HeartMap Dynamic AED Registry

项目摘要 我们的HeartMap动态自动体外除颤器登记研究（AED登记研究）的长期目标是 通过实施上市后监督确保AED的安全性。AED用于治疗院外心脏病 逮捕（OHCA）。每个主要的AEDD制造商都召回了他们的设备，以解决一个或多个潜在的问题。 安全问题。AED监测的挑战是其他医疗器械监测的典型挑战。 装置.它们在空间和时间上都是移动的，因为它们分布在预计靠近 心脏骤停的场景，并定期从一个位置移动到另一个位置。它们无处不在， 1.2现有设备约100万台，每年安装约18万台新设备。重要的是，没有 广泛部署的方法来跟踪它们的位置和在社区环境中的使用。此外，监测 每一次AED使用的结果都是必要的，以确定那些可能导致或促成死亡的使用， 因为大多数接受OHCA治疗的患者死亡。本研究将维持一个动态登记研究，以进行监测 AED的位置和使用，以便实施和维护国家AED监控系统。 最近，我们开发并试点测试了一种方法来标记AED与唯一的设备标识符（UDI）。 根据该方法，AED被标记有由二维矩阵码（QR码， 电装波公司，Chita-gun，Japan）;然后记录UDI以及器械的位置和状态 使用现代智能手机原生的开源软件，这些信息被传递到数据库， 通过因特网以真实的时间进行（非临时专利#61/498，424）。中的设备特定信息 每次使用AED后，通过重新扫描UDI动态更新数据库。我们已将UDI应用于 宾夕法尼亚州费城和华盛顿州西雅图的AED。(FDA 1U01FD004587-01，Nichol，PI）。重要的是我们有 利用与FDA的合作协议，开发和实施与 AED监护仪/除颤器制造商的财政支持。 我们已将AED登记系统与EMS流程和结果基准数据联系起来， 复苏结果联盟在一个简单的EMS登记处，以激励EMS机构参与AED 注册表 我们的主要目标是使用UDI提供可靠、有效和可持续的AED上市后监测， 智能手机和通过众包的公民参与。我们预计，通过研究， 人口至少2000万人，公共场所至少11，192台带有UDI的AED，至少16，020台 EMS治疗的OHCA，2.5%的OHCA由外行人用AED治疗。如果已知80%的AED， 一年后，估计AED准备使用的精度为1.0%，估计AED准备使用的精度为2.9%。 出院存活率与AED使用相关。

PROJECT SUMMARY The long-term goal of our HeartMap Dynamic Automated External Defibrillator Registry (AED Registry) is to ensure safety of AEDs by performing postmarket surveillance. AEDs are used to treat out-of-hospital cardiac arrest (OHCA). Each major AEDD manufacturer has recalled their devices to address one or more potential safety issues. Challenges with surveillance of AEDs are typical of challenges with surveillance of other medical devices. They are mobile in space and time, as they are distributed in locations anticipated to be close to the scene of cardiac arrest and moved periodically from one location to another. They are ubiquitous, as there are 1.2 million pre-existing devices, and about 180,000 new devices installed annually. Importantly, there is no widely deployed method of tracking their location and use in community settings. As well, monitoring the outcome of every AED use is necessary to identify those uses that may have caused or contributed to a death, since the majority of patients treated for OHCA die. This study will maintain a dynamic registry for surveillance of AED location and use so as to implement and maintain a national AED surveillance system. Recently we developed and pilot tested a methodology to tag AEDs with a Unique Device Identifier (UDI). According to this method, AEDs are tagged with a UDI that consists of two-dimensional matrix code (QR code, Denso Wave Inc., Chita-gun, Japan); then the UDI as well as the location and status of the device are recorded using open-source software native to contemporary smartphones and this information is passed to a database in real time via the internet (Non-Provisional Patent # 61/498,424). The device-specific information in the database is updated dynamically by rescanning the UDI after each use of the AED. We have applied UDIs to AEDs in Philadelphia, PA and Seattle, WA.(FDA 1U01FD004587-01, Nichol, PI). Importantly, we have leveraged this cooperative agreement with FDA to develop and implement ongoing collaborations with and fiscal support from AED monitor/defibrillator manufacturers. We have linked our AED Registry to EMS process and outcome benchmarking data available from the Resuscitation Outcomes Consortium in a simple EMS registry to incent EMS agencies to participate in the AED Registry. Our primary aim is to provide reliable, valid and sustainable postmarket surveillance of AEDs using UDI, smartphones and citizen engagement via crowdsourcing. We anticipate by study end an annual catchment population of at least 20 million individuals, at least 11,192 AEDs with UDIs in public locations, at least 16,020 EMS-treated OHCA, and 2.5% of OHCA are treated with an AED by a layperson. If 80% of AEDs are known at one year, there will be precision of 1.0% in the estimate of AED readiness for use, and 2.9% in the estimate of survival to discharge associated with AED use.