ABSTRACT
One consequence of the Covid19 pandemic in 2020 was disrupted supply chains for medical devices. In response, many providers began onsite 3d printing medical devices, without special training or custom tailored instructions. Traditional laws protecting patient safety and tort liability regarding possible malfunction of medical devices are not prepared to address the manufacture of medical devices by enduser health care facilities. The USA Food and Drug Administration (FDA) is one regulatory body that has expressed its desire to validate these uses of 3d printing in emergencies, despite concern about these home-grown devices from the standpoint of patient safety. This article explores the uncharted legal landscape concerning the growing need for national or international regulation addressing 3D printed medical devices in Health care facilities (HCFs) and point of care (POCs) venues. New laws may be needed to protect the integrity of medical products within an overarching duty to protect patient safety. © 2022, William S. Hein & Co., Inc.. All rights reserved.