Medical & Dental

Radiological Society of North America post guidelines for 3D printed anatomic models

A special interest group of the Radiological Society of North America (RSNA) has posted a set of guidelines, suggesting standard approaches for 3D printing in healthcare.

Recognizing the need for evidence-based recommendations in the sector, these guidelines have been developed over a period of two years, in review of over 500 recent papers published on the topic.

As the abstracts states, “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.”

3DPI reporting from the heart of Formnext 2016. Image shows full color 3D printed anatomical hearts by Stratasys. Photo via: Michael Petch
Full color 3D printed anatomical hearts by Stratasys. Photo by Michael Petch

Guidelines and the FDA

In recent years there has undoubtedly been a rapid increase in 3D printing industry stakeholders focusing on medical applications. In the past year alone, 3D Systems launched its On Demand Anatomical Modeling Service;  Stratasys introduced the BioMimics of realistic medical models; Carbon expanded into a medical material range; and Materialise Mimics Innovation Suite became the first software of its kind to attain FDA approval.

Medical industry bodies, understandably, have also taken note. In December 2017, the FDA published its statement on providing guidance for companies seeking to introduce 3D printed products to medicine.

Working together with the FDA, in the near future the RSNA 3D Printing Special Interest Group is seeking to co-publish a white paper to form the next benchmark for 3D printed anatomic models.

Where and when to apply 3D printing in medicine 

Though the RSNA group states that its recommendations “are not intended as comprehensive standards” for the 3D printing of medical models, the paper does make a wide range of useful and illuminating suggestions for best practice in the industry.

In one instance, the group has developed an “Appropriateness consensus guideline.” Based on the American College of Radiology Appropriateness Criteria, this is a method of rating the application of 3D printed anatomical models based on previous evidence and expert opinion, with 1-3 being “rarely appropriate” 4 – 6″ maybe appropriate, and 7-9 “usually appropriate.”

As an example, in craniomaxillofacial models, complex skull fractures are deemed “usually appropriate” for applying a 3D printed anatomical model for presurgical planning. Simple skull fractures, meanwhile, are “rarely appropriate.” This could be due to the notion that surgeons are already well equipped to perform the procedure, and so the application of a 3D printed model would add little to the presurgical planning stage.

Appropriateness consensus guideline rating for 3D printed craniomaxllifacial models. Image via 3D Printing in Medicine journal.
Appropriateness consensus guideline rating for 3D printed craniomaxllifacial models. Image via 3D Printing in Medicine journal.Appropriateness consensus guideline rating for 3D printed craniomaxllifacial models. Image via 3D Printing in Medicine journal.

Recommendations for quality control

Another sensible recommendation is for a quality control program. “Due to environmental factors and material properties, model morphology is expected to change over time,” state the authors. “As part of a complete quality control program, 3D printers should undergo regular accuracy testing, including test prints, preventative maintenance, and recalibration.”

In addition, “Laboratories may develop a process using a phantom to ensure regular quality standards for their printers.”

Full results of the “Radiological Society of North America (RSNA) 3D printing Special Interest Group (SIG): guidelines for medical 3D printing and appropriateness for clinical scenarios” is published, open access, in the journal 3D Printing in Medicine. It is co-authored by Leonid Chepelev, Nicole Wake, Justin Ryan, Waleed Althobaity, Ashish Gupta, Elsa Arribas, Lumarie Santiago, David H Ballard, Kenneth C Wang, William Weadock, Ciprian N Ionita, Dimitrios Mitsouras, Jonathan Morris, Jane Matsumoto, Andy Christensen, Peter Liacouras, Frank J Rybicki and Adnan Sheikh.

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Featured image shows 3D printed anatomical models. Photo via 3D Systems