FDA Releases Policy Guidance to Decontaminate N95 Respirators Using Dry Heat

(Tampa, December 2, 2020) Tampa based TMPC Inc., in partnership with Tex Med Consulting LLC of San Antonio received policy guidance from the U.S. Food and Drug Administration (FDA) for Dry Heat Bioburden Reduction Systems for N95 Respirators. The Ecosteryl Dry Heat System for N95 Respirators is designed to decontaminate used N95 respirators to support Single-user reuse of N95 Respirators and to reduce exposure to infections. This is especially critical when supplies of N95 respirators are insufficient during the COVID-19 pandemic.

AMB Ecosteryl of Mons, Belgium is currently manufacturing the M-Steryl Decontamination System to help Healthcare and other industries overcome and alleviate their N95 Mask shortages and provides a real opportunity to save money but also to reduce waste.

Through the convenience of on-site decontamination 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 equal to 6Log10 while maintaining mask performance and function.

AMB Ecosteryl designed the Dry Heat M-Steryl Sterilizer to safely 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 to achieve the optimum number of reuses which currently, per FDA guidelines, is no more than 5 uses (one initial use and 4 reuses). The Ecosteryl team has carried out tests to decontaminate devices 3 times, so we recommend a total of 4 uses per mask.

"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.

"Ecosteryl guidance shows 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.