PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: Mixed methods, including a structured survey and semistructured interviews.
UNASSIGNED: Eight health systems participating in the National Evaluation System for health Technology research network within the USA.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Mixed methods, including a structured survey and semistructured interviews.
UNASSIGNED: Eight health systems participating in the National Evaluation System for health Technology research network within the USA.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
UNASSIGNED：要检查唯一设备标识符(UDI)实现的当前状态，包括障碍和促进者，在参与致力于医疗设备真实世界证据（RWE）生成的研究网络的八个卫生系统中。
未经评估：混合方法，包括结构化调查和半结构化访谈。
UNASSIGNED：八个卫生系统参与了美国国家卫生技术研究网络评估系统。
UASSIGNED：被确认为参与或了解供应链中UDI实施或医疗器械识别的个人，信息技术和其卫生系统中的高容量程序领域。
未经评估：采访主题与UDI实施有关，包括障碍和促进者；UDI的使用；采用UDI的好处；以及UDI实施的愿景。数据使用定向内容分析进行分析，借鉴UDI实施和探索的先前概念模型，准备工作,实施,可持续性框架。还对卫生系统的特点和实施UDI的范围进行了简要调查。
未经同意：35个人完成了面试。八个卫生系统中有三个报告实施了UDI。确定的关于UDI实施的障碍和促进者的主题包括对UDI及其在决策者中的好处的知识；组织系统，支持技术和工作流程变更的文化和网络；以及政策授权和技术等外部因素。最后一个主题集中在RWE的UDI的可用性；缺乏可用性极大地阻碍了RWE对医疗设备的研究。
UASSIGNED：在卫生系统中采用UDI需要知识和动力，以实现运营和临床效益。这些是必要的，以支持UDI可用性的医疗设备的安全性和有效性研究和RWE生成。
未经评估：混合方法，包括结构化调查和半结构化访谈。
UNASSIGNED：八个卫生系统参与了美国国家卫生技术研究网络评估系统。
UASSIGNED：被确认为参与或了解供应链中UDI实施或医疗器械识别的个人，信息技术和其卫生系统中的高容量程序领域。
未经评估：采访主题与UDI实施有关，包括障碍和促进者；UDI的使用；采用UDI的好处；以及UDI实施的愿景。数据使用定向内容分析进行分析，借鉴UDI实施和探索的先前概念模型，准备工作,实施,可持续性框架。还对卫生系统的特点和实施UDI的范围进行了简要调查。
未经同意：35个人完成了面试。八个卫生系统中有三个报告实施了UDI。确定的关于UDI实施的障碍和促进者的主题包括对UDI及其在决策者中的好处的知识；组织系统，支持技术和工作流程变更的文化和网络；以及政策授权和技术等外部因素。最后一个主题集中在RWE的UDI的可用性；缺乏可用性极大地阻碍了RWE对医疗设备的研究。
UASSIGNED：在卫生系统中采用UDI需要知识和动力，以实现运营和临床效益。这些是必要的，以支持UDI可用性的医疗设备的安全性和有效性研究和RWE生成。
