On Current Situation Of Adverse Event Monitoring And Evaluation Again For Medical Device In Manufacturing Enterprises

Through the analysis of medical device regulations,regulatory status and adverse event monitoring status in China,reveals the medical device adverse event monitoring regulations and regulatory deficiencies,and to clarify the necessity and pressing to carry out medical device adverse monitoring work,strengthening the government supervision on medical equipment management,and protection of public life and health rights,and discuss how to work in the future to further strengthen the medical device adverse event monitoring and product market regulation.In this paper, by analyzing the procession of 2014 national medical device adverse event monitoring in the enterprise of the roles and regulations implementation. at the same time have investigated the current situation of the management of adverse events in Medical device manufacturing enterprise to Beijing, found that production enterprises in the aspect of adverse event management there are still many deficiencies, most production enterprises with no clear process and related departments, lead to employees when problem happens still exist " who to do", "what to do" and "how to do", often can't effectively deal with the crisis.The cause of the problem that manufacturing enterprises in our country are analyzed, the main body in medical device adverse event monitoring has two big problems. One is the monitoring is not clear, the other monitoring feedback mechanism is not perfect. According to China's national conditions and development situation of production enterprises medical device adverse event monitoring, we draw lessons from foreign advanced experience and give advice: from propaganda and training to strengthen enterprise consciousness of laws and regulations in a total of 7 Suggestions.Medical device adverse event monitoring and management is a new academic field in recent years, many companies for medical equipment monitoring and control is still in its infancy stage, the relevant professional works and research results are still less. In the future work, can be summarized practical experience, in quantitative medical equipment monitoring management to do further research.