FDA Releases List of Reusable Medical Devices Requiring Validated Instructions
The US Food and Drug Administration (FDA), in accordance with the requirements established by the 21st Century Cures Act, has published in the Federal Register a list of reusable medical devices for which the FDA will require:
- Validated instructions for use and
- Validation data regarding cleaning, disinfection, and sterilization in premarket notification submissions.
Manufacturers of reusable medical devices are responsible for having labeling that bears adequate directions for use, including instructions on preparing a device for use under 21 CFR 801.5 and 801.109. In recent years, there have been significant changes in knowledge and technology involved in reprocessing reusable medical devices. Additionally, there has been an evolution towards more complex reusable medical device designs that are more difficult to clean, disinfect, and sterilize. The FDA believes reusable devices must be designed for adequate reprocessing and safe reuse, with comprehensive and clear instructions for effective reprocessing procedures for use by health care facilities that reprocess these devices.
Providers are reminded of the FDA guidance, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” Providers should always consult national guidelines as well as manufacturer’s instructions to guide infection prevention and control practices for reprocessed medical devices throughout the organization.
Included with today’s notice is an example policy related to reducing the risk of infections associated with medical device reprocessing.
Want to read the full alert and receive alert emails?