Ethical and regulatory issues in the application of 3D printing in orthopaedics: A scoping review

Abstract

3D printing has revolutionised orthopaedic surgery by enabling the production of customised implants, surgical guides, and anatomical models, enhancing precision and personalised care. However, it presents significant ethical and regulatory challenges. This scoping review identifies and maps these issues. Using the Joanna Briggs Institute scoping review methodology and the PRISMA-ScR framework, a systematic search was conducted across PubMed/MEDLINE, EBSCOhost, Union Catalogue of Thesis and Dissertation (UCTD), and Google Scholar for studies published from January 2011 to the present. Keywords included “3D printing,” “orthopaedic surgery,” “ethics,” and “regulations.” Eligible studies were full-text publications in English addressing ethical and regulatory aspects of 3D printing in orthopaedics. Data were extracted and analysed thematically. Eight studies met the inclusion criteria, identifying two main themes: ethical concerns and regulatory issues. Ethical concerns included intellectual property rights and equitable access to 3D-printed solutions. Regulatory issues highlighted gaps in existing frameworks, particularly regarding customisation and point-of-care manufacturing. 3D printing offers significant benefits for orthopaedics but poses complex ethical and regulatory challenges. Clear guidelines are required to address regulatory gaps, particularly for customised and point-of-care manufacturing. Ethical frameworks must also address ownership and equitable access.

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