The Food and Drug Administration Friday revoked its emergency use authorization for Battelle Memorial Institute’s decontamination system for N95 respirators at Battelle's request.

“In response to changing customer needs, as of March 31, 2021, Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities,” FDA said.

On April 9, FDA urged health care facilities to transition away from using crisis capacity conservation strategies such as decontamination or bioburden reduction to extend the use of N95s and other similar disposable respirators due to an increased domestic supply of new respirators.

Related News Articles

Perspective
Public
All of America’s hospitals and health systems, regardless of ownership status, size or location, provide a vast range of benefits, programs and essential…
Headline
An AHA analysis released Sept. 10 highlights how tax-exempt hospitals provided nearly $150 billion in total benefits to their communities in 2022, the most…
Blog
Public
The Paragon Health Institute has published a series of new reports once again alleging large-scale “fraud” in health care. This time their target is enrollment…
Headline
An article in the latest AHA Trustee Insights newsletter highlights the latest compliance enforcement trends in health care and offers steps for organizations…
Headline
A report from AARP and the National Alliance for Caregiving released today found nearly 1 in 4 U.S. adults (63 million) are caring for an adult or child…
Headline
The Departments of Justice and Health and Human Services today announced the creation of the DOJ-HHS False Claims Act Working Group to combat health care fraud…