Maintaining Water Quality For Hemodialysis - UpToDate

4/24/2018 Maintaining water quality for hemodialysis - UpToDate
Official reprint from UpToDate®
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Maintaining water quality for hemodialysis
Authors: Nicholas Hoenich, PhD, Richard A Ward, PhD
Section Editor: Steve J Schwab, MD
Deputy Editor: Alice M Sheridan, MD
All topics are updated as new evidence becomes available and our peer review process is complete.
Literature review current through: Mar 2018. | This topic last updated: Jul 14, 2016.
INTRODUCTION AND BACKGROUND — Water is required for hemodialysis. Hemodialysis patients are
vulnerable to contaminants in the water used to prepare concentrate and dialysis fluid or in water used for
reprocessing dialyzers. This vulnerability is due to the following:
● Hemodialysis patients are exposed to extremely large volumes of water. The estimated water intake of a
healthy individual is 2 L per day or 14 L per week. By comparison, during a single dialysis treatment
lasting four hours, performed at a dialysis fluid flow rate of 800 mL/min, a hemodialysis patient is exposed
to 192 L of water or to 576 L per week, if treated three times weekly.
● Hemodialysis patients have inadequate barriers to waterborne contaminants. In healthy individuals who
are not on dialysis, the gastrointestinal tract separates blood from contaminants in the water. By
comparison, the barrier between blood and water in hemodialysis patients is the membrane within the
hemodialyzer through which transfer of contaminants is limited only by the size of the contaminant.
● Hemodialysis patients are unable to renally excrete any contaminants taken up from the dialysate.
No municipal water can be considered safe for use in hemodialysis applications in the absence of a treatment
system. All dialysis facilities therefore require an appropriately designed and correctly maintained water
treatment system to safeguard patients [1].
This topic reviews the maintenance and monitoring of the various water treatment devices used for
hemodialysis applications. The different waterborne contaminants to which hemodialysis patients are exposed
and the available water treatment systems are discussed separately. (See "Contaminants in water used for
hemodialysis" and "Water purification systems in hemodialysis".)
COMPONENTS OF QUALITY MANAGEMENT PROGRAM — All dialysis units should have a facilityspecific
quality management program for the water treatment plant and the water distribution system [2]. The quality
management program should include the following:
● Maintenance practices
● Structured monitoring program
● Detailed written description of actions to be taken in the event that deviations from normal operation are
observed, with clearly delineated lines of responsibility
Ensuring that water quality is maintained over an extended period begins with the correct initial installation
and verification of the treatment and distribution systems. (See "Water purification systems in hemodialysis",
section on 'Obtaining a water treatment system' and "Water purification systems in hemodialysis", section on
'Assembling a water treatment system' and "Water purification systems in hemodialysis", section on 'Installing
a water treatment system and verifying its performance'.)
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Once a water treatment system is installed and shown to be operating properly, a monitoring system should
be in place to ensure that performance is maintained, procedures are followed, water quality is routinely
assessed, and the requirements of appropriate standards are achieved (see 'Monitoring' below). Results
should be charted to allow trend analysis of the performance of equipment and overall water quality.
Appropriate action limits should be established, together with the action to be taken when abnormal test
results are obtained, to ensure continuing compliance with water quality standards. (See 'Action in response
to detected problems' below.)
The quality management program should be carried out by appropriately trained personnel. The medical
director of the facility should provide regular oversight.
MAINTENANCE PRACTICES — When a water treatment system is initially installed or when the system is
modified, each stage of the installation, performance validation, and operational qualification should be
agreed and documented in advance and signed off by the manufacturer/installer and the medical director of
the facility.
Once the water treatment system and its performance have been verified, the maintenance and monitoring
schedule for the water treatment plant generally becomes the sole responsibility of the hemodialysis facility.
To assist, appropriate maintenance practices should be provided by the vendor of a new system when it is
installed or when an existing system is modified. It is the responsibility of the hemodialysis facility to ensure
that such maintenance practices are made part of the quality management program and are correctly
implemented.
Major maintenance tasks, such as the replacement of deionizers and carbon beds, are best performed by
appropriately trained external contractors or by the manufacturer. Daytoday maintenance can be undertaken
by dialysis facility staff members, provided that they have received appropriate training. Such training should
be specific to the functions performed, and competence with procedures should be regularly assessed and
documented. Periodic audits of the operator’s compliance with procedures should be undertaken and
documented, and there should be an ongoing training program to maintain the knowledge and skills of
dialysis facility staff involved in the monitoring process.
Maintenance practices for individual components of the water treatment system are based on the
manufacturer’s instructions for use but may require local modification. For example, the frequency with which
it is necessary to clean reverse osmosis membranes is dependent upon the quality of the feed water and is
facility specific. (See "Water purification systems in hemodialysis", section on 'Reverse osmosis'.)
If monitoring suggests that the performance of the system or of any individual system component is inferior to
specification, reassessment and, if necessary, modification of the system or of relevant maintenance practices
should ensue. This process should continue until the monitoring demonstrates restoration of adequate
performance.
