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FDA Orders Recall of Endoscope Washers, Citing Infection Risk

The US Food and Drug Administration (FDA) recently ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to continued violations of federal law. The FDA also simultaneously issued a safety communication recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternate reprocessing methods.

Endoscopes are devices used to look inside a body cavity or organ. AERs are units used to wash and high-level disinfect flexible endoscopes and scope accessories between patients. According to the FDA, Custom Ultrasonics’ AERs could not adequately wash and disinfect the endoscopes, resulting in deadly germs becoming trapped inside the scope and then transmitted to the next patient.

The FDA’s order could not come at a more appropriate time, as the problem with the spread of antibiotic-resistant pathogens by dirty endoscopes topped the 2016 list of health technology hazards put out earlier this month by ECRI, a nonprofit organization. The order also comes amid concerns about infection outbreaks linked to improperly cleaned duodenoscopes – a type of endoscope used in endoscopic retrograde cholangiopancreatography procedures.

If you or someone you know has been injured by a defective medical device, contact our legal team. Bottar Leone, PLLC, has decades of experience investigating, prosecuting, and trying to verdict all types of cases, including those involving products liability.

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