Hemodialysis Water Quality Research Articles

Endotoxin quality of ultrapure dialysis fluid for online hemodiafiltration in several hemodialysis centers

Globally, the nephrology community is seeing a rise in the use of high-flux membranes and ultrapure water in hemodialysis (HD) machines. However, data on HD water quality could be more extensive in low- and middle-income countries. The Ministry of Health in Iraq issued a rule requiring a gradual modification in the HD water treatment system to adopt ultrapure water in all dialysis centers. The current study aimed to monitor the endotoxin of ultrapure dialysis fluid at several centers in Iraq and the clinical benefits of its use. This work evaluated the quality of ultrapure water used for dialysis in twenty-one dialysis centers within various Iraqi province hospitals. The samples were collected for 4 months from January to April 2022. Endotoxin tests in ultrapure dialysis fluid were measured by Gel Clot assay. Results showed an unacceptable difference in the ultrapure dialysis fluid's quality compared to the international standard (ANSI/AAMI/ISO-23500). Endotoxin levels in 33% of ultrapure dialysis fluid above 0.03 EU/ml, exceeding recommended international standards. The findings highlight the importance of assessing water quality in medical facilities to ensure patient safety and encourage sanitary monitoring of this procedure as a healthcare promoter. Keywords: Ultrapure water; Hemodiafiltration; Dialysis fluid; Endotoxin; Public Health Reform.

Evaluation of Some Chemical Parameters of Hemodialysis Water: A Case Study in Iran.

One of the most common diseases in the world is kidney failure, which can lead to the death of patients. Hemodialysis is a treatment for patients whose kidneys are failing. The water used to perform dialysis must be healthy, safe, and clean. This study aimed to investigate the concentration of heavy metals in hemodialysis water in one of the Hospitals in Iran and compare it with European Pharmacopeia (EPH) and Association for the Advancement of Medical Instrumentation (AAMI) standards. The present study is a descriptive-analytical study conducted on the inlet water of hemodialysis machines in hospital. The samples were collected for 3 months from June to September 2021, Which was examined in terms of free residual chlorine, electrical conductivity, pH, and calcium, magnesium, sodium, aluminum, zinc, copper, and lead concentration. Metals concentration in hemodialysis water was measured by Inductively Coupled Plasma Mass Spectrometry (ICP-MS) technique. The average value of parameters such as electrical conductivity, pH, residual free chlorine, sodium, calcium, magnesium, zinc, copper and lead in the hemodialysis water was less than the AAMI and EPH standards limits. There was a significant difference at the 95% confidence level with the standard limits, but the aluminum concentration was higher than the standard limits. Also, by examining the medical files of dialysis patients, the most observed problems were anemia and bone diseases, which are probably caused by exposure to high concentrations of aluminum in hemodialysis water. In present study the aluminum concentration is higher than the standard limits. Considering that the higher aluminum concentration can cause diseases such as anemia, bone diseases, nervous deterioration, and death in hemodialysis patients, therefore, it is recommended to continuously evaluate and monitor the quality of hemodialysis water and the performance of its treatment system.

Analysis of hemodialysis water quality from 2008 to 2016 in Minas Gerais, Brazil

Water quality requirements for hemodialysis are crucial for preventing health risks for renal patients. Theobjective of this study was to assess the quality of the water used for hemodialysis treatments in the state ofMinas Gerais. The analytical results for 25 parameters in 1056 hemodialysis water samples from 89 renaldialysis units were analyzed. Data were obtained through the Minas Gerais Hemodialysis Unit QualityMonitoring Programme between July 2008 and December 2016. The effects of the Programme on patienthealth protection were assessed by evaluating compliance with legal limits and the efficacy of implementinginspections from 2012. Considering the 1056 samples analyzed, 264 (25%) presented at least one parameterin disagreement with current legislation. Conductivity (9.8%), endotoxin (6.9%), fluoride (4.2%) andheterotrophic bacteria (2.2%) were the most critical parameters. Nevertheless, the concentrations of all theseparameters (except fluoride) decreased after implementing inspections. The average levels of 15 parametersdecreased throughout the study period. The annual percentage of non-compliance decreased from 44% in2008 to 23% in 2016. It was verified the relevance of the implementation of the Program in the prevention ofpossible disorders to the patients’ health, indicating the importance of its continuity.

