In a significant move to expedite the fight against COVID-19 and other contagious pathogens, the U.S. Environmental Protection Agency (EPA) has granted Sterifre Medical, Inc. expedited registration to begin commercial development and deployment of the company’s novel automated device disinfectant system. Co-invented by CU Denver’s Mark Golkowski, professor in the College of Engineering, Computing, and Design, the AURA™ system is the first automated, point-of-care solution providing fast disinfection. It replaces the need for cumbersome and often less effective manual disinfection with wipes for a host of medical equipment and personal items in hospitals and other health care settings, protecting the safety of health care workers and patients alike from healthcare associated infections (HAI).
The AURA™ system utilizes a patented application of hydrogen peroxide and activated oxygen to inactivate microorganisms. In addition to its validated disinfection, the AURA™ system also virtually eliminates the significant amount of time spent on manual disinfection and costs the same as current methods, and improves 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, the epicenter of the United States’ first COVID-19 outbreak. “Our first-of-its kind AURA system addresses many of the challenges that healthcare facilities face today. Sterifre is committed to putting state of the art, fully approved tools in the hands of the healthcare workers.”
As the regulator for microbicides used for hospital disinfection, the EPA’s expedited registration for Sterifre recognizes the company conducted extensive microbial testing at an approved 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.
“The EPA is very focused on providing access to innovative solutions like our AURA 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 that the entire surface of items remains wet with disinfectant for up to five minutes to thoroughly kill microorganisms. Because of the variability of this manual process, studies show that items that have been improperly wiped may not be thoroughly disinfected, increasing the risk of hospital associated infections for healthcare workers and patients alike. These harsh chemicals can also impact the health of caregivers themselves. According to a JAMA Network Open journal article, recurrent disinfectant exposure is associated with increased rates of Chronic Obstructive Pulmonary Disease (COPD) in frontline caregivers.
“Even under normal circumstances, an enormous amount of medical equipment is manually disinfected multiple times each day using a variety and huge number of chemical wipes. And that time adds up,” Shea explained. “With increasing demands on our frontline healthcare workers, and concern for staff and patient safety, an automated, hands-free solution is needed”.
The massive amounts of wipes used daily across the country have tremendous environmental impacts as well. It’s not widely known that disinfectant wipes are made from unwoven, non-biodegradable plastic fiber, and U.S. hospitals discard almost 8 billion wipes annually. “With the enormous financial and environmental cost associated with the current products, I think that we would all agree that an automated point-of-care solution is urgently needed,” Shea said.
Fast, Automated Disinfection 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 medical equipment such as thermometers, glucometers, otoscopes, stethoscopes, oximeters, pads/sensors, cords/cables, doppler probes and many more,” said Mark Golkowski, PhD, AURA™ co-inventor and professor and associate dean in the College of Engineering, Design and Computing. Sterifre can disinfect radios, phones, tablets, remote controls, and call buttons, all of which can spread infectious microorganisms and increase the risk of HAI. Staff can also use AURA™ at the end of shift to disinfect personal items like phones, keys, ID badges and jewelry.
“In replacing wipes and sprays, the system allows doctors, nurses and patients to finally do what we have known needs to be done to control infections but was not previously practical or possible,” stated Golkowski, a co-founder and member of the Sterifre board of directors.
The patented technology uses a well-recognized disinfectant that is consumed in the process, leaving no residual disinfectant on devices. “The AURA™ patented application of hydrogen peroxide and activated oxygen creates an environment that quickly kills bacteria and viruses including many multi-drug-resistant organisms, but without any residue or 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.
AURA™ systems are now available for pre-order with delivery beginning in 2022. For more information visit www.sterifre.com/.