Application of FMEA Combined with Bundle Intervention Strategy in the Mixed Formulation of PIVAS Antineoplastic Drugs
Objective Identify the risks in the process of mixing and blending antineoplastic drugs,and develop effective strategies to reduce the operational risks of mixing and blending antineoplastic drugs.Methods Failure mode and effects analysis(FMEA)was used to identify risk factors in the mixing and blending process of antieoplastic drugs,and to develop bundled intervention measures for failure modes with medium to high risk levels.The risk priority values,occupational protection measures,and the number of incidents of non-standard dispensing operations before and after intervention were compared to evaluate the role of bundled intervention strategies in reducing the related risks in the mixed dispensing process of antieoplastic drugs.Results The entire process of PIVAS antineoplastic drug mixing and blending includes seven major steps:static environment management,personnel management,item management,pre-dispensing preparation,mixed blending,finished infusion verification,and site cleaning,as well as 62 potential failure modes,among them,24 failure modes with medium to high risk levels are included in the management of bundled intervention strategies.After intervention,the 24 item high-risk factors with medium to high risk factors decreased to 3.The RPN value decreased by 480,with a decrease of 55％.The number of non-standard occupational protection measures decreased from 63.5±9.01 to 35.17±5.60,and the number of incidents of non-standard blending operations per month decreased from 50.5±7.56 to 29.67±3.83,the differences were statistically significant(P＜0.05).Conclusion The FMEA method is helpful to discover the potential failure modes in the PIVAS anti-tumor drug mixing process.The bundled intervention strategy can significantly reduce the risk priority index,and the occurrence of non-standard events in the mixing and blending process and protective measures.The combination of the two methods can effectively reduce the risk of non-standard operations in the anti-tumor drug mixing process.
万方数据
维普
