Ultrapure Dialysis Water: Is it really pure? (original) (raw)

The quality of dialysis water

Nephrology Dialysis Transplantation, 2003

Introduction. Every week, haemodialysis patients are exposed to 400 l of water used for the production of dialysis fluids which, albeit with the interposition of a semi-permeable artificial membrane, come into direct contact with the bloodstream. It is therefore clearly important to know and monitor the chemical and microbiological purity of dialysis water. Methods. In this review, we analyse the sources of chemical and microbiological water contamination, and the problems involved in water purification systems and modalities. We also analyse the compliance of dialysis units with the microbiological standards established by the most widely accepted guidelines relating to the quality of dialysis fluids. Results. The risk of chemical contamination is due mainly to the primary pollution of municipal water, whereas the most important microbiological problem is the control of bacterial growth in the water treatment and distribution system. Dialysis water treatment implies various levels of pre-treatment, a final purification module (which, in many cases, is reverse osmosis: RO) and a hydraulic circuit for the distribution of the purified water. RO-based treatment systems produce water of optimal chemical and microbial quality, and so dialysis units need to concentrate on maintaining this quality level in the long term by means of effective maintenance and disinfection strategies. The most widely accepted standards for water purity are those recommended by the Association for the Advancement of Medical Instrumentation and the European Pharmacopea, which respectively allow bacterial growth of <200 and <100 c.f.u./ml, and an endotoxin concentration of <2 and <0.25 IU/ml. However, a number of multicentre studies have reported that 7-35% of water samples have bacterial growth of >200 c.f.u./ml, and up to 44% have endotoxin levels of >5 IU/ml.

Standard on Microbiological Management of Fluids for Hemodialysis and Related Therapies by the Japanese Society for Dialysis Therapy 2008

Therapeutic Apheresis and Dialysis, 2009

The Committee of Scientific Academy of the Japanese Society for Dialysis Therapy (JSDT) proposes a new standard on microbiological management of fluids for hemodialysis and related therapies. This standard is within the scope of the International Organization for Standardization (ISO), which is currently under revision. This standard is to be applied to the central dialysis fluid delivery systems (CDDS), which are widely used in Japan. In this standard, microbiological qualities for dialysis water and dialysis fluids are clearly defined by endotoxin level and bacterial count. The qualities of dialysis fluids were classi-fied into three levels: standard, ultrapure, and online prepared substitution fluid. In addition, the therapeutic application of each dialysis fluid is clarified. Since highperformance dialyzers are frequently used in Japan, the standard recommends that ultrapure dialysis fluid be used for all dialysis modalities at all dialysis facilities. It also recommends that the dialysis equipment safety management committee at each facility should validate the microbiological qualities of online prepared substitution fluid. Key Words: Bacteria, Central dialysis fluid delivery system, Endotoxin, Standard of fluid for hemodialysis.

Bacteria- and Endotoxin-Free Dialysis Fluid for Use in Chronic Hemodialysis

Artificial Organs, 1994

As the quality of water in the dialysis fluid varies considerably, dialysis fluid is contaminated with a high percentage of bacteria and endotoxins. The bacterial populations contained in the dialysis fluid are as heterogeneous as the chemical structure of the endotoxins that result. The latter can pass through the dialysis membrane whereby high-flux membranes permit a larger number of retransportable molecules than low-flux membranes. A central aim toward a future, safe dialysis process should, therefore, be the production of a dialysate that is free of bacteria and endotoxins. As we were able to demonstrate

Section IV. Dialysis fluid purity

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2002

From the early days of dialysis it is known that water used for haemodialysis must be purified in order to prevent severe clinical side effects due to contamination of the water [3-8]. In brief, this means that all water contaminants (particles, dissolved substances such as ions, trace elements, organic substances, nitrogen compounds, and microorganisms) should be removed prior to entering the dialysis machine.

Water Treatment for Hemodialysis: A 2005 Update

Contributions to Nephrology, 2005

Water for dialysis represents an additive risk factors to the cbronic infammatory state documented in patients on ESRD. The possibility of sustaining proinflammatory cytokines trough microbial derived products, coming.from dialysate or infused solutions, is enhanced by biofilm presence on piping and on water treatment system or monitor components. Spread use of reverse osmosis, loop distribution system and pre-treatment components tailored to local raw water characteristics bave greatly contributed to a generaI improvement in final water quality. Notwithstanding these contributions literature stilI reports fatal accidents or significant percentage of dialysis units not complying to the water quality standards. Technological improvement lowers chemical contamination but microbial quality relays more on quality assurance programs than on technology. Optimal water quality represents part ofthe anti-inflammatory strategies we need to assure to our dialysis patients to improve outcome.