Agencies issue guidance for duodenoscope and other reusable device makers

The Food and Drug Administration today issued final guidance for makers of reusable duodenoscopes and other reprocessed medical devices aimed at assuring that their cleaning and disinfection or sterilization instructions consistently reduce microbial contamination. In addition, the Centers for Disease Control and Prevention issued an interim protocol for health care facilities wishing to use routine culturing to assess the adequacy of duodenoscope reprocessing. The FDA guidance lists six criteria manufacturers should address in their reprocessing instructions for users. In addition, the agency said manufacturers seeking to bring to market certain reusable devices (such as duodenoscopes, bronchoscopes and endoscopes) should submit for review their data validating the effectiveness of their reprocessing methods and instructions. FDA last month issued safety recommendations to prevent possible microbial infections from reprocessed reusable duodenoscopes – flexible, lighted tubes that are threaded through the mouth into the small intestine to drain fluids from blocked pancreatic and biliary ducts.