Battelle has received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) to support front-line healthcare workers as they face critical shortages of personal protective equipment (PPE), the company announced on Sunday.
“I want to thank the FDA team for their professionalism and help in authorizing the use of our technology at this critical moment for our nation,” said Lou Von Thaer, President and CEO of Battelle and five-time Wash100 Award recipient. “Everybody who has worked on this project shares the same goal of protecting first responders and healthcare workers who are at the front lines of the pandemic.”
The Battelle CCDS Critical Care Decontamination System will operate 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 contaminants, including SARS-CoV-2. Battelle CCDS can decontaminate the same respirator mask up to 20 times without degrading the mask’s performance.
Healthcare systems using 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 to ensure 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.
“This will not only help Ohio’s healthcare workers on the front lines of the COVID-19 crisis, but Battelle will also be helping health care workers in hot spots throughout the country including New York and Washington states,” said Ohio Governor Mike DeWine.
Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries.