| 韩倩倩,黄东臣,杨静,杨昭鹏,王春仁.定制式和患者匹配增材制造医疗器械医工交互全过程构成要素与控制方法研究[J].中国药事,2019,33(12):1438-1443 |
| 定制式和患者匹配增材制造医疗器械医工交互全过程构成要素与控制方法研究 |
| Component Elements and Control Methods of the Whole Process of Medical and Manufacturing Interaction for the Customized and Personalized Additional Manufacturing Medical Devices |
| 投稿时间：2019-03-26 |
| DOI：10.16153/j.1002-7777.2019.12.017 |
| 中文关键词: 定制式和患者匹配医疗器械 增材制造 医工交互 |
| 英文关键词: customized and personalized additional manufacturing medical devices additional manufacturing medical and manufacturing interaction |
| 基金项目:十三五国家重点研发计划课题支持（编号2016YB1101704）；中国食品药品检定研究院学科带头人基金（编号2015X2） |
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| 中文摘要: |
| 目的：在现阶段生产和临床应用经验的基础上，以保障定制式和患者匹配增材制造医疗器械的安全性和有效性为目的，围绕医工交互环节，寻找并提炼其关键环节及其构成要素，提出要素控制的重要性并探讨相关控制方法。方法：通过检索和研究现阶段文献，深入临床机构和企业调研。对使用定制式和患者匹配增材制造医疗器械的临床机构、生产企业和患者的沟通流程进行研究，梳理每个环节和关键要素。基于现阶段法规，提炼各关键要素的控制方法，结合中国医疗器械行业协会3D打印医疗器械专委会组织制定的团体标准，形成本文。结果与结论：现阶段，定制式和患者匹配增材制造医疗器械的生产和临床应用仍缺乏足够的实践经验，所以出于安全有效应用和质量控制的考虑，有必要通过对医工交互全过程的监控，实现定制式和患者匹配医疗器械全过程的严密控制，使其设计开发、生产加工和临床应用得到保障。 |
| 英文摘要: |
| Objective: Based on the current production and clinical application experience, the paper focuses on the process of medical and manufacturing interaction, and discovers and refines the key factors and the components for the safety and effectiveness of the customized and personalized additional manufacturing medical devices. The importance of factor control is put forward and the relevant control methods are discussed. Methods: The literatures were searched and reviewed and clinical institutes and manufacturing companies were studied in detail. The communication processes between the clinical institutes, manufacturing companies of the customized and personalized additional manufacturing medical devices and the patients were also studied to sort out each link and every key element. Based on the current regulations, the control methods for the key elements were refined and combined with the group standards established by the 3D Printing Medical Devices Committee of China Association for Medical Devices Industry to form this paper. Results and Conclusion: So far, there still lacks sufficient practical experience in the production and clinical application of the customized and personalized additional manufacturing medical devices. Therefore, for the benefit of safe and effective application and quality control, it is necessary to monitor the whole process of medical and manufacturing interaction so as to achieve the strict monitoring of the whole process and guarantee their design, development, production and clinical applications. |
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