医用耗材SPD风险评价模型研究

Risk assessment model of medical consumables supply-processing-distribution

目的 探讨失效模式与效应分析(FMEA)在医用耗材SPD管理模式中的应用,构建风险模型。方法 应用失效模式与效应分析法,结合鱼骨图(因果)分析法作为工具,探究医用耗材SPD模式的风险影响因素,基于问卷调查法进行风险类型调研,结合描述性统计方法计算风险系数。结果 风险由高到低依次是法规风险(RPN=27.24),其次是信息系统风险(RPN=24.41)、第三方管理风险(RPN=23.42)、院内管理风险(RPN=16.38)。结论 应结合政策法规完善医疗机构耗材管理制度,严格限制SPD服务商的业务内容,医疗机构发挥医用耗材管理主导地位,对SPD服务商进行严格考评,加强第三方团队管理,同时在全方位保障信息数据安全的基础上,完善医用耗材管理信息系统。

Objective To explore the application effect of failure mode and effect analysis management(FMEA) in SPD management mode of medical consumables, and build a risk model.Methods FMEA and the tool of fishbone analysis method(Causal Factor Analysis) were used to explore the risk factors of SPD of medical consumables. The risk types were investigated based on the questionnaire survey method. Descriptive statistical methods were used to calculate the risk coefficient.Results The rank of risk from high to low was: the regulatory risk(RPN equal to 27.24), the information system risk(RPN equal to 24.41), the risk of third party management(RPN equal to 23.42), and the risk of hospital management(RPN equal to 16.38).Conclusion The management system of medical consumables should be improved according to policies and regulations, and the business content of SPD service providers should be strictly limited. Medical institutions should play a leading role in the management of medical consumables, strictly evaluate SPD service providers, and strengthen the third party team management. Meanwhile, on the basis of comprehensive guarantee of information and data security, the consumables management information system should be improved.