Endoscope Washers and Washer/Disinfectors - 510k Review Requirements
This guidance establishes the 510(k) review requirements for endoscope washers, washer/disinfectors intended for use in healthcare facilities (hospitals, clinics, healthcare professional offices). It covers electromechanical and microprocessor-controlled devices used to process endoscopes that are not normally used in sterile areas of the body, cannot be terminally sterilized, or where professional standards permit high-level disinfection. Manual endoscopic cleaning accessories are excluded from this guidance.
Recommended Actions
- Develop comprehensive test protocols for process validation including:
- Process parameter testing
- Simulated-use testing under worst case conditions
- In-use clinical testing
- Prepare detailed documentation including:
- Complete device description and specifications
- Software validation documentation
- Toxicological evaluation of residues
- Comparison to predicate devices
- Create comprehensive labeling including:
- Detailed user manual
- Service manual
- Installation requirements
- Compatible accessories list
- Validate compatibility with identified accessories:
- Detergents
- Enzyme cleaners
- Disinfectants
- Establish quality control measures for:
- Process monitoring
- Maintenance requirements
- Error detection/handling
- Prepare 510(k) submission package following guidance structure and requirements
- Maintain documentation of all testing and validation activities for potential FDA requests
Key Considerations
Clinical testing
- In-use testing required with actual patient-used scopes
- Must evaluate major types of scopes indicated in labeling
- Requires statistically derived sample size for each scope type
- Must include control and treated scopes
- Need microbiological data on bioburden loads before/after use
- Statistical evaluation of results required
Non-clinical testing
- Process parameter tests showing machine maintains specified parameters
- Simulated-use tests under worst case conditions
- Evaluation of washing effectiveness
- Testing of disinfection phase effectiveness
- Validation of rinse phases
- Testing of any additional parameters (alcohol rinse, air drying, etc.)
- Combined process effectiveness testing
Software
- Software validation required
- Considered “major” risk category
- Must follow FDA Software Reviewers Guide requirements
Labelling
- User manual requirements including:
- Intended use
- Compatible endoscope models
- Limitations of use
- Installation instructions
- Operating instructions
- Chemical preparation/handling
- Pre/post processing recommendations
- Error indications
- Maintenance requirements
- Service manual requirements
Safety
- Must evaluate toxicological residues
- Assessment of residue levels after processing
- Demonstration of residue removal to non-toxic levels
- Evaluation of residue accumulation over device life
Other considerations
- Must identify compatible accessories (detergents, enzyme cleaners, disinfectants)
- Installation requirements (electrical, plumbing, venting)
- Process monitoring capabilities
- Comparison to legally marketed predicate devices
Relevant Guidances
- Regulatory Requirements for Medical Device Washers and Washer-Disinfectors
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Content of Premarket Submissions for Device Software Functions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- UL 544: Medical Electrical Equipment
Original guidance
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