Could non-critical medical devices and other items used at the patient bedside present infection risks?
Richard Shea, CEO of Sterifre Medical Inc., thinks so. His company has just raised $8 million in a Series B private equity round of financing to market products for rapid, point-of-care device disinfection in healthcare facilities. Shea was previously the CEO of Olympus Respiratory America, a provider of COPD treatment products, and was one of the founding executives of Stericycle Inc.
“Initially we will be focused on three areas: non-critical, point-of-care medical devices, environment-of-care items that patients come into contact with, and hospital personnel health and wellness items,” Shea tells MD+DI. “Research has shown that disinfecting these items is an acute problem for nurses. Non-critical devices include items like radios/phones, tablets, thermometers, glucometers, otoscopes, stethoscopes, oximeters, pads/sensors, cords/cables, doppler probes, etc. Patient-use items include remote controls, phones, tablets, call buttons, etc. Finally, at the end of a shift, a clinician’s personal items such as phones, keys, ID badges, jewelry, etc. can be thoroughly and quickly disinfected prior to going home.”
Sterifre’s automated point-of-care system, Aura, seeks to address user concerns with current disinfection approaches. “As more and more medical devices become smaller and more accessible at the patient bedside, there are compelling patient and clinician benefits,” said Shea. “However, it is well documented that medical devices used at the point of care can harbor pathogenic microorganisms. There are also studies that show that the use of disinfectant wipes may not remove and/or kill all pathogens present for a variety of reasons. This means that patients and caregivers could be potentially exposed to medical devices that are contaminated, creating the potential for infection transmission.
“Similarly, it is well documented that many common hospital disinfectants degrade medical devices, damaging plastic housings, screens, keypads, cords, and cables,” he continued. “This may make a device difficult to use accurately, damage the device to the point that it is removed from service, or add to the hospital financial burden of having to replace damaged devices.”
The system uses a patented combination of a micro-condensed hydrogen peroxide spray and a cold plasma ozone, Shea said. “This creates an environment that inactivates microorganisms including many multi-drug-resistant organisms [MDROs]. Our proprietary technology uses two well-recognized disinfectants that are consumed in the process, thereby leaving no residual disinfectant on devices after disinfection. Since the only byproduct of Aura is clean air, the system can be used at the point of care.
“Hydrogen peroxide combined with cold plasma ozone were chosen due to the broad microbicide effects combined with broad material compatibility,” he added. “This combination was also chosen as it can be safely used at the point of care.”
With only air remaining as a by-product, the system “eliminates or greatly reduces the medical device damage associated with disinfectant caused environmental stress cracking. Eliminating this damage will result in higher end user satisfaction for medical device manufacturers,” he said. “Hospitals are well aware of the issues around disinfectant wipes and sprays including protocol compliance, damage to devices, efficacy, variability in dwell time, variability in organisms treated, and negative environmental impact.”
Shea also believes Aura could also reduce the millions of wipes thrown away by the healthcare industry each year.
The Aura system can be placed on a countertop at a nurse’s station or utility room or it can be placed on a cart or a wall, which Shea said keeps the system at hand to treat point-of-care devices. “It only requires an electrical outlet, [and] there is no plumbing connection needed,” he explains. “The system continually monitors the treatment parameters. All that is required is to place the devices inside, close the door, and push one button. Aura will automatically indicate when the devices are disinfected. This creates surety of treatment versus manual processes.”
Sterifre is currently discussing “beta test site placement and the reception has been enthusiastic,” Shea said.
The company is also working to establish registration with EPA, which Shea said regulates microbicides used for hospital disinfection. “We are well on our way to establishing these approvals for a broad set of efficacy claims,” he said. When asked whether the system needs FDA approval or clearance, he said that the company’s initial focus is for low-level and intermediate-level disinfection. “This is the level of disinfection that devices such as those listed above require. The EPA is the regulatory authority for hospital disinfectant systems like Aura, as they are for hospital disinfectant wipes and sprays. With high-level disinfection and sterilization, FDA registry would become necessary.”
Shea encourages “all device companies that don’t currently list hydrogen peroxide or ozone as disinfectants to contact us so that we can establish a testing protocol specific to their device(s). Aura is the only system with the unique attributes of broad compatibility, automation, wide spectrum efficacy, and sustainability.”