FDA MedWatch - Use Duodenoscopes with Innovative Designs to Enhance Safety

New information on completed postmarket surveillance studies and updates on the transition duodenoscopes with innovative designs.

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication Today, the FDA issued an update to the previous safety communication on duodenoscopes to provide new information on completed postmarket surveillance studies (also known as 522 studies) as well as updated information on the transition to fully disposable duodenoscopes and those with disposable components. The FDA continues to encourage duodenoscope manufacturers to transition away from fixed endcap duodenoscopes to disposable/disposable component duodenoscopes with more modern design features that facilitate or eliminate the need for reprocessing. Hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components, such as disposable endcaps, or to fully disposable duodenoscopes. Read More Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to edwardlorilla1986.paxforex@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA