Fujifilm Medical Systems plans to remove four legacy duodenoscope models from clinical use "based on the limited number currently in use," according to a Food and Drug Administration safety alert issued Jan. 13.
The four models are Fuji ED-250XL5, ED-250XT5, ED-450XL5 and ED-450XT5. Fuji will replace any of the retired models with the ED-530XT duodenoscope as well as necessary accessories, like brushes, at no cost to the facility.
Duodenoscopes are notoriously difficult to clean and have been linked to roughly 350 superbug infections in the U.S., the FDA found. However, in the letter Fujifilm sent to customers, the company said it "is not conducting this product removal due to a known safety risk."
The letter continues to say that Fujifilm "has not received any recent reports of adverse events associated with these legacy scopes," and is instead taking this action to give U.S. customers the must recent model of the scope.
The FDA recommends all provider organizations take Fujifilm up on its offer to return the old scopes. The FDA's other recommendations include:
- Train staff on Fujifilm's reprocessing instructions for the new model and implement them as soon as possible
- Immediately remove duodenoscopes from service if they show signs of damage like loose parts, damaged channel walls or kinks in the tubing
- Contact a Fujifilm sales representative with any questions