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Infection risk with duodenoscopes prompts FDA to order postmarket surveillance studies

Oct. 05, 2015 12:46 PM ETOlympus Corporation (OCPNF) StockOLYMY, FUJIF, FUJIY, OCPNFBy: Douglas W. House, SA News Editor
  • The prevalence of duodenoscope-related infections prompts the FDA to order three manufacturers, Olympus America (OTC:OCPNF) (OTCPK:OCPNY), Fujifilm Medical Systems (OTCPK:FUJIF) (OTCPK:FUJIY) and Pentax LIfe Care's Hoya, to conduct postmarket surveillance studies to better understand how the devices are reprocessed in the hospital setting. The companies, who have 30 days to submit their plans to the FDA, must assess how well health care personnel are following instructions to clean and disinfect the devices between patients. The studies will also enable the FDA and manufacturers to better understand the rate of contamination of duodenoscopes used in clinics.
  • Duodenoscopes are flexible lighted tubes used in endoscopic retrograde cholangiopancreatography procedures (ERCP), which are performed ~500K times each year in the U.S. to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions. The complex design of the devices makes it more difficult to remove contaminants compared to other endoscopes. The FDA perceives, based on its own analysis, that the manufacturer's instructions for reprocessing are not consistently being followed correctly because the procedure is labor intensive and prone to human error.
  • Results from the studies could help inform the FDA's risk mitigation strategies, which could include revised product labeling.

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