Unique device identifiers for coronary stent postmarket surveillance and research: A report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier Demonstration
Unique device identifiers for coronary stent postmarket surveillance and research: A report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier Demonstration
复制标题
DOI：
10.1016/j.ahj.2014.07.001
复制
发表时间：
2014-10-01
影响因子：
4.8
通讯作者：
Drozda, Joseph P., Jr.
中科院分区：
文献类型：
--
作者：
Tcheng, James E.;Crowley, Jay;Drozda, Joseph P., Jr.
背景虽然电子产品识别在消费领域无处不在，但医疗器械的唯一识别在2014年才刚刚开始实施。为了评估医疗保健中的唯一设备识别符(UDI)，美国食品和药物管理局(FDA)资助了医疗器械流行病学网络倡议，包括演示在多医院系统(Mercy Health)的信息系统中实施冠状动脉支架UDI数据。本报告描述了演示的第一阶段。方法由美国心脏病学会和心血管血管造影术和干预学会提名的介入心脏病学家专家小组由行业代表、医疗保健转型小组的卫生系统成员、美国心脏病学会国家心血管数据注册中心和FDA的代表召集，以阐明最佳利用UDI相关数据所需的概念。专家小组确定了3个：(1)UDI相关数据(如研究)的用例，(2)临床相关属性(如支架尺寸)的补充数据集，以及(3)对这些数据进行权威管理的治理和管理原则。结果确定了18个用例，涵盖临床护理、供应链管理、消费者信息、研究、监管和监测领域。除了FDA全球唯一设备识别数据库的属性外，还需要9个额外的特定于冠状动脉支架的属性来满足用例要求。关于治理的建议被阐明为与UDI相关的数据管理的基本原则。结论这一确定支持有效使用UDI相关数据的必要扩展的过程应该是可推广的。医疗设备的UDI系统的实施必须预测全局信息和设备特定信息。
Background Although electronic product identification in the consumer sector is ubiquitous, unique identification of medical devices is just being implemented in 2014. To evaluate unique device identifiers (UDIs) in health care, the US Food and Drug Administration (FDA) funded the Medical Device Epidemiology Network initiative, including a demonstration of the implementation of coronary stent UDI data in the information systems of a multihospital system (Mercy Health). This report describes the first phase of the demonstration.Methods An expert panel of interventional cardiologists nominated by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions was convened with representatives of industry, health system members of the Healthcare Transformation Group, the American College of Cardiology National Cardiovascular Data Registry, and FDA to articulate concepts needed to best use UDI-associated data. The expert panel identified 3: (1) use cases for UDI-associated data (eg, research), (2) a supplemental data set of clinically relevant attributes (eg, stent dimensions), and (3) governance and administrative principles for the authoritative management of these data.Results Eighteen use cases were identified, encompassing clinical care, supply chain management, consumer information, research, regulatory, and surveillance domains. In addition to the attributes of the FDA Global Unique Device Identification Database, 9 additional coronary stent-specific attributes were required to address use case requirements. Recommendations regarding governance were elucidated as foundational principles for UDI-associated data management.Conclusions This process for identifying requisite extensions to support the effective use of UDI-associated data should be generalizable. Implementation of a UDI system for medical devices must anticipate both global and device-specific information.