中国药物警戒 ›› 2011, Vol. 8 ›› Issue (12): 738-740.

• 管理及工作研究 • 上一篇    下一篇

广东省医用缝合线可疑不良事件重点监测分析

杨丽君, 王宏, 邓剑雄, 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:2011-08-02 出版日期:2011-12-10 发布日期:2015-07-30
  • 作者简介:杨丽君,女,硕士,副主任医师,医疗器械不良事件监测。

Monitoring and Analysis of Suspected Adverse Events on Medical Suture Line in Guangdong

YANG Li-jun, WANG Hong, DENG Jian-xiong LU Shu-tang   

  1. Guangdong Center for ADR Monitoring, Guangdong Guangzhou 510080, China
  • Received:2011-08-02 Online:2011-12-10 Published:2015-07-30

PDF (PC)

511

摘要： 目的 通过重点监测方法分析医用缝合线导致的可疑不良事件。方法 监测我省42家医院使用医用缝合线致可疑不良事件的信息,录入epidata 3.02软件,用EXCEL对信息进行统计分析。结果 在全部88例可疑不良事件中,可吸收缝合线导致的不良事件占53.4%。缝合线导致的不良事件主要表现为缝合线易断裂、感染、缝线反应、不吸收或延迟吸收、切口愈合不良。引起不良事件的可能原因主要包括产品因素、患者体质因素、使用者操作因素。88.6%的不良事件需要通过进一步治疗来避免对患者的伤害。结论 医用缝合线导致的可疑不良事件并非少见,其安全性值得长期重点监测。

关键词: 医疗器械不良事件, 监测, 医疗器械安全性, 医用缝合线

Abstract: Objective Analyzing suspicious adverse events induced by medical suture line through emphasis on monitoring. Methods Information of suspicious adverse events caused by medical suture line in 42 hospitals in Guangdong were monitored. Data was inputted in Epidata 3.02 software and was analyzed statistically by Excel. Results In all 88 suspected adverse events, the percentage of which caused by absorbable medical suture line is 53.4%. These events were mainly showed as sutures easy to break, infection, suture reaction, no absorption or delayed absorption, and poor wound healing. The agents may include product quality, patients' body constitution, users' operation. 88.6% of these patients need further treatment to prevent further injury. Conclusion It is considerable that the adverse events caused by medical suture line could be. It's safety should be specially monitored in long term.

Key words: medical device adverse events, monitoring, medical device safety, medical suture line

中图分类号: