Reprocessing of Medical Devices Can Be a Smart Business, Clinical Decision

The organization Practice Greenhealth says that the healthcare industry ranks among the largest users of energy and the highest producers of waste, and is a major consumer of paper, water, food and other resources, resulting in an industry with a significant environmental footprint. Diconsiglio (2008) estimates that U.S. healthcare institutions dispose of more than 4 billion pounds of waste annually, making the health industry the second-largest contributor to landfills, which is second only to the food industry. Environmental stewardship in the healthcare environment encompasses numerous components, including eliminating medical supplies that produce toxic byproducts; using waste management strategies and energy and water reduction; engaging in environmentally preferable purchasing and other initiatives.

One related strategy is the reprocessing of reusable or single-use medical devices (SUDs) where appropriate. As Kwakye, et al. (2010) observe, “Already, more than 25 percent of U.S. hospitals ... are using reprocessing as a means of decreasing the tons of disposable waste generated annually. We have found it to be a common-sense strategy that uses detailed quality-control standards to recalibrate, clean, sterilize and remanufacture medical equipment. The result has been a significant waste reduction and cost savings.”

Ascent, a leader in the remanufacturing of medical devices in the U.S., says that its hospital partners have realized hundreds of millions of dollars in cost savings through the use of medical device remanufacturing programs in 2009. On a per-hospital basis, some hospitals saved more than $600,000 per year. Ascent’s programs also helped customers reduce their environmental footprint by diverting an estimated 5.3 million pounds of total waste from landfills.

Ascent tracks savings realized by its customers year-over-year. Cost savings resulting from Ascent’s remanufacturing programs were up more than 20 percent in 2009 and were up more than 50 percent versus 2007. While the savings are noteworthy, Ascent sees room for even more significant savings to the healthcare system in the future.

“Hospitals are under significant pressures to control costs. For our customers, a focus on systemic supply chain solutions that optimize resources has proven beneficial,” says Rick Ferreira, president of Ascent. “Our customers realize it’s not just about having the best product; it’s about having the best product while considering how using that product impacts the hospital’s performance overall. Ascent’s remanufacturing programs give hospitals a strategy for medical devices that allows them to not only save money, but deploy more of their scarce resources to enhancing patient care through quality initiatives while reducing their environmental footprint.”

Some healthcare professionals are still on the fence about reprocessing, and as Kwakye, et al. (2010) point out, the “uptake of such green practices by hospitals has continued to be slow because of a misunderstanding of the process and concerns about patient safety.” Some clinicians may be holding onto misperceptions regarding third-party processing, a prejudice Thording says may lie in the perception that reprocessing has not evolved with the times. “Some medical professionals still think of reprocessing as an in-hospital function as it was in the past,” says Lars Thording, senior director of marketing at Ascent. “However, few or no hospitals engage in in-house reprocessing today due to the technological and regulatory complexity involved. As regulatory requirements for reprocessed medical devices have increased over the years, it has become more challenging and more expensive for hospitals to reprocess devices internally. Most hospitals now opt for a safer and more efficient form of reprocessing – through third-party reprocessors like Ascent.”

It is important for the purpose of this discussion to define what is meant by reprocessing of SUDs; the Food and Drug Administration (FDA) defines an SUD as any device intended for one use or on a single patient, and a reprocessed SUD is defined as an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of additional use on a patient. The majority of reprocessed SUDS are in the Class II designation, which carries medium risk and requires submission of a premarket notification report that establishes evidence of equivalence to devices already on the market in terms of safety, effectiveness and intended use. An example of Class II devices is laparoscopic equipment, drills and pulse oximeter sensors. The highest risk category, Class III devices (such as balloon angioplasty catheters and implanted infusion pumps) requires for FDA premarket approval valid scientific data proving safety and effectiveness, in addition to a satisfactory inspection of the reprocessing facility.

Kwakye, et al. (2010) acknowledges the economic-driven shift that has occurred in healthcare institutions as they attempt to drive down costs via reprocessing without sacrificing patient safety: “Before the introduction of SUDs, most medical devices were manufactured for multiple uses and were reused after cleaning and sterilization by locally trained hospital staff. With increasing concerns regarding safety and rising costs of sterilizing multiple-use devices, healthcare migrated to SUDs. But as these also became increasingly sophisticated, their costs drove healthcare organizations to explore other options such as reprocessing which was conducted and monitored by hospitals. However, because of staffing shortages and stricter FDA regulations, there has been a major shift from in-house reprocessing to use of third-party reprocessing companies. These private companies now reprocess more than 100 types of SUDs.”

“It’s common to believe that there has to be a trade-off between sustainability, quality and cost – you improve the performance in one area and the other will suffer,” says Thording. “However, with reprocessing of SUDs, there is no such trade-off. Reprocessed and remanufactured devices are substantially equivalent to original ones. And while many sustainability initiatives are costly, reprocessing is a unique solution that simultaneously saves money while improving environmental responsibility.” Thording adds, “Most people in healthcare have understood the need to embark on substantial cost-savings initiatives, and given the safety of reprocessed devices, few people in healthcare that have been introduced to Ascent’s reprocessing programs are hesitant. Some people lack understanding about the science on which reprocessing is based and the overall sophistication of the industry. The best way to address this misconception is through education. Ascent actively engages its hospital partners to thoroughly educate them on the facts and science of reprocessing, as well as the value of reprocessing as a key supply strategy. As a result, most informed practitioners see the value in reprocessing. We welcome anyone to tour our plant facilities so they can see the science of reprocessing first-hand.”

