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DeWine Expects FDA Approval Today for Battelle Tech – businessjournaldaily.com


YOUNGSTOWN, Ohio — In an unexpected press conference from the statehouse in Columbus, Gov. Mike DeWine and Lt. Gov. Jon Husted reiterated the urgency of getting the full approval for new technology from Battelle Memorial Institute to sterilize N95 masks, a critical piece of personal protective equipment that’s in short supply during in the coronavirus pandemic.

Though there was no conference planned for Sunday, DeWine held the conference after the U.S. Food and Drug Administration announced earlier in the morning it would only approve the limited use of Battelle’s technology to sterilize 10,000 surgical masks in Ohio daily, despite its ability to sterilize up to 160,000 masks daily in the state between two systems.

With the dwindling supply of N95 respirator masks — as well as other personal protective equipment, such as gloves, gowns and eye protection — approving the full capability of the technology is important for health care workers, first responders and nursing home employees throughout the state, DeWine said, as well as those in other states where Battelle systems are already in place or en route.

“This is not a problem that’s unique to Ohio,” DeWine said. “They’re ready to go forward. They’re ready to move. But we’ve been waiting for FDA approval.”

After a talk with FDA officials Saturday, DeWine and Husted said they were hopeful that Sunday would bring good news about the approval. When they learned of the limited approval, DeWine said in a prepared statement Sunday morning that the decision was “reckless.” He immediately reached out to the White House and spoke with President Donald Trump, who assured the governor “he would do everything he could to make sure this got done today,” he said.

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Sunday afternoon, Trump tweeted he hoped the “FDA can approve Mask Sterilization equipment ASAP,” citing DeWine and Battelle’s equipment.

DeWine also spoke with U.S. Sens. Sherrod Brown, D-Ohio, and Rob Portman, R-Ohio, on the matter.

Minutes before the press conference, DeWine had a phone call with FDA Commissioner Stephen Hahn, who advised the governor “this was going to be cleared up today,” DeWine said.

“We’re not there yet. We’ve not gotten the approval,” DeWine said. “But I’m grateful for the call and I’m hopeful.”

In a video call, Battelle President and CEO Lewis “Lou” Von Thaer said the science had been proven and that the systems in Ohio are ready to be turned on tomorrow.

“We’ve already done a few thousand of these in a test case and we’re ready to turn this system on,” Von Thaer said.

The system sterilizes the N95 mask by keeping it under pressure for a few hours with a concentrated hydrogen-peroxide vapor to decontaminate them, “including bugs that are worse that COVID-19,” he said. Masks can be cleaned and reused up to 20 times before the materials start to degrade, he said.

Battelle has been working closely with the Ohio Department of Health and hospital systems throughout the state to establish logistics for the process. Masks are collected, wrapped in plastic, then placed in a second bag that is cleaned with alcohol before being shipped to Battelle’s lab in West Jefferson.

After the sterilization, the mask is cooled, repackaged and sent back to the same hospital whence it came.

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“We believe with this process we can do 80,000 or more locally and we can add systems as we need to,” as well as expand its production to put more systems across the country, Von Thaer said. Battelle currently has one machine assembled and ready to go in Long Island, N.Y., and has one en route to the Seattle area, with others ready to go to Chicago and Washington D.C.

Battelle has enough materials to produce three or four more systems over the next week, and is working with health officials to determine the places to locate those machines, he said. Von Thaer acknowledged the supply chain is the limiting factor, but says he hopes to build two more systems weekly after those next three to four are built, he said. Battelle is looking at other ways to modify the system to build them faster.

Under the current, limited approval, Von Thaer said he expects Battelle can sterilize and start shipping its first 10,000 masks by Tuesday, he said.

When asked if the system can be used to decontaminate other PPE, he said Battelle is in the process of getting to that point, but isn’t there yet. Teams at the nonprofit research company have been working “around the clock for the last month” on developing the current capacity and are researching ways to expand into other items, including ventilators and parts of respirators that are typically thrown away after one use, he said.

As DeWine hears from more health care workers and first responders on the front lines in dealing with the coronavirus pandemic, he hopes Sunday’s press conference will bring the sense of urgency needed to get the FDA’s approval of Battelle’s full capabilities. Currently, the limited supply is forcing workers to use N95 masks for much longer than they normally would, which is once after working with someone who is infected with COVID-19, the disease spread by the coronavirus.

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“All of these people who are really at the front line, who are there to protect us … they need this help,” DeWine said. “Innovation is really in Ohio’s DNA. We need the help of our scientists, engineers and researchers more than ever”

Not having the necessary amount of PPE makes the jobs of health care workers and first responders “unnecessarily more dangerous,” added Husted.

“Even getting through this, masks will still be necessary to maintain a safe environment for those who are most vulnerable,” Husted said. “This needs to be approved today. We can’t tip toe toward the solution. We have to run at full speed. FDA approval gives us the ability to run at full speed.”

When asked by a reporter if the FDA’s limited approval of the technology, as well as faulty test kids being sent to Ohio from the Centers for Disease Control and Prevention, were signs that the federal government was “behind the ball” on its response to the pandemic, DeWine said the crisis said it’s taught the country a lesson that “we have to invest more in public health,” and that’s it’s not a Republican nor a Democrat problem.

The second lesson learned, he said, was that the country cannot rely on other countries from which to purchase important medical equipment.

“We’ve got to be able to source this stuff in this country,” DeWine said.

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Copyright 2020 The Business Journal, Youngstown, Ohio.





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