The US Food and Drug Administration (FDA) on Friday again ordered a recall of all Custom Ultrasonics’ Endoscope Washer/Disinfector models, also known as Automated Endoscope Reprocessors (AERs), to mitigate the risk of patient infection.

FDA said its most recent inspection of the Custom Ultrasonics’ facility in April documented continued violations and that the company’s AERs “have been used in health care facilities that reported the transmission of serious bacterial infections.” The company has had issues with FDA since before it entered a consent decree with the agency in 2007.

“Violations include the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. The identified violations could result in an increased risk of infection transmission,” FDA said. “Under the terms of the consent decree, the agency is ordering Custom Ultrasonics to recall all its AERs.”

Background

AERs are free-standing units used in health care facilities to disinfect flexible endoscopes and scope accessories between uses in gastrointestinal and pulmonary tracts.

FDA has previously warned about duodenoscopes, which also can be difficult to sanitize, and have been found to spread bacteria, including carbapenem-resistant enterobacteriaceae (CRE).

In August, FDA sent a warning letter to Japan-based Olympus for failing to notify the agency of deaths or serious injuries that may have been caused by its duodenoscope. FDA pointed to 16 patients who contracted a Pseudomonas aeruginosa infection, of which some resulted in abscesses, after undergoing an endoscopic procedure with the Olympus device.

FDA has also warned two other manufacturers -- Fujifilm and Hoya – for failures related to cleaning procedures and reporting known infections.

Consent Decree

In 2012 and 2013, under the terms of the consent decree, FDA ordered Custom Ultrasonics to stop manufacturing and distributing all 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 software change, the cleared devices were permitted to remain on the market. Since the 2012 and 2013 orders, the FDA has not authorized Custom Ultrasonics to resume manufacturing or distributing any AERs, though the company has continued to service them.

Since 10 August, FDA has received 21 complaints on Custom Ultrasonics. FDA recommends that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative reprocessing methods as soon as possible. 

Guidance

In March, FDA also issued new guidance requiring manufacturers of reusable medical devices to more thoroughly test and label their devices to ensure patients are not inadvertently exposed to dangerous pathogens.

FDA Recommendation