Simone Lisa K
Biomed Instrum Technol. 2013 Nov-Dec;47(6):514-22. doi: 10.2345/0899-8205-47.6.514.
Public and internal databases were examined to evaluate software-related recalls in the medical device industry sector. In the analysis of recalls reported from 2005 through 2011, 19.4% of medical device recalls are related to software. This paper includes analysis results, challenges faced in determining the causes, and examples and trends in software-related recalls. This information can be useful in enhancing our understanding of why medical devices fail, and it can help to improve medical device safety, and patient and public health.
对公共数据库和内部数据库进行了审查，以评估医疗设备行业中与软件相关的召回情况。在对2005年至2011年报告的召回事件分析中，19.4%的医疗设备召回与软件有关。本文包括分析结果、确定原因时面临的挑战以及与软件相关召回的示例和趋势。这些信息有助于增强我们对医疗设备故障原因的理解，并有助于提高医疗设备安全性以及患者和公众健康水平。
