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.
What You Need to Know? 👇
What is the regulatory status of washers and washer-disinfectors for reusable medical devices?
Washers and washer-disinfectors intended for processing reusable medical devices are considered medical devices under Section 201(h) of the Federal Food, Drug, and Cosmetic Act and are subject to 510(k) premarket notification requirements unless specifically exempted.
When are washers and washer-disinfectors exempt from 510(k) requirements?
Devices are exempt when intended only for “general purpose” articles like laboratory glassware, or solely for washing body waste receptacles like bedpans (classified under 21 CFR 880.6800), or exclusively for flexible endoscope processing.
What is the classification status of washers for surgical instruments and respiratory equipment?
These devices are currently “unclassified” as they were legally marketed before the 1976 Medical Device Amendments. FDA has not yet initiated formal classification procedures but they remain subject to 510(k) requirements.
Why does FDA regulate these devices from a public health perspective?
FDA recognizes that ineffective cleaning and disinfection can increase disease transmission risk and negatively impact terminal sterilization effectiveness. Proper cleaning is critical for both terminal disinfection processes and subsequent sterilization procedures.
What was the implementation timeline for compliance with this guidance?
FDA provided a 12-month grace period from June 1998 for manufacturers to submit appropriate 510(k) notifications, register, list, and comply with all other regulatory requirements while exercising enforcement discretion during this transition.
What performance testing guidance should manufacturers follow for 510(k) submissions?
Manufacturers should review the August 1993 guidance for automated endoscope washers for testing requirements. FDA planned to develop interim guidance or recognize published international/national voluntary standards for these devices.
What You Need to Do 👇
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 đź”—
- 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 đź“‚
- 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 ID: 768c4e359933fdefc00099c981632f6f