FDA orders recall of medical-device cleaners

 

The U.S. Food and Drug Administration ordered a Bucks County manufacturer Friday to recall all 2,800 of its automated washing machines that are used to clean and disinfect endoscopes in hospitals and outpatient clinics.

The FDA said its action against Custom Ultrasonics, of Ivyland, was prompted by continued violations of federal law and of a consent degree that the company entered into in 2007.

Citing reports of serious bacterial infections at hospitals that use the company's machines, formally called reprocessors, the agency said in a news release that technicians should use alternate cleaning methods such as manual disinfection.

The reprocessors were used in multiple hospitals that saw outbreaks of deadly, drug-resistant bacteria in patients treated with a type of endoscope called a duodenoscope, according to former Custom employee Lawrence Muscarella. Duodenoscopes are flexible devices used to examine and treat problems in the bile and pancreatic ducts.

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