The Application of FMEA Method in the Risk Management of Medical Device during the Lifecycle

摘要

Risk management is the systematic application of management strategies, procedures, and practices to the identifying, analyzing, controlling, and monitoring of process risk. It is an important guarantee to keep good quality and reduce failures of product. For medical device, it has more risk to relate with patient health and human life, so it is necessary to manage the process risk through the lifecycle of medical device to avoid potential hazards. However, because of the effect of various uncertain factors, it is not enough to weigh the severity of risk events qualitatively, but useful measures should be taken to evaluate the risk from quantitative level. For these reasons, this paper applies FMEA (failure mode and effect analysis) method to the risk management process of medical device to clear key point of the process, then potential casualty and loss can be avoided with the help of RPN (risk priority number) number.