Post

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.

  1. Determine if your washer/washer-disinfector requires 510(k) submission based on intended use
  2. Submit premarket notification within 12 months of guidance issuance if required
  3. Register and list devices with FDA
  4. Develop and validate performance testing protocols
  5. Ensure proper labeling indicating specific intended use
  6. Review endoscope washer guidance for reference on performance testing requirements
  7. Monitor for upcoming interim guidance or recognized international standards
  8. Implement quality control measures to ensure effective cleaning and disinfection
  9. Maintain compliance with all provisions of the Act
  10. 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

  • 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
This post is licensed under CC BY 4.0 by the author.