医疗器械唯一标识系统实践浅析

Analysis of Application of Unique Device Identification System

为加强医疗器械产业健康发展,2018年起由国家药监局牵头,密集出台医疗器械唯一标识(UDI)相关政策,旨在从医疗器械生产企业、流通企业到医疗机构,通过信息化系统升级,完善医疗器械追溯体系,推动医疗器械监管体系和产业数字化升级。实践中,医疗器械生产企业、流通企业和医疗机构在UDI政策实践中发现各种问题,基于笔者团队在闽一线的实践、调研和认知,建议全医疗器械产业链围绕UDI广泛开展信息化系统升级,政府支持专业机构常态化针对企业和医疗机构就UDI实施遇到的普遍性问题以培训的方式进行公开解读。随着国家医保编码与UDI码的持续融合,UDI码的应用场景必将迅速扩大,在以信息化促“三医联动”“多码融合”方面做出更大贡献。笔者期待此文能为UDI政策的高质量推进抛砖引玉,提供参考和借鉴。

To promote healthy development of the medical device industry,since 2018,the National Medical Products Administration has introduced a series of policies relating to unique device identification(UDI),aiming to improve the traceability system of medical devices and facilitate digital upgrade of the medical device regulatory system and the industry by upgrading the information system across medical device manufacturers,distributers and medical institutions.During the process of implementing the UDI policies,medical device manufacturers,distributers and medical institutions all encountered various problems.Based on first-hand experience and field research in Fujian,the authors suggest that the medical device industry extensively upgrade its information system and government regulators sponsor routine training to provide answers and interpretations to common problems encountered by enterprises and medical institutions during UDI implementation.With the continuous integration between national health insurance code and UDI code,the application of UDI code will expand rapidly and make greater contribution to the information-based promotion of“linkage of medical treatment,health insurance and medicine”and“multicode fusion”.This paper aims to provide insights for the promotion of UDI policies.