Qualidade da água da hemodiálise do Hospital Regional de Ilha Solteira, SP

Na hemodiálise, que é a filtragem das impurezas do sangue por processo terapêutico mecânico ao qual são submetidas pessoas com perda da função renal, é usada grande quantidade de água, que deve ser idealmente pura, livre de quaisquer agentes contaminantes. Em Ilha Solteira, SP, a unidade de hemodiálise possui 21 máquinas para realizar as sessões e atende 83 pacientes. Esta pesquisa visou avaliar a qualidade da água de hemodiálise do Hospital Regional de Ilha Solteira, pela comparação das características apresentadas, e os atuais parâmetros físico-químicos e bacteriológicos da água utilizada no tratamento de pacientes renais, além de observar se os aspectos legais estão sendo cumpridos. A metodologia utilizada foi a pesquisa exploratório-descritiva com busca de informações bibliográficas e documentais com foco em leis ou normas ligadas ao tratamento da água para hemodiálise e coleta de dados microbiológicos e físico-químicos nos registros do setor de hemodiálise do hospital pesquisado nos meses de janeiro a dezembro de 2017. Para a coleta de dados, foram definidos quatro pontos de amostra para análise. Os dados obtidos atenderam o padrão para parâmetro de bactérias heterotróficas. Não foram detectadas impurezas na água observada, entre elas, coliformes termotolerantes. Os resultados físico-químicos mostraram valores compatíveis com a legislação e apontaram bom funcionamento da membrana da osmose reversa, evitando complicações aos pacientes.

Assessment of microbial contamination levels of water in hemodialysis centers in Baghdad, Iraq.

Monitoring water quality in hemodialysis systems is extremely important to maintain adequate quality services for patients suffering from kidney failure. This work aims to examine and evaluate bacteriological characteristics and endotoxin contamination levels in hemodialysis water produced in dialysis centers. Forty-eight water samples were collected and analyzed from four major hospitals in Baghdad for one year to evaluate seasonal effects. The analysis included the determination of total heterotrophic bacteria using the pour plate method, identification of bacterial isolate using the Vitek2 compact instrument, and the determination of endotoxins levels using Limulus amebocyte lysate (LAL) method. In addition, tap water samples (a source for the hemodialysis water) were also examined bacteriologically. Results showed that 44% of the tested samples for bacterial levels are higher than the maximum value of (100CFU/ml) set out by the international standards. Endotoxin values for these centers fluctuated during the study period, and 44% of them exceeded the international standards (>0.25 EU/ml). These results call for applying improved technology to modify the existing water treatment units for better control and for national standardization of the microbiological quality of hemodialysis water. PRACTITIONER POINTS: Four hemodialysis centers were assessed by measuring the bacteriological and endotoxins levels of their feed and product water. Product water showed elevated levels of bacteria that exceeded the international guideline value of 100CFU/ml. Most of the identified bacterial species were Gram-negative that arise the possibility of contributing to endotoxin generation. Product water showed fluctuated values of endotoxins. About 44% of the measured samples were higher than the international guideline values of 0.25 EU/ml.

Hemodialysis Water Parameters as Predisposing Factors for Anemia in Patients in Dialytic Treatment: Application of Mixed Regression Models.

Contamination by metals and microbiological agents in hemodialysis water can cause clinical intercurrences in hemodialysis patients. Evaluating and assuring minimum levels of contamination from metals and microorganisms in hemodialysis water can improve patient safety. The objective of this study was to assess hemodialysis water quality in a major tertiary hospital in Brazil and investigate the relationship between hemodialysis water quality and clinical intercurrences in hemodialysis patients. A prospective-observational cohort study for evaluation of water quality parameters and clinical intercurrences present by patients (n = 52) were performed from May 2014 to April 2015. Mixed linear regression models and binary regression models were fitted for water quality parameters and patients' clinical parameters. The increase in the levels of copper and nitrate in hemodialysis water was significant (p < 0.05) to explain anemia. Bone pain was related to age, sex (female), and hemodialysis treatment duration (years). Hypotensive episodes were related to serum sodium decrease. Aluminum in hemodialysis water was present in an average concentration higher than the permitted threshold (15.35 ± 14.53μg/L). Cadmium, total coliforms, Escherichia coli, and endotoxins in hemodialysis water were not detected and the heterotrophic bacteria count was below the reference limit. These parameters' concentrations varied during the study, evidencing the need for continuous monitoring.

