DeWine Gets Trump's Help in Effort to Secure FDA Approval of PPE Sterilization Process

Mar 29, 2020

Emphatically tapping the podium, Governor Mike DeWine said sometimes "you just have to rattle it." He was referring to the bureaucracy that appears to have been holding up FDA approval of a new process developed by Columbus-based Battelle Labs. The process uses vaporized hydrogen peroxide in a pressured environment to clean N95 masks for healthcare personnel. 

The governor went public with what he called the "breakthrough" during his Saturday briefing and urged the FDA to approve Battelle's plan.  "Please do this. It really is truly a matter of life and death. We need to protect our people who are risking their lives every single day."

Early Sunday morning, Lt. Gov. Jon Husted got a call that the process had been approved, but only for 10,000 pieces of equipment. Battelle has said it can process 80,000 masks at a time in each of its units. It has two in Ohio and one already assembled on Long Island. 

Gov. DeWine said "it was time to get on with it." He put in a call to the White House. President Donald Trump called him back. "We had a good conversation. He understands the importance of protecting our personnel. He indicated that he'll get this done." 

In a Sunday briefing that was not supposed to be necessary, the governor and Lt. Gov. Jon Husted revealed that they've been working to secure FDA approval for Battelle's new process for a week. Husted and Battelle chief Lou Von Thaer have been talking to the agency daily. 

It's not clear why the FDA did not grant full approval but Husted noted, "We’re pushing for speed, they’re pushing for safety." He also acknowledged the agency is being inundated with ideas seeking expedited approval to help with the COVID-19 crisis. But Husted applauded the governor for not sitting back and waiting for action. 

"If we're not solving the problem through the regular process, you have to bring an energy and an urgency to the bureaucracy so they know we've got to have this," Husted said. "That's what your leaders are supposed to do." 

Husted expects final FDA approval today. Battelle CEO Lou Von Thaer says if that happens they can begin work immediately. "We would start tomorrow in Ohio, sending the masks back on Tuesday this week," he said. 

The Ohio Hospital Association is helping to coordinate the logistics with hospitals around the state on  getting their masks to the Battelle facility in West Jefferson where the sterilization units are located. The masks will be marked and sent back to the same hospitals. Von Thaer says each mask can be sterilized 20 times before it has to be thrown away. 

The governor said he received a call from FDA commissioner Stephen Hahn just before the briefing. He's optimistic the approval will come today, and he says Battelle is ready to build and deploy more of the sterilization containers around the country. "The urgency of getting these online is not just for Ohioans," DeWine said. "It's for people throughout the country."

Many things have occurred in the state over the last few weeks regarding COVID-19. Among them: 

