Citing continued violations of a 2007 consent decree, the FDA has ordered Custom Ultrasonics to recall all 2,800 automated endoscope reprocessors in hospitals and outpatient clinics in the U.S.
The move, which comes after reports of inadequately reprocessed duodenoscopes were linked to infection transmission in hospitals across the country, follows an April agency inspection that found a number of violations, including the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.
Despite an agency request to fix the violations and provide additional validation data, the FDA has determined that the company has not adequately addressed the problems. To lessen the risk of infection transmission, the agency is recommending that healthcare facilities currently using Custom Ultrasonics AERs adopt alternative methods to reprocess flexible endoscopes as soon as possible.
This is not the first time Custom Ultrasonics has fallen under FDA scrutiny after entering the consent decree. In 2012, the agency ordered the company to stop manufacturing and distributing all AER device models and components, and ordered their recall after the company failed to obtain clearance following a significant change to the software operating system for one of the reprocessors.
Custom Ultrasonics subsequently obtained clearance, and the products were permitted to remain on the market.
Since that time, the company has not been authorized to manufacture or distribute AERs, but it has continued to service them.
Earlier this year, the FDA strengthened controls on reprocessing of certain products, including AERs, in response to the infections linked to the duodenoscopes. In final guidance, the FDA required manufacturers of the products to include data validating the effectiveness of their reprocessing methods as part of their 510(k) submissions ().
Custom Ultrasonics did not respond to a request for comment by press time. — Jonathon Shacat