RESUMO
Objective Due to the popularity of 3D technology, surgeons can create specific surgical guides and sterilize them in their institutions. The aim of the present study is to compare the efficacy of the autoclave and ethylene oxide (EO) sterilization methods for objects produced by 3D printing with polylactic acid (PLA) material. Methods Forty cubic-shaped objects were printed with PLA material. Twenty were solid and 20 were hollow (printed with little internal filling). Twenty objects (10 solid and 10 hollow) were sterilized in autoclave, forming Group 1. The others (10 solid and 10 hollow) were sterilized in EO, composing Group 2. After sterilization, they were stored and referred to culture. Hollow objects of both groups were broken during sowing, communicating the dead space with the culture medium. The results obtained were statistically analyzed (Fisher exact test and residue analysis). Results In group 1 (autoclave), there was bacterial growth in 50% of solid objects and in 30% of hollow objects. In group 2 (EO), growth occurred in 20% of hollow objects, with no bacterial growth in solid objects (100% of negative samples). The bacteria isolated in the positive cases was non-coagulase-producing Staphylococcus Gram positive. Conclusions Sterilization by both autoclave and EO was not effective for hollow printed objects. Solid objects sterilized by autoclave did not demonstrate 100% of negative samples and were not safe in the present assay. Complete absence of contamination occurred only with solid objects sterilized by EO, which is the combination recommended by the authors.
RESUMO
Abstract Objective Due to the popularity of 3D technology, surgeons can create specific surgical guides and sterilize them in their institutions. The aim of the present study is to compare the efficacy of the autoclave and ethylene oxide (EO) sterilization methods for objects produced by 3D printing with polylactic acid (PLA) material. Methods Forty cubic-shaped objects were printed with PLA material. Twenty were solid and 20 were hollow (printed with little internal filling). Twenty objects (10 solid and 10 hollow) were sterilized in autoclave, forming Group 1. The others (10 solid and 10 hollow) were sterilized in EO, composing Group 2. After sterilization, they were stored and referred to culture. Hollow objects of both groups were broken during sowing, communicating the dead space with the culture medium. The results obtained were statistically analyzed (Fisher exact test and residue analysis). Results In group 1 (autoclave), there was bacterial growth in 50% of solid objects and in 30% of hollow objects. In group 2 (EO), growth occurred in 20% of hollow objects, with no bacterial growth in solid objects (100% of negative samples). The bacteria isolated in the positive cases was non-coagulase-producing Staphylococcus Gram positive. Conclusions Sterilization by both autoclave and EO was not effective for hollow printed objects. Solid objects sterilized by autoclave did not demonstrate 100% of negative samples and were not safe in the present assay. Complete absence of contamination occurred only with solid objects sterilized by EO, which is the combination recommended by the authors.
Resumo Objetivo Devido à popularidade da tecnologia 3D, cirurgiões podem criar guias cirúrgicos específicos e esterilizá-los nas suas instituições. O objetivo do presente estudo é comparar a eficácia dos métodos de esterilização por autoclave e óxido de etileno (OE) de objetos produzidos pela impressão 3D com material ácido polilático (PLA, na sigla em inglês). Métodos Quarenta objetos em formato cúbico foram impressos com material de PLA. Vinte eram sólidos e 20 eram ocos (impressos com pouco enchimento interno). Vinte objetos (10 sólidos e 10 ocos) foram esterilizados em autoclave, formando o Grupo 1. Os demais (10 sólidos e 10 ocos) foram esterilizados em OE, compondo o Grupo 2. Após a esterilização, os objetos foram armazenados e encaminhados para cultura. Objetos ocos de ambos os grupos foram quebrados durante a semeadura, comunicando o espaço morto com o meio de cultura. Os resultados obtidos foram analisados estatisticamente (teste exato de Fisher e análise de resíduo). Resultados No grupo 1 (autoclave) houve crescimento bacteriano em 50% dos objetos sólidos e em 30% dos objetos ocos. No grupo 2 (OE) o crescimento ocorreu em 20% dos objetos ocos, com ausência de crescimento bacteriano nos objetos sólidos (100% de amostras negativas). A bactéria isolada nos casos positivos foi Staphylococcus Gram positivo não produtor de coagulase. Conclusões A esterilização tanto em autoclave quanto pelo OE não foi eficaz para objetos impressos no formato oco. Objetos sólidos esterilizados em autoclave não demonstraram 100% de amostras negativas, não sendo seguro no presente ensaio. Ausência completa de contaminação ocorreu apenas com objetos sólidos esterilizados pelo OE, sendo a combinação recomendada pelos autores.