Three-Dimensional Printing of Medical Devices Used Directly to Treat Patients: A Systematic Review.

Until recently, three-dimensional (3D) printing/additive manufacturing has not been used extensively to create medical devices intended for actual clinical use, primarily on patient safety and regulatory grounds. However, in recent years there have been advances in materials, printers, and experience, leading to increased clinical use. The aim of this study was to perform a structured systematic review of 3D-printed medical devices used directly in patient treatment. A search of 13 databases was performed to identify studies of 3D-printed medical devices, detailing fabrication technology and materials employed, clinical application, and clinical outcome. One hundred and ten papers describing one hundred and forty medical devices were identified and analyzed. A considerable increase was identified in the use of 3D printing to produce medical devices directly for clinical use in the past 3 years. This is dominated by printing of patient-specific implants and surgical guides for use in orthopedics and orthopedic oncology, but there is a trend of increased use across other clinical specialties. The prevailing material/3D-printing technology used were titanium alloy/electron beam melting for implants, and polyamide/selective laser sintering or polylactic acid/fused deposition modeling for surgical guides and instruments. A detailed analysis across medical applications by technology and materials is provided, as well as a commentary regarding regulatory aspects. In general, there is growing familiarity with, and acceptance of, 3D printing in clinical use.