[Guidelines for quality management of dialysis solutions]. / Guías de gestión de calidad del líquido de diálisis (LD).

A Best Practice Guideline about Dialysis fluid purity has been developed under the leadership of the Spanish Society of Nephrology. The Guideline has established recommendations for standards for preparing dialysate: water, concentrates and hemodialysis proportioning systems. The Guideline was based on the European pharmacopoeia, the Real Farmacopea Española, the AAMI Standards and Recommended Practices, European Best Practice Guidelines for Haemodialysis (Section IV), literature reviews, according to their level of evidence, and the opinion of the expert spanish group. Two levels of quality of water were defined: purified water and high purified water (Ultra pure) and for dialysate: standard dialysate and ultra pure dialysate. Regular use of ultra pure dialysate is necessary for hemofiltration and hemodiafiltration on-line and desirable for high-flux hemodialysis to prevent and delay the occurrence of complications: inflammation, malnutrition, anemia and amyloidosis. Water, concentrates and dialysate quality requirements are defined as maximum allowable contaminant levels: chemicals (1.1.2), microbial and endotoxins: [table: see text] Monitoring frequency, maintenance and corrective actions were specified. Methods of sampling and analysis were described in appendix (Anexos). For microbiological monitoring, TSA or R2A medium are recommended, incubated during 5 days at a temperature of 30-35 degrees C. The dialysate quality assurance process involves all dialysis staff members and requires strict protocols. The physician in charge of hemodialysis has the ultimate responsibility for dialysate quality. All suggestions and questions about this Guideline are wellcome to www.senefro.org

Guías de Gestión de Calidad del Líquido de Diálisis (LD) / No disponible

La Sociedad Española de Nefrología ha elaborado una Guía sobre la calidad del líquido de diálisis. La guía establece recomendaciones sobre los estándares necesarios para preparar el dializado: agua, concentrado y los sistemas necesarios para su elaboración.. Esta guía se fundamenta en la Farmacopea Europea, la Real Farmacopea Española, los estándares y recomendaciones prácticas de la AAMI, las Guías Europeas para hemodiálisis (sección VI) y revisión de la literatura acompañado de su nivel de evidencia, así como la opinión del Comité de expertos que ha elaborado la guía. Se han definido dos niveles de calidad del agua: purificada y altamente purificada (ultrapura) y para el dializado: dializado estandar y dializado ultrapuro. La utilización de un dializado ultrapuro es necesario para la hemofiltración y hemodiafiltración en línea y deseable en la hemodiálisis de alto flujo para prevenir complicaciones: inflamación, malnutrición, anemia y amiloidosis. Se definen los niveles máximos de contaminantes requeridos en la calidad del agua, concentrados y dializados: químicos (1.1.2), microbiológicos y endotoxinas. Simultáneamente se especifican la frecuencia de monitorización, mantenimiento, así como los mecanismos para su corrección. En los apéndices se describen los métodos de recogida de las muestras y su análisis. Para la monitorización microbiológica se recomiendan los medios TSA o R2A, con un periodo de incubación de 5 días a una temperatura de 30-35 ºC. La calidad del dializado involucra a todo el personal de diálisis y su control requiere protocolos estrictos. Los nefrólogos encargados de la diálisis tienen la última responsabilidad en la calidad del dializado. Todas las sugerencias y preguntas relacionadas con esta guía serán atendidas en www.senefro.org (AU)

A Best Practice Guideline about Dialysis fluid purity has been developed under the leadership of the Spanish Society of Nephrology. The Guideline has established recommendations for standards for preparing dialysate: water, concentrates and hemodialysis proportioning systems. The Guideline was based on the European pharmacopoeia, the Real Farmacopea Espa- ñola, the AAMI Standards and Recommended Practices, European Best Practice Guidelines for Haemodialysis (Section IV), literature reviews, according to their level of evidence, and the opinion of the expert spanish group. Two levels of quality of water were defined: purified water and high purified water (Ultra pure) and for dialysate: standard dialysate and ultra pure dialysate. Regular use of ultra pure dialysate is neccessary for hemofiltration and hemodiafiltration on-line and desirable for high-flux hemodialysis to prevent and delay the occurrence of complications: inflammation, malnutrition, anemia and amyloidosis. Water, concentrates and dialysate quality requirements are defined as maximum allowable contaminant levels: chemicals (1.1.2), microbial and endotoxins microbiological monitoring, TSA or R2A medium are recommended, incubated during 5 days at a temperature of 30-35º C. The dialysate quality assurance process involves all dialysis staff members and requires strict protocols. The physician in charge of hemodialysis has the ultimate responsibility for dialysate quality. All suggestions and questions about this Guideline are wellcome to www.senefro.org (AU)