Abstract：Objective To explore the influence of the quality control circle (QCC) activity on the reporting rate of adverse events in
the monitoring of adverse events of suspect medical devices. Methods A QCC group was set up to research on the investigate, the
status, target setting, cause analysis, countermeasure formulation, countermeasure implementation, effect confirmation, analysis and
improvement of the MDR monitoring. The data before and after the application of QCC in the monitoring of MDR were compared.
Results The reporting rate of MDR increased by 40% after the application of QCC in the monitoring of MDR, which was obviously
higher than before. Conclusion The application of QCC can significantly improve the reporting rate of MDR and effectively promote
the development of the monitoring of MDR.
谢杲. 应用品管圈对提升可疑医疗器械不良事件上报率的探究[J]. 中国医疗设备, 2019, 34(4): 149-152.
XIE Gao. Research on Improving the Reporting Rate of Medical Device Reaction Based on
the Application of Quality Control Circle. China Medical Devices, 2019, 34(4): 149-152.
