The EPA has greenlighted a first-of-its kind automated device to combat COVID and other infectious pathogens, replacing manual wipes.
KIRKLAND, WASH. – In a significant move to fight COVID-19 and other contagious pathogens in health care settings, the U.S. Environmental Protection Agency (EPA) has granted Sterifre Medical, Inc. registration to begin commercial deployment of the company’s novel, automated device disinfectant system. The AURA™ system is believed to be the first registered, automated, point-of-care solution providing fast disinfection for non-critical medical devices and common articles used in the healthcare environment. It replaces the need for cumbersome and often challenging manual disinfection with wipes, reducing exposure of health care workers and patients alike to pathogens that cause healthcare associated infections (HAI).
Research finds up to 97% of common healthcare equipment may be contaminated with multiple organisms. The AURA system utilizes a patented application of hydrogen peroxide and activated oxygen to inactivate microorganisms that cause disease. It also significantly reduces the amount of time spent on manual disinfection, is more cost effective than current methods, and can improve the quality of direct patient care. The AURA disinfection system plugs in to a standard electrical outlet in any hospital or clinic patient care area, taking up about the same counterspace as a laptop computer.
“Our mission has always been to make healthcare safer,” said Mike Goonewardene, chief commercial officer at Sterifre, which is based in Kirkland, Washington, epicenter of the United States’ first COVID-19 outbreak. “Our first-of-its kind AURA system was designed to address many of the challenges that healthcare facilities face today. Sterifre is committed to putting fully validated, approved, state-of-the-art tools in the hands of healthcare workers.”
As a regulator for microbicides used for hospital disinfection, the EPA’s registration for Sterifre recognizes the company conducted extensive microbial testing using EPA approved protocols at a laboratory under industry standard “Good Lab Practice (GLP)”. Sterifre also meets the EPA approval requirements under the Emerging Viral Pathogens Program for inactivating SARS-CoV-2, the coronavirus that causes COVID-19, because the AURA™ system has demonstrated effectiveness against viruses similar to SARS-CoV-2.
“The EPA is very focused on providing access to innovative solutions like our AURA disinfection system. Our approval and subsequent filings are for a broad set of efficacy claims.” explained Richard Shea, chief executive officer at Sterifre. “We are working closely with healthcare leaders across the country to deploy AURA as quickly as possible.”
Outmoded Approaches Don’t Meet Current Demands
Manual disinfection processes typically require the entire surface of an item remains wet with disinfectant for up to five minutes to thoroughly kill microorganisms. This timing may vary by organism and disinfectant product. Studies show up to 52% of health care workers are unaware of proper disinfection guidelines. And research finds items that have been improperly wiped may not be thoroughly disinfected, increasing the risk of pathogen transfer.
These harsh chemicals can also impact caregiver health. According to a JAMA Network Open journal article, recurrent disinfectant chemical exposure is associated with a 25-38% increased rate of Chronic Obstructive Pulmonary Disease (COPD) in frontline caregivers.
Manual disinfection also creates a significant environmental impact. It’s not widely known disinfectant wipes are made from unwoven, non-biodegradable plastic fiber, and U.S. hospitals discard almost 8 billion wipes annually.
“With increasing demands on our frontline healthcare workers, and concern for staff and patient safety, an automated, hands-free solution is needed,” Shea explained. “Even under normal circumstances, an enormous amount of medical equipment is manually disinfected multiple times each day using billions of chemical wipes. That time and environmental impact is real.”
AURA™ Slows the Spread of Germs, Increases Pace of Patient Care
“AURA is the first automated disinfection process that can be used on a host of every day medical equipment such as thermometers, glucometers, otoscopes, stethoscopes, oximeters, pads/sensors, cords/cables, doppler probes and many more,” said Mark Golkowski, Ph.D, co-inventor and Professor and Associate Dean in the College of Engineering, Design and Computing at the University of Colorado Denver.
“In replacing wipes and sprays, the system allows doctors, nurses and patients to finally do what we have known needs to be done to reduce exposure to infectious organisms but was not previously practical or in many cases possible,” stated Golkowski, a co-founder and member of the Sterifre board of directors.
The AURA technology uses a well-recognized disinfectant that is consumed in the process, leaving no residual disinfectant. “The patented application of hydrogen peroxide and activated oxygen creates an environment that efficiently kills bacteria and viruses including many multi-drug-resistant organisms, but without any damage to equipment,” explained Shea.
Since the only byproduct of AURA™ is clean air, it can be used anywhere there is an electrical outlet. The system continuously monitors treatment parameters and automatically indicates when disinfection is completed.
Sterifre has been at the forefront of infection prevention in healthcare, serving the Association for Professionals in Infection Control and Epidemiology as an APIC Strategic Partner. Sterifre, APIC and other partners work together to improve healthcare outcomes and advance education and certification for infection prevention professionals.
“Congratulations to Sterifre on this important milestone. Sterifre’s commitment to the APIC Strategic Partner Program demonstrates their commitment to the science of Infection Prevention,” said Devin Jopp, EdD, MS, CEO of APIC.
AURA™ disinfection systems are now available for pre-order with delivery beginning in 2022. For more information visit www.sterifre.com/
Sterifre Medical, Inc., is a privately held medical technology company located in Kirkland, Wash., focused on commercializing innovative, cost-effective, environmentally friendly approaches to protect patients and caregivers from the pathogenic organisms that contribute to complications associated with hospital-acquired infections that result in more than 100,000 annual deaths. Find the company online at www.sterifre.com.
This press release contains certain forward-looking statements regarding Sterifre products, technological capabilities, product registration, and future business aspirations. All such statements are based upon current Sterifre expectations and involve a number of business and technical risks and uncertainties that could cause actual results to differ materially from anticipated results described, implied or projected in any forward-looking statement, including, without limitation, regulatory approvals, unexpected changes in technologies, uncertainties inherent in product development and commercialization, intellectual property protection, and the ability of our products to gain market acceptance.
Josh Kerns for Sterifre