FDA issues regulatory warnings to three duodenoscope makers

The Food and Drug Administration has issued “warning letters” to three duodenoscope manufacturers alleging certain regulatory violations. Olympus Corp. of the Americas and Hoya Corp. were cited for failing to report infections associated with their devices to FDA within 30 days and to adequately develop, maintain and implement written Medical Device Reporting procedures. Hoya also was cited for certain alleged violations related to design validation, corrective action and process control. Fujifilm Medical Systems USA Inc. was cited for alleged violations related to design control, corrective action, inspection of parts, process validation, complaint handling, equipment testing, production processes, and device correction or removal. The letters ask the manufacturers to notify the agency within 15 days of the specific steps they have taken to correct the alleged violations. FDA this month issued guidance on supplemental reprocessing measures that may further reduce the risk of infection associated with the use of duodenoscopes – flexible, lighted tubes that are threaded through the mouth into the small intestine to drain fluids from blocked pancreatic and biliary ducts. For more on the issue, including links to the letters, visit www.fda.gov.