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FDA Orders Recall of Scope Sterilization Machines

The U.S. Food and Drug Administration (FDA) recently ordered the recall of all automated endoscope reprocessors (AERs) manufactured by Custom Ultrasonics. According to the agency, the company’s repeat violations of federal regulations could result in an increased risk of infection transmission.

“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” said Dr. William Maisel, chief scientist in the FDA's Center for Devices and Radiological Health. The FDA's recall order “is necessary to protect the public health.”

Risks Associated with Reprocessed Scopes

The FDA-ordered recall is the latest development in the agency’s alarming investigation into the safety of reprocessed endoscopes, including duodenoscopes and scope accessories. As we have previously discussed on this San Diego Injury Blog, the scopes must undergo a multi-step cleaning and disinfection procedure called reprocessing so the medical devices can be reused between patients. If the complex procedure is not performed properly, the medical devices can transmit infections, including those that are resistant to antibiotics. Earlier this year, the inability to thoroughly sterilize the specialty endoscopes was linked to a drug-resistant “superbug” that claimed the lives of three California patients.

Custom Ultrasonics’ History of Violations

In news release, the FDA acknowledged that Custom Ultrasonics has faced scrutiny since 2007, when the agency first charged the company with violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), finding that its corporate practices “posed a potential public health hazard.” Despite the safety concerns, the FDA did not force a product recall at that time. In 2012, the FDA ordered Custom Ultrasonics to halt manufacture, but it later allowed the scope-cleaning machines to remain on the market after the company made approved changes to the product.

The FDA’s most recent inspection of the Custom Ultrasonics’ facility in April 2015 revealed continued violations. Most concerning, the company is unable to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.

Approximately 2,800 AERs manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the United States. Given the risks associated with the recalled medical device, the FDA also issued a related safety communication. It recommends that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative reprocessing methods as soon as possible.

If you or someone you care about has suffered serious harm due to a dangerous or defective medical device, don’t hesitate to contact a San Diego medical product liability attorney at the Law Offices of Robert Vaage for a free consultation.