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The different purity levels of pure and ultrapure water according to the European Best Practice Guidelines for Hemodialysis

Pure water

Ultrapure water

Microbial contaminations (CFU/mL)

≤ 100

< 0.1

Bacterial endotoxins (IU/mL)

< 0.25

< 0.03

Chronic inflammation

Endotoxins can activate immune component cells in a number of ways, thereby contributing to chronic inflammation that is present in all hemodialysis patients4. Evidence demonstrates that chronic inflammation is a major risk factor for progressive atherosclerotic cardiovascular disease (CVD)5.

The usage of ultrapure dialysis fluid has been shown to reduce markers of chronic inflammation in hemodialysis patients6, therefore it is suggestive that ultrapure dialysis fluid has a beneficial effect on inflammatory diseases such as atherosclerotic CVD7.

Chronic inflammation

Endotoxins (LPS) stimulate the release of pro-inflammatory cytokines, reactive oxygen species and lipid-mediators from immune-competent cells.

Oxidative stress

Several treatment related stimuli, including bacterial endotoxins derived from dialysis fluid8,9 can increase oxidative stress — a situation in which the normal balance between production of reactive oxygen species (ROS) and antioxidant activity is tilted in favour of ROS. As oxidative stress is associated with the progression of malnutrition, anemia and inflammatory diseases such as atherosclerosis, the usage of ultrapure dialysis fluid to reduce dialysis induced oxidative mechanisms appears desirable8,9.

Advanced Glycation End Products (AGE)

The importance of ultrapure dialysis fluid in routine hemodialysis treatments is emphasized by the finding that endotoxins act in synergy with advanced glycation end products (AGE), which enhance inflammation and oxidative stress10. The use of ultrapure dialysis fluid has further been shown to reduce the plasma levels of the AGE compound pentosidine11.

Anemia treatment

Ultrapure dialysis fluid has been shown to improve iron utilization and the response to erythropoietin, meaning it could be beneficial in anemia treatment by allowing for a reduced erythropoietin dosage while maintaining optimal hemoglobin levels12,13.

Technology

Technology Technology
Technology Technology

DIASAFE®plus - a key step towards good dialysis practice

Although water used for the production of dialysis fluid is treated by a series of purification steps, it still may not meet the stringent requirements on bacterial contamination levels laid down by regulatory bodies. Located at the end of the water treatment chain, the DIASAFE®plus filter ensures required purity levels can be achieved easily through the reliable production of ultrapure dialysis fluid to ISO Standards. The DIASAFE®plus incorporates the Fresenius Polysulfone® membrane which has excellent endotoxin retention capabilities due to the superior adsorptive and sieving characteristics of the membrane. The extended surface area of 2.2m² further extends the adsorption and retention capacity.

Hygienic, fast and easy installation and exchange 

The DIAFIX™ lock system provides an easy and hygienic connection of the DIASAFE®plus to the dialysis machine with only three handling steps necessary for installation or exchange:

  1. Open the locks of the filter holder
  2. Slide DIASAFE®plus filter into the guide grooves
  3. Close the locks - DIASAFE®plus is ready to use. It’s that easy! 
Hygienic, fast and easy installation and exchange

DIASAFE®plus can be connected with three rapid handling steps only. The DIAFIX™ lock system provides an easy and hygienic connection.

DIASAFE®plus in the ONLINEplus™system

  • Ultrapure dialysis fluid prepared with DIASAFE®plus, together with hemodialyzers containing endotoxin retaining membranes (Fresenius Polysulfone®, Helixone® or Helixone®plus) are the main building blocks for a high quality hemodialysis treatment
  • The ONLINEplus™ system takes the quality standards of convective treatment modalities such as hemodiafiltration / hemofiltration (HDF/HF) one step further
  • Reliable production of sterile and non-pyrogenic substitution fluid is achieved by double filtration for ONLINE HDF/HF therapies, when using two DIASAFE®plus fluid filters in series14
  • Besides improving hygiene and safety of convective therapy modalities, the ONLINEplus™ option also offers additional treatment features and easier handling
DIASAFE®plus in the ONLINEplus™system

Schematic flow chart of ONLINE hemodiafiltration with the ONLINEplus™system.

Performance data

DIASAFE®plus dialysis fluid filters

Membrane material

Fresenius Polysulfone®

Effective Surface (m²)

2.2

Weight (g)

170

Housing material

Polypropylene

Potting material

Polyurethane

Sealings

Silicone

Connection to machine

DIAFIX™ Lock System

Filtration rate

5 mL/min x mm Hg (3.75 L/min bar; max. 2 bar)

Operating time

Standard HD: max. 12 weeks or 100 treatments ONLINE HF/HDF, ONLINE priming/rinsing: max.12 weeks or 100 treatments

Disinfection

Puristeril® 340 or Puristeril®plus (peracetic acid)
Diasteril® (hydroxyacetic acid) or Citrosteril® (citric acid)
Sporotal®100 (sodium hypochlorite) max. 11 times

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1 Dasgupta MK: Biofilms and infection in dialysis patients. Seminars in Dialysis 15: 338-346, 2002.

2 Brunet P and Berland Y: Water quality and complications of haemodialysis. Nephrology Dialysis Transplantation 15: 578-580, 2000.

3 European Best Practice Guidelines for Haemodialysis (Part 1), Section IV – Dialysis fluid purity. Nephrology Dialysis Transplantation 17 (Suppl. 7): 45-62, 2002.

4 Ward DM: Hemodialysis water: an update on safety issues, monitoring and adverse clinical effects. ASAIO American Society for Artificial Internal Organs 50 (6): XIII-XIX, 2004.

5 Yao Q et al.: Inflammation as a cause of malnutrition, atherosclerotic cardiovascular disease and poor outcome in hemodialysis patients. Hemodialysis International 8: 118-129, 2004.

6 Schiffl H et al.: Effects of ultrapure dialysis fluid on nutritional status and inflammatory parameters. Nephrology Dialysis Transplantation 16: 1863-1869, 2001.

7 Lonnemann G: When good water goes bad: how it happens, clinical consequences and possible solutions. Blood Purification 22: 124-129, 2004.

8. Locatelli F et al.: Oxidative stress in end-stage renal disease: an emerging threat to patient outcome (consensus paper). Nephrology Dialysis Transplantation 18: 1272-1280, 2003.

9 Ward RA and McLeish KR: Oxidant stress in hemodialysis patients: what are the determining factors? Artificial Organs 27: 230-236, 2003.

10 Reznikov LL et al.: Effect of advanced glycation end products on endotoxin-induced TNF-a, IL-1 and IL-8 in human peripheral blood mononuclear cells. Clinical Nephrology 61: 324-336, 2004.

11 Izuhara Y et al.: Ultrapure dialysate decreases plasma pentosidine, a marker of carbonyle stress. American Journal of Kidney Diseases 43: 1024-1029, 2004.

12 Sitter T et al.: Dialysate related cytokine induction and response to recombinant human erythropoietin in hemodialysis patients. Nephrology Dialysis Transplantation 15: 1207-1211, 2000.

13 Hsu PY et al.: Ultrapure dialysate improves iron utilisation and erythropoietin response in chronic haemodialysis patients – a prospective cross-over study. Journal of Nephrology 17: 693-700, 2004.

14 Weber C et al.: Novel online infusate-assisted dialysis system performs microbiologically safely. Artificial Organs 24: 323-328, 2000.