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Technical Brief

A Comparison of the Defect Rate Between Original Equipment Manufacturer and Reprocessed Single-Use Bipolar and Ultrasound Diathermy Devices

[+] Author and Article Information
Terrence J. Loftus

Medical Director Surgical Services and Clinical Resources,
Division of Care Management,
Banner Health,
1441 N. 12th Street,
Phoenix, AZ 85006
e-mail: Terry.Loftus@BannerHealth.com

Manuscript received July 16, 2014; final manuscript received June 8, 2015; published online August 6, 2015. Assoc. Editor: Rosaire Mongrain.

J. Med. Devices 9(4), 044501 (Aug 06, 2015) (2 pages) Paper No: MED-14-1209; doi: 10.1115/1.4030858 History: Received July 16, 2014

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.

Copyright © 2015 by ASME
Topics: Ultrasound , Surgery , Teams
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