FDA Approves Decontamination Of N95 Respirators For Reuse

The U.S. Food and Drug Administration issued an emergency use authorization to sterilization system that will allow about four million N95 or N95-equivalent respirators to be decontaminated each day. The sterilized respirators will be reused by healthcare workers in hospital settings.

“This authorization will help provide access to millions of respirators so our health care workers on the front lines can be better protected and provide the best care to patients with COVID-19,” said FDA Commissioner Stephen Hahn.

The sterilization system helps address the shortage of these vital masks used by healthcare workers to protect themselves from exposure to the novel coronavirus.

The FDA granted emergency use authorization or EUA to advanced sterilization products for the STERRAD Sterilization Cycles, which uses vaporized hydrogen peroxide gas plasma sterilization.

There are about 9,930 STERRAD Sterilization systems in about 6,300 hospitals across the U.S. STERRAD 100S Cycle, STERRAD NX Standard Cycle and STERRAD 100NX Express Cycle vary in reprocessing times from 55 minutes, to 28 minutes, and 24 minutes. Each can reprocess about 480 respirators per day.

Steris Corp plc. confirmed Friday that the EUA allows the company to temporarily provide a solution for decontaminating compatible N95 or N95-equivalent respirators using the 28-minute Non-Lumen Cycle available on most V-PRO models. Steris recommended decontaminating masks after each use, up to a maximum of ten times. Ten masks can be decontaminated per cycle.

Separately, Battelle, an applied science and technology development company headquartered in Columbus, Ohio, said Friday that its decontamination services for N95 respirator masks would be offered at no charge to healthcare providers. The non-profit, private company noted it is trying to help protect the workers on the front lines of the COVID-19 pandemic.

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