Going green with high-level disinfection — The benefits of noninvasive medical device reprocessing

Patient 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 offputting 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 longer,” Mr. Long explained.

 How HLD reprocessors work with health systems

The Arjo Pure program was established after Arjo acquired ReNu Medical to further the reach and create customized, noninvasive device reprocessing programs based on facility needs. “We collaborate with our customers to set up an implementation plan and schedule to meet their expectations and manage the logistics from A to Z. We also educate different areas in the facility affected by the program,” Mr. Long said.

Branded collection containers are installed in convenient hospital locations so staff can easily deposit used devices. Once everything is set up, our Arjo service organization collects used devices on a schedule that is defined by the facility and the Arjo team. The devices are brought to Arjo’s reprocessing center in Seattle, where they undergo a multistep process of sorting, pre-cleaning, high-level disinfection, testing and repackaging. “After the devices are disinfected and tested, we label them in compliance with FDA regulationsand send them back either through the distribution channel or to facilities direct, so they can be used again on a subsequent patient,” Mr. Long explained.

ReNu Medical offers a fast turnaround for reprocessing noninvasive devices, with the entire process completed within seven days. As soon as products arrive at the reprocessing center, it takes approximately four days to complete the HLD process and devices are shipped out within 24 hours of receiving a purchase order.

“Our primary goal is to deliver the highest quality products that protect patient safety, cost savings and the environment. We process millions of devices annually and believe it is critical to deliver on our quality and environmental promises to our partner facilities. These assurances provide trust that High-Level Disinfected devices, through our Arjo Pure program, are safe and effective for patients,” Mr. Long said.

Best practices for implementing an HLD reprocessing program

Intermountain Healthcare has been reprocessing noninvasive medical devices for several years, but just recently adopted HLD technology. When searching for reprocessing partners, Intermountain Healthcare looks for high yield rates for devices, as well as packaging that mimics the OEM packaging. Once a reprocessor enters into an agreement, Intermountain Healthcare works with clinical leaders to ensure that feedback channels are in place.

The reprocessing market for noninvasive devices has been moving toward more specialized niche suppliers. As a result, Intermountain Healthcare saw an opportunity to engage a second reprocessing supplier. “Reprocessing medical devices has been so successful that the products have become commoditized. This positively impacts the cost of care. We have a primary processor that handles invasive items and a second for reprocessing noninvasive products,” Dr. Gasperini said.

The two suppliers work collaboratively to deliver a great customer experience to Intermountain Healthcare. It has been a good experience working with Arjo for noninvasive devices. Because Arjo works collaboratively with everyone involved, we have made minimal changes to our current workflows and processes. That’s a benefit for us,“ Dr. Gasperini added.

Conclusion

High-level disinfection is a safe and proven technology for reprocessing noninvasive devices. Health systems that have tried this technology appreciate the cost savings, as well as the reduction in waste and harmful environmental emissions. HLD enables organizations to be mindful of their patients’ physical and financial health, as well as the health of the environment.

According to Dr. Gasperini, “We have many caregivers and patients who are concerned about the environment, and rightly so. With HLD, we anticipate very positive results for our healthcare system, our environment and our patients.”

Please click here to learn more about Arjo.

 

Patient 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.

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