Ohio Gov. Mike DeWine says FDA was 'reckless' restricting technology sterilizing surgical masks

One day after Ohio Gov. Mike DeWine publicly pleaded for the FDA to issue an emergency waiver to allow the Columbus-based Battelle Labs to use new technology to sterilize surgical masks, he was "stunned" by the FDA's decision Sunday.

The FDA-authorized Battelle can sterilize 10,000 N95 respirator masks in Ohio each day. Battelle said it has the capacity to sterilize 160,000 masks in the state daily. The FDA's decision limited Battelle's production to its headquarters in Columbus, so the company is not permitted to send its technology to other states.

DeWine called President Donald Trump on Sunday morning about the FDA's response and Trump assured him he would take action.

"The FDA's decision to severely limit the use of this life-saving technology is nothing short of reckless," DeWine said in a statement. "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."

[ All of The Enquirer's coverage of the new coronavirus is being provided for free to our readers. Please consider supporting local journalism by subscribing to The Enquirer at cincinnati.com/subscribe ]

A few minutes before DeWine spoke a previously unscheduled press conference Sunday, he spoke with FDA commissioner Stephen Hahn, who was on his way to the Situation Room. Hahn told DeWine that "this was going to be cleared up today," DeWine said.

He received a similar message from Trump.

"We had a great conversation," DeWine said. "He told me that he would do everything that he could to make sure this got done today. He understood because I told him the gravity of this, not just for Ohio but for other states, other locations. He told me that he would take action, for which I'm very grateful."

The FDA sent a letter to Battelle on Saturday, authorizing the decontamination of 10,000 masks per day at Battelle's headquarters. The letter says Battelle must provide a plan and supportive data before an additional scale-up.

Around 1:30 p.m. Sunday, the FDA released a statement that it's working with Battelle to increase production for other states.

"The EUA (emergency use authorization) issued, as requested by Battelle, currently allows for Battelle to decontaminate up to 10,000 N95 respirators per day. We understand Battelle now would like to expand that capacity, beyond their Ohio facility, and we are working with them, and the state of Ohio expeditiously so they can scale up their N95 decontamination services to other locations outside of Ohio."

Battelle built a decontamination unit in Long Island, New York, over the weekend and sent a unit to Seattle. The company intended to send more units to New York City and Washington D.C. this week.

DeWine and Lt. Gov. Jon Husted will keep pushing for the increased use of Battelle's machines. DeWine spoke with Ohio senators Rob Portman and Sherrod Brown, along with congressmen, as they try to urge the FDA to allow Battelle to operate at full capacity.

"This is not going to solve every single problem," DeWine said. "This is not going to stop the surge coming at us. But it is going to help. It has the ability to help here in Ohio and it has the ability to help across this country."

Battelle's cleaning system, the company says, takes about 12 hours. The machines are built inside large metal shipping containers.

[ Get breaking news about novel coronavirus in Greater Cincinnati and NKY by downloading the Cincinnati.com app ]