FDA Won't Pull Duodenoscopes

March 13, 2015 5:34 PM

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medical device a medical device used in several surgical procedures, the US Food and Drug Administration (FDA) has announced that it will remain on the market. Instead of pulling the device, the FDA has issued new guidance aimed at addressing the possible spread of infectious agents between uses.

“Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low” said William Maisel, M.D., M.P.H., deputy director for science a...

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