Politico reports that FDA did not want to approve the technology, until Ohio governor Mike Dewine asked President Trump to lean on FDA. Battelle is in Ohio.Unbelievable. 4 years ago, the FDA gave contractor Battelle half a million dollars to study the use of commercial decontamination equipment, using hydrogen peroxide gas, on N95 masks. Battelle said the method worked in 2016. But we are only just hearing about it, as thousands of healthcare workers get infected due, in part, to lack of these masks. WTF??!!
Either it works reliably or it doesn't, FDA. Which is it? The healthcare workforce is waiting with bated breath for the answer.
From FiercePharma:
Battelle received an emergency go-ahead from the FDA over the weekend to deploy its decontamination system for personal protective equipment (PPE), allowing healthcare workers to clean and reuse scarce N95 respirator masks.
The system is currently operating at Battelle’s Ohio facility—capable of processing up to 80,000 masks per machine, per day, within what looks like a large metal shipping container—and has been working to help stretch supplies for the OhioHealth system based in Columbus.
Using concentrated hydrogen peroxide vapor, 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.
The FDA had first OK’d the use of the system on Saturday but initially limited its use to 10,000 masks per day, according to Republican Ohio Gov. Mike DeWine, who called on the agency to unlock the system’s full decontamination capacity. DeWine also said this would have limited Battelle’s plans to deploy machines to the hard-hit New York metro area as well as Washington state and Washington, D.C.
Within hours, and after President Donald Trump also urged the FDA to approve the equipment on Twitter, FDA Commissioner Stephen Hahn tweeted late Sunday evening that the agency had issued an amended authorization.
Thank you Dr. Hahn & the FDA for your fast approval of this respected Ohio company recommended by Governor @MikeDeWine. Great potential! twitter.com/stevefda/statu…
We issued a new authorization this evening to @Battelle for their decontamination system. @US_FDA staff have been working nonstop across gov and with the private sector to deliver solutions to the American public.
45K7:07 AM - Mar 30, 2020
In the near term, Battelle’s facility plans to begin decontaminating respirator masks for three other central Ohio health systems this week.
Battelle previously engaged with the FDA from 2014 to 2016 to study the use of its decontamination machine in the midst of a potential pandemic and PPE shortage. Currently, the company is exploring its use outside of N95 masks to other equipment such as ventilator components.
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