Medical Institutions In Beijing Third Grade Class Medical Device Adverse Event Monitoring Survey Work

No medical equipment is of zero risk and absolute security. Medical devices are licensed only after pre-market research and evaluation which state that the proportion of the known benefits and known risks is acceptable, but as to the overall product life cycle and scope of use, the assessment only draws the interim conclusion of the risk evaluation. Medical Device Adverse Event Monitoring is the process which continuously and systematically detects, reports, assesses and controls the suspected medical device adverse event, and the important method and measures of Medical Device Adverse Event Monitoring. According to the medical device adverse event monitoring table statistics reports received in Adverse Drug Reaction Monitoring Center, medical institutions, as the main use of medical devices unit, have become the main adverse event monitors.This assay, based on the basic concepts of medical devices, analyzes the important role of medical device adverse event monitoring in device monitoring. Having analyzed the Medical Device Adverse Event Monitoring Management System of the United States, European Union, Canada, Australia, UK and Japan etc which are the International Coordination Working Group members, the author found that there are special agencies of monitoring and administrating medical device and special reporting system, which function to carry on the compulsory post-monitoring policy. Having analyzed our existing medical device laws and regulations, the author made it clear that in the use of medical devices in China although there are special requirements, some deficiencies still exist. This paper picks up 13 hospitals in Beijing which belong to the medical device reporting system as objects of empirical research, using the methods of questionnaires, conducting gap analysis, and in-depth interviewing people from the hospital medical device monitoring leaders, specialists and liaison officers, finding that medical institutions need to monitor medical device adverse events from the system construction, personnel, and financial support for research projects such as hospitals continue to improve medical device adverse event system, and to take various measures to further enhance the level of Adverse Event Monitoring. At the same time, regulators must quickly improve laws and regulations and other related supporting systems, to strengthen technical guidance to medical institutions.