DISINFECTION OF WATER DISTRIBUTION PIPING — Routine disinfection of the water distribution system
piping is a critical maintenance practice designed to prevent the formation of bacterial biofilm on the interior
surfaces. The water distribution piping is vulnerable to the formation of biofilm because bacteriostatic agents
that are present in feed water (and which generally inhibit bacterial proliferation and biofilm formation) are
removed by the water purification system within the dialysis facility (see "Water purification systems in
hemodialysis", section on 'Carbon filtration'). Once established, biofilm is very difficult to remove.
Furthermore, dispersal of cells from an existing biofilm colony is an essential stage of the biofilm life cycle.
Dispersal enables biofilms to spread and colonize new surfaces.
Control of bacterial proliferation and biofilm formation is best achieved by routine disinfection. The frequency
of disinfection will vary with the design of the system and the extent to which biofilm has already formed in
existing systems. Disinfection schedules should be designed to prevent bacterial proliferation, rather than to
eliminate bacteria once they have proliferated to an unacceptable level. Levels of bacteria and endotoxins
should be monitored to demonstrate that the disinfection program is effective, rather than to indicate when
disinfection should be performed. (See 'Microbial contaminant level measurements' below.)
Traditionally, disinfection has been performed using sodium hypochlorite (bleach) and/or peracetic
acid/hydrogen peroxide. These agents are more effective if the pipes are first treated with a descaling agent.
However, frequent disinfection with chemical agents can be difficult because of the lengthy period of rinsing
required to remove residual disinfection from a distribution system. Disinfection with hot water or ozonated
water is a preferred alternative since these methods leave no chemical residues (hot water) or residues with a
short halflife (ozone) and thus allow more frequent disinfection. Monthly microbiologic monitoring of water
treatment systems in a range of standalone facilities in Holland that used proactive hot water sanitization
revealed that the product water had <0.1 colonyforming units (CFU)/mL in 567 of 685 samples (82.8 percent)
and <0.03 endotoxin units (EU)/mL in 653 of 663 samples (98.5 percent) [3].
In cases where biofilm has formed and is resistant to disinfection, cleaning the system with 2 to 3 percent
citric acid before disinfection may help in biofilm removal, provided the materials of the system are compatible
with such chemical exposure [4,5].
However, in some cases, complete or partial replacement of a distribution system might be the only way to
remove biofilm.
MONITORING — A monitoring system should be in place to ensure that performance is maintained,
procedures are followed, water quality is routinely assessed, and the requirements of appropriate standards
are achieved. For standalone dialysis facilities and hospitalbased facilities, the appropriate monitoring
frequency is established using data collected during the initial validation process of the system that follows its
installation. The monitoring of chemical parameters depends on the quality of the water entering the treatment
system and the results of the validation process. Monitoring of microbiologic contaminant levels is determined
by the frequency of disinfection and the results of the validation process. International Organization for
Standardization (ISO) 23500 [2] provides guidance on this aspect of maintaining water quality.
The frequency of monitoring chemical and microbiologic contaminant levels in the feed and the product water
of home hemodialysis patients is less than in standalone or hospitalbased facilities. The sampling should be
performed every six months or after changes to the water treatment system. If the interval between sample
testing exceeds six months, documentation should be in place to demonstrate that the sampling schedule
used has been based on trend analysis.
Both the performance of the water treatment plant and the quality of the feed water should be monitored. The
ability of a water treatment system to provide highquality product water (ie, water that meets applicable
standards) can change with variations in quality of the municipal water supply. Municipal water supply quality
fluctuates seasonally. Municipal water supply may also fluctuate after work on the distribution infrastructure
and when there are changes in water abstraction practices [6]. Users should also be aware of changes in
water treatment practices that may be introduced without prior notification by the supplier. For example, many
water suppliers in the United States increased the pH of the water supply in response to an Environmental
Protection Agency (EPA) requirement to decrease lead and copper concentrations in drinking water. This
increase in pH can decrease the removal of chloramine by granularactivated carbon.
Specific challenges in monitoring the quality of feed water can exist depending on where that water is used,
for example, in a standalone dialysis facility, a dialysis facility within a hospital, or in a patient’s home. The
water supply for a standalone facility is generally via a direct water main connection. Water supplied to a
hospitalbased dialysis facility (or intensive care unit where dialysis is performed at the bedside) is usually via
the hospital water supply system. Patients who perform home hemodialysis may use either the municipal
water supply or well water.
Regardless of the setting, all dialysis facilities should establish a robust system of communication with their
municipal water suppliers. Facilities should request that they be notified in advance of any major changes in
the supplier’s water treatment practices, repair work to the municipal water distribution system supplying the
dialysis facility, or changes in municipal water quality, such as might occur with seasonal algae blooms.
Additionally, in the hospital setting, it is essential that there be good communication between the dialysis
facility and the entities that supply the feed water. This is because practices that are instituted to protect the
hospital water supply may be harmful to dialysis patients. As an example, there have been several incidents
in which hydrogen peroxide that was added to the hospital water supply to control Legionella caused the
development of methemoglobinemia [7,8] or hemolysis [9,10].
For patients treated in the home, the feedwater supply is usually from a direct water main connection.
However, in rural settings, the feed water may be from a private well. In such a setting, close attention should
be paid to the quality of the feed water since well water is subject to seasonal changes and contamination
from a variety of other sources such as agricultural waste, chemicals used in hydrocarbon extraction, septic
tanks, or underground fuel storage tank seepage. Due to its nature, well water may be subject to a higher rate
of failure in terms of microbiologic and chemical quality. A public health study of pathogens in US groundwater
supplies reported results of sampling of 244 public watersupply wells prior to any treatment [11].
