FDA Issues Emergency Use Authorization for Decontamination of N95 Respirators
The emergency use authorization will support the decontamination of 750,000 N95 respirators per day in the United States
The US Food and Drug Administration (FDA) has issued an emergency use authorization that will support the decontamination of 750,000 N95 respirators per day in the United States. The authorization will permit the decontamination of N95 or N95-equivalent respirators for health care workers in the hospital setting to reuse.
“Authorizing this sterilization system will make it easier for hospitals to ensure that heroic healthcare workers on the frontlines have the protection they need,” said HHS Secretary Alex Azar in the announcement.
The authorization was granted to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems. The systems use STERIS N95 Decontamination Cycle (non-lumen cycle) which features the use of vaporized hydrogen peroxide.
As part of the process, the vapor enters the sterilization chamber and penetrates the device while also sterilizing exposed surfaces. The system has the ability to process 10 respirators at a time in a process that requires about 28 minutes. For single-user reuse, each respirator can be processed up to 10 times.
According to FDA Commissioner Stephen M. Hahn, MD, this emergency authorization is a “game changer.”
“It will allow hospitals to decontaminate compatible N95 respirators using vaporized hydrogen peroxide sterilizers that are readily available in approximately 2,000 US hospitals,” Hahn said in the announcement.
Earlier today, the FDA announced an emergency use authorization has been granted for a blood purification system. The system can be used among adult patients with coronavirus disease 2019 who have been admitted to the intensive care unit and are currently experiencing or will experience respiratory failure.