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

Ana Paula Pereira Biazi,Jane Gonçalves Soares Costa,Marcos Aurélio Barboza De Oliveira,Lucas Monteiro Cardoso,Ulisses Alexandre Croti,Domingo Marcolino Braile

doi:10.1590/s0102-76382009000100012

Abstract

To develop an easy-handling totally closed pediatric peritoneal dialysis system and assess the sterility assurance level. From February to December 2008 was designed and developed a closed-system pediatric peritoneal dialysis at the Bioengineering Division of Braile Biomédica Indústria, Comércio e Representações S/A. Twenty systems were manufactured and submitted to sterility assurance level testing, and were divided into Group A (10)--using the sterility test--and B (10)--ethylene oxide gas penetration. In Group A, the sterility test was negative for bacteria and fungi proliferation within 14 days in all systems. In Group B, the gas penetration test showed that there was gas penetration in all points assessed. It was possible to develop a new easy-handling closed-system pediatric peritoneal dialysis and ensure its sterility.

Highlights

Cardiac surgery using cardiopulmonary bypass (CPB) represented one of the great medical achievements of the twentieth century, one of the side effects after its use is renal failure, which can occur due to many factors and are often more pronounced in children during newborn period [1,2].When a child undergo correction of congenital heart defect with CPB and evolves with renal failure, this patient can be treated by peritoneal dialysis [3,4]
BIAZI, APP ET AL - Development and assessment of sterility of a closed-system pediatric peritoneal dialysis catheter inserted in the region and, after a certain time, the liquid is drained restarting a new cycle [5,6]
Connectors and reservoirs made of polyvinyl chloride (PVC), connected and glued with solvent cyclohexanone

Summary

Introduction

Cardiac surgery using cardiopulmonary bypass (CPB) represented one of the great medical achievements of the twentieth century, one of the side effects after its use is renal failure, which can occur due to many factors and are often more pronounced in children during newborn period [1,2].When a child undergo correction of congenital heart defect with CPB and evolves with renal failure, this patient can be treated by peritoneal dialysis [3,4]. BIAZI, APP ET AL - Development and assessment of sterility of a closed-system pediatric peritoneal dialysis catheter inserted in the region and, after a certain time, the liquid is drained restarting a new cycle [5,6]. There is available in Brazil only a system of newborn peritoneal dialysis capable of controlling the volume of liquid to be infused that requires specific adapters for use [11].

Results

Conclusion