3 Duodenoscope Makers Ordered By FDA To Study Post-Market Cleaning Steps

(October 28, 2015, 12:27 PM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on Oct. 5 ordered three makers of duodenoscopes to perform post-marketing surveillance studies on how their devices, associated with patient infections, are cleaned or “reprocessed” after use.

The order was sent to Olympus America Inc., Fujifilm Medical System U.S.A. Inc. and the Hoya Corp. Pentax Life Care Division. The manufacturers must study and evaluate how well health care personnel follow cleaning and disinfecting instructions to better understand the rate of contamination.

The FDA said duodenoscopes may contribute...
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