Approximately 50 percent of wells initially considered more vulnerable to contamination and 40 percent of
wells considered less vulnerable were positive for one or more fecal indicators (total coliform bacteria,
Escherichia coli, enterococci, viruses infecting coliform bacteria, and human viruses) [11].
In contrast to standalone and hospitalbased facilities, home hemodialysis is performed with a limited amount
of technical support. The patient or their care partner should be trained to perform basic monitoring of the
water treatment infrastructure and provided with a log sheet to record all measures of water treatment system
performance. Measurements should be made after the water treatment system has been operating for at least
15 minutes and before dialysis is initiated. To ensure that dialysis is not undertaken with suboptimal water
quality, the performance of the reverse osmosis system should be monitored prior to each treatment by
checking the product water conductivity and percent rejection. If the reverse osmosis system is found to be
operating outside its acceptable range, the dialysis center responsible for the patient should be notified and
treatment delayed until the problem has been rectified. If the water treatment system includes a standalone
softener, the water hardness should be monitored prior to each treatment using a sample obtained through a
labeled sample port located between the softener and the reverse osmosis system. For hardness tests
requiring color differentiation, the person performing the analysis should be able to distinguish between the
colors of blue, purple, and red. If the person cannot differentiate these colors, an automated meter should be
used. Results should be recorded on the log sheet and reviewed as part of the maintenance and service of
the home hemodialysis system.
Ultimately, the medical director of the center supervising the care of a home dialysis patient is responsible for
ensuring appropriate measures are in place to ensure the quality of the water and dialysis fluid used by that
patient and that those measures are routinely implemented.
Methods of monitoring water quality — Monitoring of water can be divided into two categories: online
monitoring, which is comprised of manual or automated processes and confined primarily to physical
parameters (such as flow rate, pressure, conductivity, and temperature), and offline monitoring, which is
comprised of the measurement of chemical and microbiologic contaminant concentrations. Both the purified
water that is produced and the feed water should be monitored. Water samples should be obtained from the
appropriate location as detailed in the operational policies and procedures for the dialysis facility. The
operational policies and procedures should also include instructions on taking and handling the samples up to
the time of testing.
Data collected from monitoring should be charted to allow trend analysis of equipment performance. Data
should be regularly reviewed by the medical director.
Online measurements — Physical parameters such as flow rate, pressure, and temperature are
measured with standard gauges and meters and their outputs recorded manually. Conductivity (or resistivity)
is used as a convenient online measure of the total concentration of ionized species in the water. Meters
used for such measurements must be temperature compensated.
Offline measurements — Levels of chemical and microbiologic contaminants are determined on samples
of water collected at various points throughout the water treatment and distribution system.
To ensure that samples are representative of conditions during routine operation, the system should have
been in continuous operation for at least 20 to 30 minutes before any sample is taken. All sampling points
should provide direct access to the water stream to be sampled. Sampling points should not be placed in
areas of stagnant flow or at the end of a long length of deadend tubing. Prior to sampling from such points,
liquid should be allowed to flow from the sampling point for at least 30 seconds before sampling, and, if the
sample is for microbiologic quantification, aseptic collection techniques should be used.
Specific methods for measuring chemical or microbial contaminants are discussed below. (See 'Chemical
contaminant level measurements' below and 'Microbial contaminant level measurements' below.)
Filters — Filters are monitored for evidence of fouling by measuring the pressures at the inlet and outlet of
the filter (see "Water purification systems in hemodialysis", section on 'Filters'). These pressures are used to
calculate the pressure drop, or delta P, across the filter (delta P equals the pressure difference between the
inlet pressure and outlet pressure). As particulate matter accumulates, the pressure difference increases. An
increase in pressure difference above a predetermined value (which is generally provided by the filter
manufacturer) indicates that the filter should be replaced or cleaned. Failure to replace or clean the filter can
lead to a reduction in flow downstream of the filter, resulting in an inadequate pressure at the inlet of
subsequent purification devices and a degradation of performance.
Softeners — Softeners are monitored to ensure that they continue to remove calcium and magnesium ions
(see "Water purification systems in hemodialysis", section on 'Softeners'). Calcium and magnesium
concentrations in the product water can be determined indirectly using a kit to measure the hardness of the
water. Since softeners are often automatically regenerated at night when no dialysis is being performed, the
hardness of the product water should be measured towards the end of the day to ensure that the softener has
adequate capacity to remove calcium and magnesium ions throughout its operating cycle. In general, the
hardness of product water from a softener should not exceed 10 mg/L of calcium carbonate. Values above
this level should prompt an evaluation of the softener for loss of resin, fouling of the resin by iron, an
inadequate regeneration cycle, or inadequate capacity due to an increase in water throughput.
Carbon media — Carbon beds are monitored to detect exhaustion of their capacity to remove chloramine
and total chlorine (see "Water purification systems in hemodialysis", section on 'Carbon filtration'). Although
carbon can remove a wide range of organic contaminants by adsorption, removal of chloramine takes place
via an oxidationreduction reaction at active sites on the carbon surface. Over time, access to these active
sites is diminished by adsorption of soluble organic molecules and by trapping of suspended material present
in the water. Eventually, chloramine molecules reach the outlet of the bed without finding an active site. This
phenomenon is known as breakthrough.
