Tcheng James E, Crowley Jay, Tomes Madris, Reed Terrie L, Dudas Joseph M, Thompson Kweli P, Garratt Kirk N, Drozda Joseph P
Duke University Medical Center, Durham, NC.
USDM Life Sciences, Santa Barbara, CA.
Am Heart J. 2014 Oct;168(4):405-413.e2. doi: 10.1016/j.ahj.2014.07.001. Epub 2014 Jul 7.
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.
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.
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.
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.
尽管消费领域的电子产品识别无处不在，但医疗设备的唯一识别直到2014年才开始实施。为了评估医疗保健领域的唯一设备标识符（UDI），美国食品药品监督管理局（FDA）资助了医疗器械流行病学网络计划，其中包括在一个多医院系统（梅西健康）的信息系统中展示冠状动脉支架UDI数据的实施情况。本报告描述了该展示的第一阶段。
由美国心脏病学会和心血管造影与介入学会提名的介入心脏病学专家小组与行业代表、医疗保健转型集团的医疗系统成员、美国心脏病学会国家心血管数据注册中心以及FDA的代表召开会议，以阐明最佳利用与UDI相关数据所需的概念。专家小组确定了三点：（1）与UDI相关数据的用例（如研究），（2）临床相关属性的补充数据集（如支架尺寸），以及（3）这些数据权威管理的治理和行政原则。
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个额外的冠状动脉支架特定属性来满足用例要求。关于治理的建议被阐明为与UDI相关数据管理的基本原则。
这种识别必要扩展以支持有效使用与UDI相关数据的过程应该具有通用性。医疗器械UDI系统的实施必须兼顾全局和特定设备信息。
