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.
Biazi
Ana Paula Pereira
AP
São José do Rio Preto Pediatric Cardiovascular Surgery Service -Hospital de Base - São José do Rio Preto Medical School, SP, Brazil. anapabi@hotmail.com
Croti
Ulisses Alexandre
UA
Braile
Domingo Marcolino
DM
Oliveira
Marcos Aurélio Barboza de
MA
Costa
Jane Gonçalves Soares
JG
Cardoso
Lucas Monteiro
LM
D001419:Bacteria / Q000254:growth & development; D002648:Child; D005027:Ethylene Oxide / Q000032:analysis; D005658:Fungi / Q000254:growth & development; D005740:Gases / Q000032:analysis; D006801:Humans; D008567:Membranes, Artificial; D010530:Peritoneal Dialysis / Q000295:instrumentation*; D013242:Sterilization / Q000379:methods / Q000592:standards*
D005740:Gases; D008567:Membranes, Artificial; D005027:Ethylene Oxide