Abstract

BackgroundThe purpose of this study is to provide a framework for the development of a quality assurance (QA) program for use in medical 3D printing applications. An interdisciplinary QA team was built with expertise from all aspects of 3D printing. A systematic QA approach was established to assess the accuracy and precision of each step during the 3D printing process, including: image data acquisition, segmentation and processing, and 3D printing and cleaning. Validation of printed models was performed by qualitative inspection and quantitative measurement. The latter was achieved by scanning the printed model with a high resolution CT scanner to obtain images of the printed model, which were registered to the original patient images and the distance between them was calculated on a point-by-point basis.ResultsA phantom-based QA process, with two QA phantoms, was also developed. The phantoms went through the same 3D printing process as that of the patient models to generate printed QA models. Physical measurement, fit tests, and image based measurements were performed to compare the printed 3D model to the original QA phantom, with its known size and shape, providing an end-to-end assessment of errors involved in the complete 3D printing process. Measured differences between the printed model and the original QA phantom ranged from -0.32 mm to 0.13 mm for the line pair pattern. For a radial-ulna patient model, the mean distance between the original data set and the scanned printed model was -0.12 mm (ranging from -0.57 to 0.34 mm), with a standard deviation of 0.17 mm.ConclusionsA comprehensive QA process from image acquisition to completed model has been developed. Such a program is essential to ensure the required accuracy of 3D printed models for medical applications.

Highlights

  • The purpose of this study is to provide a framework for the development of a quality assurance (QA) program for use in medical 3D printing applications

  • Using a patient’s own medical image data, 3D printing can be used to create individualized, life-size patient-specific models. These models are increasingly being used as aids in surgical planning for complex cases [1,2,3,4,5,6,7,8,9,10,11]. 3D models can contribute to surgical procedures by providing surgeons with an accurate life size physical reproduction of the anatomy of interest

  • Leng et al 3D Printing in Medicine (2017) 3:6 going into the future, it is important that quality assurance (QA) programs are in place as part of the development and maintenance of a 3D printing program

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Summary

Introduction

The purpose of this study is to provide a framework for the development of a quality assurance (QA) program for use in medical 3D printing applications. Using a patient’s own medical image data, 3D printing can be used to create individualized, life-size patient-specific models. While the accuracy of medical imaging is a critical first step in 3D printing, the additional elements of segmentation and processing of imaging data and the technical aspects of the 3D printing process can all affect the accuracy of the final 3D printed model. Each of these production steps should be individually evaluated, analyzed and optimized. Medical confidence in the accurate representation of patient anatomy and pathology is a necessary component of medical 3D printing applications

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