Columbus, Ohio (March 29, 2020)—The U.S. Food and Drug Administration has approved Columbus-based non-profit Battelle’s request to begin sterilizing surgical masks for reuse during the COVID-19 coronavirus pandemic.
The FDA has amended its initial approval, granted early Sunday, now allowing Battelle to sterilize the N95 surgical masks without a daily limit.
The revised order authorizes Battelle to decontaminate up to 10,000 compatible N95 respirator masks per chamber load, with the machine able to process four chambers per sterilization process. Battelle said it can run two sterilization processes per machine per day, sterilizing 80,000 masks per machine.
Sterilized masks can be reused up to 20 times. Once that limit is reached, the masks are discarded. Battelle CEO Lewis Von Thaer said they are currently limited to only sterilizing N95 masks, but it is moving toward gaining approval for other PPE like ventilator parts.
The initial order from the FDA limited the number to 10,000 per 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,” said Ohio Governor Mike DeWine in a statement issued Sunday night. “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 added in the same statement. “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, New York, 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.
The new order also authorized Battelle to operate the machines in other locations, meaning the non-profit can begin plans to operate the machines in New York, Washington, and Washington D.C.
FDA Commissioner Stephan Hahn, M.D. released the following statement regarding the government’s response to Battelle’s request:
This is an example of everyone working quickly to help find a solution. FDA staff have been working around the clock to help mitigate this pandemic as swiftly as possible. After receiving Battelle’s request today, we turned it around in a matter of hours and issued a new authorization allowing them to ramp up their capability to decontaminate more respirators. FDA is committed to working across government and with the private sector to find solutions fast. We are willing to be flexible and adapt to this pandemic, so that we can get essential medical devices to those in need to protect against COVID-19.
Von Thaer said he expects to not only sterilize up to 80,000 masks per machine per day, but also to have those masks back in circulation on the same day.
Earlier Sunday, DeWine said that after an initial limiting by the FDA of a new surgical mask sterilization process, he expected, after several conversations between state and federal officials, to receive full approval by the end of the day.
DeWine and Husted released a statement early Sunday expressing frustration after they say the U.S. Food and Drug Administration decided to limit the use of new technology to sterilize desperately-needed surgical masks.
In the statement, DeWine and Husted announced the FDA has authorized Columbus-based Battelle to sterilize only 10,000 surgical masks in Ohio each day, despite their ability to sterilize up to 160,000 masks per day with two operational machines in Ohio alone.
During a Sunday briefing, DeWine said he received a call from Hahn, who told DeWine the situation would be cleared up today.
“We’re not there yet, we’ve not gotten the approval, but I am grateful for the call and I am hopeful,” DeWine said.
DeWine also said Trump told him, “I’m moving. I’ll get this done.”
Trump mentioned Battelle’s FDA request during a briefing later Sunday afternoon.
“Today I got involved and the FDA is now involved trying to get a fast approval for the sterilization of masks,” the president said. “That would be a tremendous difference. It would be really helpful.”
The governor said FDA approval normally takes days, but what has happened in a matter of hours is commendable, even if the initial response wasn’t what the state wanted to see.
Prior to Sunday’s briefing, Battelle released the following statement:
We are thankful that the Food and Drug Administration granted Emergency Use Authorization to operate Battelle CCDS at our facilities. We continue to work with FDA to maximize the impact of the Critical Care Decontamination System by expanding use to other locations as well as increasing the number of respirator masks that are allowed to be processed each day.
STATEMENT FROM BATTELLE LABS
DeWine made a public appeal to the FDA Saturday, during his daily news conference, to approve the process as soon as possible.
“Please, please, give us the approval to use these,” he said. “We have nurses, we have doctors, we have people working in nursing homes who need the masks.”
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