Exclusive: FDA seeks to speed updates to 'superbug' device labels

February 25, 2015 12:08 AM

3 0

WASHINGTON/NEW YORK (Reuters) - The U.S. Food and Drug Administration is working to speed label changes for medical devices linked to a "superbug" outbreak in California, possibly to include new warnings and more stringent cleaning and disinfecting instructions, a senior official said.

Last week the FDA warned that the complex design of the reusable duodenoscopes, which are threaded through the mouth, throat and stomach and used in a variety of gastrointestinal procedures, makes them difficult to disinfect properly, even when instructions provided by the manufacturers are followed...

Read more

To category page