3D printing is a technology that builds many successive layers of raw material to complete a three-dimensional object according to the predesigned model. The implementation of 3D printing in medicine deserves particular attention because it can cure conditions not responding to conventional treatment. For example, this technology is used to make cranial implants, prostheses, and drugs with unique dosages and formulations (PEW, 2020). However, the application of 3D printing in medicine is concerned with several legal and ethical issues. 3D printing can be used in facilities that do not fall under FDA inspection (PEW, 2020). It means that healthcare facilities not have enough experience with medical 3D printing can use this technology in practice, and the FDA cannot properly oversee them, which, in turn, poses risks to patient safety. Even more issues are related to 3D bioprinting that uses cells as raw materials. Since 3D-printed organs are customized, they cannot be used in clinical trials, so their safety may vary from case to case (Gilbert et al., 2017). Additionally, the output of 3D bioprinting is not specifically regulated (Gilbert et al., 2017). It means the quality and safety of bioprinted tissues are not standardized yet, and companies using this technology can charge any price for their products. Thus, since the use of 3D printing in medicine has many benefits but is poorly regulated, policymakers should develop regulations specific to this technology to ensure patient safety and the accessibility of healthcare.
Gilbert, F., O’Connell, C. D., Mladenovska, T., & Dodds, S. (2017). Print me an organ? Ethical and regulatory issues emerging from 3D bioprinting in medicine. Science and Engineering Ethics, 24(1), 73-91. Web.
The PEW Charitable Trusts [PEW]. (2020). What is medical 3D printing—and how is it regulated? Web.