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.