UPDATE | FDA expands approval for Ohio company's protective mask sterilization plan
After pressure from Ohio Gov. Mike DeWine, the FDA has fully approved technology that permits sterilizing surgical masks in Ohio and other parts of the country.
The FDA originally approved 10,000 masks a day to be sterilized, but has since allowed unlimited sterilization which Columbus based company Battelle says they are capable of decontaminating 80,000 respirator masks per system a day.
During a press briefing Sunday, DeWine urged the FDA to approve the method, and even revealed that he had called President Trump for help.
"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," said Ohio Governor Mike DeWine. "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," said Lt. Governor Jon Husted. "This Ohio-driven solution has the potential to save lives now and in the future across the United States."
Battelle says they plan to send two machines to New York hospitals which will sanitize 160,000 masks a day.
Machines will also be sent to Washington.
The FDA says each mask can be sterilized 20 times.
The FDA has approved a new N95 mask sterilizing technology, but limited how many masks a day can be sterilized.
The approval for Columbus based company, Battelle, allows the company to sterilize 10,000 surgical masks a day, despite the capability to sterilize 160,000 masks in a single day in Ohio.
In the FDA’s approval, they say the masks can be used up to 20 times.
Gov. Mike DeWine spoke about the technology Saturday during a news briefing and encouraged the FDA to fully approve the proposal.
He says the authorization of just 10,000 masks is limited to Battelle's Columbus headquarters and prevents the company from sending its technology to other states such Washington and New York, which are considered the hardest hit areas from COVID-19.
"The FDA's decision to severely limit the use of this life-saving technology is nothing short of reckless," said Governor DeWine. "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. This is a matter of life and death. I am not only disappointed by this development, but I'm also stunned that the FDA would decline to do all it can to protect this country's frontline workers in this serious time of need."
Battelle says they planned to send around 20 machines to New York, Washington state, Washington D.C., and other areas across the United States.
DeWine said Sunday he and Lt. Governor Jon Husted pledge to keep fighting for increased use of the technology.
During a Sunday press briefing, DeWine said he had spoken with President Trump about his desire to get the full approval.
Trump tweeted after the conversation saying "Hope the FDA can approve Mask Sterilization equipment ASAP."