Becker's Clinical Quality & Infection Control

21 Executive Briefing Sponsored by: P atient well-being is naturally a top priority for health systems. However, leading organizations are increasingly turning their attention to the environmental impact of their operations. Many reprocess their single-use medical devices which extends their life, reduces waste and saves money. Historically, ethylene oxide (EtO) has been the "go-to" technology for sterilizing invasive devices, as well as noninvasive devices. While EtO still plays an important role in invasive device sterilization, growing numbers of health systems are recognizing that high-level disinfection, or HLD, is a greener and more economical alternative to reprocessing noninvasive devices. Becker's Hospital Review recently spoke about HLD with Randy Long, CEO of ReNu Medical (a subsidiary of Arjo), and Julia Gasperini, DPM, supply chain program manager for custom packs and medical device reprocessing at Intermountain Healthcare in Salt Lake City. What is HLD? With high-level disinfection, noninvasive medical devices are completely submerged in a hot water bath for a specific time and at a specific temperature. Absolutely no chemicals are involved. "Arjo's solution via ReNu Medical's pasteurization technology is similar to what has been used for a very long time with food products like beer, wine, juice and more," Mr. Long explained. The bath reaches temperatures high enough to kill viruses, bacteria and all microorganisms. HLD doesn't kill a small number of bacterial spores, which is what differentiates it from sterilization. It is an ideal solution for noninvasive products, but it isn't appropriate for invasive devices. Reprocessing of single-use medical devices is regulated by the FDA, which provides peace of mind to health systems. The FDA has issued enforcement priorities governing reprocessing and the safe reuse of devices labeled "single-use only." It considers reprocessed devices to be "substantially equivalent" to original manufactured devices and subjects third-party reprocessors to the same applicable regulatory guidelines as the original device manufacturer. "Patient safety and quality care are always foremost for us at Intermountain Healthcare. The beauty of third party medical device reprocessing is that it's a highly regulated process," Dr. Gasperini said. Both the General Accounting Office (GAO) and the CDC have stated that no evidence exists that reprocessed devices have harmed any patients. Why is HLD preferable to EtO for reprocessing noninvasive devices? When compared to ethylene oxide, high-level disinfection offers four important advantages to health systems: 1. Safety. There is considerable industry scrutiny related to the toxicity of EtO, especially as it relates to the safety of the employees working at sterilizing centers. "I'd estimate 70 percent of the total volume of devices reprocessed in the U.S. market fall into the noninvasive category, so why use a chemical solution when there is a completely nontoxic alternative? Most healthcare facilities are trying to find a safe alternative to ethylene oxide, but many aren't aware that HLD is a green and safe alternative," Mr. Long said. 2. Environmental benefits. When EtO is used to reprocess medical devices, chemicals are emitted into the earth's atmosphere. In contrast, HLD has no harmful emissions, since it only utilizes hot water. "Research has shown that the HLD process is a more environmentally friendly alternative to ethylene oxide. Our leaders are behind our sustainability program and they support our continued progress in this arena," Dr. Gasperini said. 3. Product appearance. Since the HLD process relies on high-temperature water, it is less harsh to the materials typically present in noninvasive medical products. After HLD reprocessing, products look brand new. "With EtO, medical devices can return to the hospital looking faded or discolored. Although this doesn't affect the performance of the devices, it can be off- putting to some people," Dr. Gasperini noted. 4. Reduced costs. HLD also enables health systems to cycle devices more times than with EtO. This extends the product life, resulting in substantially higher savings and a lower cost per use. "Every device has a specific protocol limit for reuse, but most of the devices we reprocess can be reused up to 10 times. With EtO, those same devices can often only be reprocessed approximately five times. This delivers value to hospitals and keeps devices out of landfills Going green with high-level disinfection — The benefits of noninvasive medical device reprocessing

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