Faced with rising operational costs and healthcare policy's unclear direction, many hospitals have begun utilizing reprocessed medical devices, a trend that could cut $500,000 to $2 million off a facility's budget every year. The reprocessed medical device market thrives thanks to companies like Kalamazoo, Mich.-based Stryker, which plays a big role in developing and marketing a varied device portfolio. Stryker's Sustainability Solutions Senior Marketing Director, Bill Scott sheds light on the market's developments, challenges and future prospects.
Question: How long has Stryker’s Sustainability Solutions been reprocessing medical devices?
Bill Scott: Stryker was the first original equipment manufacturer to enter the single-use device reprocessing business through the 2010 acquisition of Ascent Healthcare Solutions, the oldest and largest third-party SUD reprocessing company. As the market leader, we now serve over 3,000 hospitals and health systems helping them realize both financial and environmental sustainability. In 2016, Stryker’s reprocessing program helped health systems save $299 million and eliminate 12.9 million pounds of medical waste from landfills.
Q: What challenges does Stryker’s Sustainability Solutions face in reprocessing (financial, backlash from the medical community, etc.)?
BS: SUD reprocessing is widely embraced by U.S. hospitals because it is a key strategy for achieving financial and environmental sustainability without sacrificing quality patient care. That said, many health systems have yet to realize the full cost savings and waste reduction potential of SUD reprocessing. Typically, one of two challenges gets in the way.
The first is clinician resistance. In many cases, skepticism is rooted in misperceptions and can be overcome through education. Some clinical leaders simply aren't familiar with the science and strict regulatory framework upon which the SUD reprocessing industry was built. Hearing from peers is also important, especially former skeptics. Terrence J. Loftus, MD, MBA, FACS, formerly at Banner Health was a self-proclaimed skeptic. He was curious to know how the reprocessed SUDs his health system used performed against the same devices purchased new, so he launched an independent double-blind study. His findings, which were published in the December 2015 issue of Journal of Medical Devices, demonstrated that OEM devices were nearly five times more defective than reprocessed SUDs. After seeing the findings, he admits his initial feelings were short-sighted, given the strong value proposition of reprocessed SUDs.
Another challenge is vendor pushback, which has steadily increased as the SUD reprocessing market has grown. The most common strategies vendors deploy to restrict a hospital's access to reprocessed SUDs include contractual limitations, threatening to pull representative support from cases and introducing incremental technology upgrades. The Association of Medical Device Reprocessors (AMDR) published a complete list of the most common competitive tactics along with educational resources to help hospitals maximize savings and sustainability.
Q: How have the FDA's regulations and guidelines improved the quality of reprocessed devices?
BS: The SUD reprocessing industry wouldn't be where it is today if not for FDA regulation. Regulation provided a strong foundation for dramatic industry growth, which I referenced above, and helped the industry achieve an outstanding track record of patient safety. Third-party SUD reprocessors are subject to more stringent FDA requirements than OEMs. One way we ensure quality is by function testing and inspecting 100 percent of our reprocessed devices before they go back on the shelf at a hospital. By comparison, OEMs only batch test single-use devices they manufacture.
Q: What does Stryker’s Sustainability Solutions look for in a reprocessing partner? On the flip side, what do/should hospitals look for in a reprocessing partner?
BS: Health systems that achieve the greatest success with SUD reprocessing embrace it as a key initiative to achieve financial and environmental sustainability. For many health systems today, sustainability is critical to achieving their mission. Building a successful SUD reprocessing program doesn't happen overnight. It takes education, c-suite buy-in, clinician champions, goal-setting, engagement and compliance.
Health systems should look for a third-party reprocessor that is committed to growing their savings year-over-year, does not limit the purchase of reprocessed devices, provides ample training and onsite support and will guarantee mutually agreed upon savings targets.
Q: Can you talk about vendor independence and shared risk's impact on the reprocessed device market?
BS: Health systems are looking for suppliers that are invested in helping them achieve their financial and environmental goals. To that end, Stryker offers a savings guarantee — if goals are not met, we will close the gap by compensating the difference.
Vendor influence over supply decisions should never compromise an organization's goals. That's why it's important not to give one vendor too much control. It weakens their accountability to you. Partner with multiple vendors and, if clinical autonomy is threatened by representative influence in the EP lab, look into training programs that allow your own staff to play the support role traditionally fulfilled by the original manufacturer's representatives. At Stryker, we now offer an EP Education Program to help customers gain more independence and we have also seen some health systems, including Duke University Heart Hospital, develop their own training.