Profiling Total Viable Bacteria in a Hemodialysis Water Treatment System

Culture-dependent methods, such as heterotrophic plate counting (HPC), are usually applied to evaluate the bacteriological quality of hemodialysis water. However, these methods cannot detect the uncultured or viable but non-culturable (VBNC) bacteria, both of which may be quantitatively predominant throughout the hemodialysis water treatment system. Therefore, propidium monoazide (PMA)-qPCR associated with HPC was used together to profile the distribution of the total viable bacteria in such a system. Moreover, high-throughput sequencing of 16S rRNA gene amplicons was utilized to analyze the microbial community structure and diversity. The HPC results indicated that the total bacterial counts conformed to the standards, yet the bacteria amounts were abruptly enhanced after carbon filter treatment. Nevertheless, the bacterial counts detected by PMA-qPCR, with the highest levels of 2.14 × 107 copies/100 ml in softener water, were much higher than the corresponding HPC results, which demonstrated the occurrence of numerous uncultured or VBNC bacteria among the entire system before reverse osmosis (RO). In addition, the microbial community structure was very different and the diversity was enhanced after the carbon filter. Although the diversity was minimized after RO treatment, pathogens such as Escherichia could still be detected in the RO effluent. In general, both the amounts of bacteria and the complexity of microbial community in the hemodialysis water treatment system revealed by molecular approaches were much higher than by traditional method. These results suggested the higher health risk potential for hemodialysis patients from the up-to-standard water. The treatment process could also be optimized, based on the results of this study.

The Quality of Dialysis Water: A Case Study in the Educational Hospitals of Yazd, Iran

Background: The chemical and physical quality of water used for dialysis fluid is a vital factor in the patients overall care who receive dialysis. Therefore, the water used for this purpose must be treated with advanced methods before being used for dialysis. Objectives: The current study aimed to determine the chemical and physical quality of dialysis machines input water and compare it to the standards of Association for the advancement of medical instrumentation (AAMI) and European Pharmacopeia (EPh) in Yazd educational hospitals, i.e. Shahid Sadoughi and Shahid Dr. Rahnamoon. Materials and Methods: This cross-sectional study is performed in three months (October to December) in 2013. This research was conducted on 24 samples of dialysis machines input water. The samples were tested by titrimetric method, turbid metric method, flame photometer, pH meter, and EC meter. The SPSS V16.0 software was used for statistical analyses. Results: Based on results of the research, except chloride that its mean concentration was higher than the EPh standard, mean concentrations of cations and other compounds were significantly less than the standards (P < 0.01). Also there was a significant difference between the measured parameters in the dialysis machines input water in two educational hospitals with 99% confidence. Conclusions: The evaluation of hemodialysis water quality showed that these hospitals were not significantly polluted and the water quality complied with AAMI and EPh standard limits.

Microbial quality of hemodialysis water, a survey of six centers in Lagos, Nigeria

Patients with end-stage kidney disease (ESRD) on maintenance hemodialysis (HD) are usually exposed to large volumes of dialysate, which is separated from patients' blood only by thin membrane of dialyzer. It is therefore essential to frequently monitor the quality of HD water to ensure that it meets the recommended standards. The objective of this study was to evaluate the microbial quality of HD water in Lagos, Nigeria. Four sets of pre- and post-treatment water samples, 20 mL each, were collected from six HD centers in Lagos and tested for microbial contamination using the molten Tryptic soy agar in accordance with Association for Advancement of Medical Instrumentation (AAMI) and European Best Practice Guidelines (EBPG). Pyrogen tests were also conducted on pre- and post-treatment samples using standard technique. Information on water treatment modalities, maintenance practices and quality control measures in each center were obtained using a questionnaire. All centers use treated water for HD purpose. None of the HD centers met EBPG/AAMI guidelines for microbial contaminants as the mean levels of Escherichia coli in both feed and treated water were 441.7 ± 87.90 and 168.5 ± 64.03, respectively. E. coli was the commonest organism isolated in both feed and treated water in all the centers. HD water quality is still a neglected problem in our environment and more efforts are required to ensure good water quality for HD purpose.

Prevent infection linked to the dialysis water in a hemodialysis center in Fez city (Morocco)

BackgroundWater treatment systems are a critical variable in dialysis therapy. Rigorous control of hemodialysis water quality is particularly important in order to guarantee a better quality of life of the hemodialysis patients. The objective of the study was to evaluate the chemical, microbiological quality and antimicrobial resistance of bacteria isolated from water and dialysate in a public HD center.MethodsFifty five samples of water and dialysate were collected weekly over a period of 4 months. The samples were collected from 4 points in the distribution loop. The microbiological and chemical analyses were performed according to our national standards. Antimicrobial susceptibilities patterns of isolated bacteria were determined by disk diffusion method.ResultsThe chemical and microbiological parameters in all dialysis water and dialysate samples are in accordance with national standards. However, 70 Gram-negative bacteria were identified: Pseudomonas sp, Ochrobactrum antropi and Burkholderia cepacia, isolated at 52.8%, 12.8% and 17% simultaneously. Fourteen per cent of the isolates were resistant to three or more antibiotics. All resistant bacteria belong to the genus of Pseudomonas, 80% were resistant to tetracycline and to co-trimoxazole, 30% to ceftazidime. No colistin and imipenem resistance was observed.ConclusionTo avoid a health risk due to bacterial contamination, an adequate system for water treatment, disinfection of the hemodialysis system and microbiological monitoring of the water and dialysate are necessary.

