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Implementing unique device identification in electronic health record systems: Organizational, workflow, and technological challenges

机译：在电子病历系统中实现唯一的设备标识：组织，工作流程和技术挑战

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BACKGROUND:: The United States Food and Drug Administration (FDA) has proposed creating a unique device identification (UDI) system for medical devices to facilitate postmarket surveillance, quality improvement, and other applications. Although a small number of health care institutions have implemented initiatives comparable with the proposed UDI system by capturing data in electronic health record (EHR) systems, it is unknown whether institutions with fewer resources will be able to similarly implement UDI. OBJECTIVE AND METHODS:: This paper calls attention to organizational, workflow, and technological challenges in UDI system implementation by drawing from the literature on EHR and clinical research systems implementation. FINDINGS:: Organizational challenges for UDI system implementation include coordinating multiple stakeholders to define UDI attributes and characteristics for use in EHRs, guiding organizational change within individual institutions for integrating UDI with EHRs, and guiding organizational change for reusing UDI data captured in EHRs. Workflow challenges include capturing UDI data in EHRs using keyboard entry and barcode scanning. Technological challenges involve interfacing UDI data between EHRs and surgical information systems, transforming UDI and related patient data from EHRs for research, and applying data standards to UDI within and beyond EHRs. DISCUSSION AND CONCLUSIONS:: We provide recommendations for regulations, organizational sharing, and professional society engagement to raise awareness of and overcome UDI system implementation challenges. Implementation of the UDI system will require integration of people, process, and technology to achieve benefits envisioned by FDA, including improved postmarket device surveillance and quality of care.
机译：背景：：美国食品药品监督管理局（FDA）提议为医疗设备创建一个独特的设备识别（UDI）系统，以促进售后市场监测，质量改进和其他应用。尽管少数医疗机构通过捕获电子健康记录（EHR）系统中的数据，已经实施了与拟议的UDI系统相当的举措，但未知的是，资源较少的机构是否能够类似地实施UDI。目的和方法：本文通过参考有关EHR和临床研究系统实施的文献，提请注意UDI系统实施中的组织，工作流程和技术挑战。结果：UDI系统实施的组织挑战包括协调多个利益相关者以定义用于EHR的UDI属性和特征，指导单个机构内部的组织变革以将UDI与EHR集成，并指导组织变革以重用EHR中捕获的UDI数据。工作流程的挑战包括使用键盘输入和条形码扫描在EHR中捕获UDI数据。技术挑战包括在电子病历和手术信息系统之间连接UDI数据，将电子病历中的UDI和相关患者数据转换为用于研究，以及在电子病历内外将数据标准应用于UDI。讨论和结论：我们为法规，组织共享和专业协会的参与提供建议，以提高人们对UDI系统实施挑战的认识并克服这些挑战。 UDI系统的实施将需要人员，流程和技术的集成，以实现FDA预期的收益，包括改善售后设备监控和护理质量。

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