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.

Submitted in fulfilment of the requirements of the degree of Doctor of Technology: Public Management, Durban University of Technology, 2017. / The world over, countries are burdened with existing and emerging diseases and while that affected all nations, sub-Saharan Africa carried the heaviest portion. This filtered to Zimbabwe where a myriad of health challenges are faced. Unavailability of medicines coupled with poor inventory management of these medicines has been prevalent. Insufficient financial resources and increasing cost of healthcare costs is one of the pressing matters. It is also important to note that these challenges are occurring at a time when government is realising the crucial role of procurement in addressing health challenges. Due to the extent, depth, breadth and nature of the health challenges and their criticality in establishing sustainable and affordable health system in Zimbabwe, a case study approach has been adopted where data from questionnaires, interviews, documents and observations were corroborated and triangulated in an effort to bring to the surface deep-seated procurement matters and how they are related to the challenges provided. Thus, in terms of the research findings, it was first revealed that the procurement legislative frameworks and processes are fragmented and not in one place resulting in multiple accountabilities. It was further shown that the framework is inappropriate in a healthcare set-up where issues of speed and flexibility in addressing requirements are paramount. It was also shown that procurement planning being a critical aspect is regrettably and detrimentally missing in procurements. In addition, the selection criteria as set out in the regulations and practiced by individual state health facilities indicated over-reliance on price and that being the case, key aspects such as quality and supply-lead time are missed and yet are very necessary in terms of evaluation among other factors. In the findings, the peripheral role of procurement staff with clinicians being also at the epicentre of purchasing decisions was presented. Perhaps related to that was the inadequacy of procurement skills and competences from the procurement personnel. Last on the findings, financing and the frequency of disbursement was unmatched with hospital requirements and thus resulting in unavailability of adequate medicines and equipment. / D