江西省9810例医疗器械不良事件数据统计分析

Statistic Analysis of 9810 Cases of Medical Device Adverse Events in Jiangxi Province

目的了解江西省医疗器械不良事件发生概况和特点,为进一步及时有效报告和制定防控措施提供参考。方法选取2014年1月-2015年6月江西省医疗器械不良事件数据进行描述性统计和分析。结果医疗器械不良事件报告主要来源于医疗器械经营企业和使用单位;涉及Ⅱ类和Ⅲ类医疗器械的不良事件是医疗器械不良事件的构成主体。结论健全不良事件监管法规,完善报告制度;加强生产企业专业培训,强化报告意识;改进监测报告系统功能,提高报告质量。

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.