Additive manufacturing in orthognathic surgery: A case study
Abstract
Over the last few decades, 3D printing has played an increasingly important role in the daily lives of healthcare professionals, with the local production of medical devices (MDs) (known as "in-house" MDs), both patient-specific and non-patient-specific. This production, on a non-industrial scale, meets the specific needs of target patient groups. It is only possible if the needs cannot be met, at the appropriate performance level, by an equivalent CE-marked device available on the market. In order to improve the safety of these devices, the European authorities have drawn up a new regulation (EU 2017/745), the requirements of which will lead to changes in current practice for both manufacturers and healthcare establishments. In France, there are currently few examples of in-house production of medical devices that comply with the new regulations. The aim of this book is to present these regulatory requirements through the eyes of a maxillo-facial surgeon, with a particular focus on orthognathic surgery. After introducing various notions about 3D printing and then orthognathic surgery and the place 3D printing occupies in it, we present a concrete case of setting up an intra-hospital pro-duction chain that complies with EU regulation 2017/745. To illustrate our point, we use the production of patient-specific, computer-assisted occlusal splints to guide orthognathic surgery in the maxillofacial surgery department of Nantes University Hospital.
Keywords
three-dimensional printing, computer-aided design, control and regulation of an installation, chirurgie orthognathiqueChapters
Metrics
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
