基于失效模式与效应分析婴儿培养箱风险分析

Risk Analysis of Infant Incubator Based on Failure Modes and Effect Analysis

目的定量评估婴儿培养箱在使用中的潜在风险。方法通过收集、整理和归纳大理大学第一附属医院儿科2014年以前的婴儿培养箱故障维修资料和科室管理资料,利用失效模式和效应分析(FMEA)识别出其失效模式,再根据其严重度(S)、发生概率(O)和探测度(D)的评价标准,计算风险顺序数RPN(RPN=S×O×D),再提出风险控制措施,风险控制措施实施后再分析RPN值是否得到降低。结果婴儿培养箱被识别出的9个主要失效模式的平均风险顺序数为29,采取FMEA风险控制措施实施一年后平均风险顺序数降为7。结论 FMEA的应用能明显降低婴儿培养箱的临床使用风险,减少潜在失效模式的发生。

Objective To quantitatively evaluate the potential risks of infant incubator in use. Methods The breakdown maintenance records and department management data of infant incubators in department of pediatrics in our hospital before 2014 were collected, systemized and summarized. The failure modes and effects analysis (FMEA) was used to identify the failure mode. Then, according to evaluation standards of severity (S), occurrence (O) and detection (D), the risk priority number (RPN, RPN=S x O x D) was calculated. Afterwards, the risk control measure was proposed and implemented to analyze whether RPN value was reduced or not. Results The average RPN value of 9 main failure modes identified in infant incubators was 29, subsequently was reduced to 7 in one year after implementing risk control measures of FMEA. Conclusion The FMEA could be applied to obviously reduce clinical use risks of infant incubators as well as the occurrence of potential failure modes.