Lessons from 342 medical device failures

D. Wallace, D. R. Kuhn
{"title":"Lessons from 342 medical device failures","authors":"D. Wallace, D. R. Kuhn","doi":"10.1109/HASE.1999.809487","DOIUrl":null,"url":null,"abstract":"Most complex systems today contain software, and systems failures activated by software faults can provide lessons for software development practices and software quality assurance. This paper presents an analysis of software-related failures of medical devices that caused no death or injury but led to recalls by the manufacturers. The analysis categorizes the failures by their symptoms and faults, and discusses methods of preventing and detecting faults in each category. The nature of the faults provides lessons about the value of generally accepted quality practices for prevention and detection methods applied prior to system release. It also provides some insight into the need for formal requirements specification and for improved testing of complex hardware-software systems.","PeriodicalId":369187,"journal":{"name":"Proceedings 4th IEEE International Symposium on High-Assurance Systems Engineering","volume":"3 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"1999-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"30","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Proceedings 4th IEEE International Symposium on High-Assurance Systems Engineering","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1109/HASE.1999.809487","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 30

Abstract

Most complex systems today contain software, and systems failures activated by software faults can provide lessons for software development practices and software quality assurance. This paper presents an analysis of software-related failures of medical devices that caused no death or injury but led to recalls by the manufacturers. The analysis categorizes the failures by their symptoms and faults, and discusses methods of preventing and detecting faults in each category. The nature of the faults provides lessons about the value of generally accepted quality practices for prevention and detection methods applied prior to system release. It also provides some insight into the need for formal requirements specification and for improved testing of complex hardware-software systems.
342起医疗器械故障的教训
今天,大多数复杂的系统都包含软件,由软件故障引起的系统故障可以为软件开发实践和软件质量保证提供经验教训。本文提出了一个分析与软件相关的医疗设备故障,没有造成死亡或伤害,但导致召回的制造商。分析通过故障的症状和故障对故障进行分类,并讨论了每一类故障的预防和检测方法。故障的性质提供了关于在系统发布之前应用的预防和检测方法的普遍接受的质量实践的价值的教训。它还提供了对正式需求规范和改进复杂硬件软件系统测试的需求的一些见解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信