FDA approves decontamination of 750,000 N95 respirators per day

Posted at 5:49 PM, Apr 10, 2020

The FDA announced on Friday that it has issued an emergency use authorization to allow up to 750,000 N95 respirators to be decontaminated each day by STERIS Corporation.

Generally, N95 respirators are for one-time use, as doctors and nurses throw them away between patient visits. With the decontamination of the respirators, each respirator could be reused 10 times.

Saving these respirators could help decrease the demand for these masks amid a shortage as hospital see an influx of COVID-19 patients.

"This EUA is another game changer. It will allow hospitals to decontaminate compatible N95 respirators using vaporized hydrogen peroxide sterilizers that are readily available in approximately 2,000 U.S. hospitals," said FDA Commissioner Stephen M. Hahn, M.D. "It's another important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by health care personnel on the front lines of the COVID-19 pandemic."

This is the second EUA issued for the decontamination of respirators. Two weeks ago, the FDA issued authorization to Battelle in Ohio after some wrangling by Gov. Mike DeWine. Battelle is now authorized to decontaminate up to 160,000 respirators per day.

STERIS said that the respirators take 28 minutes to decontaminate.

“Healthcare providers are on the front lines of this pandemic and are in desperate need of personal protective equipment,” said Walt Rosebrough, President and Chief Executive Officer of STERIS. “We are pleased to be able to offer a partial solution for healthcare providers during this crisis, and hope that this temporary authorization will provide some relief to them"

The authorization is only allowed during the spread of the pandemic and if there is not an adequate supply of respirators.

Justin Boggs is a writer for the E.W. Scripps National Desk. Follow him on Twitter @jjboggs or on Facebook .