FDA OKs on-site decontamination systems for reusing millions of N95 respirator masks

FDA
Use a low-temperature process and hydrogen peroxide gas, the decontamination systems could allow each mask to be reused a limited number of times. (Andrew Harnik, Associated Press)

The FDA greenlighted its second and third systems for decontaminating N95 respirators, both previously used on-site at many health systems nationwide. Together, the agency estimates this will allow nearly 5 million masks to be processed and reused per day.

One emergency authorization, for the V-PRO systems manufactured by Steris, was described as "another game changer" by FDA Commissioner Stephen Hahn in the fight against COVID-19 and the spreading coronavirus.

“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,” Hahn said in a statement. This would provide about 750,000 cleaned masks on a daily basis, with each being reprocessed up to 10 times.

Steris' V-PRO maX 2 Low Temperature
sterilizer (Steris)

A few days later those numbers received a bigger boost, with the FDA authorizing the Sterrad decontamination systems developed by Advanced Sterilization Products, or ASP. 

With about 9,930 installed at about 6,300 hospitals, this could add a daily capacity of about 4 million N95 respirator masks, according to the agency.

The Sterrad machines also employ hydrogen peroxide gas, with hardware varying in reprocessing times from about a half-hour to an hour to handle about 480 respirators per day. 

“Healthcare providers are on the front lines of this pandemic and are in desperate need of personal protective equipment,” said Steris President and CEO Walt Rosebrough. “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.”

RELATED: Battelle deploys decontamination system for reusing N95 masks

The V-PRO systems use a low-temperature process to clean up to 10 respirators at a time over about a half-hour. Steris said its process should only be used if there is insufficient supply of new masks. In addition, the system has not been authorized for cellulose- or paper-based respirators.

The FDA previously gave the go-ahead to Battelle’s centralized decontamination solution, which also uses hydrogen peroxide vapor. With hardware built into large metal shipping containers, the company said they were capable of processing 80,000 masks per machine, per day.

Those systems were rated to clean the same N95 mask up to 20 times without degrading its performance, according to Battelle.

Editor's note: This story has been updated to include the ASP authorization.

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