个性化3D打印骨科器械医工交互风险分析及控制  

Risk analysis and control on medicine-engineering interaction of personalized 3D printed orthopedic device

作　　者：姬文婵 刘鹏飞 李宁 JI Wenchan;LIU Pengfei;LI Ning(Shaanxi Medicine and Vaccine Inspection Center,Shaanxi Province,Xi’an710000,China)

机构地区：[1]陕西省药品和疫苗检查中心,陕西西安710000

出　　处：《中国医药导报》2024年第31期193-196,F0003,共5页China Medical Herald

基　　金：陕西省药品科学监管和监管科学研究项目(SXYJ202310)。

摘　　要：3D打印技术被广泛应用于医疗领域,尤其是为满足骨科患者个性化需求提供更多的可能性。医工交互贯穿个性化3D打印医疗器械设计开发的全过程,因此重视医工交互过程的风险控制是临床手术可行性及产品输出安全有效性的关键。本文基于现有法规标准,通过检索研究2019年3月至2024年3月的文献,深入企业调研,从监管角度出发对个性化3D打印骨科医疗器械医工交互的工作流程中各个环节进行详细梳理与总结。挖掘医工交互过程中可能影响产品质量及临床应用的潜在风险,为正在启动3D打印计划的医疗器械企业和医疗机构提供相应的控制方法,从而降低个性化3D打印骨科医疗器械的不良事件发生率,提高监管效率。3D printing technology is widely used in the medical field,especially providing more possibilities to meet the personalized needs of orthopedic patients.Medicine-engineering interaction runs through the entire process of design and development of personalized 3D printed medical devices.Therefore,paying attention to risk control in medicine-engineering interaction process is the key to the feasibility of clinical surgery and the safety and effectiveness of product output.Based on existing regulations and standards,the paper searches and studies literature from March 2019 to March 2024,conductes in-depth corporate research,and conductes a detailed review and summary of each link in medicine-engineering interaction work flow of personalized 3D printed orthopedic medical devices from a regulatory perspective.The paper explores potential risks that may affect product quality and clinical applications in the process of medicine-engineering interaction,providing corresponding control methods for medical device companies and institutions that are launching 3D printing plans,thereby reducing the incidence rate of adverse events in personalized 3D printed orthopedic medical devices,and improving regulatory efficiency.

关 键 词：3D打印 骨科医疗器械 医工交互 风险管理 

分 类 号：R197.39[医药卫生—卫生事业管理]