FDA revokes emergency approval of N95 mask decontamination system

The FDA has revoked emergency use authorization for a system made by Battelle Memorial Institute to decontaminate N95 masks. 

The agency said April 30 that Battelle requested that the authorization be revoked. 

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

The FDA recently urged hospitals to move away from using crisis capacity conservation strategies such as decontamination to extend the use of N95 and other masks, citing an increased domestic supply.

The FDA granted authorization to Battelle's mask decontamination system in March 2020. The company received more than $400 million in federal contracts to develop the system, which can sterilize 10,000 masks in 150 minutes. 

The agency sent a warning letter to Battelle in October, saying it didn't have adequate procedures for identifying adverse events. The National Nurses Union had alleged the technology was "not safe and may not work."

Dozens of nurses reported last May that they had negative reactions to the decontaminated masks, including sore throats, headaches and nausea. 

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Learning Opportunities

Featured Whitepapers

Featured Webinars