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首页> 外文期刊>Journal of clinical engineering >Adverse Event Triggered Event Reporting for Devices Report of a Food and Drug Administration-Supported Feasibility Pilot of Automated Adverse Event Reporting
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Adverse Event Triggered Event Reporting for Devices Report of a Food and Drug Administration-Supported Feasibility Pilot of Automated Adverse Event Reporting

机译：食品药品管理局支持的自动不良事件报告可行性试验的设备报告的不良事件触发事件报告

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Despite US Food and Drug Administration (FDA) requirements for reporting medical device adverse events (AEs), only an estimated 10% of events are actually reported, and many of those lack important data. As part of its plan to strengthen postmarket surveillance of medical devices, the FDA sponsored a pilot project of the Adverse Event Triggered Event Reporting for Devices (ASTER-D) system developed by Outcome Sciences for automated AE reporting. The objective of this study is to test the feasibility of using ASTER-D to report medical device AEs. This was a cooperative effort of Outcome Sciences, FDA, and Meicy Health. The ASTER-D system enables a new functionality within the electronic health record for initiating AE reports from triggering events with prepopulated patient- and incident-specific data and minimal disruption to clinician workflow. The ASTER-D system employs health information exchange principles to automate medical device safety reporting and create a "safety information exchange" that allows safety information collected by various organizations to be available to others to facilitate postmarket surveillance. Mercy implemented ASTER-D for AEs related to coronary stents occurring in its cardiac catheterization laboratories in the context of Mercy's automated incident reporting software system and incorporated prototype unique device identifiers to link reports to key device attributes. Mercy succeeded in submitting an AE using ASTER-D to the FDA's Medical Product Safety Network database. This pilot provides proof of concept of ASTER-D's functionality. Further testing with greater numbers of AEs, with different devices, and in other healthcare settings, is required.
机译：尽管美国食品和药物管理局（FDA）要求报告医疗器械不良事件（AE），但实际上仅报告了估计的事件的10％，其中许多缺乏重要数据。作为加强医疗设备上市后监视计划的一部分，FDA赞助了由Outcome Sciences开发的用于自动AE报告的设备不良事件触发事件报告（ASTER-D）系统的试验项目。这项研究的目的是测试使用ASTER-D报告医疗器械不良事件的可行性。这是结果科学，FDA和Meicy Health的共同努力。 ASTER-D系统启用了电子健康记录中的一项新功能，可通过触发事件来触发AE报告，这些事件具有预先填充的患者和事件特定数据，并且对临床医生工作流程的干扰最小。 ASTER-D系统采用健康信息交换原理来自动执行医疗设备安全报告，并创建“安全信息交换”，从而使其他组织收集的安全信息可供其他人使用，以促进售后监控。 Mercy在Mercy的自动事件报告软件系统的背景下，针对与在其心脏导管实验室中发生的冠状动脉支架相关的AE实现了ASTER-D，并结合了原型独特的设备标识符，以将报告链接至关键设备属性。 Mercy成功地使用ASTER-D向FDA的医疗产品安全网络数据库提交了AE。该飞行员提供了ASTER-D功能的概念证明。需要使用更多的AE，使用不同的设备以及在其他医疗保健环境中进行进一步测试。

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