The FDA on Sunday night issued an amended approval order, revoking a Saturday order that only permitted Battelle to use the device at its headquarters in Columbus, and only to clean 10,000 masks per day. The limited order angered DeWine, leading him to rebuke the agency publicly Sunday morning and seek intervention from President Donald Trump. Before the limited order, Battelle had planned to immediately deploy to New York City its new technology, which it said could clean up to 160,000 masks a day in Ohio alone.
The new, expanded order still requires Battelle to operate the devices and report results to the FDA, but instead says the firm can sanitize 10,000 masks per chamber load at its headquarters and at “satellite facilities," as long as Battelle provides “confirmation that all chambers, critical parameters, logistics, processes, containment systems, and labeling are identical and in place."
Like the earlier order, each mask is approved to be sanitized and re-used up to 20 times. DeWine administration and Battelle officials said the technology will help increase the availability of the respirator masks, also used by first responders, amid a national shortage.
(Scroll down to read the order, or click here for a PDF.)
The updated order follows assurances from Trump and FDA Commissioner Stephen Hahn, who each contacted DeWine after the Ohio governor publicly blasted the agency’s decision and announced a news conference where he planned to discuss the issue further.
“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 healthcare workers who are at the front lines of the pandemic.”
“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,” DeWine said in a statement. “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.”
DeWine had touted the new technology, developed by Battelle, at a Saturday news conference, saying his administration was pushing the FDA to approve its use in Ohio and three areas hit hard by COVID-19 — Seattle, New York and Washington, D.C.
Battelle leaders said their technology could sterilize up to 160,000 respirator masks for re-use per day in Ohio alone, and said Saturday they’d already shipped a device to New York anticipating approval.
But the FDA’s initial order, which appeared to catch Ohio officials off-guard, would have only allowed the device to be used on a limited basis in Columbus. DeWine issued an uncharacteristically scathing statement Sunday morning and announced the news conference, while also reaching out to the White House for intervention.
At the news conference, before the expanded order was issued, Von Treer said his staff had been in contact with FDA regulators, explaining to them how the technology works and sharing their internal testing data.
He said their concerns were more about how the technology would be used and scaled up, rather than with the underlying technology itself.
“We’ve been back and forth in dialogue. I think they’re very comfortable with the technology, and it’s just the logistics and making sure they understand exactly how we’re going to use these systems and parsing through those final details," he said.
Battelle for decades has developed technology used by the military to protect against biological and chemical hazards. It said the new mask-cleaning technology builds off research conducted for the FDA in 2015 that assessed the feasibility of cleaning N95 respirator masks in the event of a PPE shortage resulting from a pandemic.
The technology uses hydrogen peroxide in a cleaning process that takes several hours, according to Battelle officials.
While he said he was angered with the FDA decision, DeWine, speaking earlier Sunday, chalked up the delays to “bureaucracy" that’s typical to all levels of government.
“I don’t know everything that’s going on. Bureaucracy is true in Washington. Bureaucracy is a problem in Columbus, too,” DeWine said. “I have received calls from people and I’ve had to go into our bureaucracy and try to get it done. So I sort of felt, the president felt the way I feel sometimes, and that’s ‘I gotta go do it. This is not supposed to happen this way.’ That just happens as much as you try for it not to happen. The impression I got from the president’s reaction, was ‘Let’s go fix it.’ And that’s the right answer.”
©2020 Advance Ohio Media, Cleveland. Distributed by Tribune Content Agency, LLC.
