Technical Brief: A Comparison of the Failure Rate between Original Equipment Manufacturer and Reprocessed Single-use Energy Devices
Author: Terrence J. Loftus MD, MBA, FACS
Source: ASME Journal of Medical Devices
Background: Reprocessing has emerged as an attempt to control the cost of single use energy devices despite limited data on failure rates. This study compares the surgical team reported failure rates between original equipment manufacturer (OEM) single-use energy devices to reprocessed (RP) devices. Method of Approach: Data was retrospectively collected over a seven month period for two types of energy devices. Rates were calculated based on the reported device failures and the number of devices purchased. Results: A total of 3112 devices were purchased in the reporting period. There is a significant difference (p < 0.001) in reported energy device failures between OEM and RP, with a higher percentage of failures (2.0% vs. 0.41%) reported by the surgical team with the OEM devices. OEM devices failed 4.9 times more frequently than RP devices. Conclusion: OEM single-use energy devices fail more frequently than RP devices based on device failure reports from the surgical team.