(Tampa, November 18, 2020) Tampa based TMPC Inc., in partnership with Tex Med Consulting LLC of San Antonio announce a pending emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a Dry Heat Decontamination System for N95 Respirators. The Ecosteryl Dry Heat Decontamination System for N95 Respirators is designed to decontaminate used N95 respirators to prevent exposure to aerosolized infectious particles. This is especially critical when supplies of N95 respirators are insufficient during the COVID-19 pandemic.
TexMed Consulting and AMB ecosteryl submitted a request for an EUA for the M-Steryl Device using dry heat decontamination in July 2020 and anticipates receiving EUA authorization under the Tier III Umbrella authorization.
AMB Ecosteryl of Mons, Belgium is currently manufacturing and selling the M-Steryl Decontamination System throughout the world to help Healthcare and other industries overcome and alleviate their N95 Mask shortages and proves a real opportunity to save money but also to reduce waste.
Through the convenience of on-site sterilization of used masks using a tabletop M-Steryl device, Healthcare or any facility dependent on N95 respirators can be assured that they are achieving coronavirus kill at 6 Log10 or greater while maintaining mask performance and function.
AMB Ecosteryl designed the Dry Heat M-Steryl Sterilizer to reprocess N95 Respirator masks. Published reports and peer-reviewed literature have demonstrated that dry heat processing is the preferred method for assuring both viral inactivation and N95 respirator performance in order to achieve the optimum number of reuses which currently sits at a total of 4 uses (one initial use and three reuses).
“AMB Ecosteryl has leveraged their deep scientific capability to fight this pandemic and chose Tex Med Consulting to be their Exclusive US Distributor,” said William Jewett, CEO of Tex Med. “Tex Med is proud of our efforts to combat COVID-19,” Jewett added.
“This device can decontaminate an N95 mask during a 2-hour cycle. The device can decontaminate up to 2,100 N95 Masks, or 144 gowns, during a 24-hour cycle,” said Joe Teasley, CEO of TMPC Inc. “The cost savings, simple use, and the capability to decontaminate the masks at your location gives back the control your team needs to combat the Covd-19 pandemic,” he added.