UNREAL: FDA Sat on Critical Mask-Sanitizing Technology, Leaving the Job Up to Grandmas with Sewing Machines

N95 FFRs contaminated by aerosol exposure in the HPV decontamination chamber (via FDA.gov)

Ohio Attorney General Dave Yost has had enough of the FDA’s dithering over approval of an innovative process that could get millions of N95 masks to hospitals and other healthcare facilities, where they are in critically short supply as the Chinese coronavirus continues to stretch their resources. “If this isn’t cleared up by morning, I’m ready to sue the FDA,” Yost wrote on his Facebook page on Sunday afternoon.


What’s the problem? Yost says the FDA is limiting the number of masks that an Ohio organization, Battelle Memorial Institute, can sterilize for reuse. Battelle has pioneered a technology that uses hydrogen peroxide vapor to make N95 masks safe for reuse and wants to ramp up production at their facility so they can send the masks where needed, but the FDA essentially shrugged and seemed to say, ‘what’s the big hurry?’

“The Food and Drug Administration — after dithering all week — finally gave Battelle approval to sterilize a measly 10,000 masks a day,” Yost said. “They could be doing 160,000 per day.”

And while the FDA dithers, grandmas across the nation are hunched over their sewing machines, heroically pumping out handmade masks to help fill the need for the critical protective masks.

“Gov. Mike DeWine has called the President. The FDA commissioner assured him that this would be taken care of. But as of this writing, the FDA has not moved,” said Yost.

President Trump praised Battelle on Twitter Saturday, and urged the FDA to move quickly to approve increased production of the masks:

“Here’s the thing,” Yost said, “if the technology is safe and works, there is no rational basis to limit it. If it is unsafe or doesn’t work, then it shouldn’t be permitted at all.”

He called the decision to limit the number of masks to 10,000 per day “simply irrational.”

Yost pointed out something that has become increasingly evident to every sentient American over the last two weeks: “The FDA is not known for innovation. Or responsiveness. Their timelines for quick action are measured with a multi-year calendar.”

Yost pointed to a study Battelle submitted to the FDA–in 2016. The details about Battelle’s innovative technology have been in the grubby little hands of FDA bureaucrats for nearly for years, and now, in the midst of a global Wuhan flu pandemic, the FDA can’t seem to make up its mind.

In the 2016 study, which can be viewed on the FDA’s website, Battelle warned:


In the event of a pandemic (e.g. influenza), large numbers of FFRs [filtering facepiece respirators] will be used by healthcare workers for protection. It was estimated that during a 42-day influenza pandemic over 90 million N95 FFRs will be needed to protect healthcare workers, resulting in a shortage of FFRs.

An interagency working group of the U.S. government published a comprehensive report on the technology, which concluded that “respirators should be capable of being repeatedly decontaminated during a crisis for up to 50 cycles without causing damage to the respirator.”

Battelle’s study found that “the ability to decontaminate the respirator was demonstrated even after multiple cycles (up to 50) of biological exposure/decontamination” and is “a viable approach to decontaminate large numbers (>50) of FFRs simultaneously.”

So why is the FDA throttling the Battelle’s ability to decontaminate masks, limiting them to 300,000 masks per month when they could be pumping out nearly 5 million? See above, where I said that every sentient American now understands what’s going on here: federal bureaucracies are always inefficient and often incompetent, which is why critical time was wasted in the run-up to the spread of the coronavirus in the U.S. after the CDC screwed up the tests.

Yost has lost patience with the feds. “This is an emergency,” he said. “Time is of the essence, and as Gov. Mike DeWine said, it’s literally a matter of life and death — for our health care professionals treating the sick, and for the sick themselves.”

“I hope tomorrow morning I wake up to news that the FDA has come to its senses and realized that its job is to save lives. If not, we will be pulling our papers together for court. Win or lose, they can tell it to the judge,” he concluded.

When time is of the essence, relying on a sclerotic federal bureaucracy in a life-or-death matter could end very, very badly. Let’s hope President Trump can shake things up at the FDA and remove the barriers standing in the way of this potentially life-saving technology.

Life comes at you fast update: About an hour after this article was published, Gov. Mike DeWine took to Twitter to announced that the FDA had approved a ramping up in production by Battelle:

Sometimes the squeaky wheel really does get the grease.

Follow me on Twitter @pbolyard



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