Perhaps it is the “unknowns” traditionally associated with third-party reprocessing that give clinicians and administrators pause when weighing the cost-benefits of reprocessing against potential patient safety threats. “Reprocessing and remanufacturing are safe and viable solutions that address hospitals’ economic and environmental responsibilities,” Thording says. “The devices remanufactured by Ascent and other third-party reprocessors comply with the FDA’s 510(k) and Quality System Regulation (QSR) requirements. These agencies consider reprocessed devices to be substantially equivalent to original devices. The Association for Professionals in Infection Control and Epidemiology (APIC) supports the FDA’s requirements for reprocessing medical devices. Other data supports the safety of reprocessed medical devices, including a 2008 Government Accountability Office (GAO) report stating that reprocessed single-use devices do not present an elevated health risk. Also, the FDA’s MAUDE database, which tracks device failures, consistently confirms that reprocessed medical devices do not fail more frequently than new ones.” Thording continues, “Reprocessing is catching the attention of world renowned healthcare institutions and academic medical centers. A recent study by Johns Hopkins researchers concluded that reprocessing offers hospitals a viable and safe solution for curbing costs while reducing their environmental footprint. The study results were published in the March 2010 issue of the journal Academic Medicine.”

As Kwakye, et al. (2010) note, “...One barrier to the widespread adoption of reprocessing is its potential impact on patient safety. Safety concerns include the possible malfunction of devices, the risk of infectious diseases, and the ethical dilemma about reprocessing presents given the absence of patient consent to use of such devices as part of treatment. Many physicians and politicians have lobbied for legislation requiring written patient consent, documentation of all reprocessed SUDs used during treatment, and stricter systems of tracking SUD failures and injuries, while holding reprocessors fully liable for any adverse events. The government has responded to these concerns by conducting several investigations and hearings about the reprocessing of SUDs and has introduced stricter regulations at all levels of production.”

The Medical Device User Fee and Modernization Act of 2002 required that all reprocessed SUDs are to be labeled and identify the reprocessor, and also created more stringent FDA oversight of reprocessed SUDs than in the past. In January 2008, the Government Accountability Office (GAO) issued the report, “Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased and Available Information Does Not Indicate That Use Presents an Elevated Health Risk,” in which the agency outlined steps taken by the FDA to improve its regulation of reprocessing and its reporting of related adverse events. The GAO (2008) stated that although available FDA data fail to allow for in-depth comparisons, reprocessed SUDs do not present an increased health risk when compared with new, non-reprocessed devices. Of the 434 adverse events reported to the FDA between 2003 and 2006 in which reprocessed SUDs were identified, 65 involved a reprocessed device, and all adverse events were similar to those reported for new devices.

With this kind of data in hand, Thording says it’s easy to make a business case for reprocessing. “Reprocessing medical devices is the single most impactful sustainability initiative currently undertaken by hospitals in the U.S. As sustainability has become an increasingly important issue in healthcare, Ascent has helped hundreds of hospitals reduce their environmental footprints through reprocessing and remanufacturing medical devices that are marketed in North America as ‘single use’ by the original manufacturer and are often needlessly thrown away. In 2009, Ascent helped its healthcare partners reduce overall disposable waste by 5.3 million pounds. Ascent not only helps hospitals reduce disposable waste through the re-use of single-use devices, but also by capturing other OR devices that are broken down and recycled.”

The money saved through reprocessing can help divert resources where they are needed most in budget-strapped hospitals. “Consider the ‘tower’ of medical devices that was showcased in the Ascent booth at AORN,” Thording says. “By reprocessing the devices displayed in the tower, a hospital could divert 386 pounds of waste and save $57,685 when compared to the cost of ‘single-use’ devices. That cost savings alone could pay the annual salary of an additional nurse, or could be redirected to other patient-care quality initiatives. Some hospitals save more than $500,000 annually through reprocessing, allowing for major equipment purchases or hiring even more staff. Each hospital can decide where to re-direct their cost-savings based on their greatest needs. The end result is increased quality of healthcare through more sustainable resource allocation.” Thording continues, “The business case for reprocessing medical devices is a powerful one. Consider the fact that remanufactured medical devices are half the cost of single-use devices. Administrators understand that they’re not only saving 50 percent of the purchasing cost for each device, but they’re also saving money that would be spent on special handling and waste management of that device were it discarded into the waste stream without further re-use. The cost savings on each device add up quickly. Reprocessing allows hospitals to deploy more of their scarce resources to enhancing patient care through quality initiatives. In today’s challenging healthcare environment, cost-savings from reprocessing can make all the difference between hiring and firing a nurse.”

References

Diconsiglio J. Reprocessing SUDs reduces waste, costs. Mater Manag Health Care. 2008;17:40–42.

Food and Drug Administration. Center for Devices and Radiological Health. Reprocessing of Single Used Devices: Definitions. Available at: http://www.fda.gov/Cdrh/reprocessing/definitions.html.

Government Accountability Office (GAO). Report to the Committee on Oversight and Government Reform, House of Representatives. Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk. Jan. 31, 2008.

Kwakye G, Pronovost PJ and Makary MA. A call to go green in healthcare by reprocessing medical equipment. Academic Med. 85(3):398-400. March 2010.

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