FDA reverses recall of 2,800 scope-cleaning machines

The Food and Drug Administration has reversed the recall of around 2,800 scope-cleaning machines in used in hospitals and clinics nationwide despite a top agency scientist last year finding that the action was ''necessary to protect public health.''

The FDA had called for pulling the equipment from the market in November because it said Custom Ultrasonics of Ivyland, Pennsylvania, had repeatedly violated federal safety laws and those lapses could up the risk of infection for patients. The agency again issued a recall in January after a Senate report linked Custom's machines to a series of superbug outbreaks across the country.
 
Now the FDA had backed off, saying the company's signature product, the System 83 Plus machine, could continue to be in the field while regulatory issues were sorted out.

According to regulators and the company, the sophisticated machines known as Automated Endoscope Reprocessors (AERs) still could not be used to disinfect a specific type of gastrointestinal scope called a duodenoscope that had been tied to 41 infection outbreaks worldwide and at least 24 deaths in the US.

The machines could still 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.

Meanwhile, in a statement posted on the company's website, Alicia Nakonestchny, CEO and president, Custom Ultrasonics Inc, said, the company is "working with the FDA to resolve duodenoscope issues as quickly as possible."

The agency's reversal was a concern, according to Lawrence Muscarella, who left his position as director of infection control at Custom Ultrasonics in 2013 over his safety concerns, Muscarella told Kaiser Health News.

"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. This may be unprecedented in the history of medical device regulations," he said.