Prior to recent bacterial outbreaks at hospitals involving lingering carbapenem-resistant (CRE) bacteria on duodenoscopes, FDA was only requiring statements from endoscope manufacturers that they have validated their reprocessing instructions for disinfecting the reusable scopes. But now, after seeing some inadequate cleanliness test results from the companies – “we are asking to see a higher safety margin," FDA told “The Gray Sheet” March 5.
“Given the complexity of these devices, and our knowledge that failure to follow the cleaning instructions is the most common cause of transmission of infection, we do not want the...