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Key features

Dialysis fluid purity

The quality and purity of dialysis fluids are of major concern in modern renal replacement therapies as large volumes of dialysis fluid come into contact with the patient’s bloodstream. Dialysis fluids may contain microbial impurities such as endotoxins derived from bacterial fragments. Endotoxin fragments may have molecular weights well below 2000Da - small enough to pass across both low and high flux membranes (Figure 1). Endotoxins are known to cause acute adverse reactions and promote long-term complications in hemodialysis patients1,2.

In order to avoid endotoxin related complications during routine hemodialysis, the European Best Practice Guidelines for Hemodialysis (EBPG)3 strongly recommend the usage of ultrapure water. Ultrapure water or dialysis fluid can easily be achieved through the application of special dialysis fluid filters – such as DIASAFE®plus. 

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.

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

DIASAFE Plus
Fresenius Polysulfone

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! 

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

Performance data

DIASAFE®plus dialysis fluid filters


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