Ohio governor gets FDA approval for N95 mask sterilization tech

COLUMBUS, Ohio —A Columbus-based medical technology company received approval Sunday night to start sterilizing 160,000 surgical masks per day for reuse, but only after Gov. Mike DeWine and President Donald 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 earlier Sunday granted Battelle only partial approval, leading to a public rebuke from Mr. DeWine, who then called the president in 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, a Republican, praised Mr. Trump on the GOP president’s preferred communication platform: Twitter.

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.”

During his own Sunday afternoon news conference, Mr. DeWine referenced his conversation with Mr. Trump and said he also spoke with the head of the FDA, Dr. Hahn.

“[Commissioner Hahn] said that this was going to be cleared up today,” Mr. DeWine 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.

Battelle’s units can sterilize the same mask up to 20 times.

The Block News Alliance consists of the Pittsburgh Post-Gazette, The Blade of Toledo, Ohio, and television station WDRB in Louisville, Ky. Nicki Gorny is a reporter for The Blade.