基于多维度数据追踪模式下的医疗设备安全风险管理研究

Research on medical equipment safety risk management based on multidimensional data tracking mode

目的:研究分析基于多维度数据追踪模式下的医疗设备安全风险管理方法,降低医疗设备管理风险发生频率。方法:采用安全风险管理方法,从多元角度采集医疗设备数据,构建多维度设备状态量相关性模型,分析设备安全风险信息,评估设备安全风险,根据风险严重性划分级别,针对风险超出接受范围的医疗设备实施安全风险管理,并与传统方法1和传统方法2对医疗设备安全风险管理后的风险发生频率进行比较。结果:采用安全风险管理方法对同类型医疗设备及不同类型的医疗设备管理后,设备风险发生频率始终较为稳定且低于两种传统方法。该方法同类型设备风险发生频率<2%,两种传统方法平均风险频率为15%~25%;该方法不同类型设备风险发生频率<5%,而两种传统方法的设备性能检测合格率变化波动较大,平均风险频率在25%左右。结论:基于多维度数据追踪模式下的医疗设备安全风险管理方法能识别管理医疗设备风险,降低风险发生频率,促进设备良好运行。

Objective:To design a medical equipment safety risk management method based on multidimensional data tracking mode and reduce the frequency of medical equipment management risks.Methods:The multi-dimensional data tracking model was analyzed to design the medical equipment safety risk management method,and the multidimensional equipment state quantity correlation model was established by collecting medical equipment data from multiple perspectives.The equipment safety risk information was analyzed,the equipment safety risks were evaluated,and the levels were classified according to the risk severity.The safety risk management was implemented for the medical equipment whose risks exceeded the acceptance range.The risk occurrence frequency of this method and two traditional methods after implementing safety risk management on medical equipment was compared.Results:Regardless of the same type of medical equipment or different types of medical equipment,the risk occurrence frequency of the new method was relatively stable and lower than that by traditional methods.The risk frequency of the same type of equipment in new method was less than 2%,and the average risk frequency of the two traditional methods was 15%~25%.The risk frequency of different types of equipment in new method was less than 5%,and the qualified rate of equipment performance testing in the two traditional methods fluctuated greatly,the average risk occurrence frequency was about 25%.Conclusion:The medical equipment safety risk management method based on multidimensional data tracking mode can identify and manage the risks of medical equipment,reduce the frequency of occurrence of the risks and promote the good operation of the equipment.