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Older Model Duodenoscopes Pulled from Market

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Santa Clara, CAFuji, the maker of allegedly defective duodenoscopes, has announced it plans to remove its legacy 250/450 duodenoscope models from clinical use. The decision is reportedly based on the limited number of duodenoscopes currently in use, not because of a known safety risk, and noted that it has not received any recent reports of adverse events associated with these scopes.

The US Food and Drug Administration (FDA) has issued a warning that duodenoscopes could be linked to the spread of deadly bacteria. This warning concerns ERCP endoscopes, also known as duodenoscopes, and comes on the heels of reports of serious multi-drug resistant bacteria in patients who had medical procedures involving the medical devices. Duodenoscope lawsuits have now been filed after patients reportedly developed infections linked to devices.

In December 2015, Fuji issued validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. At that time, the FDA recommended that users and health care facilities apply the revised reprocessing instructions for the ED-530XT duodenoscope to reprocess the older 250/450 duodenoscope models while formal validation testing continued for these particular models.

According to a statement from the FDA, the validated manual reprocessing procedures for the ED-530XT duodenoscope outlined in December 2015 remain the same. Health care facilities should continue to use these validated instructions when reprocessing Fuji ED-530XT duodenoscope models.

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