The FDA issued new guidance on duodenoscopes, a medical device which has come into the spotlight after being linked to a number of infections, and deaths, across the country. According to the updated information for healthcare providers, the FDA has received inquiries from healthcare providers about whether they should cancel ERCP procedures, based on the fact that one specific model duodenoscope manufactured by Olympus does not currently have a 510(k) clearance. The agency is does not recommend these procedures be canceled for patients who need them. Olympus has a pending 510(k) application for this device, and the company continues to market the product while the application is under review. The FDA is not taking action against Olympus regarding its device during our review of the application, because based on the information currently available to them, they "believe that that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year ." In addition, the FDA said they have no evidence that the lack of a 510(k) clearance was associated with the infections, and analysis indicates that the reported duodenoscope-associated infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers. The agency is recommending healthcare providers, among other things, thoroughly clean and disinfect duodenoscopes, pursuant to the manufacturers’ instructions, have a comprehensive quality program in place for reprocessing duodenoscopes and if providers suspect that a duodenoscope may be associated with a patient infection, take it out of service and meticulously clean and disinfect it until it is verified to be free of pathogens.
New FDA information on medical device linked to number of deaths
The removal of the specific medical device in question could create a shortage.
Mar 5, 2015
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