Wilson Natalia A, Tcheng James E, Graham Jove, Drozda Joseph P
College of Health Solutions, Arizona State University, Phoenix, AZ, USA.
Duke University School of Medicine and Health System, Durham, NC, USA.
Med Devices (Auckl). 2021 Nov 30;14:411-421. doi: 10.2147/MDER.S339232. eCollection 2021.
The US Food and Drug Administration's Unique Device Identification System Rule of 2013 mandated manufacturers to assign unique device identifiers (UDIs) to their medical devices. Most high-risk (Class III), moderate-risk (Class II) and implantable devices now have UDIs. To achieve the necessary next step for a comprehensive UDI-enabled system for patient safety, UDIs must be electronically documented during patient care, a process not routinely done. The purpose of this research was to study the implementation experiences of diverse health systems in order to develop a roadmap for UDI implementation at the point of care.
Semi-structured interviews were conducted with personnel at health systems that had implemented UDI for implantable devices in their cardiac catheterization labs or operating rooms. Interviews were audio-recorded, transcribed, and analyzed using the framework methodology of Ritchie and Spencer. Data interpretation involved development of a conceptual model and detailed recommendations for UDI implementation. An expert panel evaluated and provided input on the roadmap.
Twenty-four interviews at ten health systems were conducted by phone. Participants described implementation steps, factors and barriers impacting implementation. Findings populated a UDI implementation roadmap, that includes Foundational Themes, Key Components, Key Steps, UDI Use, and Outcomes.
The UDI implementation roadmap provides a framework for health systems to address the necessary steps and multilevel factors that underpin UDI implementation at the point of care. It is intended to guide and advance routine electronic documentation of UDIs for devices used during clinical care, the critical next step for a comprehensive UDI-enabled system to enhance medical device safety and effectiveness for patients.
美国食品药品监督管理局2013年的《医疗器械唯一标识系统规则》要求制造商为其医疗器械分配唯一设备标识符（UDI）。现在，大多数高风险（III类）、中度风险（II类）和可植入设备都有UDI。为了实现全面启用UDI的系统保障患者安全的必要下一步，必须在患者护理期间以电子方式记录UDI，而这一过程并非常规操作。本研究的目的是研究不同卫生系统的实施经验，以便制定在护理点实施UDI的路线图。
对在其心导管实验室或手术室为可植入设备实施UDI的卫生系统人员进行了半结构化访谈。访谈进行了录音、转录，并使用里奇和斯宾塞的框架方法进行分析。数据解释包括开发概念模型和关于UDI实施的详细建议。一个专家小组对路线图进行了评估并提供了意见。
通过电话对十个卫生系统的24名人员进行了访谈。参与者描述了实施步骤、影响实施的因素和障碍。研究结果形成了一个UDI实施路线图，包括基础主题、关键组件、关键步骤、UDI使用和结果。
UDI实施路线图为卫生系统提供了一个框架，以解决在护理点实施UDI的必要步骤和多层次因素。它旨在指导和推进临床护理期间使用的设备的UDI常规电子记录，这是全面启用UDI的系统提高医疗器械对患者安全性和有效性的关键下一步。
