The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers.
In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. Battelle said it is no longer operating or marketing the vaporized hydrogen peroxide systems, according to the revocation letter.
The FDA warned Battelle in October that it must improve its adverse-event reporting procedure for decontaminated masks. The institute came under scrutiny in May 2020 for its claim that CCDS could decontaminate an N95 up to 20 times for reuse by multiple wearers. Major media organizations and nurses questioned the claims about the number of times an FFR could be safely decontaminated and reused.
In response, Battelle cited an FDA-supported study it submitted to the agency in 2016 that said the system can reprocess N95 masks up to 20 times. (The agency subsequently published the study.)
The FDA issued Battelle the original EUA on March 28, 2020, and revised and reissued it on March 29, 2020, June 6, 2020, and January 21, 2021. The federal government contracted with Battelle to manufacture up to 60 of the portable systems for deployment to healthcare facilities.
The agency recently recommended that healthcare personnel and facilities transition away from crisis capacity strategies like decontaminating or bioburden reducing disposable respirators for reuse.
“As a result of changing customer needs, Battelle requested voluntary withdrawal of the EUA from the FDA,” Battelle spokesperson Katy Delaney said in an email to Medical Design & Outsourcing. “Battelle is proud to have been part of the nation’s response to the pandemic by helping health care providers through the N95 respirator shortage.”
You can read the revocation letter here.
This article has been updated with comments from Battelle.