FDA approves face mask decontamination process to make desperately needed N95 respirators reusable
The Food and Drug Administration approved a decontamination process for N95 face masks, a move that could help to address the shortage of masks available for health care professionals.
The process is called the Battelle CCDS Critical Care Decontamination System, according to a statement from the agency. Through the process, N95 and N95-equivalent respirators could be made available for reuse by health professionals, helping to “prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of FFRs (filtering facepiece respirators) during the COVID-19 pandemic,” the statement noted.
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On its website, Battelle, an Ohio-based science and tech company, claims that their process can decontaminate “thousands of N95 respirators using concentrated, vapor phase hydrogen peroxide” without impairing performance of the N95 respirators.
Initially, Battelle had only been approved by the FDA to decontaminate masks on a limited basis.
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Gov. Mike DeWine urged the FDA to reconsider while also noting he had reached out to the president for support. On Sunday, the governor provided an update that the FDA would allow Battelle to sterilize masks without a daily limit.
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.
While the shortage of N95 masks has prompted some to seek out alternatives, such as sewing their own face masks or covering their nose and mouth with a bandana, these options aren’t as effective as N95 masks in preventing contraction of the novel coronavirus, according to CNET.
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The Associated Press reported last week that imports of critical medical supplies were plummeting due to factory closures in China, where manufacturers had been required to sell all or part of their goods internally rather than export to other countries.
No medical-grade N95 masks, made almost entirely in China, have arrived at U.S. ports so far this month. Companies such as Facebook, Apple and SoftBank announced that they were donating N95 masks to health care organizations to assist in pandemic response efforts.
The Associated Press contributed to this story.