FDA approves Battelle mask sterilization technology at full capacity
Ohio-based company Battelle announced on Sunday that it had received emergency approval from the Food and Drug Administration to begin using its new mask sterilization technology in the fight against COVID-19, according to a spokesperson for the company who spoke with 13abc.
According to Battelle, the Critical Care Decontamination System can sterilize up to 80,000 masks per day per device, but the FDA had
“I want to thank the FDA team for their professionalism and help in authorizing the use of our technology at this critical moment for our nation,” said Lou Von Thaer, President and CEO of Battelle in a press release. “Everybody who has worked on this project shares the same goal of protecting first responders and healthcare workers who are at the front lines of the pandemic.”
Ohio Governor Mike DeWine previously expressed his disappointment in the FDA's initial decision to only give the company's device limited approval, stating that it was a "matter of life and death."
Following the FDA's new decision, the governor released a statement saying, "I want to thank President Trump for his leadership and Dr. Hahn of the FDA for approving the use of this life-saving technology that Battelle has developed. This will not only help Ohio's healthcare workers on the front lines of the COVID-19 crisis, but Battelle will also be helping health care workers in hot spots throughout the country including New York and Washington state."
Currently, Battelle's devices are housed at its headquarters in Columbus. The company also plans to ship two of the devices to New York -- one to New York City and another to Stony Brook -- and others to Washington, two of the hardest-hit states during the coronavirus outbreak.
According to the company, healthcare systems that wish to use the device "will collect worn respirator masks daily in accordance with an approved procedure and courier these respirator masks to Battelle CCDS operations as systems come online." Healthcare systems are asked to contact the company directly.
Battelle says their technology will allow a mask to be sterilized up to 20 times before it needs to be discarded, drastically extending the life of scarce personal protective equipment.