Ethical Considerations in the Application of Medical 3D Printing Technology

Written by: Apichat Chaisarn

Edited by: Hargun Champi, Aiyada Iuemwananonthachai

Usage of 3D Printing Technology in Medicine

Three-dimensional printing in medicine has recently surged in popularity due to its customizability for use as implants or transplants in various diseases and conditions including osteoarthritis, organ failure, and neurodegenerative diseases. 3D bioprinting creates tissue using the patient’s cells, resulting in tissues or organs with mostly perfect compatibility. Such technology can also be used for tissue repair through creating scaffolds which are a support medium for cells. The technology also opens up opportunities for using 3D-printed tissue for medical education due to its lower difficulty in preparation and associated cost.

Possible Short-term Patient Safety

• Immune response to the printed tissues.

• Passing of the material used in the printed tissue, including inert biomaterial, through the body could potentially cause cytotoxicity, disruption of organs, and clotting.

• Introducing pathogens into patients’ body

• Development of the cells is quite varied between patients and the complexity of some organs, leading to difficulties in controlling the quality of the printed tissues and organs.

• Research on the efficacy of printed tissues cannot be generalized to the population due to the inherent differences in the origin of the tissues.

Possible Long-term Patient Safety

• Tumor formation due to the production process may cause DNA damage, and the unpredictable behavior of printed tissues.

• Creation of heterogeneous tissue with weak spots which could fail under stress.

• Printed organs from patients’ own cells may demonstrate similar genetic predisposition to some conditions which cause the failure of the organ itself.

• Irreversibility of transplanted 3D tissues is  possible as it could already be partially accepted and absorbed by the body, and the attempt to reverse the implantation may cause more harm, leading to loss of chance in future treatments.

• Further clinical testing is largely unviable due to the need for first-in-human trials, N-of-1 studies, and the need for the inclusion of children and its associated ethical concerns.

Regulatory Status

• 3D printing technology exists in a regulatory gray area between biological and medical devices, which is exempted by most regulatory bodies.

• Many regulatory bodies are still undecided on the matter, having only Japan and South Korea’s authorities provided any regulatory guidance.

• Responsibilities are still left unclear on whether the physician or the manufacturer should be held responsible for the harms that the 3D-printed tissues may cause to patients.

Conclusion

With many benefits that could come with 3D printing technology in medicine, ethical considerations should be weighed carefully between multiple factors (e.g., patient safety, regulations); humans’ lives and dignity should be of utmost importance in researching and developing such technology. Further research should be conducted before any major implementation of 3D printing in medicine.

Works Cited

Deane, Andrew S., and Kelsey T. Byers. “A Review of the Ethical Considerations for the Use of 3D Printed Materials in Medical and Allied Health Education and a Proposed Collective Path Forward.” Anatomical Sciences Education, vol. 17, no. 6, July 2024, pp. 1164–73, https://doi.org/10.1002/ase.2483.

Gilbert, Frederic, et al. “Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine.” Science and Engineering Ethics, vol. 24, no. 1, Feb. 2017, pp. 73–91, https://doi.org/10.1007/s11948-017-9874-6.

Van Daal, Manon, et al. “Personalized 3D Printed Scaffolds: The Ethical Aspects.” New Biotechnology, vol. 78, Dec. 2023, pp. 116–22, https://doi.org/10.1016/j.nbt.2023.10.006.