FDA Retreats From Recall Of Scope-Cleaning Machines Tied to Outbreaks

(By Chad Terhune for Kaiser Health News)

The Food and Drug Administration has dropped a recall of some 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 Custom Ultrasonics of Ivyland, Pennsylvania, had repeatedly violated federal safety laws and 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 being addressed. Read article here…..

Kaiser Health News is a nonprofit national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.


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