Avaliação do desempenho essencial das Máquinas de Hemodiálise de um EAS de grande porte

Abstract

Chronic Renal Disease is among the top 20 causes of death in the world, and with the growing number of patients in need of replacement therapies it presents itself as a serious public health problem. Hemodialysis eliminate excess fluids and substances in the body of the patient with renal failure, and therefore the hemodialysis sector becomes one of the main ones within a Health Establishment. In Brazil more than 133,000 patients undergo renal replacement therapies, and according to research, about 5% of the adverse events that occur with patients come from the equipment. The objective of this work was to evaluate parameters of hemodialysis machines of a large Health Care Establishment using the ABNT NBR IEC 60601-2-16:2015 standard, and to establish a relationship between the results of compliance tests and the history and characteristics of the analyzed equipment. For that, a preliminary study on Chronic Renal Disease and the Hemodialysis Machine was performed, followed by the study of the specific standard for the dialysis equipment. It was then established which tests could be performed simulating the dialysis process, without the presence of a patient, and then tests were performed on equipment in the Hemodialysis and Transplant sectors. The results obtained show that besides the equipment's life time, items such as the number of corrective maintenance and the number of hours in operation have a great influence on its performance, even when submitted to the preventive maintenance process. This work has reached its initial objective, and through it it one can conclude that it is essential that the equipment within an EAS complies with the manufacturer's manual and current regulations. The study show that preventive maintenance is fundamental to the proper functioning of the equipment, and that attention is required when they approach the deactivation period.