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Olympus Validates Duodenoscope Data for FDA

March 16, 2016 By Rebecca Rudolph-Witt

The FDA alerted clinicians in gastroenterology and infection control specialties that Olympus updated its duodenoscope reprocessing guidelines, specifically for models TJF-160F and TJF-160VF, on March 15. The updates were the result of a FDA mandate that duodenoscope manufacturers validate the manual cleaning process of the scopes following national superbug outbreaks linked to the instruments.

The focus of these updates is to do more of what reprocessing staff were already tasked with, but on a more thorough level. For instance, during manual cleaning, the new instructions including more flushing with increase flushing volume and more brushing than previously required. Olympus also introduced a reusable brush to clean the distal end of the scope, including the elevator recess.

These changes, with detailed descriptions, were communicated by Olympus to healthcare facilities possessing these models, and they were advised to update staff. For the full letter, click HERE. 

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