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OEM single-use devices are nearly five times more likely to be defective than reprocessed ones: study

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Phoenix, Arizona, USA – March 15, 2016 – Original equipment manufacturer’s (OEM) single-use devices (SUDs) may have higher defect rates than comparable reprocessed devices, a study in Journal of Medical Devices suggests. The independent study led by Banner Health was designed to increase the data available on defect rates of reprocessed SUDs. OEMs have historically claimed new devices have lower defect rates when compared to reprocessed devices. The FDA considers reprocessed SUDs that meet the FDA’s regulatory requirements to be substantially equivalent to new devices. The new study’s data supports the FDA’s position and suggests that reprocessed SUDs may actually have lower defect rates than new devices.

“In the era of value-based purchasing, medical devices that cost twice as much and are reported to be defective more frequently challenge conventional definitions of reliability and value,” study author Dr. Terrence J. Loftus, MD, MBA, FACS, former Medical Director Surgical Services and Clinical Resources at Banner Health, said in the report published in the December issue of Journal of Medical Devices. The findings are also available for purchase at ASME.org.

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Study data was collected over a seven-month period in 2013 for two types of bipolar and ultrasound diathermy devices used at Banner Health. A total of 3,112 devices were included in the study – roughly 55 percent of them were reprocessed devices and roughly 45 percent were new devices. Devices were determined to be defective by a surgical team member when they did not function in a manner consistent with the intended purpose. OEM devices were reported as defective 4.9 times more frequently than reprocessed devices.

“Dr. Loftus’ study confirms that, with SUD reprocessing, it’s possible to get superior quality for lower cost, while reducing the environmental impact of healthcare delivery. Reprocessed SUDs are exactly the kind of value-driven solutions health systems need today,” said Brian White, President, Stryker’s Sustainability Solutions.

While Banner Health is a long-standing customer of Stryker’s Sustainability Solutions, the study was conducted independently, and was not sponsored by a medical device manufacturer or a third-party reprocessor.

Sustainability Solutions’ more than 2,500 U.S. hospital and health system customers saved $262 million in 2015 and eliminated 12.25 million pounds of medical waste from landfills. When hospitals purchase reprocessed medical devices, they decrease the cost of healthcare and can re-direct these savings toward other initiatives that improve patient outcomes.
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