Objective To determine if the standardized B&D type test for hospital steam sterilizer is correctly indicating cycle failures in slower come-up ramps cycles. Methods Two commercially available B&D type test were challenged in a quality control sterilizer. A common failure was simulated in triplicate cycles, using a standardized cycle configuration, and then compared to triplicate cycles of a common cycle configuration. Tests procedures were conducted according to B&D manufacturer test standard and results were compared to standardized endpoint specifications. Results We found that B&D type tests are only capable of detecting the presence of non-condensable gases if the sterilization equipment is adjusted to meet all the cycle requirements of the test. False positive results were obtained with come-up ramp time of 3 min. Correct results were only obtained with come-up ramp of 1.7-1.9 min. Conclusions Until the ISO 17665 and AAMI ST-79 standards are revised, equipment qualification experts should observe come-up time duration criterion for B&D type test cycles according to ISO 11140-4. Sterile Processing Department professionals must add the come-up ramp criterion to cycle evaluation before clearing the equipment for routine use. This will allow B&D correct performance, reducing the infection risk from unsterilized medical device.

Objetivo: Discutir os aspectos que devem ser considerados na validação concorrente da limpeza no Centro de Materiais e Esterilização (CME). Método: Revisão narrativa da literatura científica, legislação e normatização pertinentes. Resultados: A validação da limpeza na rotina deve considerar: o design dos produtos, a definição e a exequibilidade dos procedimentos operacionais padrão, além da estrutura do CME, dimensionamento, seleção e treinamento de pessoal, registro e interpretação dos resultados obtidos pelos testes químicos na rotina. Conclusão: A validação concorrente da limpeza dos produtos para saúde no CME imprime a cultura da valorização dessa etapa do processamento entre todos os colaboradores do setor, de tal forma que a limpeza passa a ser, de fato, o núcleo central do processamento.

Objetivos: Avaliar a eficácia de um procedimento operacional padrão para limpeza de fresas intramedulares flexíveis, bem como o alcance da esterilidade, e evidenciara citotoxicidade da sujidade residual de uma fresa flexível utilizada na prática assistencial. Métodos: Fresas intramedulares flexíveis foram pesadas antes do processamento,após contaminação desafio e depois da limpeza. Elas foram contaminadas com Soil Test™, suspensão de Geobacillus stearothermophilus, na concentração de106 UFC/mL, e farinha de osso bovino. Após processamento, as amostras foram incubadas em meio de cultura por 21 dias. A sujidade residual de uma fresa utilizadana prática foi submetida ao teste de citotoxicidade in vitro. Resultados: As amostras, embora esterilizadas, apontaram acúmulo de sujidade e o processamento foi ineficaz.A sujidade residual apresentou efeito citotóxico. Conclusão: Recomenda-se que o design flexível das fresas seja descontinuado pela insegurança no processamento.

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Objective: This study aims to compare water and power consumption in four cycle confi gurations (number of pulses in the conditioning phase, drying time, and vacuum depth set point) for steam sterilization. Methods: A descriptive study of four different cycle confi gurations: In confi guration A, conditioning phase vacuum pulses were set to a total of three, with a lower vacuum set point of 90 mbar and a higher pressure set point of 1500 mbar. The drying phase was set for 45 minutes with a vacuum level of 90 mbar. Water and power consumption were measured during the entire conditioning phase, and every 15 minutes during the drying phase. In confi guration B the conditioning phase vacuum set point was adjusted to 150 mbar and the other parameters were identical to confi guration A. On confi gurations C and D, the quantity of vacuum pulses was set to fi ve, with higher pressure adjusted to 1500 mbar in both confi gurations. The lower vacuum set point was adjusted to 90 mbar in confi guration C and to 150 mbar in confi guration D. Results: Water consumption at the drying phase had the most impact on the total water consumption for the entire cycle. Conclusion: This study shows that increasing drying time to solve wet packs will increase water consumption, a scarce natural resource, and should be the last option to achieve dry loads at the end of the cycle.