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FDA Orders Recall of Custom Ultrasonics Endoscope Cleaning Devices

Nov 25, 2015

On November 13, 2015, the Food and Drug Administration (FDA) ordered Custom Ultrasonics to recall its automated endoscope reprocessors (AERs) from health care facilities because the devices do not properly clean and disinfect endoscopes between uses.

The FDA, in ordering a recall, cited Custom Ultrasonics' continued violations of federal law and a consent decree entered with the company in 2007. The violations could result in an increased risk of transmitting infections, the FDA said in a news release.

The agency also issued a safety communication on November 13 recommending that health care facilities currently using Custom Ultrasonics AERs find alternative methods to reprocess flexible endoscopes as soon as possible.

In the news release, the FDA says it has been working with federal partners and manufacturers to better understand the factors contributing to bacterial infections associated with duodenoscopes and how to best mitigate them.

An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently used in hospitals and outpatient clinics throughout the United States. The FDA's recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9. Within seven business days after receiving the FDA's recall order, Custom Ultrasonics must provide a written recall proposal. "We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations," said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health.

AERs are Class II (moderate risk) medical devices that are used to decontaminate endoscopes between uses. AERs are designed to expose both outside surfaces and interior channels of endoscopes to chemical solutions in order to kill microorganisms and prevent the spread of infection. Visible debris must be removed before an endoscope is placed in an AER. The elevator mechanism and the recesses surrounding the elevator mechanism must be manually scrubbed.

Under the terms of a 2012 consent decree, Custom Ultrasonics had to stop manufacturing and distributing AER device models and components, after the company failed to obtain FDA clearance following a significant change to the software operating system for one of its AERs. After Custom Ultrasonics obtained clearance for the significant change to the software operating system, the cleared devices were permitted to remain on the market. Since the 2012 order, the FDA has not authorized Custom Ultrasonics to resume manufacturing or distributing any AERs, though the company has continued to service them.

In April 2015 recent inspection of Custom Ultrasonics' facility, the FDA documented continued violations and determined that Custom Ultrasonics has not adequately addressed its continued violations, which could result in an increased risk of infection transmission to patients.

Endoscopes have been linked to outbreaks of drug-resistant bacterial infections in hospitals across the country. Seven patients at Ronald Reagan UCLA Medical Center contracted an antibiotic-resistant strain of bacteria after undergoing endoscopic procedures with a device made by Olympus Corp. Two of the patients died from the infection. Cedars-Sinai Medical Center in Los Angeles reported four infections with the same superbug in patients treated with the same endoscope. Infections following endoscope procedures have occurred in Seattle, Pittsburgh, and Chicago. On November 20, a North Carolina woman filed a wrongful death lawsuit against Olympus after her husband died from an antibiotic-resistant bacterial infection following an endoscopy procedure. The lawsuit also names Custom Ultrasonics.

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