Research On Current Situation Of Adverse Event Monitoring For Medical Device In Jiangsu Province

Purpose: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 probe into the typical products of adverse events, clarify the necessity and pressing of Jiangsu province to carry out medical device adverse monitoring work, put forward our country public health policy of post market medical device regulatory recommendations for development, strengthening the government supervision on medical equipment management, and protection of public life and health rights.Methods:By reviewing medical devices adverse event monitoring in the related literature, the collection of national, Jiangsu Province, Suzhou drug authorities and adverse reaction monitoring center internal working documents, data, enterprise reporting data. From the medical devices adverse event monitoring in the perspective of China’s medical device regulations, supervision and monitoring work condition starting comprehensive analysis, discovers the existence the insufficiency and the aspects needed to be improved, and discuss how to work in the future to further strengthen the medical device adverse event monitoring and product market regulation.Results:In recent years, the international medical device regulatory focus has emerged from the pre-market approval to the post-marketing transfer trend, and our country adverse events work start later, and the work actual effect less than expected, adverse event reporting quantity and the product on the market are not matching, quality is not high. At present, whether it is due to the quality of the product itself or from product design, materials, production, storage, use and other factors causing adverse events, has not been paid enough attention, not to provide good foundation for the work of post-marketing. Medical device regulations system is not perfect, supervision is weak, there are still many problems, in view of this situation, puts forward six problems and suggestions on the development of public health policies and regulations, by means of further strengthening of medical device adverse event monitoring, product evaluation, control the risk, the supervision work in medical equipment development, production, sales and use of the entire process, guarantee people’s life safety and healthy.Conclusion:Our country has initially established the adverse events of medical device regulations and monitoring network, but our province’s adverse events monitoring work is generally weak. At present, report number, report quality is not high, they are two big problems, and it has a great effect on the medical device risk prevention and control. In the occurrence of adverse events, both the product quality problems and product design, materials, use and other factors, regulators should pay attention to the problems, through collect adverse event information, to use of public health policies and regulations to carry out medical device products risk analysis, and strengthening post market medical device regulation.