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.