{"title":"342起医疗器械故障的教训","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":"{\"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}","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}
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.
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