医疗器械唯一标识质量提升创新实践——以北京市为例

Innovative Practice for Quality Improvement of Unique Device Identifier:A Case Study in Beijing

2022年6月北京市药品监督管理局联合北京市卫生健康委员会、北京市医疗保障局印发了《北京市医疗器械唯一标识工作质量提升方案》,其旨在提升医疗器械唯一标识(UDI)的实施质量,通过问题梳理、培训交流、研究制定长效机制及推广应用,充分发挥示范单位引领作用,助推医疗器械生产、经营、使用单位更好地落实UDI制度。2022年,北京市药品监督管理局以问卷形式对北京市第二类和第三类医疗器械UDI实施情况进行了调研,从医疗器械注册人、经营企业、使用单位、UDI标签标识质量现状等方面进行分析,并提出了提升医疗器械企业实施UDI的建议措施,以期为其他地区UDI的落地实施与持续改进工作提供借鉴和参考。

In June 2022,Beijing Municipal Medical Products Administration,in collaboration with Beijing Municipal Health Commission and Beijing Municipal Medical Insurance Bureau,issued the Quality Improvement Plan for Unique Device Identifier in Beijing.The plan aims to improve the implementation quality of unique device identifier(UDI)through problem identification,training and communication,research and development for long-term mechanisms,and promotion and application.By fully leveraging the leading role of demonstration units,the initiative aims to support better implementation of the UDI system by medical device manufacturers,distributers,and healthcare institutions.In 2022,the Beijing Municipal Medical Products Administration conducted a survey using questionnaires to assess the implementation of UDI for second and third-class medical devices in Beijing.The analysis covered aspects such as medical device registrants,operational enterprises,user units,and the current status of UDI identification label quality.The paper proposes measures to enhance the implementation of UDI by medical device enterprises,intending to serve as a reference and guidance for the implementation and continuous improvement of UDI policies in other regions.