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Guidelines for Medical 3D Printing and Appropriateness for Clinical Scenarios David H

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Guidelines for Medical 3D Printing and Appropriateness for Clinical Scenarios David H Washington University School of Medicine Digital Commons@Becker Open Access Publications 2018 Radiological Society of North America (RSNA) 3D printing Special Interest Group (SIG): Guidelines for medical 3D printing and appropriateness for clinical scenarios David H. Ballard et al Follow this and additional works at: https://digitalcommons.wustl.edu/open_access_pubs Chepelev et al. 3D Printing in Medicine (2018) 4:11 https://doi.org/10.1186/s41205-018-0030-y RESEARCH Open Access Radiological Society of North America (RSNA) 3D printing Special Interest Group (SIG): guidelines for medical 3D printing and appropriateness for clinical scenarios Leonid Chepelev1†, Nicole Wake2,3†, Justin Ryan4†, Waleed Althobaity1†, Ashish Gupta1†, Elsa Arribas5†, Lumarie Santiago5†, David H Ballard6, Kenneth C Wang7, William Weadock8, Ciprian N Ionita9, Dimitrios Mitsouras1, Jonathan Morris10, Jane Matsumoto10, Andy Christensen1, Peter Liacouras11, Frank J Rybicki1*, Adnan Sheikh1 and RSNA Special Interest Group for 3D Printing Abstract Medical three-dimensional (3D) printing has expanded dramatically over the past three decades with growth in both facility adoption and the variety of medical applications. Consideration for each step required to create accurate 3D printed models from medical imaging data impacts patient care and management. In this paper, a writing group representing the Radiological Society of North America Special Interest Group on 3D Printing (SIG) provides recommendations that have been vetted and voted on by the SIG active membership. This body of work includes appropriate clinical use of anatomic models 3D printed for diagnostic use in the care of patients with specific medical conditions. The recommendations provide guidance for approaches and tools in medical 3D printing, from image acquisition, segmentation of the desired anatomy intended for 3D printing, creation of a 3D-printable model, and post-processing of 3D printed anatomic models for patient care. Keywords: 3D printing, Appropriateness, Guideline, Quality, Radiology, Additive manufacturing, Anatomic model Background Printing) described for proposed new billing codes, in- In 2016, the Radiological Society of North America cluding those for the American Medical Association. (RSNA) approved a proposal to create the Special Inter- These practice parameters and recommendations are est Group on 3D Printing (SIG). This document fulfills not intended as comprehensive standards but do reflect two of the original SIG goals: to provide recommenda- several salient aspects of clinical anatomic modeling and tions towards consistent and safe production of 3D appropriateness. The guidelines subcommittee of the printed models derived from medical images, and to de- SIG will maintain and devote the time and effort neces- scribe a set of clinical scenarios for 3D printing is appro- sary to continually develop and update these recommen- priate for the intended use of caring for patients with dations. This subcommittee is comprised of volunteer those medical conditions. This project also fills a previ- members of the SIG who form the writing group of this ously unmet need for practice parameters/guidelines re- document. garding the clinical service of anatomic modeling (3D In its current state, medical 3D printing [1–576]has been performed for a variety of patients, but without * Correspondence: [email protected] evidence-based appropriateness guidelines. For many † Leonid Chepelev, Nicole Wake, Justin Ryan, Waleed Althobaity, Ashish body parts, this document includes a comprehensive as- Gupta, Elsa Arribas and Lumarie Santiago contributed equally to this work. 1Department of Radiology and The Ottawa Hospital Research Institute, sessment of appropriateness from the medical literature, University of Ottawa, Ottawa, ON, Canada supplemented by expert opinion (SIG members) when Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Chepelev et al. 3D Printing in Medicine (2018) 4:11 Page 2 of 38 there is a paucity of peer-review data. After the clinical approach at scoring. Consensus among members is used decision to use 3D printing for patient care, there are when there is a paucity of evidence. many subsequent steps, as reviewed in prior literature Each category was led by a separate writing group, [563, 566, 577]. These include image acquisition, image composed of a small group of experts in that domain of segmentation (demarcation of the desired 