaning and rinsing procedures
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Device Labeling Requirements and Content for Premarket Approval Applications
Related references and norms
- ANSI/AAMI/ISO 11134-1993: Sterilization of Healthcare Products – Requirements for Validation and Routine Control
- ISO 10993-1:1992: Biological evaluation of medical devices - Part 1: Evaluation and Testing
Original guidance
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