风险管理在医疗器械管理中的应用

Application of Risk Management in Medical Device Classification

目的探讨风险管理在医疗器械管理中的应用效果。方法选取2020年2月至2021年2月各科室的650件医疗器械作为实验组,实施风险管理;选取2019年1月至2020年1月实施风险管理前各个科室的650件医疗器械作为对照组,实施常规管理,比较实施风险管理前后医疗器械管理质量与管理缺陷发生率。结果实施风险管理后,医疗器械的摆放与排列、数量与规格、器械小部件完好及附加物品的放置合格率均明显高于实施前(P<0.05);实施后医疗器械管理缺陷总发生率为0.61%,明显低于实施前6.31%(P<0.05);实施后供给与回收及时度、安全性能、清洁与包装质量评分均明显高于实施前(P<0.05)。结论对医疗器械实施风险管理可有效提高管理质量与水平,值得推广。

Objective To discuss the application effect of risk management in medical device classification.Methods A total of 650 pieces of medical devices from various departments from February 2020 to February 2021 were selected as the experimental group to implement risk management and a total of 650 pieces of medical devices from various departments before the implementation of risk management from January 2019 to January 2020 were selected as control group to implement routine management.And the quality of medical device management and the incidence of management defects before and after the implementation of risk management were compared.Results After the implementation of risk management,the placement and arrangement,quantity and specification of medical devices,the integrity of small parts of the device and the placement qualification rate of additional items were significantly higher than those before the implementation(P<0.05).The total incidence of medical device management defects after the implementation was 0.61%,significantly lower than 6.31%before the implementation(P<0.05).After the implementation,the supply and recovery timeliness,safety performance,cleanliness and packaging quality scores were significantly higher than before the implementation(P<0.05).Conclusion The implementation of risk management for medical devices can effectively improve the management quality and level,and it is worth popularizing.