Quality of hemodialysis water in a resource‐poor country: The Nigerian example

Hemodialysis (HD) patients are exposed to large volumes of water, separated from patients' blood by semipermeable membrane of dialyzers. Chemical contaminants in poorly treated water impact negatively on quality of life of these patients. This survey was carried out to assess the HD water quality in Lagos, Nigeria. Ten milliliters of feed and treated water from all six HD centers in Lagos were tested for aluminum, copper, zinc, magnesium, calcium using atomic absorption spectrometry; sodium and potassium were tested using flame photometry, fluoride with molecular photoluminescence method; sulfate using turbidimetry, nitrates measured by cadmium column reduction method, chloramines and free chlorine were measured using N, N-diethyl-1-P-phenylenediamine colorimetric method. Information on sources of feed water, frequency of testing of HD water, methods of water treatment, type of water purification system and maintenance was also obtained. All centers used borehole as main source of water supply. None of the centers met Association for the Advancement of Medical Instrumentation (AAMI) guidelines for most chemical contaminants. Only chlorine (0.48 ± 0.07 mg/L) and potassium (3.9 ± 0.95 mg/L) levels met AAMI standards after treatment. Mean levels of chemical contaminants in treated water were as follows: aluminum 0.04 ± 0.01 mg/L, zinc 0.27 ± 0.08 mg/L, chloramines 0.16 ± 0.03 mg/L, fluoride 1.83 ± 0.40 mg/L, sulfate 117 ± 86.1 mg/L which were mildly elevated; calcium 126.00 ± 22.7 mg/L, sodium 179 ± 25.6 mg/L, and nitrate 70.5 ± 50.8 mg/L, which were markedly elevated; and magnesium 8.3 ± 3.38 mg/L, which was moderately elevated above AAMI recommended levels. HD water quality is poor in our environment. Concerted efforts are required to ensure good quality water for HD.

Quality of hemodialysis water: A 7-year multicenter study

Since dialysis was introduced 30 years ago, constant progress in technology permitted shortening the length of hemodialysis (HD) sessions. Through growing concerns about the inadequacy of tap water for dialysate production, hospitals soon opted for water treatment systems dedicated to HD. Nonetheless, persistent bacterial contamination and the occurrence of pyrogenic reactions were reported in some HD centers. Several factors contributing to this situation were identified. After the introduction of highly permeable synthetic membranes in the late 1970s, microbiologic problems reappeared. Thus, in 1977, the Centers for Disease Control and Prevention (CDC) issued proposed guidelines for HD water quality, followed in 1981 by an American National Standard for HD water, issued by the Association for the Advancement of Medical Instrumentation (AAMI). This Standard was also followed in Canada up to 1986, at which time a National Standard for Canada was released by the Canadian Standards Association (CSA). This prompted the Laboratoire de santé publique du Québec (LSPQ) to implement in the Province of Québec a voluntary HD water quality monitoring program. All 36 HD centers in the Province agreed to participate. The program was launched in February 1987. Water was sampled monthly for bacteria over a 7-year period (February 1987 to January 1994), and every 3 months for pyrogen and chemicals. Participation was more than 95%. Bacteriologic samples were processed in duplicate on heterotrophic plate count agar by the pour plate technique. Incubation was for 48 ± 3 hours at 35 ± 0.5°C, and the colonies were counted on a Quebec colony counter (New Brunswick Scientific Co, New Brunswick, NJ). Pyrogen determinations were made using the limulus amebocyte lysate (LAL) test on 1:20 sample dilution by the gel-clot method. Chemical elements were measured by inductively coupled plasma emission, graphite furnace absorption, conductivity, ultraviolet light absorption, or colorimetry. Only fully treated HD water samples were selected from the 11,000 water samples received. Of the 5,820 samples retained for this study, 3,547 were for bacterial, 1,112 for pyrogen, and 1,161 for chemical analyses. Overall compliance to the CSA Standard was 70% for bacteria, 56% for pyrogen, and 86% for chemistry. The performance of different types of water treatments were compared and discussed; the best overall compliance was obtained by reverse osmosis combined with deionization (RO + DI). The type of water treatment that proved most popular was RO alone, which was used by 22 HD centers (61%). It was concluded that current technology made it possible to produce treated water that regularly met all the requirements of the CSA Standard for HD purposes. To achieve this, a rigorous disinfection and maintenance program of all the components in the water treatment system was primordial. We recommend reformulating the maximum acceptable limit of the CSA Standard for bacteriology, as well as allowing use of nutrient-poor media in an effort to improve bacterial recovery from treated water samples.

FDA Issues Alert on Hemodialysis Water Quality Systems

FDA Issues Alert on Hemodialysis Water Quality Systems