FDA-developed decontamination system wins EUA for COVID-19 use

The Food and Drug Administration (FDA) on March 29 awarded Emergency Use Authorization (EUA) for a decontamination system to help address critical shortages of personal protective equipment (PPE) for healthcare workers on the front lines of COVID-19 diagnosis and treatment.

The Battelle CCDS (Critical Care Decontamination System) is based on research that Battelle performed for the FDA in 2015 (Richter et al., 2016) to assess the feasibility to decontaminate N95 respirator masks in the event of a PPE shortage resulting from a pandemic. In that FDA study VPHP decontamination, using the same system parameters and critical end points as the current system, was shown to result in 6-log reduction of G. stearothermophilus while not degrading the filter performance of N95 respirators for multiple decontamination cycles. Battelle is currently conducting research to validate that other equipment, including surgical masks and ventilator components, can be decontaminated using this process.

The CCDS system is now operating at Battelle’s West Jefferson, Ohio, facility under the EUA and is capable of decontaminating up to 80,000 respirator masks per system each day using concentrated, vapor phase hydrogen peroxide (VPHP). The respirator masks are exposed to the validated concentration level for 2.5 hours to decontaminate biological contaminates, including SARS-CoV-2. Battelle CCDS™ can decontaminate the same respirator mask up to 20 times without degrading the mask’s performance.

Healthcare systems that wish to use Battelle CCDS™ will collect worn respirator masks daily in accordance with an approved procedure and courier these respirator masks to Battelle CCDS™ operations as systems come online. The PPE will be labeled with a barcoded serial number for tracking the chain-of-custody throughout the process. This ensures that the hospital system receives its own masks back. Each respirator mask will be marked with the number of times that mask has been processed.

Read more: https://www.businesswire.com/news/home/20200329005039/en/Battelle-Develo...

Read about the FDA study here: https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-s...