Reprocessing has emerged as an attempt to control the cost of single-use bipolar and ultrasound diathermy devices despite limited data on defect rates. This study compares the defect rates, as reported by surgical teams, between original equipment manufacturer (OEM) single-use bipolar and ultrasound diathermy devices and reprocessed (RP) devices. Data were retrospectively collected on 3112 devices over a 7-month period for two types of bipolar and ultrasound diathermy devices. There is a significant difference (p < 0.001) in reported bipolar and ultrasound diathermy device defects between OEM and RP. OEM single-use bipolar and ultrasound diathermy devices were reported to be defective more frequently than RP devices based on reports from the surgical team.
A Comparison of the Defect Rate Between Original Equipment Manufacturer and Reprocessed Single-Use Bipolar and Ultrasound Diathermy Devices
Manuscript received July 16, 2014; final manuscript received June 8, 2015; published online August 6, 2015. Assoc. Editor: Rosaire Mongrain.
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Loftus, T. J. (August 6, 2015). "A Comparison of the Defect Rate Between Original Equipment Manufacturer and Reprocessed Single-Use Bipolar and Ultrasound Diathermy Devices." ASME. J. Med. Devices. December 2015; 9(4): 044501. https://doi.org/10.1115/1.4030858
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