Four Older Duodenoscope Models Being Removed From Clinical Use

Megan Brooks

Disclosures

January 13, 2017

Fujifilm Medical Systems Endoscopy Division is removing four older duodenoscope models from clinical use in the United States, the US Food and Drug Administration (FDA) said today in a safety communication.

The company informed the FDA of its plans to remove duodenoscope models ED-250XL5, ED-250XT5, ED-450XL5, and ED-450XT5 in the United States.

These devices are indicated for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

The company said it is not removing the four older duodenoscope models because of a known safety risk, and noted that it has not received any recent reports of adverse events associated with these scopes

The company said only a "limited number" of these older models are currently in use in the United States and the decision to remove them from clinical use was purely a "business decision" for the purpose of providing all US users with the company's most recent model of duodenoscope, the ED-530XT.

The company said it will replace the older duodenoscope models with the ED-530XT, in addition to necessary accessories, at no cost. Alternatively, the company will provide "reasonable reimbursement" for the return of the duodenoscopes.

The ED-530XT model includes the company's latest cleaning and reprocessing guidelines, issued in December 2015. "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," the company said in a customer notification letter.

The FDA recommends that facilities and staff take the following actions:

  • Remove from circulation and return your facility's 250/450 duodenoscope models to Fuji, as outlined in Fuji's customer notification letter.

  • Train appropriate staff on Fuji's validated reprocessing instructions for the ED-530XT model and implement them as soon as possible.

  • Implement the reprocessing procedures for Fuji's ED-530XT duodenoscope in accordance with the manufacturer's reprocessing instructions issued in December 2015.

  • Immediately remove from service to assess, repair, and/or replace any duodenoscope that shows signs of damage. Examples of damage may include loose parts, damaged channel walls, kinks or bends in tubing, holes in the distal end, or other signs of wear or damage.

  • Contact your Fuji (FMSU-ESD) sales representative if you have any questions or concerns regarding this removal, a damaged device, or the validated reprocessing instructions for the ED-530XT duodenoscope.

Healthcare professionals are encouraged to report adverse events related to the use of these products to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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