Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices and single-use devices initially supplied as non-sterile. It covers devices that require cleaning, disinfection or sterilization before initial use or between uses.
Recommended Actions
- Review device design to optimize cleanability and reprocessing
- Develop comprehensive reprocessing instructions addressing:
- Point-of-use processing
- Cleaning methods and parameters
- Disinfection/sterilization requirements
- Inspection criteria
- Storage conditions
- Validate reprocessing instructions through:
- Cleaning validation studies
- Disinfection/sterilization validation
- Human factors validation
- Simulated use testing
- Document validation results and maintain records
- Include appropriate warnings and precautions in labeling
- Establish tracking system for reuse life if applicable
- Provide user training resources and support contact information
- Monitor post-market experience and update instructions as needed
Key Considerations
Non-clinical testing
- Validate cleaning processes separately from disinfection/sterilization processes
- Use at least two quantitative test methods to measure clinically relevant soil
- Conduct simulated-use testing under worst-case conditions
- Validate extraction methods for recovery of residual soil
- Validate cleaning endpoints and acceptance criteria
Human Factors
- Develop consistent reprocessing instructions across product lines
- Validate that users can understand and follow the instructions
- Consider use environment and personal protective equipment
- Observe and document participant behavior during validation
- Address any known post-market human factors issues
Labelling
- Provide comprehensive, sequential instructions from initial to terminal processing steps
- Include diagrams, photos, illustrations where helpful
- Specify all required equipment, accessories, and parameters
- Include warnings and precautions
- Provide contact information for questions
Biocompatibility
- Validate that residual cleaning agents and disinfectants are reduced to non-toxic levels
- Consider endotoxin removal requirements for certain devices
Safety
- Include safety warnings and precautions
- Specify appropriate personal protective equipment
- Address chemical exposure risks
- Include disposal instructions for failed devices
Other considerations
- Consider device design features that facilitate cleaning
- Validate reuse life and provide tracking method
- Consider material compatibility with cleaning/sterilization methods
- Address storage conditions and shelf life
- Consider point-of-use processing requirements
Relevant Guidances
- Design Considerations for Medical Devices Intended for Home Use
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Design Controls for Medical Device Manufacturers
Related references and norms
- AAMI TIR12: Designing, testing and labeling reusable medical devices for reprocessing in health care settings
- AAMI TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- AAMI/ANSI ST81: Sterilization of medical devices - Information to be provided by the manufacturer
- IEC 62366: Medical devices – Application of usability engineering to medical devices
- ANSI/AAMI HE75: Human Factors Engineering – Design of Medical Devices
Original guidance
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- HTML / PDF
- Issue date: 2015-03-17
- Last changed date: 2020-03-02
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket Approval (PMA), 510(k), Premarket, Investigational Device Exemption (IDE)
- ReguVirta summary file ID: 6a449cb82a0824f81865e80a72de6024
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