Medical Device Safety and Recalls: Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes

Today, the FDA issued a safety communication to alert users of the Olympus TJF-Q180V duodenoscope of new, validated manual reprocessing instructions.  Health care professionals, including those working in reprocessing units in health care facilities are encouraged to implement the instructions as soon as possible. The high level disinfection procedure and pre-cleaning step can be put in place immediately. The new manual cleaning instructions can be implemented when a new brush becomes available.  Olympus anticipates shipping the new brush no later than May 8, 2015. Recommendations for facilities and staff that use and reprocess the Olympus TJF-Q180V duodenoscope are included in FDA’s safety communication.

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