FDA Recalls Endoscope Reprocessors Over Infection Risks

November 13, 2015

The US Food and Drug Administration (FDA) announced today that it has ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) because of persistent regulatory violations that "could result in the increased risk of infection transmission."

The recall order, issued under a 2007 consent decree, is the FDA's latest action in a long-running campaign to reduce the spread of antibiotic-resistant pathogens by dirty endoscopes, particularly duodenoscopes. This problem topped the list of health technology hazards in 2016 put out earlier this week by the nonprofit ECRI Institute.

The AERs in question include the System 83 Plus, System 83 Plus 2, and System 83 Plus 9, all of which wash and disinfect used endoscopes. The FDA puts the number of these devices in hospitals and outpatient clinics at roughly 2800. Endoscopes reprocessed by AERs from Custom Ultrasonics have figured into reports of "serious bacterial infections," according to an agency news release.

"We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations," said William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health. "The FDA's recall order stemmed from the company's continued violations of federal law and the consent decree and is necessary to protect the public health."

The FDA is advising healthcare facilities that use the company's AERs to switch to other methods of reprocessing endoscopes as soon as possible. These include manual high-level disinfection, liquid chemical sterilization, and alternative AERs, as long as they comply with reprocessing instructions from endoscope manufacturers.

In the Regulatory Doghouse Since 2005

Custom Ultrasonic has been in a regulatory doghouse since the FDA warned it in 2005 about substandard manufacturing processes.

In January 2007, the company and the FDA signed a "consent decree of permanent injunction." Custom Ultrasonics agreed to stop making and distributing its AERs until its manufacturing methods and controls complied with FDA regulations. Operations resumed several months later when the FDA, satisfied that the company was toeing the line, lifted the injunction.

However, the FDA ordered Custom Ultrasonics in 2012 to cease operations again and recall all AER models on the market after the company failed to obtain approval of a significant software change for one of its products, according to the agency. After the company got that approval, the FDA rescinded the recall of the cleared devices, but it didn't give Custom Ultrasonics a green light to resume making and selling its key products. The company continued to service what it already had sold.

In March 2015, Custom Ultrasonics asked for permission to start up operations. The FDA inspected the company's facility a month later and cited it for failing to validate that its AERs can adequately wash and disinfect endoscopes to reduce the risk for infection. The company was given time to correct inspection violations, but the FDA said its response was inadequate. Accordingly, the agency invoked the power given to it by the consent decree to order the recall.

Alicia Nakonetschny, president and CEO of Custom Ultrasonics, did not respond to a request for an interview.


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