On January 13, 2017, the FDA announced that Fuji informed the FDA of its plans to remove legacy 250/450 duodenoscope models from clinical use. Fuji will replace the 250/450 duodenoscope models, in addition to necessary accessories (i.e., brushes), with the ED-530XT model at no cost.
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.
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. The validated reprocessing instructions, when followed correctly, are intended to effectively clean and high-level disinfect the Fuji ED-530XT duodenoscope.
See the FDA Safety Alert
See the FDA’s Infections Associated with Reprocessed Duodenoscopes webpage
See also Medical Law Perspectives, October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment
See the Medical Law Perspectives March 11, 2015, Blog: Uncleanable ERCP Duodenoscopes: Manufacturer, Hospital, and Physician Liability?