Risk Management for Medical Devices

Medical devices developed for human application are used for diagnostic or treatment purposes. They may either be an instrument, an apparatus or a material. Moreover, these devices can be used for daily patient care as well as for medical scientific purposes. Risk management involves the identification, understanding, control, and prevention of failures when the medical devices are connected to the patient and also for the people who use these medical devices. In this paper, we present a multi-criteria decision-making model to prioritize medical devices according to their criticality. Devices with higher criticality scores can be assigned a higher priority in a maintenance management program. A computerized medical management system is described. The results demonstrate that it is a useful tool in tracking device inventory and maintenance history. Also risk classes have been designed for medical devices based on the time of testing, risk must be identified in relation to patient and personal staff. The results of this paper take into consideration the advances in device reliability, reduced preventive maintenance requirements, and internal device surveillance (self test) along with changes in standards. Key-Words: criticality prioritization, medical devices, models, maintenance requirements, risk, software