Beitler Brian G, Abraham Paul F, Glennon Alyssa R, Tommasini Steven M, Lattanza Lisa L, Morris Jonathan M, Wiznia Daniel H
Department of Orthopaedics and Rehabilitation, Yale School of Medicine, 800 Howard Ave 1st Floor, CT, 06519, New Haven, USA.
Department of Orthopaedic Surgery, Keck School of Medicine of USC, Los Angeles, CA, USA.
3D Print Med. 2022 Feb 1;8(1):7. doi: 10.1186/s41205-022-00134-y.
3D printing is revolutionizing the medical device landscape through its ability to rapidly create patient-specific anatomic models, surgical instruments, and implants. Recent advances in 3D printing technology have allowed for the creation of point-of-care (PoC) 3D printing centers. These PoC centers blur the line between healthcare provider, medical center, and device manufacturer, creating regulatory ambiguity. The United States Food & Drug Administration (FDA) currently regulates 3D printed devices through existing medical device regulations. However, the FDA is increasingly interested in developing guidelines and regulations specifically for PoC 3D printing due to its rapid adoption across the healthcare institutions. In this article, we review the regulatory framework that governs medical devices, discuss how PoC 3D printing falls within this framework, and describe a novel conceptual framework that the FDA has proposed. Finally, through analysis of the aforementioned regulations and discussions with industry medical 3D printing regulatory experts, we provide recommendations for PoC medical 3D printing best practices so that institutions are best positioned to utilize this revolutionary technology safely and effectively.
3D打印正在彻底改变医疗设备领域，因为它能够快速创建针对患者的解剖模型、手术器械和植入物。3D打印技术的最新进展使得即时医疗（PoC）3D打印中心得以建立。这些PoC中心模糊了医疗服务提供者、医疗中心和设备制造商之间的界限，造成了监管上的模糊性。美国食品药品监督管理局（FDA）目前通过现有的医疗器械法规对3D打印设备进行监管。然而，由于PoC 3D打印在医疗机构中的迅速应用，FDA越来越有兴趣制定专门针对PoC 3D打印的指南和法规。在本文中，我们回顾了管理医疗器械的监管框架，讨论了PoC 3D打印如何纳入该框架，并描述了FDA提出的一个新颖的概念框架。最后，通过对上述法规的分析以及与行业医疗3D打印监管专家的讨论，我们为PoC医疗3D打印的最佳实践提供建议，以便各机构能够处于最佳位置，安全有效地利用这项革命性技术。
