Development and assessment of sterility of a closed-system pediatric peritoneal dialysis.

Objective: To develop an easy-handling totally closed pediatric peritoneal dialysis system and assess the sterility assurance level.

Methods: 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.

Results: 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.

Conclusions: It was possible to develop a new easy-handling closed-system pediatric peritoneal dialysis and ensure its sterility.