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FDA Continues to Advise against use of Custom Ultrasonics Duodenoscope Reprocessor

Feb 26, 2016

Following a mandatory recall, the U.S Food and Drug Administration (FDA) is asking hospitals to stop using Custom Ultrasonics duodenoscope reprocessors. Duodenoscopes are devices that are snaked through the gastrointestinal tract to visualize and treat problems in the duodenum, the first section of the small intestine. The devices came under increased scrutiny after they were linked to outbreaks of CRE bacterial infections; these are "superbugs" resistant to antibiotics.

In November, the FDA ordered Custom Ultrasonics to recall its Automated Endoscope Reprocessors used to disinfect duodenoscopes. In an updated safety communication, the agency essentially said Custom Ultrasonics attempted to negotiate the terms of the recall. Instead of recalling all 2,800 of its endoscope cleaning machines, the company proposed fixing them. The FDA called this action "inadequate" and reiterated the terms of the recall in a January 29, 2016 letter.

In light of these events, the FDA is once again asking hospitals to discontinue use of the reprocessors. In its update the agency said "Because Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection, the Agency continues to recommend that health care facilities using Custom Ultrasonics AERs transition to alternative methods to reprocess flexible endoscopes as soon as possible, as emphasized in its November 13, 2015 Safety Communication."

According to Fierce Medical Devices, the FDA has known of 142 contaminated duodenoscopes since 2010. The agency was criticized last year for its slow response to the issue. In January 2015, two patients died and 7 were injured in a duodenoscope-linked outbreak of CRE at a Los Angeles hospital.

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