COLUMBUS -- The U.S. Food and Drug Administration on Sunday gave full approval of the use an Ohio company's new technology to sterilize desperately-needed surgical masks in the state and other parts of the United States.
Ohio Gov. Mike DeWine and Lt. Gov. Jon Husted on Sunday evening thanked President Trump and Commissioner Stephen Hahn, M.D. of the U.S. FDA for the approval.
The FDA has authorized Columbus-based Battelle to deploy its groundbreaking technology to sterilize surgical masks without a daily limit, which will allow Battelle to operate at its desired capacity.
The agency ruled that upgrading its emergency use authorization from partial to full “is appropriate to protect the public health or safety.”
The Battelle Critical Care Decontamination System is capable of decontaminating up to 80,000 respirator masks per system each day.
"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," DeWine said.
"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."
“We‘re grateful that the President and the FDA moved quickly to help us get this solution back up and running,” Husted said. “This Ohio-driven solution has the potential to save lives now and in the future across the United States.”
In addition to offering this technology in Ohio, Battelle intends to send one machine to New York City and one to Stony Brook, N.Y., which will provide for the sterilization of up to 160,000 surgical masks for New York's healthcare workers each day. Machines will also be dispatched to the state of Washington.
Battelle plans to ship four more units elsewhere in the United States next week and 15 additional machines in the coming weeks.