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.
Overpriced and Under-Delivering… A Cautionary Tale
NBC News, in an investigatory piece titled “Trump administration paying huge premium for mask-cleaning machines. Which don’t do the job.” shines light on how one solution from Battelle, is grossly over-charging for mask decontamination, which may not even work. Nurses from California to Virginia are concerned about their own safety when using Battelle’s recycled masks. They should be – since there is no published science to support how Battelle’s system works under real-world conditions. We’ve highlighted California nurses concerns here.
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.
Hydrogen Peroxide Vapor Decontamination Called Unsafe By California Nurses and They Are Right
California nurses are being asked to reuse N95 respirators decontaminated by Hydrogen Peroxide Vapor (HPV) systems, they’re nervous about the safety of the respirators, and they are right. Unlike Helios, HPV decontamination will not work if the respirators has secretions from humans like facial oil. The oil creates a barrier to the decontaminating vapor, which will leave portions of the mask susceptible to viral load. Additionally, there are questions of how well HPV decontamination will work with moist respirators. Respirators will be moist from use…humans expel about 250ml of water from breathing throughout the day. If the respirators are moist at the start of the decontamination cycle, the hydrogen peroxide vapor can be diluted by the moisture, potentially affecting the efficacy of the decontamination cycle. Read the full story here.