Desenvolvimento e avaliação da esterilidade de sistema de diálise peritoneal pediátrico fechado

Abstract

Objective: Develop a system for pediatric peritoneal dialysis totally enclosed, easy management and assess the level of assurance of sterility.Methods: In the period February to December of 2008, was designed and developed at the Section of Bioengineering of Braile Biomédica Indústria, Comércio e Representações S/A® a system of peritoneal dialysis pediatric closed. Twenty systems were built undergoing trials on the level of assurance of sterility, and divided into group A (n=10) using the test for sterility and B (n=10) penetration of the gas ethylene oxide.Results: In group A, the sterility test was negative for the proliferation of bacteria and fungi in 14 days in all systems. In group B, the gas penetration test showed that there was penetration of gas in all points evaluated.Conclusions: It was possible to develop a new system for peritoneal dialysis pediatric closed easily managed and ensure its sterility.