Hemodialysis - Bacteriological Dialysate Purity

Guideline Organization

Recommendation (Evidence Level)

Evidence

Comments

CARI-Australia
2005

European guidelines should be the basis for optimal dialysate production (Level B)

Dialysis Adequacy:
Water quality for hemodialysis


Dialysis adequacy
3. Dialysis membranes
Point b

- Ultrapure water may reduce long-term risk of accelerated vascular damage, improve response to erythropoetic agents and reduce catabolic nutritional state. (Level III/IV)
- Water quality should be stringently monitored
LAL if testing is available (Level B)

CSN-Canada

EBPG-Europe
2002

• Pure water minimum (European Pharmacopoeia): cfu < 100/mL; Endotoxin (LAL) < 0.25 IU/mL  (Level C)

• Ultrapure water: cfu < 0.1/mL; Endotoxin < 0.03 IU/mL

Guideline IV.1 Water treatment system

- Check at least weekly during the validation phase and at least monthly during maintenance
- Ultrapure water strongly recommended for conventional and high-flux membranes

KDOQI-US

UK-Guidelines
2002

• The limits for bacterial counts (100 cfu/ml) and endotoxin (0.25 IU/ml) are based on the European Pharmacopoeia (3) and the European Renal Association Best Practice Guidelines (4). (Good practice)

Haemodialysis Guideline 3: Concentrates and water for haemodialysis

- New equipment should be capable of producing ‘ultrapure’ dialysis fluid (bacterial counts <0.1 cfu/ml and endotoxin <0.03 IU/ml) in order to meet the best practice guidelines. (Good practice)