Battelle Earns FDA EUA for Decontaminating Respirator Masks

FDA has granted Emergency Use Authorization (EUA) to Battelle's CCDS Critical Care Decontamination System for processing up to 80,000 respirator masks per system each day. CCDS employs concentrated, vapor-phase hydrogen peroxide (VPHP) for decontamination. The system has been validated to decontaminate masks of SARS-CoV-2, the company reported. The masks are placed on shelves inside a container, and a portable, external VPHP system is hooked up to the outside of container. The system was first envisioned by Battelle as part of a study commissioned by FDA in 2015. That study involved determining the feasibility of N95 respirator mask decontamination in the event of a personal protective equipment (PPE) shortage in a pandemic. The FDA study showed that VPHP decontamination using the same system parameters and critical end points as the current system resulted in 6-log reduction of G. stearothermophilus while not degrading the filter performance of N95 respirators for multiple decontamination cycles, Battelle reported in a news release. "We have proven that VPHP is effective at decontaminating N95 respirator masks up to 20 times at large scale," said Matt Vaughan, president of contract research at Battelle. The masks are exposed to the validated concentration level for 2.5 hours to decontaminate biological contaminates, including SARS-CoV-2, the company reported. Battelle is currently examining whether other supplies such as surgical masks and ventilator components can be decont...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Source Type: news