Research on Classification Monitoring Model of Medical Device Adverse Events Based on Risk Management / 中国医疗器械杂志

ABSTRACT

<p><b>OBJECTIVES</b>To increase the number and quality of adverse events reported in medical devices, dealing with adverse events that have occurred in time, preventing the occurrence of adverse events, and ensuring the safety of device use.</p><p><b>METHODS</b>Based on risk management methods, through a comprehensive analysis of risk of adverse events, scientifically assessing the risk level and completing the classification of adverse events. Administrative supervision departments take corresponding supervision measures according to the classification results.</p><p><b>RESULTS</b>Building a classification monitoring model of medical device adverse events based on risk management.</p><p><b>CONCLUSIONS</b>The classification of adverse events will help the administrative supervision department to focus on the work, reduce the workload, and improve the efficiency of supervision.</p>