Stérilisation de guides d’implantologie imprimés sur mesure à l’hôpital : validation d’un essai de stérilité et étude de déformation

Abstract

Medical device made to measure by 3D printing are now emerging in hospital. In order to improve the precision of surgery and facilitate the treatment of complicated cases, patient specific surgical guides for dental implantology are made by stereolithography in our facial surgical unit. This new activity requires to ensure the safety of patients and health personnel by validating the various step of the manufacturing circuit. In this context, the goal of this work was to study the quality of autoclave sterilisation of the patient specific surgical guide made to measure in our hospital. A protocol of sterility test was designed and validated. Sterility of implantology guides 0, 7, 14and 28days after sterilisation was checked. The impact of the autoclave sterilisation on the medical device structure was evaluated by visual check and during surgeries. The sterility of the implantology guides up to 28days after sterilisation was also validated. The protocol of sterility test executed can be extended to other hospitals interested in validating a sterility test. No deformation was observed by surgeons during the dental implant process. Future studies may be necessary to check the accurate impact of sterilisation on surgical guide structure.