Regulatory Requirements for Medical Device Washers and Washer-Disinfectors
This guidance clarifies the regulatory status and 510(k) submission requirements for washers and washer-disinfectors intended for processing reusable medical devices. It specifically addresses unclassified washers and washer-disinfectors used for cleaning and disinfection of stainless steel devices, surgical instruments, respiratory therapy equipment, and other medical devices.
Recommended Actions
- Determine if your washer/washer-disinfector requires 510(k) submission based on intended use
- Submit premarket notification within 12 months of guidance issuance if required
- Register and list devices with FDA
- Develop and validate performance testing protocols
- Ensure proper labeling indicating specific intended use
- Review endoscope washer guidance for reference on performance testing requirements
- Monitor for upcoming interim guidance or recognized international standards
- Implement quality control measures to ensure effective cleaning and disinfection
- Maintain compliance with all provisions of the Act
- Consider public health implications in device development and validation
Key Considerations
Non-clinical testing
- Performance testing should be provided in 510(k) submission
- Validation of processing steps effectiveness
- Demonstration of cleaning and disinfection effectiveness
Labelling
- Clear indication of intended use for processing reusable medical devices
- Specific identification of the types of medical devices that can be processed
Safety
- Must ensure effective cleaning to prevent transmission of diseases
- Must ensure effective cleaning to support subsequent sterilization processes
- Critical consideration when washer-disinfector is used as terminal process
Other considerations
- Registration and listing requirements apply
- 12-month grace period for compliance with premarket notification requirements
- Different requirements based on intended use (general purpose vs. medical devices)
- Specific classification for endoscope washers as Class II devices
Relevant Guidances
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Liquid Chemical Sterilants and High Level Disinfectants - Content and Format of 510k Submissions
Related references and norms
- No specific norms mentioned in the guidance
Original guidance
- Regulatory Requirements for Medical Device Washers and Washer-Disinfectors
- HTML
- Issue date: 1998-06-01
- Last changed date: 2020-03-18
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket
- ReguVirta summary file ID: 768c4e359933fdefc00099c981632f6f
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