ALGUNAS CONSIDERACIONES SOBRE ENDOTOXINAS

Aunque el tema no pudo dejar de tratarse en el ítem 1-4, por estar relacionado íntimamente con la calidad microbiológica, en el presente punto se brindan algunos conceptos complementarios. Según la Farmacopea europea, la concentración de endotoxina en el agua de diálisis no debe superar 0,25 U.I. / ml. La recolección debe efectuarse de la misma forma que para el recuento de (bacterias) Gérmenes totales, y el método de dosaje se basa en la utilización de un reactivo preparado a partir de células sanguíneas de límulo (Limulus polyphemus o "horseshoe crab"), un crustáceo norteamericano.

CONCLUSIONES

La contaminación microbiana del agua de diálisis preparada a partir de agua potable de una red comunal constituye un riesgo de infección para el paciente dializado. En Europa, el agua de diálisis debe responder a la exigencia de la Farmacopea europea. Si ésta agua se utiliza para la producción en serie de líquido de sustitución, suministrado al paciente por vía venosa, debe responder a criterios muy severos para la preparación de soluciones de transfusión (soluciones parenterales) (48)

 
REFERENCIA BASE SOBRE LA METODOLOGÍA ANALÍTICA:

Trabajo Publicado por Ledebo I, Nystrand R. Defining the microbiological quality of dialysis fluid. Artif Organs 1999 Jan;23(1):37-43.

Este estudio demuestra un incremento de 10 a 100 veces en el recuento bacteriano del fluido de diálisis incubado en Tryptone Glucose Extract Agar (TGEA) a 20 °C durante 5 días comparados con la incubación en Tryptic Soy Agar a 37 °C durante 2 días. (20 a 22 °C)

Eau de dialyse. Pharmacopée Européenne. Conseil de l'Europe 3e édition. 1997 addendum 2001.

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43/. Ledebo I, Nystrand R. Defining the microbiological quality of dialysis fluid. Artificial Organs 1999; Jan 23 (1): 37-43. This study showed a 10-100 fold increase in recovery of bacteria from dialysis fluid incubated on Tryptone Glucose Extract Agar (TGEA) at 20 ºC for 5 days compared with incubation on Tryptic Soy Agar at 37 ºC for 2 days. EDTNA|ERCA JOURNAL 2002 XXVIII 3 113

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