Performance Analysis for Medical Devices

Abstract

The objective of this study is to investigate the performance of the medical devices by analyzing the problems of the medical devices that do not meet the international standards. The data used in this study were obtained by interpreting of the performance test results of medical devices. The study includes high risk group medical devices used at the departments of operation room and intensive care in Cerrahpasa Faculty of Medicine in Istanbul University. The performance tests of total 542 medical devices were performed and the measurement results were interpreted according to the Inspection and Preventive Maintenance System (IPM) procedures which were developed by Emergency Care Research Institute (ECRI). The obtained data were analyzed and the results were given in graphics. This study showed that the controlling of the performance of the medical devices especially the high risk group medical devices in the hospital will be helpful in quality assurance studies. As a result of this, a preventive maintenance program was created. Thus, tracing the problems before they happen and stocking required spare parts were made possible. Additionally, the analysis of the medical devices according to the manufacturer helped us to decide the right during the purchasing of the new devices.