Building UDI Into Longitudinal Data For Surveillance and Research (BUILD)

将 UDI 构建到监测和研究的纵向数据中 (BUILD)

• 批准号: 9351171
• 负责人: Joseph Peter Drozda
• 金额: $ 10万
• 依托单位: MERCY HEALTH
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-15 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9351171
• 关键词: Building; UDI; Into; Longitudinal; Data

7. Project Summary/Abstract The BUILD proposal combines into one initiative 3 of the 6 projects developed by the MDEpiNet SMART Informatics Think Tank, which was a multi-stakeholder assembly of device manufacturers, system architects, informaticists, supply chain professionals, clinicians, and researchers, many of whom will be working on this initiative. The purpose of the Think Tank projects was to further MDEpiNet's goal of supporting the FDA in strengthening the medical device postmarket surveillance system. The 3 pilot projects included in BUILD significantly overlap in leveraging unique device identifiers (UDIs) as the index to connect data sources and move information on devices to clinicians and researchers to assess device effectiveness and safety and support innovation. They are the Extension of UDI Implementation Pilot; Medical Device Data Capture and Exchange: Leading Practices and Future Directions; and Electrophysiology structured reporting Providing UDI for Leads and devices using industry Standards to Electronic Health Records and CVIS systems (ePulse). The Extension of UDI Implementation Pilot builds on a previous FDA demonstration whereby UDI were incorporated in the electronic information systems of a single health system resulting in integration of clinical and device data and the creation of a database that was useable for device surveillance and research. This process will be replicated at 2 additional health systems and a distributed data network of the 3 systems will be developed using the National Cardiovascular Data Registry's (NCDR) CathPCI as the hub. The Medical Device Data Capture and Exchange project builds a consortium of hospital organization, manufacturer and other stakeholder leaders that will collaboratively work to outline the current environment of UDI use; assess project outcomes; and conceptualize innovative solutions for capture and exchange of implantable device data. It will elucidate the best practices in exchange of UDI through the supply chain to the point of care. The ePulse project, then, focuses on the point of care and will use industry-standard nomenclature and interoperability profiles, incorporating UDI to capture critical data at the time of device implantation. These granular data will be communicated to EHRs in C-CDA format. The data will then be available for use for patient care, device surveillance, quality improvement and registries such as the NCDR's ICD Registry. The proposal, then, is to build an end to end initiative that would define leading practices for moving medical device data from the point of manufacture through the supply chain to the point of use and to capture clinical data, combine it with device data, and make the integrated data set available to the patient's electronic health record, to databases at the 3 participating health systems, and the CathPCI Registry. The methodology developed by this initiative will be extensible to all implantable medical devices. Finally, the BUILD initiative will create a road map for other health systems to replicate these methods to improve care quality and patient safety. 1

7.项目摘要/摘要 建造方案将MDEpiNet开发的6个项目中的3个合并为一个倡议 Smart Informatics智库，这是一个由设备制造商、系统和设备制造商组成的多利益相关者集合 建筑师、信息学家、供应链专业人员、临床医生和研究人员，其中许多人将成为 致力于这一倡议。智库项目的目的是促进MDEpiNet支持以下目标 美国食品药品监督管理局在加强医疗器械上市后监督体系方面。包括的3个试点项目 在利用唯一设备标识符(UDI)作为连接数据源的索引方面，构建显著重叠 并将有关设备的信息传递给临床医生和研究人员，以评估设备的有效性和安全性 支持创新。它们是UDI实施试点的扩展；医疗设备数据捕获和 交换：领先实践和未来方向；以及提供UDI的电生理结构化报告 适用于使用电子健康记录和CVIS系统(EPulse)行业标准的引线和设备。 UDI实施试点扩展建立在先前FDA演示的基础上，其中UDI是 合并到单一医疗系统的电子信息系统中，从而集成临床 和设备数据，以及创建一个可用于设备监视和研究的数据库。这 流程将在另外2个医疗保健系统复制，3个系统的分布式数据网络将 以美国国家心血管数据注册中心(NCDR)的CASTPCI为中心开发的。医学部 设备数据捕获和交换项目建立了一个由医院组织、制造商和 其他利益相关者领导人，他们将协同工作，概述UDI的当前使用环境；评估 项目成果；并构思用于捕获和交换可植入设备数据的创新解决方案。 它将阐明通过供应链到关注点交换UDI的最佳做法。EPulse 然后，Project将重点放在关注点上，并将使用行业标准的命名和互操作性 配置文件，结合UDI以捕获设备植入时的关键数据。这些细粒度数据将是 以C-CDA格式传达给EHR。然后，这些数据将可用于患者护理、设备 监督、质量改进和注册，如NCDR的ICD注册。 因此，建议是建立一个端到端计划，定义移动的领先实践 医疗器械数据从制造点通过供应链到使用点并捕获 临床数据，将其与设备数据结合，并使集成的数据集可用于患者的电子设备 3个参与的保健系统的数据库和公共卫生服务登记处的健康记录。方法论 由该倡议开发的产品将可扩展到所有植入式医疗设备。最后，构建倡议 将为其他医疗系统创建路线图，以复制这些方法，以提高医疗质量和患者 安全。 1