FDA approves Battelle Critical Care Decontamination System
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
Get authentic, real-time news that helps you fight COVID-19 better.
Install PlexusMD App for doctors. It's free.
The Food and Drug Administration has approved the limited use of a process that would clean much-needed N95 protective face masks and allow them to be reused, the agency said in a release. Columbus-Ohio based Battelle uses a “vapor phase hydrogen peroxide” process to decontaminate the masks being used by healthcare providers and others to protect against the spread of COVID-19. Battelle says its Critical Care Decontamination Systems could decontaminate up to 80,000 masks per day.

But the FDA is restricting the number of masks that Battelle can decontaminate with its process to 10,000 per day. From the FDA release:

Battelle is authorized to decontaminate up to 10,000 compatible N95 respirators per day, consistent with the data provided to FDA. Battelle shall provide FDA weekly reports, including data according to a testing plan for scale-up reviewed by FDA, regarding the decontamination of compatible N95 respirators, including any reductions in decontamination ability

Ohio Gov. Mike DeWine criticized the limit as “reckless,” according to the Columbus Dispatch. “Battelle’s innovative technology has the capability to protect healthcare professionals and first responders in Ohio and across the country, but in this time of crisis, the FDA has decided not to support those who are risking their lives to save others,” DeWine said in a statement.

It wasn’t immediately clear why the FDA had decided to restrict the number of masks Battelle could decontaminate per day. We reached out to the agency for comment and will update if we hear back.

N95 respirators are disposable, snug-fitting face masks that can keep virus-laden droplets away from a wearer’s mouth and nose. The Centers for Disease Control and Prevention notes that the masks’ effectiveness is “highly dependent upon proper fit and use.”

Source: https://www.fda.gov/media
Dr. T●●●●z H●●●●●●i and 8 others like this9 shares
Like
Comment
Share