  • Nearly 188,000 Ohioans have filed for unemployment, according to new numbers released by the state Thursday. 
  • Daycares closed at 11:59 p.m. Wednesday unless they secured a temporary pandemic childcare license from the Ohio Department of Job and Family Services. A limited number of temporary licenses were awarded and are intended to provide care for healthcare, emergency personnel, and other essential employees. 
  • DeWine has issued an order to freeze state government hiring as well as new contracts to save the state money. 
  • The state issued a stay-at-home order, which took effect at 11:59 p.m. Monday, March 23. This means Ohioans must only leave their homes for essential needs like groceries, medicine or exercise. To view which businesses are open and closed, click here.
  • DeWine ordered centers for people with disabilities to close. Alternatives have been offered to those who need them. 
  • Public playgrounds have been ordered to close. 
  • Supreme Court Chief Justice Maureen O'Connor will be inviting local courts to apply for a share of $4 million in grant funding to help them acquire video conferencing technology to reduce the need for in-person trials and transactions to prevent the spread of the coronavirus.
  • Ohio Medicaid will expand telehealth services to get in contact with health professionals amid the outbreak. It'll include phone calls, FaceTime and smart phones.
  • Barbershops, hair and nail salons, spas and tattoo parlors were ordered to close at end of business Wednesday, March 18. 
  • More than 180 Bureau of Motor Vehicles locations have also been shut down. Five around the state will remain open to issue commercial driver's licenses. DeWine is asking the Ohio General Assembly to pass legislation that will grant a grace period for people who can’t renew licenses. He's also asking law enforcement, including State Highway Patrol, to not issue tickets for someone who has an expired license.
  • DeWine is asking all businesses, including nonprofits, manufacturers and retailers, to check each employee's temperature before the individual enters the workplace every day. If the person's temperature is elevated, they should be sent home. He's also encouraging employees to check their own temperature every day as a precaution. 
  • Lt. Gov. Jon Husted has encouraged people to apply for unemployment benefits online. Requests have skyrocketed. The state is reducing the wait time to receive benefits to help those left without work suddenly due to coronavirus. Go to unemployment.ohio.gov to apply. He also asked small businesses who need financial relief to go to sba.gov/disaster
  • Hospitals are postponing elective surgeries until further notice. The state issued the order Tuesday to conserve protective equipment for health care workers and keep beds open. Patients will receive a call if their surgery has been canceled. The Ohio Hospital Association also says that hospitals across the state are prepared for a 25% surge in COVID-19 cases if that happens. 
  • Ohio has postponed its primaries. Not even 12 hours before polls were supposed to open, Dr. Amy Acton, the director of the Ohio Department of Health issued a health emergency to shut down polling locations. The new proposed voting date is June 2 but the details still have to be worked out by the courts and/or the state legislature. Absentee ballots would be allowed until then. For more information on what happened, click here.
  • Lt. Gov. Jon Husted gave an update on unemployment requests. 78,000 requests have been filed. It was 6,500 two weeks ago. He also asked small businesses who need financial relief to go to sba.gov/disaster.  absentee ballot, click here.
  • The state has shut down more facilities, including gyms, fitness centers, recreation facilities, theaters, indoor water parks and indoor trampoline parks. 
  • University of Akron has decided to keep classes online for the rest of the semester. The school has also asked students to leave the residence halls by 11 p.m. Wednesday. 
  • Kent State employee has tested negative for COVID-19 after coming into contact with a patient who has the disease. Students have been ordered to leave the residence halls by the end of the week and are eligible for a refund. The university has also announced it will start limiting operations at all eight campuses Monday afternoon. 
  • Bars and restaurants closed down Sunday night temporarily to prevent large gatherings. DeWine said he came to the decision after he received multiple complaints about crowds over the weekend. Carry-out and delivery options are still available. 
  • The state is implementing a COVID-19 treatment plan for individuals with an addiction or mental health issues. This includes more telehealth services that will allow patients to video chat with professionals or call a landline. The plan will also implement a service that will allow people to get their medications without having to physically go to a pharmacy. Pharmacies are making sure they have adequate supplies of medications
  • The Cleveland Clinic is officially offering drive-thru coronavirus testing with a doctor's order. It's in partnership with University Hospitals, which is doing the same. The testing location is in University Circle.
  • Summit County confirmed its first case of COVID-19 Friday. A woman in her 50s is a case of community spread, which means she didn't travel or have direct contact with other COVID-19 patients. The county and the city of Akron have declared public health emergencies. All community centers in Akron closed Monday.  
  • President Donald Trump declared a national emergency Friday under the Robert T. Stafford Disaster Relief and Emergency Assistance Act. This allows the White House to get direct aid quickly from the Federal Emergency Management Agency (FEMA) for disasters and health crises. Trump has also been tested for COVID-19 and doesn't have it.  
  • Lawmakers plan to send a letter to Trump with 17 requests for state relief, such as having access to more protective equipment for health care workers. 
  • DeWine issued an order that prohibits visitors in jails. The state also isn't allowing visitors in nursing homes, assisted-living facilities and psychiatric facilities. 
  • Ohio K-12 schools shut down Monday afternoon for three weeks. DeWine said he will help schools with whatever they need, but it's up to administrators to figure out how to determine details of educating students while they're at home and when they return. 
  • Kent State University, Oberlin College and Ohio State University have canceled in-person classes for the rest of the semester. Classes will be online. Kent State has also postponed pre-commencement and commencement for spring. Many other schools are doing the same. 
  • Ohio has temporarily banned mass gatherings of 100 or more people together in close promiximity in a certain place. This includes parades, fairs, theaters and more.