Patients are protected from exposure to chloramine resulting from breakthrough by placing two carbon beds
in series and monitoring the chloramine concentration after the first bed. When exchangeable carbon beds
are used, the first bed is discarded when breakthrough is detected, the second bed is moved into the first
position, and a new bed is installed in the second position. When permanent carbon beds are used, it is often
simpler to replace the carbon in both beds.
Fouling of a carbon bed occurs when suspended matter in the water is trapped in the bed by depth filtration.
This trapped material increases the resistance to flow through the bed and reduces the feed pressure to the
next element in the purification cascade. Channeling occurs when the packing of carbon particles in a bed
becomes nonuniform. Under such conditions, open passages form in the bed. Water passes through these
channels, decreasing contact between the water and the carbon particles and thereby reducing the ability of
the bed to remove contaminants. Monitoring the pressure drop between the inlet and outlet of a carbon bed
provides information on fouling (an increase in pressure drop at a constant flow rate) or channeling (a
decrease in pressure drop at a constant flow rate). If either condition is detected, backflushing may prolong
bed life. However, backflushing does not regenerate exhausted bed capacity.
Deionizers — Deionizers are monitored to ensure product water quality and to indicate when new resin beds
are needed (see "Water purification systems in hemodialysis", section on 'Deionization'). Because undetected
failure of a deionizer can be extremely hazardous to patients, the resistivity of the product water must be
monitored continuously with a temperaturecompensated meter. The meter should be coupled to an alarm
system that is audible in the patient treatment area and that diverts product water to drain if the resistivity falls
below 1 megaohm [MΩ]·cm (1 micro Siemens (S)/cm or 0.1 mS/m).
Reverse osmosis — Reverse osmosis systems are monitored to:
● Ensure continued removal of contaminants at the desired level
● Ensure production of sufficient product water
● Indicate when the membranes should be cleaned or replaced
To facilitate such monitoring, samples are generally taken from multiple points (figure 1) (see "Water
purification systems in hemodialysis", section on 'Reverse osmosis'). Measurements of conductivity and flow
rate are used to calculate the percent solute rejection (a measure of contaminant removal) and the percent
recovery of product water (a measure of membrane fouling) (figure 2).
Reverse osmosis systems may be single pass, in which the waste or rejected water stream is discharged
directly to drain, or configured so that an amount of the waste water stream is recycled into the feedwater
stream. In the latter system, the absolute value of percent solute rejection depends upon the point at which
the feedwater conductivity is measured. If the measurement is made before the point at which the recycled
water enters the feedwater stream, the calculated solute rejection provides a measure of the overall
performance of the reverse osmosis system. If the measurement is made after the point at which the recycled
water enters the feedwater stream, the calculated solute rejection provides a measure of the performance of
the reverse osmosis membranes, and the value may be slightly lower.
When the productwater flow rate or percent recovery of product water changes by some predetermined
amount (typically 10 percent at constant temperature, pressure, and feedwater flow rate), the membrane
modules should be cleaned using the manufacturer's recommended method. An increase in pressure drop of
10 percent should also prompt cleaning of the membranes. If cleaning fails to restore performance, the
membrane modules might need to be replaced. The life of reverse osmosis membranes can be prolonged by
pretreatment of the feed water. As an example, softening the feed water will help minimize fouling with
calcium and magnesium salts. In addition, removal of chlorine by carbon can protect membranes from
degradation.
CHEMICAL CONTAMINANT LEVEL MEASUREMENTS — Most chemical contaminants can be determined
off site. Measurements should be carried out by trained and accredited persons or in accredited laboratories,
with records maintained within the dialysis unit. Suggested assay methods of testing for water contaminants
have been published by national organizations such as the American Public Health Association [12] and also
form part of methodologies detailed in national standards [13]. The assay used for each chemical contaminant
must have a minimum detection level below the maximum allowable level for that contaminant.
Disinfectants are normally added to drinking water to ensure that the water meets applicable standards.
Commonly used disinfectants are chlorine, chloramine, and chlorine dioxide. When water is distributed via
complex networks such as those found within buildings, these can incorporate a storage tank to ensure
adequate water supply and pressure at times of peak demand; biocides may be added locally to minimize the
risk from Legionella.
The rationale for this is outlined in documents produced by the Environmental Protection Agency (EPA) in the
US and the Health and Safety Executive (HSE) in the United Kingdom.
Chlorine dioxide and silverstabilized hydrogen peroxide are commonly used for this purpose. Silverstabilized
hydrogen peroxide presents risks to dialysis patients, and its use in settings where the water used in dialysis
units is derived from the building water distribution network rather than a "rising main" supply should be
avoided, if possible [8,14,15].
The maximum residual disinfectant levels for commonly used disinfectants (chlorine, chloramine, and chlorine
dioxide) are set lower in water used for the preparation of dialysis fluid than drinking water (table 1).
MEASUREMENT OF DISINFECTANT RESIDUES
Chlorine and chloramine — Due to their volatility, chlorine and chloramine testing must be performed
immediately after drawing the sample.
