AVALIAÇÃO DE DISPOSITIVOS MÉDICOS PROCESSADOS: MICROSCOPIA ELETRÔNICA DE VARREDURA COMO FERRAMENTA COMPLEMENTAR À ESTERILIDADE

Abstract

The introduction of new materials in the manufacture of medical devices (MD) is almost always associated with greater expense and waste generation, which is why the practice of reuse has been widespread, however, with different regulations. After processing, MD must offer quality and safety, through validated processes and scanning electron microscopy (SEM) analysis is combined in the search for maintaining efficiency. The objective was to evaluate the sterility and surface structure of MD after processing, based on an experimental study with autoclaved samples in the sterilization material center of a sentinel health service in Rio de Janeiro, collected based on the type of material, size and criticality in use. The sterility test was carried out in an official laboratory, by direct inoculation, under quality conditions. SEM analysis evaluated the structural characteristics of samples after processing and of an unused straight connector, for comparison with the same processed product. The sterility test showed 100% satisfaction, however, in the SEM, the existence of changes in the microstructure of the surface of several samples was observed, however, these were confirmed only in the comparative test. The study makes it possible to plan strategies to relate the number of processing cycles to surface changes and safety of use and to develop processing protocols and systematic surveillance of the reuse of single-use materials, not only for their economic relevance, but above all from the point of ethical, legal, biological, functional and care views.