Devices

FDA Backs Off Scope Cleaner Recall: Kaiser News

FDA has inexplicably reversed position on its recall of some 2,800 Custom Ultrasonics scope-cleaning machines, according to a Kaiser Health News report. The agency had ordered the equipment off the market 11/2014, saying that Custom repeatedly violated safety laws, increasing the risk of patient infection. The recall was reiterated at the beginning of this year after a Senate report linked Custom’s machines to several superbug outbreaks nationwide.

According to Kaiser, FDA now says that the company’s signature product, the System 83 Plus, can remain in use while regulatory issues are being addressed. Regulators and the company said the automated endoscope reprocessors still cannot be used to disinfect duodenoscopes that have been tied to 41 infection outbreaks worldwide and at least 24 deaths in the U.S. But they can be used to wash other types of endocopes.

“Based on information provided by the company, FDA has determined that the products may remain in the field,” an agency statement said. Kaiser says that an FDA spokesperson declined to discuss the information provided by the company that led to the decision. And Custom CEO Alicia Nakonetschny didn’t respond to Kaiser’s request for comment after touting the reprieve and expressing optimism about receiving FDA clearance for all scopes at some point. “We want to assure our customers who reprocess duodenoscopes that we are working with FDA to resolve duodensocope issues as quickly as possible,” she said on the firm’s Web site.

Former Custom Ultrasonics director of infection control Lawrence Muscarella told Kaiser it is “troubling for FDA to order the removal of a medical device it has linked to patient injuries and deaths and then to abruptly reverse course with no clear explanation. This may be unprecedented in the history of medical device regulation.” Muscarella reportedly left the company in 2013 due to what he called safety concerns, after 18 years on the job.

The January Senate report found that the company’s machines were used in at least nine of the 16 U.S. hospitals identified as having scope-related infections. “Considering that only about 10% to 20% of the automatic endoscopic reprocessors used in American hospitals are Custom Ultrasonics’, it appears the defective machines played a significant role in allowing the duodenoscopes to remain contaminated between uses,” it said. It also added that scope-related infections could not be solely attributed to the company’s equipment.

An agency 11/2014 safety communication said that Custom could not prove that its equipment could adequately disinfect endoscopes in general. It also didn’t report adverse events tied to its equipment within 30 days as required by regulations. At the time, FDA chief scientist for medical devices William Maisel said the recall “is necessary to protect the public health.”

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