COLUMBUS — A Columbus-based medical technology company received approval Sunday to start sterilizing 160,000 surgical masks per day for reuse, but only after Gov. Mike DeWine and President Trump publicly pressured federal regulators to act with urgency.
The company, Battelle, plans to use a new method to sterilize the N95 surgical masks that are in high demand because of the coronavirus pandemic. But first the firm needed the OK of the U.S. Food and Drug Administration. The FDA early Sunday granted Battelle only partial approval, leading to a public rebuke from Mr. DeWine, who then called the President seeking assistance.
On Sunday evening Battelle spokesman T.R. Massey confirmed to The Blade that the FDA had revisited its original decision and granted full approval.
“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,” Lou Von Thaer, president and CEO of Battelle, said in a statement. “Everybody who has worked on this project shares the same goal of protecting first responders and health-care workers who are at the front lines of the pandemic.”
Mr. DeWine also expressed his gratitude for the full-approval of the sterilization technology.
"I want to thank President Trump for his leadership and Dr. [Stephen] Hahn of the FDA for approving the use of this life-saving technology that Battelle has developed," Mr. DeWine said. "This will not only help Ohio's health-care 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."
The governor’s call to the President came after the FDA originally gave Battelle permission to sterilize only 10,000 masks per day. After the men spoke by phone, Mr. DeWine praised Mr. Trump on the President’s preferred communication platform: Twitter.
I have just talked with @realDonaldTrump about this issue, and we had a good conversation. He understands the problem and says he will do everything he can to get this approved today. Thank you, @POTUS. https://t.co/iha2F2AXgv
— Governor Mike DeWine (@GovMikeDeWine) March 29, 2020
Mr. Trump then took to his own Twitter account and nudged the FDA to get moving. He also spoke about the matter during a televised news conference late Sunday afternoon. Mr. Trump said he was involved in trying to get the necessary approval.
“We’re trying to get fast approval for the sanitation of masks,” he said. “That will make a tremendous difference.”
Hope the FDA can approve Mask Sterilization equipment ASAP. As per Governor @MikeDeWine, there is a company in Ohio, @Battelle, which has equipment that can sterilize masks quickly.
— Donald J. Trump (@realDonaldTrump) March 29, 2020
During his own Sunday afternoon news conference, Mr. DeWine referenced his conversation with the President, and said he also spoke with the head of the FDA, Mr. Hahn.
“[Commissioner Hahn] said that this was going to be cleared up today,” he said, referring to a conversation between the two just minutes before the 2 p.m. news conference. “He thought we would be able to have what we want. What we want is help for our first-responders. What we want is help for our medical personnel who desperately need this."
The governor’s office had previously said that there would be no news conference on Sunday, unless there was a major development that state officials needed to communicate.
That development was the highly anticipated announcement from the FDA, which had been reviewing the Battelle technology.
The laboratory claims each of its new machines are capable of sterilizing 80,000 masks each day, and Mr. DeWine said two machines are ready to start sterilizing masks in Ohio, putting the potential turnaround here at 160,000 sterilized masks each day.
Mr. DeWine and Lt. Gov. John Husted during the news conference did not clarify the reason the FDA initially granted only limited approval. But they did stress the importance of the technology as a way to leverage a limited supply of personal protective equipment in the state and country.
"This is not going to solve every single problem," Mr. DeWine said. "It's not going to stop the surge coming at us. But it is going to help.”
Mr. Von Thaer said his company could begin sterilizing masks on Monday.
"I suspect we will start taking inventory tomorrow and be sending masks back on Tuesday of this week," said Mr. Von Thaer, who spoke at the conference via video. He added that their capacity would significantly increase should broader approval come down on Sunday.
Battelle's units can sterilize the same mask up to 20 times.
Mr. DeWine noted the FDA’s limited decision would have prevent Battelle from dispatching its machines as planned to other parts of the country. In addition to two machines ready to go in Ohio, Battelle has plans in the works to set up two units in New York. Additional units were to be sent to other parts of the country in the coming weeks, including Washington and Washington, D.C.
The governor also released the state’s most recent coronavirus statistics on Sunday afternoon: 1,653 confirmed cases in 66 counties, including 403 hospital admissions and 139 intensive care admissions. There were 29 deaths in 14 counties.
Those who have been diagnosed range in age from 1 to 98, with a median age of 52, and they are split about evenly between male and female.
The state reported 94 cases of coronavirus, including 13 hospitalizations and two deaths, in Lucas County as of Sunday.
Numbers reported by the Ohio Department of Health continue to not match up with numbers reported by the Toledo-Lucas County Health Department, which on Sunday reported 78 total cases here, including 2 deaths. Ages range from 22 to 98, and 45 are male compared to 33 female.
Gretchen DeBacker, a spokesman for the local coronavirus response effort, said discrepancies between state and county data typically reflect differences in reporting deadlines, the way state and local officials receive reports, and the work health officials must go through to confirm reported cases, among other issues.
Lucas County continues to see the most coronavirus cases in northwest Ohio.
Wood County has 12 confirmed cases and five hospitalizations; Fulton County has two confirmed cases; Ottawa County has one confirmed case — an individual who is hospitalized; and Sandusky County has three confirmed cases with two hospitalizations, according to the latest figures the state.
Staff writer Sarah Elms contributed to this report.
First Published March 29, 2020, 6:44 p.m.
