Autoclave sterilization of an in-house 3D-printed polylactic acid piece: biological safety and heat-induced deformation

Aims Fused filament fabrication 3D printing with polylactic acid filaments is the most widely used method to generate biomodels at hospitals throughout the world. The main limitation of this manufacturing system is related to the biomodels’ temperature sensitivity, which all but prevents them to be sterilized using conventional methods. The purpose of this study is to define an autoclave temperature-resistant FFF-PLA 3D printing protocol to print 3D fractures biomodels during preoperative planning. Methods and results Six different printing protocols were established, each with a different infill percentage. Ten distal radius biomodels were printed with each protocol and each biomodel was subject to 3D scanning. The biomodels were subsequently autoclave-sterilized at 134 °C and subjected to a new scanning process, which was followed by a calculation of changes in area, volume and deformity using the Hausdorff–Besicovitch method. Finally, 192 polylactic acid models were produced using the printing protocol offering the greatest resistance and were contaminated with 31 common nosocomial pathogens to evaluate the effectiveness of sterilizing the model printed using the said protocol. Sterilization resulted in a mean deformation of the biomodel of 0.14 mm, a maximum deformity of 0.75 mm, and a 1% area and a 3.6% volume reduction. Sterilization of the pieces printed using the analyzed protocol was 100% effective. Conclusions The analyzed 3D printing protocol may be applied with any FFF-PLA 3D printer, it is safe and does not significantly alter the morphology of biomodels. These results indicate that 3D printing is associated with significant advantages for health centers as it increases their autonomy, allowing them to easily produce 3D biomodels that can be used for the treatment of fractures.