Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators.
Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators.
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DOI：
10.1136/bmjsit-2022-000167
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发表时间：
2023
期刊：
影响因子：
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中科院分区：
文献类型：
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作者：
在参与致力于医疗器械真实世界证据（RWE）生成研究网络的8个卫生系统中，检查唯一器械标识符（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。八个卫生系统参加了美国卫生技术研究网络国家评估系统。被确定参与或了解其卫生系统中供应链、信息技术和大批量程序领域的UDI实施或医疗器械识别的个人。访谈主题与UDI实施有关，包括障碍和促进因素; UDI使用; UDI采用的好处;以及UDI实施的愿景。数据进行了分析，使用定向内容分析，借鉴以前的概念模型的UDI实施和探索，准备，实施，维持框架。还对卫生系统的特点和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单方面宣布死亡。确定的关于UDI实施的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化的组织系统、文化和网络;以及政策授权和技术等外部因素。最后一个主题关注RWE的UDI可用性;缺乏可用性严重阻碍了RWE对医疗器械的研究。在卫生系统内采用UDI需要了解并推动实现业务和临床效益。这些是支持医疗器械安全性和有效性研究以及RWE生成的UDI可用性所必需的。
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.
有关医疗设备的现实世界证据的多机构分布式数据网络：将唯一的设备标识符构建到纵向数据（构建）中。
影响因子：
2.1
作者：
Drozda, Joseph P., Jr.;Graham, Jove;Muhlestein, Joseph B.;Tcheng, James E.;Roach, James;Forsyth, Tom;Knight, Stacey;McKinnon, Andrew;May, Heidi;Wilson, Natalia A.;Berlin, Jesse A.;Simard, Edgar P.
通讯作者：
Simard, Edgar P.