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Recall of defective endoscope reprocessesors cancelled without explanation

Accreditation Insider, May 10, 2016

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The Food and Drug Administration (FDA) announced last week that it was cancelling the recall of 2,800 Custom Ultrasonics automated endoscope reprocessors (AER.) Custom Ultrasonics was one of the corporations embroiled in the duodenoscope scandal last year, after contaminated scopes caused scores of deaths and infection outbreaks.

 “Based on information provided by the company, the FDA has determined that the products may remain in the field,” the FDA said to Kaiser Health News (KHM).

The FDA gave no other explanation about its reversal, despite supporting the recall as recently as this February. The agency also said that while Custom Ultrasonics AERs shouldn’t be used to wash Olympus brand scopes, the FDA says they can be used to wash scopes from other brands.

KHN reports that dirty scopes have been linked to 41 infection outbreaks globally, and 24 deaths in America. A U.S. Senate report found that at least nine of 16 U.S. hospitals with infection outbreaks used Custom Ultrasonics brand AERs. Legislators went as far to sayadded that Custom Ultrasonics’ automated endoscope reprocessors likely contributed to patient infections.

“Considering that only about 10% to 20% percent of the AERs used in American hospitals are Custom Ultrasonics AERs, it appears the defective machines played a significant role in allowing the duodenoscopes to remain contaminated between uses,” the Senate report investigation concluded.

Custom Ultrasonics has been in trouble with the FDA since 2007, when the company signed a federal consent decree because its “actions posed a potential public health hazard because endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients.” The company has been banned from making or selling new AERs since 2012. The AER recall was sent outissued in November 2015, after an FDA inspection revealed continued violations of federal law and consent decree, such as a failure to validate if whether their Custom Ultrasonics AERs could properly disinfect scopes.

Lawrence Muscarella, who left his position as director of infection control at Custom Ultrasonics in 2013 over his safety concerns, told KHN that the FDA’s reversal is concerning.

 "It is certainly troubling for the 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 regulations," he said.


 



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