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FDA Reportedly Reverses Decision on Endoscope Recall

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Washington, DCFollowing a 2015 announcement of an endoscope recall, linked to an endoscope-cleaning device and a 2016 announcement confirming the recall, the US Food and Drug Administration (FDA) has now said a machine used to clean duodenoscopes can stay on the market. The product, known as the System 83 Plus machine, is made by Custom Ultrasonics. According to reports, the recall was initially announced to protect public health after improperly cleaned duodenoscopes were linked to several infection outbreaks in the United States.

On November 13, 2015, the FDA announced it had ordered Custom Ultrasonics to recall all 2,800 of its automated endoscope reprocessors (AERs) from health care facilities. The FDA alleged at the time that Custom Ultrasonics committed “continued violations of federal law” and “failed to meet its legal and regulatory obligations.”

AERs are used to wash and disinfect endoscopes, ensuring they do not spread infections from patient to patient. But according to the FDA, a 2015 inspection of Custom Ultrasonics’ facility uncovered violations of federal regulations, including lack of documentation that the AER devices were properly washing and disinfecting the endoscopes.

On February 23, the FDA updated its Safety Communication, advising health care facilities using Custom Ultrasonics’ AERs to “transition to alternative methods to reprocess flexible endoscopes as soon as possible.” The Safety Communication also noted that the FDA sent a letter to Custom Ultrasonics requiring the company to remove the devices from the market.

A US Senate investigation into the superbug outbreaks linked Custom Ultrasonics to the spread of infection. A report issued in January 2016, titled “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients,” noted that Custom Ultrasonics and other makers of AERs failed to adequately test whether the duodenoscopes (a type of endoscope) could be properly cleaned in real-world settings. And although the hospitals took a share of the blame handed out by the Senate - including not properly reporting infection outbreaks - the Senate was especially critical of device makers and the FDA.

According to the Senate report, between 2012 and 2015, there were 25 different outbreak infections linked to closed-channel duodenoscopes and at least 250 patients affected. In the United States, many - but not all - of the hospitals that experienced outbreaks used an AER made by Custom Ultrasonics. Of 16 domestic hospitals linked to infections, Custom Ultrasonics machines were used in at least nine, leading the Senate to conclude that the company’s AER “played a significant role in allowing the duodenoscopes to remain contaminated between uses.”

Furthermore, the Senate writes, “Custom Ultrasonics’ AERs do not appear to have consistently provided HLD [high level disinfection] when used to clean duodenoscopes after procedures, and the company, like the duodenoscope manufacturers, appears to have repeatedly abused the expectations of the current regulatory system.”

Despite the FDA’s recall and the Senate investigation, however, the FDA has now reportedly said the AER devices can remain on the market. A letter sent from Custom Ultrasonics to health care professionals (found online at notes the company is working with the FDA to validate reprocessing instructions, and states the System 83 Plus remains in use for certain endoscopes, excluding duodenoscopes.

Lawsuits have been filed against the makers of various endoscope devices alleging patients were harmed by improperly disinfected endoscopes.


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