中国药物警戒 ›› 2010, Vol. 7 ›› Issue (3): 172-174.

• 医疗器械不良事件监测 • 上一篇    下一篇

广东省骨科植入物不良事件调查分析

王宏, 杨丽君, 邓剑雄, 邢欣, 林国良, 卢淑棠   

  1. 广东省药品不良反应监测中心,广东 广州 510080
  • 收稿日期:2016-02-19 修回日期:2016-02-19 出版日期:2010-03-08 发布日期:2016-02-19
  • 作者简介:王宏,男,主治医师,医疗器械不良事件监测。

Investigating and Analyzing the Orthopedic Implants Administration Events in Guangdong Province

WANG Hong, YANG Li-jun, DENG Jian-xiong, XING Xin, LIN Guo-liang, LU Shu-tang   

  1. Guangdong Center for ADR Moritoring, Guangzhou 510080, China
  • Received:2016-02-19 Revised:2016-02-19 Online:2010-03-08 Published:2016-02-19

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摘要： 目的 总结广东省部分医院骨科植入物不良事件发生率及其特点。方法 对2008年广东省七家医院涉及骨科植入物的全部病例进行筛查,对发现的126例可疑不良事件进行统计分析。结果 七家医院2008年骨科植入物可疑不良事件总发生率为5.87%,其中第一次入院病例发生率（2.43%）远小于第二次入院病例发生率（16.51%）,脊柱内固定物不良事件发生率较高,其余植入物不良事件发生率无明显差异。植入物断裂、松动、变形及感染是可疑不良事件最常见表现（69%）,植入物材料因素和设计因素是导致不良事件的主要原因（72.22%）。结论 临床上对骨科植入物不良事件存在大量的漏报现象,需要加强骨科植入物不良事件监测工作。

关键词: 医疗器械不良事件, 骨科植入物, 分析, 主动监测

Abstract: Objective To investigate some of the hospitals in Guangdong Province of cases involving orthopedic im-plants, concluded the incidence of administration events and characteristics. Methods seven hospitals in Guangdong Province related to orthopedic implants screening of all cases in 2008, the discovery of the 126 cases of suspected adverse events for statistical analysis. Results The incidence of the administration events of the orthopedic implants was 5.87%, which was much higher in the second admitted cases(16.51%) than in the first(2.43%). The administration events incidence of the spinal internal fixation was higher, the others were without statistical difference. The fracture, the loosen, the distortion and the infection were the most familiar manifestation(69%), the material ant the designing factors of the implants were the main causes of the administration events(72.22%). Conclusion There is a large number of omissions phenomenon in clinical administration events of orthopedic implants,, which need to strengthen orthopedic implants, adverse event monitoring.

Key words: Medical Device Administration Events(MDAE), orthopedic implants, analyze, pro-active monitoring

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