ABSTRACT
The nano-enabled technology of 3-D printing for medical devices presents a dynamic new avenue for meeting patient needs. 3-D printers can generate food, soaps, cosmetics, body parts, metal devices, or medicines. This technology enables continuity of health care delivery despite disruptive breaks in any supply chain due to war, shortage, or broken distribution lines due to pandemic force majeure.1 Featuring custom-tailored attributes for each device, economic efficiency by eliminating transport costs during emergencies, avoiding issues of distribution supply chains, and offering biocompatibility, 3-D printed medical devices during the COVID-19 pandemic2 provided a very attractive alternative to enduring medical supply shortages worldwide. Beyond the covid-19 pandemic exigencies, 3-D printed medical devices promise custom-tailored meals to meet medical needs that are unique for each patient's metabolism and a wide variety of tools for patient care that will change the shape of global commerce.3 3-D printing offers the alluring promise of biocompatible medical devices, matching any patient's unique anatomy, using a specific patient's imaging data, or using a standard design to make multiple identical copies of the same device, but without delays for transport or shipping and insurance costs. The global health impact of these efforts, from the standpoint of patient safety4 and overall deterrence of unnecessary or unsafe medical practices, remains unclear due to the absence of regulation and monitoring. The reality is that commerce can reduce or eliminate transport and storage costs associated with shipping and can change international trade. Yet, 3-D printing simultaneously offers great promise to meet challenges arising from the arcane role of intellectual property rights (IPR)5 in shaping the creation and transfer of nanomedicines and nanotechnologies to attain health equity and meet universal needs of health for all. These millennial technological changes may permanently alter how civil society does business for global health. © 2022, Andover House, Inc.. All rights reserved.
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.