Evaluating the Financial Impact of Reprocessed Single-Use Devices

Don’t let reprocessing skeptics steer your facility away from savings

The purchase of reprocessed single-use devices (SUDs) is a key initiative deployed by thousands of health systems looking to reduce costs and divert waste. The positive financial and environmental impact of reprocessing can be significant, with some hospitals saving more than $1 million and diverting up to 28,000 pounds of waste annually.

To achieve maximum savings potential, program leaders need to build internal support and buy-in from staff, clinicians and senior leadership. While the SUD reprocessing industry has safely remanufactured devices under strict FDA oversight since 2000, some clinicians still question the safety of reprocessed devices, and some prefer not to use them in their procedures. Physician skeptics can ultimately impact a facility’s ability to save.

Looking at the Roots of Skepticism

The single-use label itself is potentially misleading. Intuitively, one might believe a product labeled “single use” can be used only once. However, per FDA regulation, many medical devices labeled as “single use” can be safely reprocessed to extend their effective lifespan. The decision to label a device “single use” is solely at the discretion of the original equipment manufacturer (OEM). Consider that OEMs may be financially motivated to use the single-use label.

Another common misperception some clinicians have about reprocessed devices is that they fail more often than OEM devices. Some clinicians may not understand the science and strict regulatory oversight of the third-party reprocessing industry. Every reprocessed SUD is fully function tested and inspected according to FDA standards after being cleaned and before being sterilized. This process is more rigorous than OEM requirements, who only function-test a small sample of devices they manufacture.

Solving the Quality Debate with Real-World Data

Banner Health in Phoenix, Ariz., faced this hurdle in 2013 when their Clinical Consensus Group was tasked with the decision of whether or not to implement SUD reprocessing at their facility. The group was split with some surgeons in support, while others were concerned with potential device quality. To help settle the debate the medical director of surgical services and clinical resources at Banner Health, Terrence J. Loftus, MD, MBA, FACS, launched a comparison study of SUD and original device defect rates.

Loftus and his team believed the study would show that reprocessed devices failed more than OEM devices or that their failure rates were equivalent to OEM devices. To their surprise, the findings showed OEM devices had a defect rate 4.9 times greater than reprocessed devices.

To conduct the study, Loftus turned to the Supply Chain Services database to look for data on the defect rates between reprocessed SUDs and OEM devices at their facility. The study, “A Comparison of the Defect Rate Between Original Equipment Manufacturer and Reprocessed Single-Use Bipolar and Ultrasound Diathermy Devices,” published in Journal of Medical Devices retroactively analyzed real-world operating room data. Unlike studies conducted in the laboratory, Loftus felt it was important to look at results based on real clinician experiences in the OR.

He compared seven months of data on 1,393 OEM and 1,719 reprocessed ultrasonic and bipolar diathermy devices, totaling 3,112 devices and examined how many of these devices were reported as “defective” by OR clinicians. Defective was defined as any time a member of the surgical team (surgeon, scrub tech, first assistant or circulating nurse) determined the device was not functioning in line with its intended purposes.

Tips for Addressing Reprocessing Skepticism

Not all clinicians are skeptics. Some clinicians believe reprocessed SUDs have more accountability because each device coming off the line is tested compared to original devices which are only batch tested. But even one skeptic can prevent a program from achieving optimal results. If misperceptions about device quality are keeping your facility from realizing cost savings associated with the purchase of reprocessed SUDs, follow these tips:

  • Educate your staff about the intricate remanufacturing process. This can include touring a reprocessing facility to see the rigorous remanufacturing process firsthand and ask questions.
  • Provide staff recent data and material dispelling quality concerns, such as the Banner study or webinar “Building a Case for Reprocessed Medical Devices.”
  • Start small. Begin reprocessing a select number of devices and as clinicians feel more confident, continue to add new devices and grow your program and savings. Find a reprocessing partner who can support your facility during the integration process and while you grow.
  • Share your successes as you hit savings and waste diversion milestones. The more visibility staff, clinicians and leadership have into the program, the more likely they are to support it and help it grow.

SUD reprocessing enables hospitals to purchase high-quality devices at a reduced cost while supporting environmental waste reduction initiatives. That means there is both a strong business and clinical case for purchasing reprocessed SUDs. It is common to believe that there has to be a trade-off between sustainability, quality and cost. However, with SUD reprocessing, there is no such trade-off. Don’t let skeptics keep your facility from achieving significant financial savings and waste diversions.

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