The U.S. Food and Drug Administration has dropped a recall of about 2,800 scope-cleaning machines used at hospitals and clinics nationwide despite a finding by a top agency scientist last year that the action was “necessary to protect public health.”
The FDA had ordered the equipment off the market in November because it said Custom Ultrasonics of Ivyland, Pa., had repeatedly violated federal safety laws, and that those lapses could increase the risk of infection for patients. The agency reiterated the recall in January after a Senate report linked Custom’s machines to several superbug outbreaks across the country.
Now the FDA has backed off, saying the company’s signature product, the System 83 Plus machine, can remain in the field while regulatory issues are addressed.
Regulators and the company said these sophisticated washing machines known as Automated Endoscope Reprocessors still cannot be used to disinfect a specific type of gastrointestinal scope called a duodenoscope that’s been tied to 41 infection outbreaks worldwide and at least 24 deaths in the U.S. But the machines can be used to wash other endoscopes, despite the company’s history of regulatory troubles since 2007.
“Based on information provided by the company, the FDA has determined that the products may remain in the field,” the agency said in a statement.
A spokeswoman for the FDA declined to discuss the new information that the company provided.
Custom Ultrasonics Chief Executive Alicia Nakonetschny didn’t respond to a request for comment. Earlier, she expressed optimism about receiving FDA clearance for all scopes at some point.
“We want to assure our customers who reprocess duodenoscopes that we are working with FDA to resolve duodenoscope issues as quickly as possible,” she said on the company’s website.
Lawrence Muscarella, a former director of infection control at Custom Ultrasonics, where he worked for 18 years, questioned the FDA’s actions.
“It is certainly troubling for the FDA to order the removal of a medical device it has linked to patient injuries and deaths, and then to abruptly reverse course with no clear explanation,” said Muscarella, who left the company in 2013 because of what he called safety concerns.
Custom Ultrasonic scope-cleaning machines can cost $30,000 to $50,000 and typically take about 30 minutes to wash scopes with disinfectant after some manual cleaning. About 1,000 hospitals and clinics nationally rely on the company’s equipment to prepare reusable endoscopes for the next patient.