基于失效模式、影响及危害性分析的呼吸机部件失效危害度变化研究

目的研究呼吸机部件失效模式和影响,分析比较不同时间段呼吸机部件失效发生和危害的变化情况。方法统计陆军军医大学大坪医院2012年和2016年呼吸机机故障数据,选取其中部件原因故障失效数据2012年52台,2016年26台,采用失效模式、影响及危害性分析进行分析,参考刘延武文章方法分为13种模式,以风险优先数(RPN)值定量确定呼吸机部件失效危害度并比较。结果 2012年呼吸机部件故障的发生率为43.6%,2016年呼吸机部件故障的发生率为16.4%。2016年因呼吸机部件故障失效发生数量和发生概率较2012年大幅度下降,RPN值下降的部件有空氧混合器(空气)、空氧混合器(氧气)、呼气流量传感器、湿化器、呼吸回路、电源、面板,下降值分别为-108、-120、-40、-14、-192、-64、-50;RPN值增加的部件为吸(呼)压力传感器、支架、显示器,增加值分别为180、12、48;其他部件为RPN值不变,整体呼吸机部件失效危害度下降。结论通过失效模式、影响及危害性分析RPN值计算可以有效掌握呼吸机各部件可靠性与失效危害度变化,结合应用分析与实际需求及时改进呼吸机预防性维护、使用维护培训和维修管理措施,可以保障呼吸机使用过程中的可靠性,提高使用安全性。

Study on failure criticality change of ventilator components based on failure modes,effects and criticality analysis

Objective To study failure mode of ventilator components and its effects, and analyze and compare failure occurrence and damage of the ventilator components in different periods. Methods The statistical data of ventilator failure in Daping Hospital of Military Medical University in 2012 and 2016 were collected, 52 cases of component failure in 2012 and 26 cases in 2016 were selected. The failure modes, effects and criticality analysis(FMECA) were used to analyze the failure data.The component failures were divided into 13 modes by Liu Yanwu. The failure criticality of ventilator components were quantitatively determined and compared by risk priority number(RPN) value. Results The incidence of ventilator component failure was 43.6 % in 2012 and 16.4 % in 2016. The number and probability of ventilator component failure in 2016 were significantly lower than those in 2012. The components with reduced risk priority RPN values were air source, oxygen source, expiratory flow sensor, humidifier, respiratory circuit, power supply and panel. The decline values were-108,-120,-40,-14,-192,-64 and-50, respectively. The components with increased risk priority RPN value were suction(exhalation) pressure sensor,bracket and display, and the added values were 180, 12 and 48, respectively. The RPN value of other components remained unchanged, and the failure criticality of the whole ventilator components decreased. Conclusion It is demonstrated that failure mode, impact and hazard analysis RPN value calculation could effectively provide reliability and failure hazard changes of various ventilator components. Combined with application analysis and actual needs, timely improvement of ventilator preventive maintenance, maintenance training and maintenance management measures can ensure the reliability of ventilator use and improve usage security.