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FDA Recall Reversal on Equipment Tied to Superbug Outbreak

FDA Recall Reversal on Equipment Tied to Superbug Outbreak


The recent outbreak of superbugs like CRE has investigators looking for all possible causes, including cleaning equipment. One such piece of equipment is used to wash and disinfect medical devices that require a light and camera, such as an endoscope. The Federal Food and Drug Administration linked this machine manufactured by Custom Ultrasonics, Inc. In the outbreaks in Seattle and Los Angeles and ordered the company to remove it from hospitals. That machine is still service with little explanation from the federal agency as to why.

The Recall

In 2015, the FDA ordered the recall of the 2,800 automated endoscope reprocessors manufactured by the Pennsylvania company Custom Ultrasonics. The agency had determined the machines played a key role in deadly CRE outbreaks that occurred in a number of cities. This sophisticated machine had washed the duoendoscopes tied to the patient deaths.

In January 2007, a consent decree was issued that requires Custom Ultrasonics to stop making and selling their cleaning device. The FDA issued the recall because the company failed to comply with that order. Customs was also required to pay for damages.

The Reversal

On May 9, 2016, the agency reversed their recall order despite their researchers claim that this piece of equipment was a public health risk. By backing off, Custom Ultrasonics can continue to sell their signature product, the System 83 Plus while the agency sorts out the regulatory issues.

The only comment made by the FDA was a generic statement saying that based on information provided by the manufacturer, the product could stay in the field. Custom Ultrasonics also issued a statement about the reversal, saying their company was working with the agency to resolve the issues quickly.

As part of the reversal, the FDA will require regular validation of the cleaning machines to prove their effectiveness on all instruments including endoscopes and duoendoscopes.

Continuing Risk

The reversal is a concern for the medical community, according to the former director of infection control at Custom Ultrasonics, Lawrence Muscarella. The Senate investigation into the CRE outbreaks and the ensuing patient deaths did determine that the use of this machine was one of a number of factors that contributed to the contamination. Not all of the hospitals with outbreaks related to the use of a duoendoscope had this machine in service, though.

Ultimately, the problem with the duoendoscopes is a design issue. The intricate apparatus makes them difficult to clean by any means. They require repeated washing and then testing to ensure they are no longer contaminated. The model of the scope made by Olympus that was linked to the deadly CRE outbreaks was also recalled by the FDA.

The reversal comes with little explanation from the FDA, which is puzzling. The change of attitude of the agency appears to send the wrong message, according to Muscarella and patients should question their safety when undergoing procedures requiring a reusable endoscope.

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