Free chlorine may be measured using syringaldazine (FACTS) or tetramethylbenzidine (TMB)based test
strips. Total chlorine may be measured using ThioMichler’s ketone (TMK) or N,Ndiethylp
phenylenediamine (DPD)based test strips or tablets. Other methods, such as the ferrous
colorimetric/titrimetricbased assay or test strips for free and/or total chlorine, are also available.
There is no direct test method for the quantification of the chloramine in water. It is determined by calculating
the difference between measured total and freechlorine concentrations. When totalchlorine tests are used
as a single analysis, the maximum level for both chlorine and chloramine should not exceed 0.1 mg/L. Since
there is no distinction between chlorine and chloramine, this safely assumes that all chlorine present is
chloramine.
Such measurements can be made using the DPD assay or a "dip and read" test strip or by an online monitor.
When using DPD assays or test strips, users should be aware that the presence of manganese and organic
chloramines may interfere and that, at low concentrations, there may be some uncertainty in the levels due to
human perception of the color changes.
When using commercially produced indicators, care should be taken to ensure that the indicator selected is
appropriate for the application. Furthermore, because test strips can be sensitive to heat and humidity,
manufacturer's instructions for storage and use must be stringently adhered to.
Chlorine dioxide — When chlorine dioxide is used as a sterilant, residual chlorine dioxide and a range of
byproducts such as chlorite, chlorate, and organic disinfection byproducts (DBPs) may be present. There is
increasing use of chlorine dioxide to prevent growth of Legionella bacteria in hospital water systems. National,
European, and international standards do not address the maximum permitted levels of chlorine dioxide or its
breakdown products in dialysis water, as there is little information about their potential toxicity to hemodialysis
patients. These compounds have low molecular weights, and their removal by carbon is critically dependent
upon the type of carbon used [16].
Colorimetric methods can be used to quantify chlorine dioxide at low levels. One such method is an extension
of the DPD method for determining free and total chlorine, in which glycine is used to eliminate chlorine
interference. A second method uses chlorophenol red (CPR), which reacts specifically with chlorine dioxide
and which is capable of measuring of concentrations within the range 0.01 to 0.1 mg/L of chlorine dioxide.
Alternately, a selective fluorescence method based on the oxidation of rhodamine dyes by chlorine dioxide in
an ammoniaammonium chloride buffered solution may be used [17].
When chlorine dioxide is used as a sterilant, residual chlorine dioxide and a range of breakdown products,
namely chlorite, chlorate, and organic disinfection byproducts (DBPs), may be present. Additional information
relating to methods for quantifying chlorine dioxide and its byproducts are available from the United States
Environmental Protection Agency (EPA) website.
Tests intended for the quantification of chlorine and chloramine should not be used for the quantification of
chlorine dioxide or its breakdown products.
No national, European, or international standards address the maximum permitted levels of chlorine dioxide
or its breakdown products in dialysis water. There is little information about the potential toxicity of chlorine
dioxide and its daughter products to hemodialysis patients. It is suggested that, if chlorine dioxide is used,
chlorine dioxide levels in the feed and product water be measured using a commercially available test kit and
that the maximum acceptable chlorine dioxide level in the product be set at 0.1 mg/L.
Chemicals added to control Legionella — In addition to chlorine dioxide, silverstabilized hydrogen
peroxide or silver copper ionization may be in hospitals to control Legionella in cold water distribution
systems.
These technologies are discussed in detail in EPA draft document 815D15001 (October 2015).
Ideally, dialysis units should draw their water from a direct "rising main" supply rather than from the hospital
water supply. It is recognized, however, that this may not be possible in every instance, and the local addition
of chemicals or the use of silver copper ionization for the control of Legionella has patient safety implications
of which both nephrologists and hospital engineering staff should be aware.
MICROBIAL CONTAMINANT LEVEL MEASUREMENTS — In order to meet accepted standards, dialysis
water should contain a total viable microbial count of less than 100 colonyforming units (CFU)/mL and an
endotoxin concentration of less than 0.25 endotoxin units (EU)/mL [18].
It should be noted that, even at such levels, significant transfer of singlestranded DNA may occur [19,20].
Such transfer has been implicated in cytokine induction [20] and, thus, could potentially contribute to the
microinflammatory state present in dialysis patients. However, with the exception of one retrospective cohort
study from Japan showing that lower endotoxin levels in dialysis fluid were associated with a decreased risk
for allcause mortality [21], there has been no systematic study of the longterm effects or sequelae of further
reducing microbial contaminant levels (see "Contaminants in water used for hemodialysis", section on
'Bacterial contaminants'). Water that achieves the standard for dialysis applications is also the starting point in
the production of ultrapure dialysis fluid or for online infusion fluid used in hemodiafiltration. (See "Ultrapure
dialysis fluid", section on 'Production of ultrapure dialysis fluid'.)
Careful attention needs to be paid to sample collection and analysis [2,2224]. Detailed methods for sampling
and culturing of water for dialysis are available in the Appendix of European Best Practice Guidelines for
Haemodialysis, Part 1 [23]; the European Dialysis and Transplant Nurses Association/European Renal Care
Association (EDTNA/ERCA); the Guidelines on Control and Monitoring of Microbiological Contamination in
Water for Dialysis [25]; and the International Organization for Standardization (ISO) 23500 [2]. A brief
overview is provided below.
