FDA recalls All Custom Ultrasonics Automated Endoscope Reprocessors

Washington, DC: The U.S. Food and Drug Administration (FDA) has ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm' continued violations of federal law. The identified violations could result in an increased risk of infection transmission. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.

These actions are part of the FDA' commitment to patient safety and ongoing efforts to minimize the risk of patient infections associated with reprocessed endoscopes, including duodenoscopes and scope accessories.

An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the United States. The FDA' 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' recall order, Custom Ultrasonics must provide a written recall proposal to the FDA.

AERs are Class II medical devices that require 510(k) clearance and are used to wash and high-level disinfect endoscopes to decontaminate them between uses. AERs are designed to expose outside surfaces as well as interior channels of endoscopes to chemical solutions in order to kill microorganisms and prevent the spread of infection from these reusable medical devices. An endoscope must be thoroughly cleaned to remove any visible debris prior to placing it in an AER, which includes manually scrubbing the elevator mechanism and the recesses surrounding the elevator mechanism. In 2012, under the terms of the consent decree, the FDA ordered Custom Ultrasonics to stop manufacturing and distributing all AER device models and components, and ordered their recall 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.

The safety communication issued by the FDA today recommends that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.

The safety communication is based on both the recent violations of the law and consent decree and reports that endoscopes reprocessed by Custom Ultrasonics' AERs have been used in health care facilities that reported the transmission of serious bacterial infections.

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Last updated on Nov-16-15