可追溯性医疗器械不良反应管理方法及价值

Method and value of traceability of medical device adverse reaction

目的分析可追溯性医疗器械不良反应管理方法,并探讨其价值。方法总结使用可追溯性医疗器械不良反应43例的管理方法,并探讨其减少医疗器械不良事件的价值。结果干预后整体不良事件发生率显著降低,差异有统计学意义(P<0.05)。结论可追溯性管理医疗器械不良事件起到追根溯源的作用,有效减少了厂家设计原因、性能原因以及临床医生的实际操作原因和使用辅材原因的原因。

Objective To analyze the value and the method of traceability of medical device adverse reaction. Methods 43 cases used traceability of medical device adverse reaction. To discuss its reduction of medical device adverse event value. Results After the intervention, the overall incidence of adverse events was significantly reduced than before （P 〈 0.05）. Conclusion The traceability management of medical device adverse events has the function of finding hard and thorough search, so it can effectively reduce the manufacturers design, performance and practical reasons clinicians and the auxiliary cause.