失效模式与效应分析在眼科精密器械集中式管理中的应用
Applicability of failure mode and effect analysis for centralizedmanagement of ophthalmic precision instruments
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摘要: 目的 加强眼科精密器械的集中式管理,优化管理流程,提高器械清洗效率,减少损耗,降低成本,提高交接准确率。方法 2013年4月成立失效模式与效应分析(FMEA)质控组,对眼科精密器械的集中式管理进行风险评估,通过执行分析,确定高风险因子,制定并实施改进措施,对比运用FEMA前后RPN控制效果和清洗效果,将眼科精密器械按使用时间分为两组,即对照组5 046件(2013年1-3月),实验组6 887件(2013年4-6月)。结果 运用FEMA前后,5个失效模式的RPN 值较之前显著下降,其中4个失效模式的RPN值<100,达到该院消毒供应室风险控制可接受值,1个失效模式的RPN值为105,属于风险受控区间值;实施FMEA管理后器械清洗质量不合格、器械损耗及交接错误发生率分别降低8.1%、2.2%、2.4%,差异有统计学意义(P<0.05)。结论 将FMEA模式运用于医院眼科精密器械的集中式管理中,可用以论证改进措施是否有效,方便及时调整,可有效促进医院眼科精密器械质量的持续改进。Abstract: OBJECTIVE To strengthen centralized management of ophthalmic precision instruments,optimize the management process,improve the cleaning efficiency of instruments,reduce the loss and costs and improve transfer accuracy.METHODS FMEA quality control team was established in Apr.2013,and a risk assessment on the centralized management of ophthalmic precision instruments was carried out.High-risk factors were identified,improvement measurements were developed and implemented by analysis.To compare RPN control effect and cleaning effect of instruments before and after the use of FEMA,ophthalmic precision instruments were divided into two groups by using time,namely control group with 5046pieces(Jan.- Mar.2013),and experimental group with 6887pieces(Apr.-Jun.2013).RESULTS After the implementation of FMEA management,the RPN values of 5failure modes were significantly descended,in which the RPN values of 4failure modes were <100,reaching the acceptable value of risk control of hospital disinfection supply room,and one RPN value was 105,belonging to the risk control interval value.The number of cleaning failure to instruments,instruments loss and transfer errors was reduced 8.1%,2.2% and 2.4%(P<0.05),respectively,there were significant differences between the results.CONCLUSION Applying FMEA for centralized management of ophthalmology precision instruments,demonstrates the effectiveness of the improvement measurements,and adjusts timely,and can effectively promote the continuous improvement of ophthalmology instruments quality.
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