Management of 3D printing customized medical devices in a hospital
10.3760/cma.j.cn111325-20240906-00735
- VernacularTitle:某医院3D打印定制式医疗器械管理实践探索
- Author:
Xiaohua LIU
1
;
Yun TIAN
1
;
Chaonan XU
1
;
Hanjing ZHANG
1
;
Xinyun XUE
1
Author Information
1. 北京大学第三医院医学工程处，北京 100191
- Publication Type:Journal Article
- Keywords:
3D printing;
Customized medical devices;
Implants;
Management mode;
File-record management
- From:
Chinese Journal of Hospital Administration
2025;41(3):245-248
- CountryChina
- Language:Chinese
-
Abstract:
3D printing technology customized medical devices can accurately adapt to the complex anatomical structure of the human body, and have become a new meaning to promote the development of precision medicine. In order to ensure the safety and effectiveness of the clinical use of 3D printed customized medical devices and standardize the management process of such products, a tertiary hospital had started the file-record management of 3D printed customized medical devices since March 2021, covering access approval management, production verification, surgical process management and postoperative traceability management. This practice had achieved standardized management of 3D printed customized medical devices and achieved good results. The 3D printed bone fixation fusion used by the hospital was officially approved as a medical device product registration certificate in March 2023; 109 orthopedic patients recorded the use of 3D printed custom medical devices in 2023, with a significant increase compared to 54 patients in 2022. This practice could provide references for other hospitals to carry out standardized management of the use of customized medical devices. In the future, hospital should further balance regulation and innovation, promote multi-party collaboration, strengthen data integration, ensure data security, and enhance the level of refined management of medical devices.
