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.
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.https://www.fiercebiotech.com/medtech/battelle-deploys-decontamination-system-for-reusing-n95-masks
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