Sample collection — Samples should be collected into sterile, pyrogenfree containers and analyzed as
soon as possible after collection. If samples cannot be analyzed within four hours of collection or are sent to
an offsite laboratory, the sample should be refrigerated (not frozen) or packed on ice in an insulated container
suitable for shipping. For samples analyzed off site, the laboratory's instructions for shipping must be followed
to ensure that analysis is performed within 24 hours of the sample being taken.
The storage and handling of samples for endotoxin analysis is dependent upon the measurement technique.
Individual laboratories' instructions for sample handling and storage must be followed.
Analytical methods — The use of common clinical laboratory methods intended for bloodborne bacteria,
commercial water test kits, or dip samplers are not recommended, due to their lack of sensitivity and
specificity for waterborne bacteria. This is important because water used for hemodialysis purposes generally
has low bacterial levels. Specific, validated, and sensitive analytical methods of sample plating and sample
culture must be used.
Sample plating — The following methods are considered suitable.
Membrane filtration — Membrane filtration is filtration of the sample through a membrane filter with
pore diameter 0.45 micrometer or less. Membrane filtration is used when the sample needs to be
concentrated in order to detect low levels of contamination (usually <1 CFU/mL). The volume to be filtered
should be determined by the suspected level of contamination and should be between 10 mL and 1000 mL.
Because the membrane filter technique might not be readily available in clinical laboratories, the spread plate
assay or the pour plate assay can be used as alternatives for water and standard dialysis fluid [26]. (See
'Spread plate technique' below and 'Pour plate technique' below.)
Spread plate technique — 0.1 to 0.3 mL of a sample is spread over the surface of a culturecontaining
Petri dish (typically 90 mm in diameter). The detection limit of this technique is 5 CFU/mL when 0.2 mL of
sample is used as the inoculum. If the spread plate technique is used, the sample must not be applied with a
calibrated loop. Calibrated loops are commonly used in clinical laboratories for culturing body fluids and apply
a very small volume (typically 0.001 to 0.01 mL) to the culture plate. As a result, the minimum sensitivity of the
calibrated loop technique is on the order of 1000 CFU/mL. This sensitivity is unacceptable when the
maximum allowable level of bacteria is 100 CFU/mL and the action level is 50 CFU/mL.
Pour plate technique — A sample (typically 1 mL) is placed in a Petri dish, and 15 to 20 mL of molten
medium is added. The sample and medium are mixed carefully by gentle rotation and allowed to set. The time
between addition of the sample and addition of the molten medium should not exceed 15 minutes. The plate
is inverted and incubated. If 1 mL of sample is used, the detection limit of this technique is 1 CFU/mL.
Sample culture — The culture medium, incubation temperature, and incubation time have been optimized
for the culture of organisms in dialysis water.
● Culture medium – A lownutrient agar, such as Tryptone Glucose Extract Agar (TGEA) or Reasoner’s
Agar 2A, should be used [27]. Blood agars must not be used, since they are too rich in nutrients for
growth of organisms adapted to the nutrientpoor environment of purified water.
● Incubation temperature – Samples should be incubated at 17 to 23ºC [28,29].
● Incubation time – Samples should be incubated for at least seven days [28,29]. A long incubation time
allows the growth of species that are better adapted for growth at a higher temperature and/or on richer
media.
These conditions have been shown to give good recovery for most environmental bacteria found in purified
water. Other test methods may also be used, provided that such methods have been appropriately validated
and compared with the cited methods. The United States standard for dialysis water quality (American
National Standards Institute [ANSI]/Association for the Advancement of Medical Instrumentation [AAMI]
13959:2014) allows the use of Trypticase soy agar or Standard Methods Agar incubated for 48 hours at 35°C
[18]. These culturing conditions have not yet been included in the equivalent International Standard [30],
because of an ongoing debate regarding their validation and equivalence to the other conditions listed above.
The standard test for determining endotoxin concentrations is the Limulus amebocyte lysate (LAL) assay. A
number of different techniques are in use, and endotoxin testing should be performed by fully trained
personnel. It is important to use sample containers, validated for storage of samples for endotoxin
determination. Such containers are usually specified by the testing laboratory or the manufacturer of the LAL
assay kit.
Culture results obtained using the methods outlined are only a relative indicator of the bioburden in water and
do not provide a measure of the absolute bacterial burden. With new systems, it is important to recognize that
biofilm takes some time to form and mature. Therefore, little or no growth might be seen in fluid samples
taken during the first month of operation, even if no disinfection is performed.
Algae, mold, and fungi may also be present in water distribution systems; however, no limits are specified in
respect of water used for hemodialysis applications.
ACTION IN RESPONSE TO DETECTED PROBLEMS — Dialysis units should have written policies that
describe actions to be taken when an abnormality is detected in the water treatment or distribution system.
Appropriate action limits should be established for each measured parameter.
Because failure of a water treatment system can lead to serious adverse events, personnel responsible for
daytoday operation of the water treatment system should be additionally trained to recognize system failures
and have the authority to act immediately in the event of such failures. For example, a technician who
observes the exhaustion of a deionizer must have the authority to order the cessation of all dialysis
treatments until the exhausted deionizer is replaced. (A deionizer is a water purification process by which ion
exchange resins are used to remove ionic contaminants from water; deionizer performance must be
monitored closely since, once the resins are exhausted, ions previously removed are rereleased back into
the water, which can cause significant toxicity to patients). (See "Water purification systems in hemodialysis",
section on 'Deionization'.)
