Battelle Closes Sites, Asks FDA To Pull Mask Decontamination EUA

Source : Medtech Insight

In a further sign the need for medical face masks are not as dire as they were at the start of the coronavirus pandemic, the US Food and Drug Administration has withdrawn Battelle Memorial Institute’s emergency use authorization (EUA) for its mask decontamination system.

Battelle was granted an EUA by the FDA for its Critical Care Decontamination System (CCDS) in March 2020 after grave concerns that health care workers didn’t have enough N-95 respirators to protect themselves from COVID-19. Battelle’s device was the first of its kind to receive an EUA to allow hospitals to decontaminate and reuse face masks. At the time, the decision was so significant that even former President Donald Trump took credit for the authorization – even though such decisions are made based on the FDA’s own scientific evaluation. ()

Since then, however, face mask production has ramped up significantly and there’s been less strain on the supply of N-95 medical grade masks, as the general public have been using alternatives such as cloth masks for protection. The FDA in January even updated its EUA for face mask decontamination systems to allow a mask to be decontaminated up to four times. ()

Battelle asked the FDA in early April to withdraw its EUA. The company also told the agency that it ceased operations of its product at decontamination sites, as well as its marketing activities. In response, the FDA wrote back on 30 April that the request has been approved by the agency, and the CCDS is no longer allowed on the market under an EUA.

“Because Battelle has notified FDA that it has ceased operations and associated activities, and requests withdrawal of the authorization, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization,” the agency said on 30 April.

The FDA further encouraged Battelle to notify its customers of the decision.

By Ferdous Al-Faruque