FDA releases early results from duodenoscope reprocessing studies

Early results from studies to better understand how duodenoscopes are reprocessed in real-world settings have found higher than expected contamination rates after reprocessing, the Food and Drug Administration announced yesterday. The agency reminded health care facilities that reprocess duodenoscopes of “the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes,” among other recommendations. FDA issued safety recommendations in 2015 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. The agency also ordered Olympus, Fujifilm and Pentax to conduct postmarket surveillance studies to determine whether health care facilities are able to properly clean and disinfect the devices. Final results from the studies are expected next year. “I want to emphasize that an individual patient’s risk of acquiring infection from an inadequately reprocessed medical device remains relatively low given the large number of such devices in use,” said Jeff Shuren, M.D., director of the Center for Devices and Radiological Health.