FDA issues reprocessing safety recommendations for reusable duodenoscopes

The Food and Drug Administration today 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. According to the advisory, the agency has received in the past two years 75 reports encompassing about 135 patients involving possible microbial transmission from reprocessed duodenoscopes, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae. To minimize the risk of infection, FDA recommends that facilities and staff reprocessing duodenoscopes closely follow all manufacturer instructions for cleaning and processing the devices; specific reprocessing instructions in the manufacturer’s labeling for each device; and guidelines and practices for general endoscope reprocessing established by the infection control community and endoscopy professionals. Among other actions, FDA recommends that providers implement a comprehensive quality control program for reprocessing duodenoscopes; inform patients of the benefits and risks associated with such procedures; and report any suspected infections associated with reprocessing the devices to the manufacturer and FDA.