3D anatomy), medical imaging and 3D printing. The SIG Executive creating 3D-printable file types for each segmented part, committee, led by the Guidelines Chairperson, formed printing, and post processing of 3D medical models. the review panel. Ratings were generated via by a vote of This document differs from existing works, including Special Interest Group members at in-person meetings. case reports, small and larger studies, and 3D printing The results of the ratings follow the following 1–9 for- review articles in the literature. This is not a review art- mat (with 9 being the most appropriate): icle; instead of reviewing the literature or providing data regarding the clinical utility of medical 3D printing, the 1–3, red, rarely appropriate: There is a lack of a clear RSNA SIG has assembled a group of experts to begin to benefit or experience that shows an advantage over provide consensus recommendations on the practice of usual practice. medical modeling and 3D printing, particularly for prac- 4–6, yellow, maybe appropriate: There may be times tice within healthcare facilities. 3D printing of anatomical when there is an advantage, but the data is lacking, or models within a hospital has recently become recognized the benefits have not been fully defined. as point-of-care manufacturing. These recommendations 7–9, green, usually appropriate: Data and experience create a foundational outline to provide practice recom- shows an advantage to 3D printing as a method to mendations for those steps required for medical 3D print- represent and/or extend the value of data contained in ing, including image acquisition, segmentation, printing, the medical imaging examination. post-processing, and model verification. The supporting evidence was obtained through struc- tured PubMed searches, as detailed in the Appendix.In Methods rare circumstances, supporting literature was recom- Consensus methodology recommendations mended directly by the members of the committee and The recommendations regarding medical image acquisi- was explicitly identified outside of the structured tion, image data preparation and manipulation, generation PubMed search results. of 3D printed models, quality control, communication A subset of applications of 3D printing, including in with referring physicians, preoperative planning using 3D congenital heart, vascular, craniomaxillofacial, musculo- printed models, and considerations regarding materials skeletal, genitounirary, and breast pathologies was se- were discussed and summarized by members of the RSNA lected for detailed review. All final components of this Special Interest Group for 3D Printing during several section were vetted and approved by vote of Special meetings, including on August 31 (Silver Spring, MD) and Interest Group members at several face-to-face meetings December 1, 2017 (Chicago, IL) after review of the rele- including on August 31 (Silver Spring, MD) and Decem- vant medical 3D printing literature [1–576] and the local ber 1, 2017 (Chicago, IL) as well as via internal posting clinical practice of representative members of the Special on the SIG member intranet. Interest Group. Relevant recommendations were further exposed to internal online discussion and summarized by Results a focused taskforce. The final recommendations were Consensus methodology recommendations reviewed and vetted by all RSNA 3D printing SIG Medical image acquisition members. The most common medical imaging modalities for 3D printing are computed tomography (CT) and magnetic Appropriateness consensus guideline generation resonance imaging (MRI); however, any 3D imaging data- The Special Interest Group has initiated the quality and set including sonography (e.g., echocardiography) may be safety scholarship to identify those clinical situations for utilized as input data for segmentation. The international which 3D Printing is considered an appropriate, and not standard format for these imaging files is Digital Imaging appropriate, representation of the data contained in a and Communications in Medicine (DICOM). At this time, medical imaging examination. These documents highlight DICOM images are not routinely sent directly to a 3D appropriateness of medical 3D printing for clinical printer for printing, so medical images are segmented and utilization, research, scientific, and informational pur- converted to a file type that is recognized by 3D printers. poses. This work is loosely modeled after the American Common file types include Standard Tessellation Lan- College of Radiology Appropriateness Criteria® [553, 554] guage (STL), OBJ, VRML/WRL, AMF, 3MF, and X3D. in that the guidelines committee
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