Multiple Patient Use Arthroscopy Pump Tubing Sets - Safety, Testing and Labeling Requirements
This guidance provides recommendations for 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use. These devices deliver irrigation fluid to surgical sites during arthroscopic procedures. The guidance addresses the risk of cross-contamination between patients due to backflow of patient fluids through the irrigation tubing when using a single source of irrigation fluid for multiple patients.
Recommended Actions
- Implement a backflow-prevention valve design and validate its effectiveness
- Develop clear separation between single-use and multi-patient use components
- Conduct comprehensive performance testing including bench, backflow prevention, and microbial ingress testing
- Validate reprocessing instructions for reusable components
- Develop comprehensive labeling that clearly identifies component usage and handling requirements
- Establish and validate shelf life claims through appropriate testing
- Complete biocompatibility evaluation according to ISO 10993-1
- Implement risk management process following ISO 14971
- Validate sterility and maintain sterile barrier system integrity
- Document all validation data in the 510(k) submission
Key Considerations
Non-clinical testing
- Bench testing under simulated use conditions including cycle testing of connections and tubing performance evaluation
- Backflow-prevention valve testing using both microbiological and chemical markers
- Microbial ingress testing for connector components
- Validation of shelf life claims through package integrity testing and device functionality assessment
Human Factors
- Apply human factors and usability engineering principles to reprocessing instructions development and validation
Labeling
- Clear identification of multi-patient use components and duration
- Consistent terminology with provided definitions
- Clear instructions for installation and handling
- Identification of compatible systems and accessories
- Directions for proper handling to prevent backflow
- Clear disposal/reprocessing instructions based on component type
Biocompatibility
- Evaluate cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity
- Follow ISO 10993-1 requirements for external-communicating devices
Safety
- Include backflow-prevention valve or other feature to prevent fluid backflow
- Validate safety features to prevent over-pressurization
- Ensure sterility maintenance throughout shelf life
Other considerations
- Risk management following ISO 14971
- Sterility validation for components labeled as sterile
- Reprocessing validation for reusable components
- Pyrogenicity testing for bacterial endotoxins and material-mediated pyrogens
Relevant Guidances
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- ISO 14971: Medical devices – Application of risk management to medical devices
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- AAMI/ANSI/ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging
- AAMI/ANSI/ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Original guidance
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