COLUMBUS, Ohio (July 15, 2020)–The Battelle CCDS Critical Care Decontamination System™ (CCDS) passed both filtration efficiency and fit-related evaluations through 20 cycles for two different 3M respirators tested (models 1860 and 8210), with results published in 3M’s latest technical bulletin.
According to the bulletin, 3M has evaluated the effect of multiple decontamination processes on the fit and filtration performance of certain 3M N95s. The company states there are at least four key aspects of successful decontamination of respirators that must be considered for effective respirator decontamination. The method must:
- Inactivate the target organism, such as the virus that causes COVID-19;
- Not damage the respirator’s filtration;
- Not affect the respirator’s fit; and
- Be safe for the person wearing the respirator.
3M has evaluated the effect of the Battelle CCDS process on the respirators tested and found that the decontamination process is not expected to have a detrimental impact on respirator filtration or fit for up to 20 cycles. Battelle evaluated the decontamination efficacy, showing that the CCDS process inactivates SARS-CoV-2. Battelle also measured the residual hydrogen peroxide content to be below OSHA’s Permissible Exposure Limit (PEL) concentration of 1 part per million.
3M collaborated with several decontamination equipment manufacturers and institutions that are investigating ways for hospitals to safely decontaminate 3M’s N95 Filtering Facepiece Respirators (FFRs) in line with the CDC guidance on Decontamination and Reuse of FFRs and has been studying ways to decontaminate filtering facepiece respirators for years.
“The Battelle CCDS™ was developed in response to the 2014 Ebola outbreak, at the request of the FDA,” said Battelle President and CEO, Lou Von Thaer. “In 2020, after COVID-19 hit the U.S. and caused exactly the kind of PPE shortage this system was designed to address, CCDS was quickly mobilized as a stopgap measure to alleviate the N95 shortage.”
The FDA confirmed in 2016 that Battelle’s process is safe and effective for decontaminating N95 respirators and a 2020 Duke University study found that “N95 respirators still met performance requirements even after decontamination with hydrogen peroxide vapor in the laboratory setting for over 50 times.” Further, Massachusetts General Hospital’s 2020 independent evaluation of CCDS concluded that “the decontamination methods are safe and effective.” An April 2020 CDC study and a June 2020 National Institute for Occupational Safety and Health (NIOSH) study confirm the safety of Battelle’s decontamination methods.
There is no cost to hospitals, healthcare workers, or first response agencies for respirators that Battelle decontaminates. Battelle is currently operating more than 40 decontamination facilities around the country and 22,000 organizations are enrolled in the service. Decontaminated respirators are barcoded and returned directly to the organization that provided them for cleaning. The entire process takes 3 – 5 days.
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. For more information, visit www.battelle.org.
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