MAINTENANCE AND MONITORING SCHEDULES AND DOCUMENTAION — Water treatment systems
require regular supervision, maintenance, and servicing. Each water treatment system should have a log
book with written records documenting every intervention, repair, servicing, or maintenance procedure. All
servicing, maintenance, interventions, and changes to the water treatment system should be recorded.
Maintenance practices and monitoring schedules depend upon the design of the water treatment system and
the quality of the feed water. Typical parameters to be monitored and the frequency of monitoring are shown
in the table (table 2). Not every item listed is required in all dialysis facilities, since the water treatment system
components used are dependent upon the quality of the feed water.
Routine monitoring should also be performed and documented to ensure ongoing compliance with the dialysis
water quality requirements (table 3). Trend analysis of monitoring data should be used to provide information
on system performance, thus enabling a preventive rather than a reactive approach to system maintenance.
The monitoring schedule should be based on the results of the system validation. Frequency of monitoring
should also take into consideration the consequences of failure of a given purification process and the
accumulated history of the performance of the water treatment and distribution system. For example,
deionizers must be monitored continuously since the exhaustion of a deionizer may acutely expose patients
to dangerously high concentrations of contaminants. In addition, the deionizer monitor must be connected to
appropriate safety systems. Similarly, if the feed water contains chloramine, carbon beds must be monitored
at least daily because of the risk of acute hemolysis in patients exposed to chloramine.
Parameters that are measured continuously online should be recorded daily. Such parameters include the
water production rate, the percent rejection and product water recovery of a reverse osmosis unit, and
pressures throughout the water treatment and distribution system.
The concentrations of chemical contaminants in the final product water should be determined when systems
are newly installed or modified as part of installation verification. Analysis for chemical contaminants might
also be necessary when changes in supply water or component performance, such as a decrease in reverse
osmosis rejection rate, are detected. In the latter cases, it may be sufficient to analyze for a single
contaminant, such as aluminum, rather than for all contaminants (table 4 and table 5). The observation that
parameters measured online remain stable over time provides some additional assurance that water quality
is being maintained independent of the measurement of concentrations of individual contaminants. However,
a complete analysis of all contaminants should be performed at least annually.
As noted above, levels of bacteria and endotoxin should be regularly monitored to validate the effectiveness
of the disinfection procedure used to limit biofilm formation [31] (see 'Disinfection of water distribution piping'
above). Samples for surveillance cultures and endotoxin testing should be collected before the system is
disinfected, which is when the highest levels of contamination are likely to be present. When a new system is
installed or the integrity of an existing system is broken, frequent disinfection and monitoring should be
performed until consistently low levels of bacteria are observed. The frequency of disinfection and monitoring
may be decreased if the accumulated data consistently show low levels of contamination; however, at least
monthly disinfection and monitoring is recommended.
With new systems, it is important to recognize that biofilm takes some time to form and mature. Therefore,
little or no growth might be seen in fluid samples taken during the first month of operation, even if no
disinfection is performed. For that reason, caution should be exercised in extending the disinfection interval
based on culture results obtained during the first few months of operation of a new system.
MAINTAINING WATER QUALITY IN NONDIALYSIS UNIT SETTINGS — The general considerations
described in the previous sections of this topic are equally applicable to water treatment infrastructure used
for the provision of water for dialysis in the intensive care unit or in the patient's home. In these settings, to
ensure that dialysis is not undertaken with suboptimal water quality, prior to each treatment, the performance
of the reverse osmosis system should be monitored and recorded by checking the productwater conductivity
and percent rejection. In addition, monitoring of carbon media should be performed. Sampling for chemical
and microbiologic quality should be as described previously. (See 'Offline measurements' above and
'Microbial contaminant level measurements' above.)
Patients undergoing home hemodialysis (and/or helpers) should have received adequate training to perform
the required monitoring; this training should be appropriately documented.
As in the dialysis facility, when any repairs or component replacements are made to water treatment
equipment, the impact on water quality should be evaluated and a chemical analysis performed, if indicated.
Feedwater quality needs to be checked at least every six months.
SUMMARY AND RECOMMENDATIONS
● All dialysis units should have a facilityspecific quality management program for the water treatment plant
and the water distribution system. The quality management program should include routine maintenance
and monitoring practices and a written description of actions to be taken when deviations from normal
operation are observed. The quality management program should be carried out by appropriately trained
personnel, with oversight by the medical director of the facility. (See 'Components of quality management
program' above.)
● Maintenance practices for individual components of the water treatment system are based on the
manufacturer’s instructions for use but may require local modification. Major maintenance tasks are best
performed by appropriately trained external contractors or by the manufacturer; daytoday maintenance
can be undertaken by trained dialysis facility staff members. (See 'Maintenance practices' above.)
● Routine disinfection of the water distribution system piping is a critical maintenance practice designed to
prevent the formation of bacterial biofilm on the interior surfaces. Biofilm is very difficult to remove once
established. (See 'Disinfection of water distribution piping' above.)
