基于FMEA的心脏起搏器系统风险分析

中国药物警戒 ›› 2014, Vol. 11 ›› Issue (2): 104-108.

基于FMEA的心脏起搏器系统风险分析

程云章^{1, 2}, 罗文香¹, 黄芳芳¹

1上海理工大学医疗器械与食品学院,上海 200093;
2上海医疗器械高等专科学校,上海 200093

收稿日期:2013-07-31 修回日期:2016-02-03 出版日期:2014-02-08 发布日期:2016-02-03
作者简介:程云章,男,博士,教授,医疗器械风险管理。

Risk Analysis of Pacemaker System Based on Failure Mode and Effect Analysis

CHENG Yun-zhang^{1, 2}, LUO Wen-xiang¹, HUANG Fang-fang¹

1School of Medical Instrument and Food, University of Shanghai for Science and Technology, Shanghai 200093, China；
2Shanghai Medical Instrumentation College, Shanghai 200093, China

Received:2013-07-31 Revised:2016-02-03 Online:2014-02-08 Published:2016-02-03

摘要/Abstract

摘要： 目的探讨心脏起搏器在使用过程出现的问题及统计分析这些问题引起的潜在风险,对风险值最高的部件进行模拟分析并改善,保证心脏起搏器在寿命周期内的安全性和有效性。方法采用失效模式与效应分析（FMEA）研究心脏起搏器的潜在风险。结果统计得出心脏起搏器导线风险值最高,采用ANSYS软件模拟导线体结构,从微观方面探索导线体发生断裂时其结构特性的变化,并用导线机械性能理论对导线进行尝试性的改进。结论起搏器导线性能得到改善,心脏起搏器寿命得到延长。

关键词: 风险管理, 失效模式与效应分析, 心脏起搏器, 风险分析

Abstract: ObjectiveTo investigate issues of the cardiac pacemaker in use process and analyze potential risks caused by these issues, then to analyze and improve parts on highest risk value to ensure the safety and effectiveness of the cardiac pacemaker in the whole life cycle. MethodsUsing FMEA to study the potential risk of the cardiac pacemaker. ResultsThe highest risk value of cardiac pacemaker is wire. The article adopts ANSYS to simulate wire structure to explore some changes in structure features from the micro when it fractures. Then tentative improvement was carried out on the wire according to the theory of wire mechanical property. ConclusionPerformance of wire of the cardiac pacemaker is improved, service life of the cardiac pacemaker is extended.

Key words: risk management, Failure Mode and Effect Analysis, cardiac pacemaker, risk analysis

中图分类号:

R917

程云章, 罗文香, 黄芳芳. 基于FMEA的心脏起搏器系统风险分析[J]. 中国药物警戒, 2014, 11(2): 104-108.

CHENG Yun-zhang, LUO Wen-xiang, HUANG Fang-fang. Risk Analysis of Pacemaker System Based on Failure Mode and Effect Analysis[J]. Chinese Journal of Pharmacovigilance, 2014, 11(2): 104-108.

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