FMEA与FMECA在PIVAS事前防范用药错误中的应用

FMEA and FMECA Applied in the Prevention of Medication Errors of PIVAS

关键词:  失效模式  危害分析  静脉用药调配中心  用药错误

Key words:  failure mode  criticality analysis  pharmacy intravenous admixture services(PIVAS)  medication errors

摘要:

目的 加强静脉用药调配中心（pharmacy intravenous admixture services，PIVAS）用药错误前瞻性、系统性防范，保障患者用药安全。方法 借鉴失效模式和影响分析（failure mode and effects analysis，FMEA）和失效模式、影响及危害分析（failure mode，effects and criticality analysis，FMECA）的风险管理方法，对失效模式危害性进行分析，对风险优先指数（risk priority number，RPN）值高的9个中等风险的失效模式进行改善并进行效果评价。结果 优先改善的9个中等风险的失效模式降为3个，共下降116个RPN值，下降幅度达52.25%，除适应证错误外，其他失效模式用药错误发生率明显降低，差异有统计学意义（P<0.05），PIVAS的用药错误得到有效控制。结论 PIVAS应重点防范违反无菌操作。FMEA和FMECA是适合事前防范PIVAS用药错误的质量管理工具。

Abstract:

OBJECTIVE To strengthen the prospective and systematic prevention of medication errors in pharmacy intravenous admixture services(PIVAS) and to ensure the safety of medication for patients. METHODS The failure mode and effects analysis(FMEA) and failure mode, impacts and criticality analysis(FMECA) risk management methods were used to analyze the hazards of failure modes. The nine moderate-risk failure modes with high risk priority number(RPN) values were improved and evaluated. RESULTS The nine moderate-risk failure modes which were preferentially improved reduced to three, with a total decrease of 116 RPN values, a decrease rate of 52.25%. In addition to the indication errors, the incidence of medication errors in other failure modes was significantly reduced(P<0.05), and the medication errors in PIVAS were effectively controlled. CONCLUSION PIVAS shall focus on preventing violation of aseptic practices. FMEA and FMECA are quality management tools which are suitable for the prevention of medication errors of intravenous medications.