Este trabalho apresenta o estudo do processo de esterilização de materiais e instrumentais cirúrgicos em autoclaves que se utilizam do agente esterilizante, o vapor à baixa temperatura de formaldeído. Processo esse utilizado para materiais termosensiveis, ou seja, que não suportam temperaturas superiores a 80°C. Assim objetivo desse trabalho, foi avaliar essa tecnologia de esterilização a baixa temperatura, que já é utilizada há mais de 20 anos em vários países, inclusive aqui no Brasil, porém com pouco detalhes de estudos conclusivos sobre o assunto na literatura nacional e internacional. Este estudo foi baseado nas Normas ABNT NBR 15659 e NF EN ISO 25424 que tratam especificamente dos requisitos, métodos e cuidados na esterilização de vapor a baixa temperatura e formaldeído, implementando um protocolo de verificação para estudo da tecnologia. Para tanto foi elaborada uma metodologia de avaliação, da instalação de esterilizadores que utilizam como agente esterilizante o formaldeído. Na verificação da eficácia da metodologia 3 tipos de equipamentos de esterilização foram testados. Os equipamentos testados são de fabricação brasileira (02 deles) e um de fabricação sueca. Os testes foram feitos em 6 hospitais, onde foram avaliados desde a sua instalação, avaliação dos parâmetros de tempo, temperatura e pressão (com equipamentos calibrados e rastreados pelo INMETRO), avaliação do nível de resíduos no material (com laudos feitos por laboratórios credenciados), uso de indicadores de processo (biológicos e químicos), avaliação ambiental (ar e saída do dejeto para o esgoto), controles de manutenções preventivas e segurança do operador (EPI). Todos os ciclos avaliados apresentaram resultados dentro dos parâmetros mínimos sugerido na Norma ABNT NBR 15659 e NF EN ISO 25424. Concluindo que se seguindo rigorosamente o que pede a Norma e os manuais dos fabricantes dos equipamentos, pode-se perfeitamente obter um processo seguro de esterilização para o Hospital, e atender todos os níveis de segurança tanto para o operador como para o paciente que irá usar o material processado no ciclo de esterilização. / This work presents the study of the sterilization process of surgical materials and instruments in autoclaves using the sterilizing agent, the low temperature vapor of formaldehyde. This process is used for thermosensitive materials, is they do not withstand temperatures above 80 ° C. The objective of this study was to evaluate the low temperature sterilization technology, which has been used for more than 20 years in several countries, including here in Brazil, but with little details of conclusive studies on the subject in the national and international literature. This study was based on the ABNT NBR 15659 and NF EN ISO 25424 standards that specifically deal with the requirements, methods and care in low temperature steam sterilization and formaldehyde, implementing a verification protocol for technology study. For this, an evaluation methodology was elaborated for the installation of sterilizers that use formaldehyde as the sterilizing agent. In the verification of the effectiveness of the methodology 3 types of sterilization equipment were tested. The equipment tested is of Brazilian manufacture (02 of them) and one of Swedish manufacture. The tests were carried out in 6 hospitals, where they were evaluated since its installation, evaluation of parameters of time, temperature and pressure (with equipment calibrated and tracked by INMETRO), evaluation of the level of residues in the material (with reports made by accredited laboratories), use of process indicators (biological and chemical), environmental assessment (air and exits to the sewage), preventive maintenance controls and operator safety (EPI). All the evaluated cycles presented results within the minimum parameters suggested in the Standard ABNT NBR 15659 and NF EN ISO 25424. Concluding that strictly following the norms and the manuals of the equipment manufacturers, it is perfectly possible to obtain a safe process of sterilization To the Hospital, and meet all levels of safety for both the operator and the patient who will use the material processed in the sterilization cycle.

