FDA releases updated results from duodenoscope reprocessing studies

Updated preliminary results from studies to better understand how duodenoscopes are reprocessed in real-world settings continue to show higher than expected contamination rates after reprocessing, the Food and Drug Administration announced today. The agency reminded health care facilities that reprocess duodenoscopes about the importance of strictly adhering to the manufacturer’s reprocessing and maintenance instructions, following best practices and reporting adverse event information to FDA. In 2015, FDA 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. 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, and has instructed the manufacturers to conduct root cause analyses. Final results from the analyses are expected later this year. In the meantime, the agency is exploring possible additional steps to reduce contamination rates. “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.