FDA: Certain Fujifilm duodenoscopes removed from clinical use

Editor's Note

The Food and Drug Administration (FDA) on January 13 issued a Safety Communication that Fujifilm Medical Systems (Wayne, New Jersey) will remove its legacy 250/450 duodenoscope models from clinical use based on the limited number currently in use.

Fuji will replace the 250/450 models with the ED-530XT model, in addition to necessary accessories at no cost.

Posted 01/13/2017] AUDIENCE: Gastroenterology, Nursing, Risk Manager ISSUE: Fuji informed the FDA of its plans to remove legacy 250/450 duodenoscope models from clinical use based on the limited number currently in use. The validated manual reprocessing procedures for the ED-530XT duodenoscope outlined in December 2015 remain the same.