It’ll take every weapon we have…

A story of technology, advocacy, a sentence or two by a President, and moving mountains as another company answers the call.

“Why can’t these masks be reused? Can’t we sterilize them?” – A few sentences spoken privately – and then publicly – by the President of the United States. And almost overnight, a small Ohio company, Battelle, was called up to fight in the war against the coronavirus pandemic.

Their weapon? Technology and equipment capable of sterilizing surgical masks, N95 masks, and other types PPE – Personal Protective Equipment. Its slow and steady trajectory through the FDA regulatory process was about to be loaded onto a rocket – and propelled with jet fuel.

Their technology is capable of sterilizing large quantities of surgical masks, the item most in need at this time. Hospitals were going from 10,000 individual uses to 300,000 overnight, and the supply chain, as the world would begin to learn, was just not there to provide the materials – because every place in the world was demanding them all at the same time.

Back in 2014 Battelle began to develop the equipment and provisionally were allowed to use it in three health systems in the state of Ohio. The product would start to see increased interest in 2019 when the coronavirus reared its fierce head, and moreso in 2020, when medical teams were reusing masks, and some had taken to sewing their own.

But it was a Sunday night press conference, and a strategically dropped sentence or two by the President of the United States, Donald Trump, that enabled the tortoise-like approval process of the FDA to wake up and move, and the plan was launched.

Ohio Governor Mike DeWine said President Trump told him, “I’m moving. I’ll get this done.”

Within a day or so the FDA granted emergency clearance for the huge piece of sterilization equipment to be used on Long Island – and now in Boston – and it may already be in New York City, Stony Brook, New York, and Washington state.

The first approval from the FDA was limited to 10,000 masks per day, but at the intervention of the Ohio Governor, the system was unlocked to utilize its full decontamination capacity.

Now, the equipment can decontaminate up to 10,000 compatible N95 respirator masks per chamber load, with the machine able to process four chambers per sterilization process. Battelle said it can run two sterilization processes per machine per day, sterilizing 80,000 masks per machine.

Sterilized masks can be reused up to 20 times. Once that limit is reached, the masks are discarded. Battelle CEO Lewis Von Thaer said they are currently limited to only sterilizing N95 masks, but it is moving toward gaining approval for other PPE like ventilator parts.

“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,” said Ohio Governor Mike DeWine in a statement issued Sunday night.  “We ‘re grateful that the President and the FDA moved quickly to help us get this solution up and running,” said Lt. Governor Jon Husted added in the same statement. “This Ohio-driven solution has the potential to save lives now and in the future across the United States.”

Today Boston announced its use as well.

FDA Commissioner Stephan Hahn, M.D. released the following statement regarding the government’s response to Battelle’s request:

This is an example of everyone working quickly to help find a solution. FDA staff have been working around the clock to help mitigate this pandemic as swiftly as possible. After receiving Battelle’s request today, we turned it around in a matter of hours and issued a new authorization allowing them to ramp up their capability to decontaminate more respirators. FDA is committed to working across government and with the private sector to find solutions fast. We are willing to be flexible and adapt to this pandemic, so that we can get essential medical devices to those in need to protect against COVID-19.

Von Thaer said he expects to not only sterilize up to 80,000 masks per machine per day, but also to have those masks back in circulation on the same day.

The system uses concentrated hydrogen peroxide vapor, and the filters are gassed for two and a half hours to destroy bacteria, viruses and other contaminants, including the novel coronavirus SARS-CoV-2. According to the company, the system can clean the same N95 mask up to 20 times without degrading its performance.

Currently, the company is exploring its use outside of N95 masks to other equipment such as ventilator components.

Look for smaller sterilization units to become part of hospitals’ standard equipment as time goes by, benefitting the world’s medical supply chain and protecting nurses, doctors, and technicians the way they deserve to be protected – as they work to save our lives.

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