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: 9143978
• 负责人: Joseph Peter Drozda
• 金额: $ 21.5万
• 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 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9143978
• 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. 项目总结/摘要 BUILD 提案将 MDEpiNet 开发的 6 个项目中的 3 个合并为一项倡议 SMART 信息学智囊团，是设备制造商、系统的多方利益相关者的集合体 建筑师、信息学家、供应链专业人士、临床医生和研究人员，其中许多人将成为 致力于这一举措。智库项目的目的是进一步推进 MDEpiNet 支持的目标 FDA加强医疗器械上市后监管体系。 3个试点项目纳入 BUILD 在利用唯一设备标识符 (UDI) 作为连接数据源的索引方面存在显着重叠 并将有关设备的信息传送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 实施试点的延伸；医疗设备数据采集和 交流：领先实践和未来方向；和电生理学结构化报告 提供 UDI 适用于使用电子健康记录和 CVIS 系统 (ePulse) 行业标准的导联和设备。 UDI 实施试点的扩展建立在 FDA 之前的示范基础上，其中 UDI 是 纳入单一卫生系统的电子信息系统，从而实现临床整合 设备数据以及创建可用于设备监视和研究的数据库。这 该过程将在另外 2 个卫生系统中复制，并且这 3 个系统的分布式数据网络将被 使用国家心血管数据登记处 (NCDR) 的 CathPCI 作为中心开发。医疗 设备数据采集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将共同努力概述当前 UDI 使用环境；评估 项目成果；并构思用于捕获和交换植入设备数据的创新解决方案。 它将阐明从供应链到护理点交换 UDI 的最佳实践。电子脉冲 那么，该项目将重点关注护理点，并将使用行业标准术语和互操作性 配置文件，结合 UDI 来捕获设备植入时的关键数据。这些细粒度的数据将 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、质量改进和登记，例如 NCDR 的 ICD 登记。 那么，该提案是建立一个端到端的倡议，定义移动的领先实践 医疗器械数据从制造点到供应链再到使用点并捕获 临床数据，将其与设备数据相结合，并使集成的数据集可供患者的电子设备使用 健康记录，存入 3 个参与卫生系统的数据库以及 CathPCI 登记处。方法论 该计划开发的产品将可扩展到所有植入式医疗设备。最后，BUILD 倡议 将为其他卫生系统制定路线图，以复制这些方法，以提高护理质量和患者 安全。 1