According to the FDA’s Press Release, over the past several months, anecdotal evidence of adverse events and other failures have swirled around Battelle’s CCDS mask decontamination system. This reporting informally came to the attention of the FDA during their PPE webinars– where multiple healthcare professionals from multiple jurisdictions raised concerns regarding the system. Everything from masks processed by CCDS returning with bad odors, dark stains and poor fit, to spontaneous failures of head straps. CCDS decontamination sites noted chipping paint, and thin film deposition of titanium oxides found on shelving at the end of decontamination runs (which logically would also be deposited on the processed masks), oxidized by the corrosive hydrogen peroxide from the painted interior of the CCDS system. OSHA considers inhalation of titanium oxides a workplace hazard, and has set strict inhalation limits on it. Yet as of the issuance of the FDA’s warning letter on October 7, Battelle had failed to report a single adverse event to FDA. If you believe you’ve been exposed to titanium oxides after using a CCDS processed mask, file a report directly with OSHA, and FDA, who haphazardly granted Battelle’s EUA.
More Science in Support of the Helios Decontamination Solution
Since the outbreak of the COVID-19 pandemic, N95 face masks have been in short supply. Health care workers, in particular, desperately need these masks to protect themselves from the respiratory droplets of infected patients. But because of the shortage, many have to wear the same mask repeatedly. Now, researchers have tested several methods for disinfecting N95 materials, finding that heating them preserves their filtration efficiency for 50 cycles of disinfection. Read the full article.