Navigating the intersection of 3D printing, software regulation and quality control for point-of-care manufacturing of personalized anatomical models

Abstract

3D printing technology has become increasingly popular in healthcare settings, with applications of 3D printed anatomical models ranging from diagnostics and surgical planning to patient education. However, as the use of 3D printed anatomical models becomes more widespread, there is a growing need for regulation and quality control to ensure their accuracy and safety. This literature review examines the current state of 3D printing in hospitals and FDA regulation process for software intended for use in producing 3D printed models and provides for the first time a comprehensive list of approved software platforms alongside the 3D printers that have been validated with each for producing 3D printed anatomical models. The process for verification and validation of these 3D printed products, as well as the potential for inaccuracy in these models, is discussed, including methods for testing accuracy, limits, and standards for accuracy testing. This article emphasizes the importance of regulation and quality control in the use of 3D printing technology in healthcare, the need for clear guidelines and standards for both the software and the printed products to ensure the safety and accuracy of 3D printed anatomical models, and the opportunity to expand the library of regulated 3D printers.

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