Exclusive: FDA Seeks to Speed Updates to ‘Superbug’ Device Labels
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. Pentax Medical, Fujifilm Holdings Corp and Olympus Corp are the leading makers of these endoscopes.
“We are working to expedite modifications to the label,” Dr. William Maisel, chief scientist in the FDA’s Center for Devices and Radiological Health, said in an interview. “We are also talking about updating the risk information.”