The Food and Drug Administration (FDA) has backed off a planned recall of machines used to clean medical scopes despite warnings that public health depended on it, according to Kaiser Health News.
The FDA announced the recall in November, with Deputy Director for Medical Devices William Maisel calling it "necessary to protect the public health." Now, KHN reports, the agency says that while hospitals must not use Custom Ultrasonics' System 83 Plus Automated Endoscope Reprocessors (AERs) to disinfect the duodenoscopes linked to more than 40 superbug outbreaks, they could remain in use for other endoscopes.
Alicia Nakonetschny, president and CEO of Custom Ultrasonics Inc., said in a statement posted on the company's website that the company is "working with the FDA to resolve duodenoscope issues as quickly as possible."
An FDA spokeswoman declined to comment to KHN about the matter.
But the agency's reversal is a concern, Lawrence Muscarella, who left his position as director of infection control at Custom Ultrasonics in 2013 over his safety concerns, told KHN. "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.
The results of a Senate investigation published in January found blame to go around for the outbreaks, faulting regulators, hospitals and scope manufacturers along with Custom Ultrasonics, noting that while the AERs clearly played a role, the scopes themselves are designed in a way that makes cleaning difficult.
Meanwhile, a recently unearthed regulatory report suggests superbugs linked to tainted scopes killed three more patients at Pasadena, California's Huntington Hospital, according to the Los Angeles Times. While Olympus Corp., the manufacturer of the scopes, was informed of the deaths, hospital officials said they believed informing the public of the deaths would have been a privacy violation. Officials would not say whether any more patients died from or were exposed to the same superbugs. Moreover, the report ties the deaths to a scope with a different design than the Olympus model, suggesting the contamination could be wider-ranging than previously thought.
To learn more:
- here's the KHN article
- read the LA Times article
- here's the statement from Custom Ultrasonics