Fujifilm Issues Urgent Recall of ED-530XT Duodenoscopes

Megan Brooks

July 21, 2017

Fujifilm Medical Systems USA has voluntarily recalled all ED-530XT duodenoscopes and is notifying customers in an urgent medical device correction and removal notice, according to a US Food and Drug Administration (FDA) safety communication issued today.

The company will replace the ED-530XT forceps elevator mechanism, including the O-ring seal, as well as the distal end cap and will issue new operation manuals.

The FDA has approved the updated design and labeling for the ED-530XT duodenoscope, which is used in endoscopic retrograde cholangiopancreatography procedures.

In 2015, the FDA announced that the complex design of duodenoscopes may impede effective reprocessing. Since then, the agency has been working with duodenoscope manufacturers to modify and validate their reprocessing instructions to enhance safety. This was prompted by outbreaks of antibiotic-resistant infections linked to duodenoscopes.

The problem was of such concern that the Economic Cycle Research Institute ranked it at the top of its list of health technology hazards that hospitals and clinicians should tackle in 2016, as reported by Medscape Medical News.

Earlier this year, Fujifilm informed the FDA that it was removing four older duodenoscope models from clinical use in the United States (models ED-250XL5, ED-250XT5, ED-450XL5, and ED-450XT5) and was replacing them with the newer the ED-530XT model.

Two years ago, Fujifilm issued updated manual reprocessing instructions for the ED-530XT duodenoscope model to replace those provided in the original device labeling.

The FDA worked with Fujifilm as they modified and validated reprocessing instructions for the ED-530XT duodenoscope to show "with a high degree of assurance that the instructions, when correctly followed, will lead to effective cleaning and disinfection of the ED-530XT duodenoscope," the FDA said in its statement.

Now, in light of the new safety communication, the FDA has asked healthcare providers to acknowledge Fujifilm's urgent medical device correction and removal notice; identify any affected duodenoscopes on hand; remove and replace any older operation manuals from the facility; and destroy and dispose of them properly, when new operation manuals arrive.

In the meantime, providers should continue to use the 2015 updated instructions when reprocessing Fujifilm ED-530XT duodenoscope models. "The validated reprocessing instructions, when followed correctly, are intended to effectively clean and high-level disinfect the Fujifilm ED-530XT duodenoscope," the FDA said.

Healthcare professionals and patients are encouraged to report problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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