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FDA drops recall of Custom Ultrasonics’ automated endoscope reprocessors
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The FDA has permitted Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors to remain in use for reprocessing certain endoscopes while validation for duodenoscope reprocessing continues.
The Agency issued a recall order in November after accusing the company of repeatedly violating federal law and a consent decree between the company and the FDA, which could result in an increased risk for infection transmission to patients.
The recall order pertained to all automated endoscope reprocessors (AERs), including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9, which amounted to approximately 2,800 AERs in clinics and hospitals throughout the United States.
In January, a Senate investigation of “superbug” outbreaks across the country found the company failed to validate the compatibility of its AERs with closed-channel duodenoscopes, and failed to sufficiently report problems with these devices to the FDA. The terms of the recall order were reinforced in February after Custom Ultrasonics submitted a recall strategy to the FDA that the agency deemed inadequate.
Now, the FDA has determined these AERs can remain in use while the validation process continues.
“Based on information provided by the company, the FDA has determined that the products may remain in the field for reprocessing other endoscopes during this validation,” an FDA spokesperson said in an email statement. However, “the company is notifying its customers that the System 83 Plus AERs should not be used to reprocess duodenoscopes until further notice,” they added.
In a letter on the company’s website, Alicia Nakonetschny, president and CEO of Custom Ultrasonics, did indicate that these AERs should only be used to reprocess certain endoscopes, and not for cleaning or high-level disinfection of duodenoscopes at this time, and that forthcoming instructions would be communicated to customers.
“CUI is committed to the safety and efficacy of reprocessing,” she wrote. “FDA continues to work with the industry and CUI to validate their reprocessing instructions and to enhance the safety margin of the methods used to clean and disinfect all duodenoscopes manufactured by Olympus, Pentax and Fujifilm.”
Disclosures: Nakonetschny is employed by Custom Ultrasonics Inc.