Fujifilm Holdings (TSE:4901) said today that it will pull its legacy 250/450 duodenoscope models from clinical use and replace those devices with the ED-530XT model at no cost to its customers.
The company said in a letter to its customers that the decision is not directly related to any safety concerns and that it has not received any recent reports of adverse events associated with the scopes.
The FDA is continuing to investigate the link between reprocessed endoscopes and the transmission of infectious agents by working with duodenoscope manufacturers as they incorporate new techniques to adequately disinfect the devices.
Duodenoscopes are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into a patient’s throat. More than 500,000 ERCPs using the scopes are performed annually in the U.S.
In February and March 2015, inadequately-cleaned duodenoscopes were tied to deadly suberbug outbreaks in hospitals in Connecticut, Virginia, California and Washington. The scopes associated with the infectious outbreak were made by Olympus (TYO:7733) and Hoya‘s (TYO:7741) Pentax subsidiary. No deaths have occurred in association with Fujifilm’s duodenoscopes.
Following the outbreak, the FDA published warning letters that it sent to the endoscope makers, warning them about violations that the federal watchdog found during spring inspections at plants located in the U.S. and Japan.
In December 2015, the FDA cleared FujiFilm’s revised manual reprocessing instructions for its ED-530XT duodenoscope, replacing reprocessing instructions included on the original device label.
