FDA lists reusable medical devices requiring new validation

The U.S. Food and Drug Administration (FDA) has released a list of reusable medical devices that will require validated use instructions and data regarding cleaning, disinfection and sterilization.

Published in accordance with the requirements of the 21st Century Cures Act, the release list aims to ensure that pre-market reequipments are clear for the facilities that utilize them. Manufacturers of reusable medical devices are responsible for labeling with adequate directions for preparation and use.

“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.,” stated the Federal Registrar release. “However, 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. 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.”

Devices ranged in use and specialty, including bronchoscopes, arthroscopes and disinfection reprocessing instruments for transducers.