Berkeley, Calif.-based Technical Safety Services (TSS) announces that the U.S. 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 healthcare personnel. TSS is ready to decontaminate masks immediately.
TSS has engineered and customized a scalable decontamination system specific for this 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. TSS can run at least two cycles per day with each system, company officials say. Moreover, the TSS VHP method is fully validated to consistently deliver a six-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,” says TSS’ CEO Steve Gonzales. “Decontamination will allow these important devices to be reused by healthcare personnel during the COVID-19 pandemic and beyond. This will be a game-changer.”
TSS has created a chain of custody and flow path for each hospital that ensures a safely managed process. TSS will work with each organization to ensure they comply with local and national regulatory standards.
“Over the last several months, we’ve received dozens of calls from organizations around the country about how we can help them decontaminate their PPE,” says Brent Hart, director of operations at TSS. “With VHP decontamination being a core service of TSS in other daily applications, we took the opportunity to use our expertise and decades of experience with this process to build the most robust solution in the market. TSS is ready and willing to help ensure our nation’s front-line workers have the critical PPE they need.”
