Departments of *Public Health †Pediatrics ‡Center for Healthcare Informatics and Policy, Weill Cornell Medical College, New York, NY §Surgical Outcomes and Analysis, Kaiser Permanente, San Diego CA ∥Department of Medicine, Weill Cornell Medical College ¶New York-Presbyterian Hospital #Department of Surgery, Weill Cornell Medical College, New York, NY.
Med Care. 2014 Jan;52(1):26-31. doi: 10.1097/MLR.0000000000000012.
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.
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.
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.
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.
美国食品和药物管理局（FDA）提议为医疗器械创建独特的设备标识（UDI）系统，以促进上市后监测、质量改进和其他应用。尽管少数医疗机构已经通过在电子健康记录（EHR）系统中捕获数据来实施与拟议的 UDI 系统类似的举措，但对于资源较少的机构是否能够同样实施 UDI 系统还不得而知。
本文通过引用关于 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。
UDI 系统实施的组织挑战包括协调多个利益相关者来定义用于 EHR 的 UDI 属性和特征、指导单个机构内的组织变革以将 UDI 与 EHR 集成以及指导组织变革以重用 EHR 中捕获的 UDI 数据。工作流程挑战包括使用键盘输入和条形码扫描在 EHR 中捕获 UDI 数据。技术挑战涉及在 EHR 和手术信息系统之间接口 UDI 数据、将 UDI 和相关患者数据从 EHR 转换为研究用途以及在 EHR 内外应用数据标准到 UDI。
我们提供了关于法规、组织共享和专业协会参与的建议，以提高对 UDI 系统实施挑战的认识并克服这些挑战。UDI 系统的实施将需要整合人员、流程和技术，以实现 FDA 所设想的益处，包括改进上市后设备监测和护理质量。
