Discussion on Medical Device Adverse Event Surveillance

Abstract

With the continuous development of medical technology and the wide application of medical devices, the risk of medical device adverse events is gradually increasing. In order to ensure the safety and effectiveness of medical devices, timely detection and treatment of adverse events of medical devices, and to protect the safety and rights of patients, the state continuously strengthens the monitoring of adverse events of medical devices. This paper firstly introduces the domestic and foreign medical device adverse event related regulations, it introduces the form of medical device adverse event monitoring work in China, compares and analyzes the data of medical device adverse events in recent years, and puts forward some problems in medical device adverse event monitoring work, in order to continuously improve the control and management of the risk level of medical devices, and ensure the clinical use of medical devices and patient safety.