医疗技术管理专业人员在不良事件报告中的作用

A. S. Silva Ferreira, S. Waheed
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引用次数: 0

摘要

医疗保健技术管理专业人员在医疗设备环境中发挥着关键作用。通过与美国食品和药物管理局分享他们对医疗器械问题的见解和专业知识,医疗技术管理专业人员帮助该机构解决医疗器械安全问题,并帮助提高患者安全。本文介绍了两个真实的案例研究示例,其中包含关键医疗技术管理输入的医疗设备报告提交给美国食品和药物管理局的MedSun(医疗产品安全网络)报告计划,并帮助促成了2次召回。报告中的细节由医院报告小组提供,为确定设备问题提供了独特的视角,并极大地有助于调查和解决报告的设备安全问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Role of Healthcare Technology Management Professionals in Adverse Event Reporting
Healthcare technology management professionals play a key role in the medical device environment. By sharing their insights and expertise on medical devices issues with the US Food and Drug Administration, healthcare technology management professionals help the agency resolve medical device safety concerns and help improve patient safety. This article presents two real-world case study examples in which medical device reports containing critical healthcare technology management input were submitted to the US Food and Drug Administration's MedSun (Medical Product Safety Network) reporting program and helped contribute to 2 recalls. The details in the reports, provided by the hospital reporting team, offer a unique perspective for identifying the device concern and greatly contribute to the investigation and resolution of the reported device safety issue.
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