The U.S. Food and Drug Administration (FDA) has ordered a Pennsylvania company to recall all of its automatic endoscope cleaners, alleging continued violations of federal law that could result in an increased risk of infections in patients who undergo procedures involving the devices. The FDA’s recall order applies to all of Custom Ultrasonics’ approximately 2,800 automated endoscope reprocessors (AERs) currently in use at hospitals and outpatient clinics throughout the country. AERs are dishwasher-sized medical devices used to reprocess, or clean and disinfect, endoscopes between uses.
The FDA ordered the recall after finding the company failed to adequately address continued violations in the months following an April inspection of Custom Ultrasonics’ facilities. In the inspection, the FDA determined the company showed an inability to prove its AERs can sufficiently wash and disinfect endoscopes to mitigate the risk of patient infection. In addition to federal law, the company is also in violation of a 2007 consent decree, the FDA said. The agency recommended that health care facilities currently using the company’s AERs begin using alternative methods to clean flexible endoscopes as soon as possible.
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