Custom Ultrasonics—Automated Endoscope Reprocessors: FDA Orders Recall and Recommends Facilities Transition to Alternative Reprocessing Methods

November 25, 2015 | Strategic Insights for Health System


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​In a November 13, 2015, News Release, and a November 13, 2015, Safety Communication, FDA states that in accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics, it has ordered Custom Ultrasonics to recall all of its AERs from healthcare facilities because of the firm's continued violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), applicable regulations, and the Consent Decree. or background on the Consent Decree and subsequent FDA regulatory actions since the Consent Decree was entered, see the Summary of Problem and Scope section of the Safety Communication. FDA states that its most recent inspection of the Custom Ultrasonics facility in April 2015 documented continued violations, including the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection and that the identified violations could result in an increased risk of infection transmission. FDA also states that Custom Ultrasonics must provide a written proposal to FDA within 7 business days after receiving FDA's recall order. Custom Ultrasonics posted a Response to FDA's Safety Communication on their website. The manufacturer has not confirmed the information provided in the source material.


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