Abstract：Objective To study the general situation and characteristics of medical device adverse events
in Jiangxi province to provide references for timely and effective reporting and further development
of prevention and control measures. Methods In empirical study, the data of medical device adverse
events in Jiangxi province from January 2014 to June 2015 were analyzed. Results Enterprises and
medical devices unit were the main source of medical device adverse event reporting; ClassⅡand Class
Ⅲ medical devices adverse events related to medical equipment management category constituted
the main body of the medical device adverse events. Conclusion It is important to improve adverse
events regulatory system and reporting system; it is also essential to strengthen professional training in
enterprises and the active reporting consciousness; it is necessary to improve the monitoring function of
the reporting system and to enhance the quality of reporting.
贾秀才，汤少梁. 江西省9810例医疗器械不良事件数据统计分析[J]. 中国医疗设备, 2016, 31(5): 146-148.
JIA Xiu-cai, TANG Shao-liang. Statistic Analysis of 9810 Cases of Medical Device Adverse Events in
Jiangxi Province. China Medical Devices, 2016, 31(5): 146-148.
