Solution: FDA Drops Ban on Battelle Sterilizer, 80k Unit Each x 20 Reuse per Mask


Health Editor’s Note:  The Battelle Critical Care Decontamination System (CCDS) always had the capability to sterilize 80,000 masks per unit per day.  The FDA was only going to allow them to sterilize 10,000. At this time, with the extremely essential use of N95 masks for healthcare workers who are on the front lines fighting the on-going battle against COVID-19, there cannot be enough masks.  These masks are not meant to be reused. 

To reuse an unsterilized mask, means the wearer will be less protected and there can be cross-contamination between patients seen by the healthcare worker. My question is why would the FDA seop in to limit the numbers of safe masks that can be made available for use?  Ohio Governor, Mike Dewine the poster boy for state management for COVID-19, fought for Battelle to be able to operate at full capacity, despite FDA restrictions. He won!……Carol  

WBNS TV Channel 10 Web Staff

COLUMBUS, Ohio – The U.S. Food and Drug Administration approved Columbus-based Battelle’s system that can decontaminate thousands of masks a day, according to a statement from the company.

Battelle told 10TV on Sunday night that the approval is for the use of the technology at “full capacity.”

According to a press release sent Sunday night from Battelle, the company’s CCDS Critical Care Decontamination System is now operating at Battelle’s West Jefferson, Ohio, facility.

The facility is capable of decontaminating up to 80,000 respirator masks per system each day using concentrated, vapor phase hydrogen peroxide.

According to a Sunday night statement from Ohio Gov. Mike DeWine’s office, Battelle intends to send one machine to New York City and one to Stony Brook, New York. Machines will also be dispatched to the state of Washington.

Earlier Sunday, the FDA only approved limited use of the technology at 10,000 surgical masks in the state a day, which was met by criticism from DeWine.

In a press conference on Sunday, DeWine said President Donald Trump assured him that the approval would be handled quickly.

According to Battelle, the respirator masks are exposed to the validated concentration level for 2.5 hours to decontaminate biological contaminates, including COVID-19….read more: 



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