基于关联性风险分析的过程管理策略对医疗设备运行效益的影响研究

Research on the impact of process management strategy based on relevance risk analysis on operating efficiency of medical equipment

目的:基于医疗设备关联性风险分析,制定过程性管理策略,提高医疗设备临床运行效益。方法:制定医疗设备管理对策,从主体、质量、环境、制度和诊疗角度进行风险矩阵评估,建立关联性风险综合评估模型。选取2021年4月至2022年3月上海市第八人民医院临床在用的400台医疗设备,采用数表法将其分为对照组和观察组,每组200台,对照组采用个体化风险分析法进行过程性管理,观察组采用关联性风险分析法进行过程性管理。对比分析两组医疗设备的风险等级和运行效益。结果:观察组医学影像诊断及辅助设备、手术治疗设备、生命支持与急救设备、体外循环及血液处理设备和健康监测及康复设备的高危险占比分别为17.39%(4/23)、14.58%(7/48)、12.24%(6/49)、5.55%(1/18)和5.06%(5/62),均低于对照组,其差异有统计学意义(x^(2)=4.132、4.009、6.275、4.833、4.859,P<0.05);观察组医疗设备的成本效益、社会效益、诊疗效益和发展效益评分分别为(91.37±6.15)分、(92.78±3.80)分、(95.25±2.09)分和(90.51±3.82)分,均高于对照组,其差异有统计学意义(t=2.392、3.877、4.841、2.504,P<0.05)。结论:关联性风险分析方法可降低医疗设备安全风险发生概率和危害程度,提高医疗设备临床运行效益,过程管理策略符合医疗设备全生命周期管理的实际需要。

Objective:Based on the relevance risk analysis of medical equipment,to formulate process management strategies to improve the clinical operation efficiency of medical equipment.Methods:The risk matrix was evaluated from the perspectives of subject,quality,environment,system and diagnosis and treatment perspective,the comprehensive evaluation model of relevance risk was established,and multiple process management countermeasures were formulated.400 sets of medical equipment in clinical use in Shanghai Eighth People's Hospital from April 2021 to March 2022 were selected and divided into the control group and the observation group by the digital table method,with 200 sets in each group.The control group adopted the individualized risk analysis method for process management,and the observation group adopted the relevance risk analysis method for process management.The risk level and operation benefits of the two groups of medical equipment were compared and analyzed.Results:The high risk rates of medical imaging diagnostic and auxiliary equipment,surgical treatment equipment,life support and first aid equipment,extracorporeal circulation and blood processing equipment,health monitoring and rehabilitation equipment in the observation group were 17.39%(4/23),14.58%(7/28),12.24%(6/49),5.55%(1/18)and5.06%(5/62),respectively,which were lower than those in the control group,the difference was statistically significant(x^(2)=4.132,4.009,6.275,4.833,4.859,P<0.05).The scores of cost benefit,social benefit,diagnosis and treatment benefit and development benefit of medical equipment in the observation group were(91.37±6.15)points,(92.78±3.80)points,(95.25±2.09)points and(90.51±3.82)points,respectively,which were higher than those in the control group,the difference was statistically significant(t=2.392,3.877,4.841,2.504,P<0.05).Conclusion:The relevance risk analysis method can reduce the probability and hazard degree of medical equipment safety risks,improve the clinical operation efficiency of medical equipment,and the process management strategy is in line with the actual needs of the medical equipment lifecycle management.