A Investigation Of The Status On The Construction Of Technical Organization For Medical Device Postmarket Monitoring In XinJiang

Objective To explore the more effective construction model of the medical devices adverse event(MDAE) postmarket monitoring system in Xinjiang, provide recommendation and suggestion to make a more resonable idea for the monitoring system runing. Methods The combination of qualitative and quantitative analysis was conducted in this study to propose basic concept and framework about MDAE mornitoring system, issue the problem existed and give the suggestion to perfect it. Results (1) Xinjiang uygur autonomous region Monitoring Center and five provincial monitoring technique organizations worked since DEC 31, 2007, but for the reason of absent of law basis, monitoring system worked in low efficiency. It is urgently to train the domestic monitoring staff knowledgement about the medical instrument monitoring. (2) The long term development objective of the monitoring system of medical instrument and devices adverse effects: establish a monitoring system of medical instrument and devices adverse effects that obtain the capabilities to detect the new issues, predict the risk factors, intervene and evaluate intervention measures and policy'effects according to the working function of the supervision. The monitoring organization is composed of policy study department, comprehensive intervention department, regulation implementation department, monitoring evaluation department, propagandizing and training department. All the depatment cooperate intensively to monitor the MDAE, include the measurement of accident frequency MDAE, the description of the occurrence model, analysis of the reason, prediction of the trend and the supervision of the evaluation of self effect; the process of medical instrument and devices adverse effects monitoring divided in four sectors: data collection, analysis and explanation, feedback, intervention; to evaluate periodically is an important way to insure the effective working of the monitoring system; (3) To set down a long-term objective, short-term objectives as well as the corresponding measures to accomplish the task of MDAE monitoring. Conclusions MADE system in Xinjiang is in primary stage, absent of law basis, weak of system construction, insufficient of investment, further improvement of the staff, urgently demand to formulate objective and scientific strategies, phased work plan. At the early stage of the construction of the monitoring organization, carry out the monitoring of medical instrument and devices accident scientifically and canonically under the thinking guidance of"keeping pace with the times"through setting up scientific monitoring concept, drawing up effective and feasible specific measures,...