Medical Devices Safety Enhancement and Performance Improvement Through a Periodic Calibration Program

Abstract

Today’s have been seen more than 10,000 different types of medical devices in medical centers and hospitals. Physicians need better accurate medical measurements to better diagnosing diseases, monitoring patients and delivering treatments. The lack of correct and appropriate measurements will certainly have diverse effects in diagnostic and treatment procedures. In 1999, Institute of Medicine reported more than 44,000 medical error deaths annually in medical centers. Safety and performance testing of medical devices in the medical sector is a one of the key factor in improving public health. Acquiring results of some investigations demonstrate a need for new and severe regulations on periodic performance verifications especially in high-risk equipment. The metrological reliability of four high risk medical devices, Electrosurgical unit, Defibrillator, Syringe pump and Infant incubator in use some medical centers and hospitals (privates and publics) according to international and national standards were evaluated. Quantitative analysis of some parameters that impact the safety and performance represented the amount of the obtained results in some equipment are in critical range with higher values than standard limitations. Acquiring results represent a need for severe regulations on periodic performance verifications and quality control program especially in high-risk equipment. Also it is necessary to provide training courses for operating staff in the field of meterology in medicine. One of the main aim of these training courses is to present what’s the critical operation parameters and how the operators can get good accuracy results on each medical devices.