Technical Safety Services (TSS) announced today that the FDA has issued an emergency use authorization (EUA) using vaporized hydrogen peroxide (VHP) to decontaminate compatible N95 respirators in the United States for multiple-user reuse by health care personnel.
The Berkeley, Calif.-based company has engineered and customized a scalable decontamination system specific to the process of using VHP to decontaminate compatible N95 respirators. With this process, all decontamination cycles will occur onsite or in a preferred central location with the ability to process up to 5,000 masks per cycle in each CS-20 system, the company noted. TSS said can run at least two cycles per day with each system and its VHP method is validated to consistently deliver a 6-log reduction in bioburden based on a minimum dosage of hydrogen peroxide per disinfection cycle.
“The TSS team has been working around the clock to test and get approval for the CS-20 decontamination system so we can mobilize immediately to address the shortages in respirators,” said TSS’ CEO Steve Gonzales in a news release. “Decontamination will allow these important devices to be reused by health care personnel during the COVID-19 pandemic and beyond.”
TSS said it has created a chain of custody and flow path for each hospital that ensures a safely managed process, and that it will work with each organization to ensure they comply with local and national regulatory standards.