中国药物警戒 ›› 2012, Vol. 9 ›› Issue (2): 114-116.

• 药品不良反应监测 • 上一篇    下一篇

医用缝合线器械不良事件报告分析

陈希，龙丽萍*   

  1. 湖南省食品药品安全信息中心，湖南 长沙 410013
  • 收稿日期:2011-05-23 出版日期:2012-02-10 发布日期:2015-08-10
  • 通讯作者: 龙丽萍,女,主任药师,药品不良反应监测。E-mail:540630649@qq.com
  • 作者简介:陈希，女，研究生，药品不良反应监测。

Analysis of Reports on Adverse Events of Surgical Suture Devices

CHEN Xi, LONG Li-ping*   

  1. Hunan Food and Drug Safety Information Center, Hunan Changsha 410013, China
  • Received:2011-05-23 Online:2012-02-10 Published:2015-08-10

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摘要： 目的通过对湖南省2010年全省医用缝合线器械不良事件报告的基本情况进行统计分析，为开展医疗器械不良事件监测工作提供技术支持。方法采用描述性方法，使用 Excel表格对2010年收集到的409份报告进行统计分析，对存在的问题和应对措施进行了初步的探讨。结果湖南省医用缝合线器械不良事件报告患者年龄主要集中在20~30岁，报告主要来源于使用单位，11月份上报报告数量最多，其中可吸收性外科缝线不良事件居多，不良事件临床表现主要是缝线反应和切口愈合不良，不良事件伤害程度需要内、外科治疗避免永久损伤的占报告总数的80.20%。结论应加强医用缝合线器械不良事件监测的培训，提升报表质量，使之成为公众用械安全的有效信息。

关键词: 医用缝合线, 不良事件, 器械, 分析

Abstract: Objective By analyzing the reports on adverse events of surgical suture devices in Hunan province in 2010, provide technical support for the monitoring work of medical device adverse events. MethodsWith the description method, statistically analyze 409 reports collected in 2010 with the help of Microsoft Excel, primarily discuss the existing problems and present corresponding measures. ResultsThese surgical suture adverse events in Hunan province largely occurred in the patients between 20-30 years old. The reports mainly came from medical facility, and most events happened in November, in which the majority was absorbable surgical suture adverse events. The clinical manifestations of adverse events focused on suture reaction and poor wound healing, 80.20% of all the adverse events needed internal and surgical treatment to avoid the permanent injury. ConclusionWe should strengthen the training of surgical suture adverse event monitoring, promote the quality of reports to make them become effective information available for the safe use of medical devices.

Key words: surgical suture, adverse events, devices, analysis