基于NHIC索赔代码的监控的局限性以及在韩国实施UDI的必要性
Sooin Choi1, Jin Kuk Kim2, Jinhyoung Lee3
1Department of Laboratory Medicine and Genetics, Center for Medical Device Safety Monitoring, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, 170 Jomaru-ro, Bucheon, 14584, Republic of Korea.
Scientific reports
|September 9, 2024
概括
国家医疗保险 (NHIC) 索赔代码限制了医疗器械数据的全面性,用于市场后监测 (PMS). 独特设备识别器 (UDI) 提供卓越的准确性和信号检测,用于高效的医疗设备跟踪和现实世界证据生成.
科学领域:
- 医疗信息学 医疗信息学
- 医疗器械规则 医疗器械规则
- 医疗保健中的大数据分析
背景情况:
- 韩国的电子健康大数据证据创新网络 (FeederNet) 使用OMOP共同数据模型 (CDM) 进行多机构研究.
- 由于依赖国家健康保险公司 (NHIC) 索赔代码作为标识符,人们对FeederNet中医疗器械数据的完整性存在担忧.
研究的目的:
- 批判性地评估NHIC索赔代码与市场后监督 (PMS) 独特设备识别器 (UDI) 的有效性和兼容性.
- 在FeederNet框架内确定高效医疗器械PMS的最佳标识符.
- 评估UDI和NHIC索赔代码在覆盖和注册方面的关系.
主要方法:
- 分析已注册的UDI及其在NHIC覆盖范围下的分类.
- 评估UDI和NHIC索赔代码之间的映射.
- 使用NHIC索赔代码对PMS信号检测灵敏度的比较与UDI.
主要成果:
- 只有36.02%的注册UDI被国家医疗保险覆盖,主要限于特定类别的设备,不包括软件和IVD.
- 在UDI和NHIC索赔代码之间存在复杂的,不统一的关系,每个代码有多个UDI,反之亦然.
- 与基于UDI的PMS相比,基于NHIC索赔代码的PMS显示较低的颗粒度和信号检测灵敏度,可能会掩盖设备安全问题.
结论:
- 由于细节性和数据链接的限制,NHIC索赔代码对于全面而敏感的医疗器械市场后监测 (PMS) 是不够的.
- 采用独特设备识别 (UDI) 系统对于提高医疗设备识别,跟踪和现实世界证据 (RWE) 生产的准确性至关重要.
- 未来的研究应该集中在将UDI与NHIC索赔代码集成,以开发在韩国更强大,更可靠的PMS系统.
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