The Food and Drug Administration (FDA) has approved a sterilization system that has the capability of decontaminating desperately needed respirator masks up to 20 times.
President Trump and Ohio Gov. Mike DeWine (R) had promoted the Battelle decontamination system in response to the coronavirus pandemic, which has depleted personal protective equipment in hospitals.
FDA Commissioner Dr. Stephen Hahn said Sunday the administration authorized the system, which Battelle said is capable of decontaminating up to 80,000 masks per system each day.
“We issued a new authorization this evening to @Battelle for their decontamination system. @US_FDA staff have been working nonstop across gov and with the private sector to deliver solutions to the American public,” Hahn tweeted.
Trump thanked Hahn for his “fast approval” of the Ohio-based nonprofit’s system, which was recommended by DeWine.
“Thank you Dr. Hahn & the FDA for your fast approval of this respected Ohio company recommended by Governor @MikeDeWine. Great potential!” Trump tweeted Monday morning.
On Sunday, the president said he hoped the approval would come “ASAP.”
DeWine also lauded the authorization, which he said will help Ohio and other areas of the country in desperate need of N95 masks.
The authorization will allow Battelle to sterilize masks without a daily limit, DeWine tweeted.
“Thank you @realDonaldTrump and @SteveFDA! @US_FDA has now given Columbus-based @Battelle full approval of the use of new technology to sterilize desperately-needed N95 masks in #Ohio and other parts of the United States,” DeWine tweeted.
“This will not only help #Ohio‘s healthcare workers on the front lines of the #COVID19 crisis but @Battelle will also be helping health care workers in hot spots throughout the country including New York and Washington state,” he added.
The respirator masks are decontaminated during a 2 1/2 hour process, and masks can be decontaminated up to 20 times without degrading their performance, according to Battelle.
The Battelle decontamination system is now operating its facility in West Jefferson, Ohio.
Health care systems that want to use Battelle’s system will collect respirator masks daily and send them to Battelle. The protective equipment will be labeled with a barcode serial number to ensure hospitals are sent back the same masks.
The masks will be marked with the number of times the mask has been processed.
— This report was updated at 8:48 a.m.