医疗器械不良事件主动监测模式探讨

Study of active monitoring model on adverse event of medical device

通过对辖区内医疗机构使用植入医疗器械情况的调研统计,了解目前医疗器械不良事件监测工作的现状。针对辖区内医疗器械不良事件报告率低的现象,结合现行的监测管理模式,查找并分析原因。对当前所存在的普遍问题,在现有法律、法规的基础上,提出加强监测工作、完善各种机制的建议,以规范这一领域的法制建设和行业建设,推动医疗器械不良事件监测工作的发展。

The investigation and calculation method on the use of embeded medical device in medical institution in the area shows the actual status of the monitoring work on the adverse event of medical device, Focusing on the phenomena that the reported adverse event of medical device is quite low, we use the method to analyze the cause on the base of actual monitoring management, In the face of issues, we suggest to enhance monitoring work and improve all kinds of systems to standardize the construction of laws and regulation and construction of the industry and to promote the development of monitoring work on the adverse event of medical device.