| 王新茹,张青松,王丽,夏兵,马雪皎,刘伟.基于美国FDAMAUDE数据库静脉留置针不良事件相关数据的分析[J].中国药事,2021,35(7):822-827 |
| 基于美国FDAMAUDE数据库静脉留置针不良事件相关数据的分析 |
| Analysis of Adverse Events Related to Intravenous Indwelling Needles Based on FDA MAUDE Database |
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| DOI：10.16153/j.1002-7777.2021.07.014 |
| 中文关键词: 静脉留置针 医疗器械 不良事件 器械故障 |
| 英文关键词: intravenous indwelling needles medical devices adverse events equipment failure |
| 基金项目:河南省医学科技攻关项目(编号 LHGJ20200266) |
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| 中文摘要: |
| 目的：分析静脉留置针不良事件相关数据，探讨影响静脉留置针安全性相关因素，为临床合理及安全使用静脉留置针提出建议。方法：检索美国FDA MAUDE数据库，对2015年1月1日-2020年12月期间 815例静脉留置针不良事件报告进行统计分析。结果：静脉留置针不良事件以器械故障为主，共770例， 占94.48%。主要表现为漏液、异物污染、针头故障、堵管等；发生原因主要为产品质量问题、使用不当等原因。结论：通过分析美国FDA MAUDE数据库中静脉留置针不良事件发生原因，建议我国静脉留置针生产单位加强对隔离塞处漏液情况的检查，并积极上报不良事件；建议使用单位应严格执行无菌操作规范，熟练掌握穿刺技术，特别警惕静脉输液针与静脉留置针配合使用进行输液的风险；建议监管部门进一步加强不良事件报告的公开性和风险管控措施。 |
| 英文摘要: |
| Objective: To analyze the related data of adverse events of intravenous indwelling needles, explore the related factors affecting the safety of intravenous indwelling needles, and put forward suggestions for rational and safe use of intravenous indwelling needles in clinic. Methods: The FDA MAUDE database was searched, and the reports of 815 adverse events of intravenous indwelling needles from January 1, 2015 to December 2020 were statistically analyzed. Results: The main adverse events of intravenous indwelling needles were mainly instrument failure, accounting for 94.48% in 770 cases, which were mainly manifested as liquid leakage, foreign body pollution, needle failure, pipe plug, etc. The main causes are product quality problems, improper use and other reasons. Conclusion: By analyzing the causes of adverse events of intravenous indwelling needles in FDA MAUDE database, it is suggested that Chinese intravenous indwelling needles manufacturers should strengthen the inspection of leakage at isolation plug and actively report adverse events; that the user shouldstrictly implement the aseptic operation standard, master the puncture technology, and be especially alert to the risk of intravenous infusion needle and intravenous indwelling needles; and that the regulatory authorities further strengthen the disclosure of adverse event reports and risk control measures. |
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