Olympus Duodenoscope Cleaning Instructions Validated: FDA

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In response to multiple reports of Olympus endoscopes being difficult to wash and disinfect, the manufacturer has issued updated reprocessing instructions for its TJF-160F and TJF-160VF model duodenoscopes. Earlier this year, Olympus issued a recall for thousands of endoscopes after it was found that the devices passed the antibiotic resistant CRE superbug between patients during ERCP procedures.

What’s the problem?

March 15, 2016 – As noted in the FDA’s February 2015 Safety Communication, the complex design of Olympic duodenoscopes make them difficult to clean and disinfect, a complex multi-step process called “reprocessing.” If the scopes are not properly reprocessed, residual body fluids and organic debris may remain in tiny crevices of the device, exposing subsequent patients to serious infection via microbial contamination.

FDA has reviewed and validated the updated reprocessing instructions for the Olympic TJF-160F and TJF-160VF duodenoscopes, and continues to evaluate the link between endoscopes and the transmission of infectious agents.

FDA Recommendation

FDA is advising facilities who use affected Olympus duodenoscopes to train their staff on the updated instructions and implement them as soon as possible. Olympus this week sent a letter to healthcare facilities and other users of the devices outlining the new reprocessing instructions. An updated reprocessing manual and a box of MAJ-1534 brushes required for the updated cleaning procedure accompanies the letter.

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