Abstract
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.
Highlights
IntroductionWe define PoC 3D Printing as the just-in-time creation of 3D printed diagnostic use anatomic models, surgical instruments, or other medical devices based on a patient’s medical imaging data, either at the place of patient care (such as a hospital) or in a centralized facility owned by the health care organization [7]
3D printing is a process involving the creation of a physical object from a digital 3D model through the method of additive manufacturing
Radiological Society of North America (RSNA) 3D SIG is the largest collection of physicians, engineers, and industry representatives, who have organized under a national medical organization (RSNA) to address standards and appropriateness criteria for PoC 3D printing of medical devices
Summary
We define PoC 3D Printing as the just-in-time creation of 3D printed diagnostic use anatomic models, surgical instruments, or other medical devices based on a patient’s medical imaging data, either at the place of patient care (such as a hospital) or in a centralized facility owned by the health care organization [7]. We recognize that this definition does not include 3D printing beyond patient-matched devices. Our definition of PoC 3D printing is when a healthcare provider (or healthcare organization), not a medical device manufacturer, creates a patient specific 3D printed medical device. The purpose of this review is to consolidate currently available information pertaining to the regulation of PoC 3D printed devices and to summarize the most current proposed regulatory framework for PoC printing of medical devices
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