Analysis of Safety-Critical Computer Failures in Medical Devices

被引:84
作者
Alemzadeh, Homa [1 ]
Iyer, Ravishankar K. [1 ]
Kalbarczyk, Zbigniew [1 ]
Raman, Jai [2 ,3 ]
机构
[1] Univ Illinois, Urbana, IL USA
[2] Rush Univ, Med Ctr, Sect Adult Cardiac Surg, Chicago, IL 60612 USA
[3] Rush Univ, Med Ctr, Adv Heart Failure Heart Transplant & Mech Circula, Chicago, IL 60612 USA
基金
美国国家科学基金会;
关键词
failure analysis; FDA; FDA adverse events; FDA recalls; Food and Drug Administration; MAUDE database; medical devices; safety;
D O I
10.1109/MSP.2013.49
中图分类号
TP [自动化技术、计算机技术];
学科分类号
0812 ;
摘要
Malfunctioning medical devices are one of the leading causes of serious injury and death in the US. Analysis of human-written descriptions of recalls and adverse event reports reveals safety issues in these devices and provides insights on the future challenges in the design of safety-critical devices.
引用
收藏
页码:14 / 26
页数:13
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