The Food and Drug Administration has dropped a recall of about 2,800 scope-cleaning machines in use 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 that Custom Ultrasonics of Ivyland, Bucks County, had repeatedly violated federal safety laws and that those lapses could raise 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 firm’s signature product, the System 83 Plus machine, can remain in the field while regulatory issues are being addressed.
Regulators and the company said these sophisticated washing machines known as Automated Endoscope Reprocessors (AERs) 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 maker’s history of regulatory troubles since 2007.
