[Guidelines for quality management of dialysis solutions]

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