HeartMap Dynamic AED Registry

项目总结 我们的心脏图动态自动体外除颤器注册中心(AED注册中心)的长期目标是 通过实施上市后监测，确保AEDs的安全。AEDs用于治疗院外心脏 逮捕(UchA)。每个主要的AEDD制造商都已经召回了他们的设备，以满足一个或多个潜在的需求 安全问题。对AEDs监测的挑战是对其他医疗机构监测的典型挑战 设备。它们在空间和时间上都是流动的，因为它们分布在预计靠近 心脏骤停的现场，并周期性地从一个位置移动到另一个位置。它们无处不在，就像有 120万台现有设备，每年安装约18万台新设备。重要的是，没有 广泛部署的跟踪其位置和在社区环境中使用的方法。同样，监控 每一次使用AED的结果对于确定那些可能导致或促成死亡的使用是必要的， 因为大多数接受uchA治疗的患者都去世了。这项研究将维持一个动态的登记以供监测 确定AED的位置和用途，以实施和维持一个全国性的AED监测系统。 最近，我们开发并试运行了一种使用唯一设备标识符(UDI)标记AED的方法。 根据该方法，用UDI来标记AED，该UDI包括二维矩阵代码(QR码， Denso Wave Inc.，Chita-Gun，日本)；然后记录UDI以及设备的位置和状态 使用当代智能手机原生的开源软件，并将这些信息传递到数据库 通过互联网实时(非临时专利61/498,424号)。中的特定于设备的信息 每次使用AED后，通过重新扫描UDI来动态更新数据库。我们已将UDIS应用于 宾夕法尼亚州费城和华盛顿州西雅图的AED(FDA 1U01FD004587-01，Nicole，PI)。重要的是，我们有 利用与FDA的这一合作协议来开发和实施与 来自AED监护仪/除颤器制造商的财政支持。 我们已将我们的AED注册与EMS过程和结果基准数据相关联，这些数据可从 在一个简单的EMS注册中心建立复苏结果联盟，以鼓励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AEDs上市后监测， 智能手机和通过众包的公民参与。我们预计到研究结束时会有一年的集水区 人口至少2000万人，至少11,192名在公共场所有UDIs的AED，至少16,020人 经EMS处理的uchA和2.5%的uchA由非专业人员进行AED治疗。如果80%的AED是已知的 一年内，AED准备就绪的估计精度将为1.0%，而AED准备就绪的估计精度为2.9% 与使用AED相关的存活到出院。

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.