674例输液泵不良事件回顾性分析

Retrospective Analysis of 674 Cases of Adverse Events of Infusion Pump

目的通过对输液泵不良事件开展分析,发现潜在风险,提出安全使用建议,以期在使用中减少不良事件发生,保障公众用械安全。方法本文通过对河北省医疗器械不良事件数据库中2010年8月至2018年8月的674例输液泵可疑不良事件报告进行回顾性分析,提出安全使用建议。结果输液泵作为一种临床辅助输液设备,能够精确控制药液总量和流速,但在临床使用过程中也存在着安全风险。结论输液泵生产企业应该提升产品性能,加强培训并主动开展不良事件报告工作。此外医疗机构需要提高认识,建立维护保养制度,完善风险监测管理。

Objective To reduce the occurrence of adverse events and ensure the safety of public equipment through analyzing the adverse events of infusion pump,finding potential risks and putting forward safety suggestions.Methods In this paper,a total of 674 cases of suspected adverse events of infusion pumps in the database of adverse events of medical devices in Hebei province from August 2010 to August 2018 were retrospectively analyzed and safety suggestions were put forward.Results Infusion pump,as a kind of clinical assistant infusion equipment,could accurately control the total volume and flow rate of liquid medicine,but there were also safety risks in clinical use.Conclusion The product performance of infusion pump manufacturers should be improved,training should be strengthened and the adverse events should be taken the initiative to report.In addition,medical institutions need to raise awareness,establish maintenance systems and improve risk monitoring and management.