COLUMBUS – The U.S. Food and Drug Administration relented in the face of pressure from Gov. Mike DeWine, central Ohio lawmakers and even President Donald Trump and has authorized Battelle to deploy technology to sterilize surgical masks without a daily limit, allowing the Columbus company to decontaminate tens of thousands of badly needed respirator masks each day.
We are pleased to proceed with our Critical Care Decontamination System™ #CCDS for full deployment in our home state of Ohio and across the country. https://t.co/vexx4rXlhx pic.twitter.com/Ln9bFjM5fo
— Battelle (@Battelle) March 30, 2020
The agency on Saturday approved the technology but limited it to only 10,000 surgical masks each day, sterilized in Ohio.
DeWine blasted that decision as “nothing short of reckless” and lobbied both Trump and FDA commissioner Dr. Stephen Hahn to lift the limit, which the agency agreed to late Sunday night.
“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. 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 said in a statement released after the decision was announced.
Battelle intends to send one machine to New York City and one to Stony Brook, N.Y., which can sterilize up to 160,000 surgical masks for the city’s healthcare workers each day.
Machines will also be dispatched to the state of Washington and the company plans to ship 19 more units elsewhere in the country in the next several weeks.
The systems use concentrated hydrogen peroxide vapor and can sterilize N-95 surgical masks up to 20 times without decreasing their effectiveness, Battelle president and CEO Lewis Von Thaer said.
He said the systems will be able to return 80,000 masks to Ohio hospitals as early as Tuesday after they are sterilized at Battelle’s West Jefferson cfacility.
The billions of tax dollars headed for hospitals and states as part of the $2.2 trillion coronavirus response bill won’t solve the critical shortage of protective gowns, gloves and masks, according to a report by The Associated Press.
Experts say the problem isn’t a lack of money. It’s that there aren’t enough supplies to buy.
What’s more, the crisis has exposed a fragmented procurement system that’s descending into chaos just as demand soars. Hospitals, state governments and the Federal Emergency Management Agency are left bidding against each other and driving up prices.