Bacteria- and Endotoxin-Free Dialysis Fluid for Use in Chronic Hemodialysis (original) (raw)
Related papers
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.
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.
The International journal of artificial organs, 2005
Poor water properties, use of concentrated bicarbonate, and biofilm growth in pipes and storage tanks often cause dialysis water and dialysate contamination with bacteria and endotoxins. High-flux dialysis with bicarbonate may favor endotoxin transfer from the dialysate into the blood exposing patients to serious short-and long-term side effects. Ultrafiltration across hydrophobic synthetic membranes effectively removes endotoxins from dialysis water by combined filtration and adsorption. However, repeated sterilization worsens the membrane separation properties,and limits their use. Ceramic membranes are generally more resistant to harsh operating conditions than polymeric membranes, and may represent an alternative for endotoxin removal. Previously, we proved that the ceramic membranes commercially available at that time were not retentive enough to ensure production of endotoxin-free dialysis water. In this paper, we investigated the endotoxin removal capacity of new generation c...
We measured endotoxin and bacterial levels in tap water, in water purified by reverse osmosis, and in dialysate samples over a 4-month period in a new 10-bed renal dialysis unit. Water treated by reverse osmosis is conducted to the 10 stations through 111 m of piping composed of acrylonitrile butadiene styrene (ABS). All determinations were made prior to the opening of the unit and after the system was purged for 35 h with all bedside station taps open. Formaldehyde disinfection of the piping system was attempted with a recommended protocol after 11 weeks by feeding 2.5 liters of 37% formaldehyde (0.85%, vol/vol) into the delivery system. Prior to water purging, 24 ng of endotoxin per ml was detected. This level decreased to 2.0 ng of endotoxin after the purging. Levels of endotoxin remained below 1.0 ng of endotoxin per ml throughout the duration of the study. In contrast, the level of viable microorganisms recovered from the treated water was approximately 3.5 x 104 CFU/100 ml. Even after disinfection of the system, there was no significant decrease in culturable bacteria from the water even though endotoxin levels were lower. Species isolated from the renal dialysis system were predominately pseudomonads, whereas species isolated from the tap water were Bacillus and Flavobac-terium species. ABS provides a surface suitable for long-term colonization and growth of bacteria. Currently recommended decontamination protocols are ineffective in removing potentially pathogenic bacteria from ABS pipes and thus constitute an increased risk to patients undergoing dialysis.
Bacteriological Qualities of Dialysis Fluid in Japan as of 31 December 2006
Therapeutic Apheresis and Dialysis, 2008
The Japanese Society for Dialysis Therapy (JSDT) collected the data from 3488 dialysis facilities about the status of bacteriological qualities and quality controls for dialysis fluid as of 31 December 2006. The data included the endotoxin (ET) levels, bacterial counts and usage of ET retentive filters (ETRFs). It was found that ET level measurements were performed in 2873 facilities (82.4%). The JSDT standard for ET level in dialysis fluid (<0.050 EU/mL) was achieved in 89.0%, and an ET level less than 0.001 EU/mL was achieved in 29.8%; however, bacterial counts were examined in only 1049 facilities (34.1%). The JSDT standard for the bacterial cell count in dialysis fluid (<100 cfu/mL) was achieved in 96.9%, and a count of 0.1 cfu/mL, which guarantees ultra-pure dialysis fluid, was achieved in 48.4%. ETRFs were installed in 78.5% of all facilities and in 53.4% of all dialysis machines. Although the JSDT standard is the most stringent in the world, the compliance rate was excellent. Bacteriological water qualities of dialysis fluid are extremely high in most Japanese dialysis facilities and this might have a close relationship to the high dialysis patient survival rate in Japan.
Comparison of techniques for culture of dialysis water and fluid
Introduction Microbiological culture of dialysis water and fluid is a routine safety measure. In the United States (U.S.), laboratories perform these cultures on trypticase soy agar at 35–378C for 48 h (TSA-48h), not on the tryptone glucose extract agar or Reasoner's 2A agar at 17–238C for 7 days (TGEA-7d and R2A-7d, respectively) recommended by international standards. We compared culture methods to identify samples exceeding the accepted action level of 50 CFU/mL. Methods Dialysis water and fluid samples collected from 41 U.S. dialysis programs between 2011 and 2014 were cultured at two U.S. laboratories. Each sample was cultured using (1) either TGEA-7d or R2A-7d and (2) TSA-48h. We compared proportions exceeding the action level by different methods and test characteristics of TSA-48h to those of TGEA-7d and R2A-7d. Findings The proportion of water samples yielding colony counts 50 CFU/mL by TGEA-7d was significantly different from the proportion by TSA-48h (P 5 0.001; difference in proportion 4.3% [95%CI 1.3–7.3%]). The proportions of dialysis fluid samples 50 CFU/mL by TGEA-7d and TSA-48h were not significantly different; there were no significant differences for comparisons of R2A-7d to TSA-48h. Discussion In dialysis fluid, TSA-48h was comparable to TGEA-7d and R2A-7d in identifying samples as having bacterial counts 50 CFU/mL. In dialysis water, TSA-48h was comparable to R2A-7d in identifying samples 50 CFU/mL, but TGEA-7d did yield significantly more results above 50 CFU/mL. Nonetheless, the negative predictive value of a TSA-48h result of <50 CFU/mL in dialysis water exceeded 95%.
The Dialyzer as the Last Line of Protection against Endotoxins
Updates on Hemodialysis [Working Title]
When dialysis fluid is contaminated with endotoxins, the dialyzer membrane is often referred to as the last line of protection to prevent endotoxins from entering the patient’s blood. However, a quantifiable requirement for this endotoxin retention property of the membrane has not yet been defined. The ANSI/AAMI/ISO 23500 standard series provides the framework for the microbiological quality of dialysis water, concentrates, and dialysis fluid, and defines the limit value for the non-pyrogenic endotoxin dose. After defining the boundary conditions of the endotoxin loading of the membrane by dialysis fluid and the patient’s non-pyrogenic endotoxin dose, quantifiable requirements for the endotoxin retention properties of a membrane, expressed as a dimensionless logarithmic retention value (LRV), were developed in this work. Based on standard dialysis fluid quality, the LRV should minimally be two for a protein-coated membrane after contact with patient blood and minimally be one for a ...