RESUMO
3D-printing is part of the daily practice of maxillo-facial surgeons, stomatologists and oral surgeons. To date, no French health center is producing in-house medical devices according to the new European standards. Based on all the evidence-based data available, a group of experts from the French Society of Stomatology, Maxillo-Facial Surgery and Oral Surgery (Société Française de Chirurgie Maxillofaciale, Stomatologie et Chirurgie Orale, SFSCMFCO), provide good practice guidelines for in-house 3D-printing in maxillo-facial surgery, stomatology, and oral surgery. Briefly, technical considerations related to printers and CAD software, which were the main challenges in the last ten years, are now nearly trivial questions. The central current issues when planning the implementation of an in-house 3D-printing platform are economic and regulatory. Successful in-house 3D platforms rely on close collaborations between health professionals and engineers, backed by regulatory and logistic specialists. Several large-scale academic projects across France will soon provide definitive answers to governance and economical questions related to the use of in-house 3D printing.
Assuntos
Medicina Bucal , Procedimentos Cirúrgicos Bucais , Cirurgia Bucal , França , Humanos , Impressão TridimensionalRESUMO
Emergency 3D-printing of medical devices came out as a potential solution to tackle shortages during the COVID-19 pandemic. Manufacturing medical devices in small series within hospitals is an exciting perspective in crisis management. Health professionals and additive manufacturing technology are ready for this revolution but regulative adaptations are still required. Here we present the design and production of a suture guide for cardiac surgery as a case study for a 3D-printed medical device manufactured during the COVID-19 pandemic.
RESUMO
Additive manufacturing has been extensively used during the COVID-19 pandemic to design and produce protection equipment. During clinical examinations using slit lamps, ophthalmologists are at risk of being contaminated by the SARS-CoV-2 virus, and the device itself is exposed to viral contamination. Several solutions have already been proposed for fixing transparent shields on the physician side. Here we propose a 3D-printed device fixed on the chin rest on the patient side, aiming at limiting viral spread both on the lamp itself and towards the physician.