Mask Sterilizing Technology Approved for Use by FDA

Ruben Fields
March 31, 2020

Battelle's method is the same as one confirmed last week by Duke Health, which found that N-95 masks can be safely reused after being decontaminated with vapor phase hydrogen peroxide.

"Battelle's innovative technology has the capability to protect healthcare professionals and first responders in OH and across the country, but in this time of crisis, the FDA has decided not to support those who are risking their lives to save others".

The system is now operating at Battelle's OH 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. "Everybody who has worked on this project shares the same goal of protecting first responders and healthcare workers who are at the front lines of the pandemic". "Great potential!" Trump wrote on Twitter on Monday morning.

The Centers for Disease Control and Prevention (CDC) had previously shared guidelines for extended use and limited reuse of N95 Filtering Facepiece Respirators, such as limiting mask use and using alternatives when possible.

The authorization by the FDA is limited to Battelle's Columbus headquarters and prevents it from sending its technology to other states, according to the governor.

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The process is called the Battelle CCDS Critical Care Decontamination System, according to a statement from the agency.

Research, development and lab management company Battelle has received special emergency authorization from the US healthcare regulator to put into use a system it developed to decontaminate used N95 respirator masks using concentrated hydrogen peroxide.

A fact sheet (pdf) was created to inform healthcare personnel when they were given a decontaminated respirator. Here's your Daily Crunch for March 30, 2020.

Gov. Mike DeWine urged the FDA to reconsider while also noting he had reached out to the president for support. DeWine also said this would have limited Battelle's plans to deploy machines to the hard-hit NY metro area as well as Washington state and Washington, D.C. "The number of cases will continue to grow in the coming weeks, and we need to do everything we can to ensure there is enough equipment to fight this battle, including allowing Battelle to sterilize N95 masks at full capacity", Reps.

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