SteraMist Deployed to Meet Urgent Need for Decontamination and Reuse of N95 Masks for Healthcare Workforce

BEVERLY HILLS, Calif., April 27, 2020 (GLOBE NEWSWIRE) -- TOMI Environmental Solutions, Inc.® (“TOMI”) (OTCQB:TOMZ), is a global company specializing in disinfection and decontamination, utilizing its premier Binary Ionization Technology (BIT) platform through its SteraMist products - a hydrogen peroxide-based mist and fog composed of ionized Hydrogen Peroxide (iHP). SteraMist is currently being used around the world to decontaminate N95-equivalent respirator masks, plastic PAPRs, face shields, and other medical protective equipment.

The challenging situation that has been created by the COVID-19 pandemic outbreak has led to critical shortages of personal protective equipment (PPE), placing healthcare workers at a greater risk of infection. The global supply chain is currently unable to adequately supply N95 respirators to all healthcare systems, limiting their ability to protect their healthcare workforce.

Current methods being used for PPE disinfection, such as outdated studies from vaporized hydrogen peroxide as well as ultraviolet slightly degrading polymers, lead to a small increase in particle penetration and result in less effective techniques. Due to incompatibility, chambers utilizing a high concentration of hydrogen peroxide vapor are not authorized by the FDA to disinfect respirators containing 10 percent and less cellulose-based materials or plastic face shields as the high concentration of hydrogen peroxide decontamination degrades many materials.

SteraMist, however, can decontaminate all masks, including those with up to 10% cellulose, and face shields without presenting a risk of degradation, leaving the mask decontaminated and deodorized. SteraMist iHP technology N95 method of decontamination is proven to be quicker, and less degrading, has superior material compatibility for N95 compared to both VHP (Vaporized Hydrogen Peroxide) a registered trademark of Steris and HPV (Hydrogen Peroxide Vapor) the method used by Bioquell. 

Given the existence of state and national disaster declarations, protocols have been developed and deployed at institutions across the United States at the University of Iowa, Dana-Farber Cancer Institute, in Boston, Massachusetts, Brigham and Women’s Hospital in Boston, Massachusetts and Cedars-Sinai Health Systems in Los Angeles.

A recent study, “Analysis of SteraMist ionized Hydrogen Peroxide Technology in the Sterilization of N95 Respirators and Other PPE”, was conducted by Greater Boston Pandemic Fabrication Team at the Harvard-MIT Center for Regulatory Science, Harvard Medical School, Dana-Farber Cancer Institute, Boston, Ma, Brigham & Women’s Hospital, Boston, Ma, Department of Nuclear Science and Engineering and Department of Materials Science and Engineering, MIT, Cambridge, Ma., Computational Health Informatics Program, Boston Children’s Hospital, Boston, Ma  plus others to prove SteraMist efficacy, filtration efficiency, and quantitative fit testing. The results show that iHP produces a 6-log to 9-log reduction of Geobacillus stearothermophilus (the gold standard for sterilization) after a 7-day incubation period for N95 masks and related PPE. The single-pass filtration efficiency test was performed at MIT and ICS labs to NIOSH standards. Results showed no reduction in filtration efficiency with 0.3, 0.5, and 1um particles after five (5) cycles. The quantitative fit test was tested using PortaCount Respirator Fit tester equipment and passed a reading of >200 fit, proving that iHP disinfection does not impair the ability of N95 masks to form a seal against the user’s face. It is stated in the journal article that 4,800-7,200 masks can be decontaminated on a single shift.  The data in the study supports the use of SteraMist iHP technology as a premier decontamination method for the reuse of N95 masks and many other PPE.

Another study was conducted at the University of Iowa. The study demonstrated that a 6-log and greater kill was achieved, and no significant degradation was observed up to six (6) reprocessing cycles of decontamination. The results were verified at Iowa’s NIOSH-funded center/lab that tested the N95 respirators for filtration efficiency, utilizing a nearly identical test protocol to what is known to be utilized by NIOSH. Chemical indicators (CI) were employed to verify a minimum treatment exposure of 50-100ppm of hydrogen peroxide to the test respirators. UI Heartland Center for Occupational Health and Safety laboratory analysis of the test N95 respirators indicated little to no degradation of the filtration efficiency in two test groups after six (6) reprocessing cycles. Statistical analysis demonstrated no significant difference between the two test groups and the untreated control group. Based upon these laboratory results, it was determined that application of the newly modified direct-spray protocol outlined in their document for up to six (6) reprocessing cycles per N95 respirator would be reasonable and safe under current circumstances.

Finally, a paper was published in the Insider on Dana-Farber Cancer Research decontaminating 2,000 N95 masks, Face shields and PAPR hoods within a two-hour time period.

In the Journal of Hospital Infection, a recent article was released: Disinfection of N95 respirators by ionized hydrogen peroxide in pandemic coronavirus disease 2019 (COVID-19) due to SARS-CoV-2. The study began with iHP applied three times to masks that were exposed to H1N1, an enveloped virus. Each of the three sprays lasted approximately six seconds. The masks presented no presence of Influenza A after being observed daily for 14 days, proving that iHP can kill or inactivate an enveloped virus, such as SARS CoV-2 (COVID-19). The study was performed at the Department of Microbiology, Queen Mary Hospital, Hong Kong Special Administrative Region, China, by the Infection Control Team, Queen Mary Hospital, Hong Kong West Cluster, Hong Kong, Special Administrative Region, by the China Department of Pathology, Princess Margaret Hospital, Kowloon West Cluster, Hong Kong Special Administrative Region and the China Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region, China.

TOMI Environmental Solutions has submitted an Emergency Use Application (EUA) to the FDA Under 21 U.S. Code § 360bbb–3, authorization for medical products for use in emergencies. EUA was sent to The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) which has received our submission, as we, along with the healthcare community, anxiously await their decision.

Dr. Halden Shane, TOMI’s CEO, states, “Spending decades of my life in medicine helping people with conditions and illnesses, I am now honored to be able to give back to healthcare the ability of TOMI’s technology in providing a safer environment for my fellow healthcare workers by using SteraMist to disinfect N95 masks during these trying times. We now patiently wait the approval from the FDA. With infection prevention at the forefront of everyone’s minds, TOMI is here to lead the way with SteraMist by applying our motto “Innovating for a Safer World” decontaminating N95 masks and other personal protection equipment in the safest and shortest time to date.”

TOMIEnvironmental Solutions, Inc.: Innovating for a safer world®
TOMI™ Environmental Solutions, Inc. (OTCQB:TOMZ) is a global decontamination and infection prevention company, providing environmental solutions for indoor surface disinfection through the manufacturing, sales and licensing of its premier Binary Ionization Technology® (BIT) platform. Invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, BIT solution utilizes a low percentage Hydrogen Peroxide as its only active ingredient to produce a fog of  ionized Hydrogen Peroxide (iHP). Represented by the SteraMist® brand of products, iHP produces a germ-killing aerosol that works like a visual non-caustic gas.

TOMI products are designed to service a broad spectrum of commercial structures, including, but not limited to, hospitals and medical facilities, cruise ships, office buildings, hotel and motel rooms, schools, restaurants, meat and produce processing facilities, military barracks, police and fire departments, and athletic facilities. TOMI products and services have also been used in single-family homes and multi-unit residences.

TOMI develops training programs and application protocols for its clients and is a member in good standing with The American Biological Safety Association, The American Association of Tissue Banks, Association for Professionals in Infection Control and Epidemiology, Society for Healthcare Epidemiology of America, America Seed Trade Association, and The Restoration Industry Association.

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Harold Paul