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 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.
Muscarella, a University of Pennsylvania-trained biomedical engineer who is now an infection-control consultant, said he left the company in early 2013 amid concerns over the safety of its products.
Under the 2007 consent decree, the FDA issued an initial recall of the machines in 2012, saying the company had failed to obtain clearance after a significant change to the software for one type of machine. The agency also ordered the company to stop making the machines.
But the company then obtained clearance for the software change, and the FDA did not require it to proceed with the recall, the agency said.
In the news release, the FDA said the new recall was prompted by concerns that the company had not validated that its machines can "adequately wash and disinfect endoscopes to mitigate the risk of patient infection."
Company officials did not respond to a request for comment.
Muscarella said the FDA took too long to act, and should have enforced its original recall.
"Either recall the product and make sure it's promptly removed, or don't recall a product," Muscarella said. "That's problematic from a public health standpoint."
Michael A. Carome, director of the health research group at the consumer-advocacy organization Public Citizen, agreed.
"What troubles me is the pace at which the FDA has moved on this, and the length of time they allowed problems to fester, putting patients at risk," Carome said.
The agency has raised concerns both about the reprocessing machines and about duodenoscopes.
The agency has raised particular concern about newer models with intricate mechanisms and enclosed areas that are difficult to clean. Among the manufacturers that have come under scrutiny is Olympus, which has U.S. headquarters in Center Valley, near Allentown.
Such scopes have been linked to deadly drug-resistant infections at hospitals in Los Angeles, Seattle, and elsewhere.
In Philadelphia, Thomas Jefferson University Hospital said eight patients in 2013 and 2014 tested positive for this type of infection after being examined with this type of scope.
Yet hospital officials said they had found no proof that the devices had transmitted the infections.
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