Dhruva Sanket S, Ridgeway Jennifer L, Ross Joseph S, Drozda Joseph P, Wilson Natalia A
Section of Cardiology, Department of Medicine, University of California San Francisco School of Medicine, San Francisco, California, USA.
San Francisco Veterans Affairs Medical Center, San Francisco, California, USA.
BMJ Surg Interv Health Technol. 2023 Jan 23;5(1):e000167. doi: 10.1136/bmjsit-2022-000167. eCollection 2023.
To examine the current state of unique device identifier (UDI) implementation, including barriers and facilitators, among eight health systems participating in a research network committed to real-world evidence (RWE) generation for medical devices.
Mixed methods, including a structured survey and semistructured interviews.
Eight health systems participating in the National Evaluation System for health Technology research network within the USA.
Individuals identified as being involved in or knowledgeable about UDI implementation or medical device identification from supply chain, information technology and high-volume procedural area(s) in their health system.
Interview topics were related to UDI implementation, including barriers and facilitators; UDI use; benefits of UDI adoption; and vision for UDI implementation. Data were analysed using directed content analysis, drawing on prior conceptual models of UDI implementation and the Exploration, Preparation, Implementation, Sustainment framework. A brief survey of health system characteristics and scope of UDI implementation was also conducted.
Thirty-five individuals completed interviews. Three of eight health systems reported having implemented UDI. Themes identified about barriers and facilitators to UDI implementation included knowledge of the UDI and its benefits among decision-makers; organisational systems, culture and networks that support technology and workflow changes; and external factors such as policy mandates and technology. A final theme focused on the availability of UDIs for RWE; lack of availability significantly hindered RWE studies on medical devices.
UDI adoption within health systems requires knowledge of and impetus to achieve operational and clinical benefits. These are necessary to support UDI availability for medical device safety and effectiveness studies and RWE generation.
考察参与致力于生成医疗器械真实世界证据（RWE）研究网络的八个卫生系统中，唯一器械标识（UDI）实施的现状，包括障碍和促进因素。
混合方法，包括结构化调查和半结构化访谈。
美国国家卫生技术评估系统研究网络中的八个卫生系统。
在其卫生系统中，被确定参与或了解UDI实施或医疗器械识别工作的个人，涉及供应链、信息技术和高流量程序领域。
访谈主题与UDI实施相关，包括障碍和促进因素；UDI使用情况；采用UDI的益处；以及UDI实施愿景。利用定向内容分析法对数据进行分析，借鉴先前的UDI实施概念模型和探索、准备、实施、维持框架。还对卫生系统特征和UDI实施范围进行了简要调查。
35人完成了访谈。八个卫生系统中有三个报告已实施UDI。确定的关于UDI实施障碍和促进因素的主题包括决策者对UDI及其益处的了解；支持技术和工作流程变革的组织系统、文化和网络；以及政策指令和技术等外部因素。最后一个主题聚焦于用于RWE的UDI的可用性；可用性不足严重阻碍了医疗器械的RWE研究。
卫生系统采用UDI需要了解并获得实现运营和临床益处的动力。这些对于支持用于医疗器械安全性和有效性研究以及生成RWE的UDI可用性是必要的。
