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FDA: Duodenoscopes from three major companies now safe to use with updated instructions

Accreditation Insider, February 23, 2016

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On February 19, the Food and Drug Administration (FDA) announced that reprocessing instructions for Pentax duodenoscopes had been validated and approved by the agency.  The announcement means that scopes from the three major manufactures, Olympus, Fujifilm, and Pentax, are now safe to use with their updated instructions.

Five months ago, the FDA issued safety warning against the three companies, stating that a design flaw prevented their scopes from being cleaned properly and were an infection risk. A later Senate investigation revealed that dirty scopes were the direct cause of 25 infection outbreaks since 2012

Pentax was the final company to have its updated reprocessing instructions validated by the FDA, with instructions for Fujifilm scopes and modifications to Olympus scopes approved in January.

Click here to read the FDA’s full safety communication on Pentax’s reprocessing instructions for the ED-3490TK Video Duodenoscope.



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