La chirurgie au voisinage de l’artère vertébrale nécessite une connaissance approfondie de l’anatomie et l’application d’une technique chirurgicale rigoureuse. Le fil conducteur des travaux de cette thèse sera non seulement l’amélioration des conditions de sécurité opératoire mais également le développement de nouvelles techniques permettant l’élargissement des indications chirurgicales.<p>Le premier travail a été axé sur l’étude de l’anatomie et des variations anatomiques de l’artère vertébrale. Les hypothèses suivantes ont été soulevées, relatives à l’incidence des variations anatomiques du 2ème segment de l’artère vertébrale, telles les anomalies de niveau de pénétration dans le foramen transverse et les boucles vasculaires. Une vaste étude anatomique de 500 trajectoires d’artère a été entreprise, basée sur des imageries par tomodensitométrie et résonance magnétique. Elle a permis de déceler 7% d’anomalies de niveau de pénétration et la présence de boucles vasculaires médiales dans 2% des cas, sous forme de boucles soit corporéales, soit foraminales. <p>Ensuite, toujours dans le but de sécuriser cette chirurgie complexe, s’est posée la question de l’intérêt de l’imagerie peropératoire jusqu’alors peu développée. Cette question est devenue d’autant plus pertinente qu’est apparue une nouvelle technique d’imagerie peropératoire jusqu’alors jamais testée dans les procédures liées à l’artère vertébrale extracrânienne. Cette technique, la vidéoangiographie peropératoire à la fluorescéine, a fait l’objet d’un travail multicentrique basé sur 9 interventions chirurgicales, avec pour objectifs de juger de son applicabilité, de ses limitations et intérêts, tant pour localiser l’artère durant l’abord chirurgical, que pour la visualiser après son exposition et vérifier sa perméabilité. Il a été observé que le premier segment de l’artère vertébrale possédait un aspect vidéoangiographique différent de celui des 2ème et 3ème segments, ainsi que de celui de l’artère carotide commune. De plus, des phases artérielle et veineuse ont été distinguées. Cet aspect vidéoangiographique peut être corrélé à l’anatomie de l’artère. L’intérêt de la technique réside dans l’aide qu’elle apporte pour déterminer la perméabilité du vaisseau ainsi que pour le localiser plus précisément au sein de la gaine périostée. Tant que celle-ci n’est pas exposée, la vidéoangiographie n’apporte par contre pas d’informations pertinentes pour sa localisation qui doit être strictement recherchée par les repères anatomiques usuels adaptés selon l’iconographie préopératoire.<p>Sur base de ces connaissances théoriques et chirurgicales, 2 nouvelles techniques opératoires ont été décrites et appliquées dans des indications très particulières. La première consiste en une technique de mobilisation du premier segment de l’artère en raison d’importantes tortuosités qu’il convenait de libérer pour restaurer l’accessibilité endovasculaire à une lésion intracrânienne. La seconde est une technique de fixation de l’atlas permettant de stabiliser une fracture tout en préservant la mobilité de l’articulation atlanto-axoïdienne.<p>Enfin, de nouvelles voies de recherche et de développements futurs ont été ouvertes sur base de travaux embryologiques, histologiques et anatomo-radiologiques qui ont été initiés pour juger de leur faisabilité future. <p>En conclusion, bien que complexe, la chirurgie au voisinage de l’artère vertébrale ouvre des voies d’abord spécifiques à certaines pathologies, raison pour laquelle elle mérite une attention toute particulière. De nouvelles procédures chirurgicales peuvent être développées, ainsi que des nouveaux concepts et matériel visant à améliorer la qualité de vie des patients. La singularité anatomique de l’artère vertébrale nécessite une connaissance détaillée et l’application d’une technique chirurgicale stricte. Avec le but poursuivi d’améliorer la sécurité de l’intervention chirurgicale, les travaux effectués ont clairement mis en évidence la nécessité d’une analyse approfondie de l’anatomie de l’artère vertébrale à un niveau individuel avant toute procédure. Les techniques d’imagerie intraopératoire peuvent apporter des informations utiles mais leurs avantages et limitations respectifs doivent être bien connus.<p>/ <p>Surgery around the vertebral artery requires a detailed knowledge of the anatomy and the application of a strict surgical technique. The main theme of these thesis works will be not only the improvement of the surgical security but also the development of new techniques allowing surgical indications widening.<p>The first work has been devoted to the study of the vertebral artery anatomy and variations. The following hypotheses have been raised, related to the incidence of anatomical variations of the second vertebral artery segment, such as the abnormal level of entrance into the transverse foramen and vessel loops. A large anatomical study consisting in 500 arterial trajectories has been performed, based on computed tomographic and resonance magnetic imagings. This study detected 7% of abnormal levels of entrance and the presence of vessel loops in 2% of the cases, either corporeal or foraminal loops. <p>Subsequently, the interest of intraoperative imaging techniques uncommonly applied until now has been questioned again with the goal to secure this complex surgery. This question was especially more relevant since the development of a new intraoperative imaging modality never tested in surgeries related to the extracranial vertebral artery. This technique, the intraoperative videoangiography using fluorescein, has been analyzed through a multicentric work based on 9 surgical procedures, with the goals to define its applicability, its limitations and interests for localizing the artery during the approach and for visualizing it after its exposure and checking its patency. It has been noted that the first vertebral artery segment appeared differently on videoangiography than the second and third ones, and than the common carotid artery. Moreover, arterial and venous phases should be distinguished. This videoangiographic aspect can be correlated with the vertebral artery anatomy. The interest of this technique lies in its help for confirming vessel patency and localizing it precisely inside the periosteal sheath. As far as the artery is not exposed, videoangiography brings no relevant information for its localization which must remain absolutely defined based on usual anatomical landmarks fitted to preoperative imaging. <p>Based on theoretical and surgical backgrounds, 2 new surgical techniques have been described and applied in specific surgical indications. The first one consists in a technique of rerouting of the first vertebral artery segment due to severe kinks that must be released for restoring the endovascular accessibility to an intracranial lesion. <p>Finally, new research approaches and future developments have been planed based on embryological, histological and anatomo-radiological works that have been started for evaluating their future feasability.<p>In conclusion, although complex, surgery around the vertebral artery opens specific surgical approaches to some pathologies, deserving for this reason some consideration. New surgical procedures can be developed, as well as new concepts and material with the goal to improve patient’s quality of life. The specific anatomy of the vertebral artery requires a detailed knowledge and application of a rigorous surgical technique. With the goal to improve surgical safety, works performed have clearly highlighted the necessity of an in-depth knowledge of the vertebral artery anatomy on an individual basis before any surgery. Intraoperative imaging techniques can contribute to bring relevant information but their respective advantages and limitations must be well-known.<p> / Doctorat en Sciences médicales / info:eu-repo/semantics/nonPublished