● Monitoring is performed in accordance with a predetermined schedule, which is based upon knowledge
of the system performance following the system’s installation. Both the performance of the water
treatment plant and the quality of the feed water should be monitored. In the hospital setting, it is
essential that there be good communication between the dialysis facility and the entities that supply the
feed water since practices that are instituted to protect the hospital water supply may be harmful to
dialysis patients. (See 'Monitoring' above.)
● Monitoring of water quality includes online measurements of physical parameters and offline
measurement of chemical and microbiologic contaminant concentrations of the water produced, as well
as the feed water. Individual components of the purification system are also routinely monitored. These
include filters, softeners, carbon beds, deionizers, and reverse osmosis systems. (See 'Monitoring'
above.)
● Many chemical contaminants may be determined off site, although chlorine and chloramine testing must
be performed immediately after drawing the sample. Measurements should be carried out by trained and
accredited persons or accredited laboratories and records maintained within the dialysis unit. (See
'Chemical contaminant level measurements' above and 'Chlorine and chloramine' above.)
● Microbial contaminants are tested using specific techniques that have been optimized for the culture of
organisms in purified water. (See 'Microbial contaminant level measurements' above.)
● Dialysis units should have written policies that describe actions to be taken when an abnormality is
detected in the water treatment or distribution system. Appropriate action limits should be established for
each measured parameter. Personnel responsible for daytoday operation of the water treatment system
should have the authority to act immediately in the event of such failures. (See 'Action in response to
detected problems' above.)
● Maintenance practices and monitoring schedules depend upon the design of the water treatment system
and the quality of the feed water. Monitoring, maintenance, and servicing should be documented. (See
'Maintenance and monitoring schedules and documentaion' above.)
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REFERENCES
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of experience. Adv Ren Replace Ther 2003; 10:122.
2. Association for the Advancement of Medical Instrumentation. Guidance for the preparation and quality m
anagement of fluids for hemodialysis and related therapies, ANSI/AAMI/ISO 23500:2011, Association for
the Advancement of Medical Instrumentation, Arlington, VA 2011.
3. Penne EL, Visser L, van den Dorpel MA, et al. Microbiological quality and quality control of purified
water and ultrapure dialysis fluids for online hemodiafiltration in routine clinical practice. Kidney Int 2009;
76:665.
4. Tsai YP, Pai TY, Hsin JY, Wan TJ. Biofilm bacteria inactivation by citric acid and resuspension
evaluations for drinking water production systems. Water Sci Technol 2003; 48:463.
5. Sakuma K, Uchiumi N, Sato S, et al. Experience of using heat citric acid disinfection method in central
dialysis fluid delivery system. J Artif Organs 2010; 13:145.
6. HannaAttisha M, LaChance J, Sadler RC, Champney Schnepp A. Elevated Blood Lead Levels in
Children Associated With the Flint Drinking Water Crisis: A Spatial Analysis of Risk and Public Health
Response. Am J Public Health 2016; 106:283.
7. Newbigging N, Peel W, Bell E, Isles C. Unexpected cyanosis in a haemodialysis patientdid someone
add hydrogen peroxide to the dialysis water? NDT Plus 2009; 2:158.
8. Bek MJ, Laule S, ReichertJünger C, et al. Methemoglobinemia in critically ill patients during extended
hemodialysis and simultaneous disinfection of the hospital water supply. Crit Care 2009; 13:R162.
9. NHS National Patient Safety Agency. Risks to hemodialysis patients from water supply (hydrogen peroxi
de). NPSA/2008/RRR007. https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAttachment.aspx?
Attachment_id=50485 (Accessed on April 01, 2009).
10. Hoenich NA. Disinfection of the hospital water supply: a hidden risk to dialysis patients. Crit Care 2009;
13:1007.
11. Mackler BA, Merkle JC. Current knowledge on groundwater microbial pathogens and their control.
Hydrogeol J 2000; 8:29.
12. Standard Methods for the Examination of Water and Wastewater, 22nd Edition. American Public Health
Association (APHA), Washington, DC 2012.
13. Association for the Advancement of Medical Instrumentation. Guidance for the preparation and quality m
anagement of fluids for hemodialysis and related therapies. ANSI/AAMI 23500:2014, Arlington, VA 2014.
14. National Patient Safety Agency: Haemodialysis patients: risks associated with water supply (hydrogen p
eroxide). Central Alert System reference NPSA/2008/RRR007 2008. http://www.nrls.npsa.nhs.uk/resour
ces/?entryid45=59893 (Accessed on April 11, 2016).
15. Davidovits M, Barak A, Cleper R, et al. Methaemoglobinaemia and haemolysis associated with
hydrogen peroxide in a paediatric haemodialysis centre: a warning note. Nephrol Dial Transplant 2003;
18:2354.
16. Bova G, Sharpe P, Keane T. Evaluation of Chlorine Dioxide in Potable Water Systems for Legionella Co
ntrol in an Acute Care Hospital Environment. Proc. 65th International Water Conference, Pittsburgh, PA,
2004. http://www.legionellae.org/HopkinsResearchPaperIWCOct04.pdf (Accessed on April 11, 2016).
17. Jiang ZL, Zhang BM, Liang AH. A new sensitive and selective fluorescence method for determination of
chlorine dioxide in water using rhodamine S. Talanta 2005; 66:783.
18. Association for the Advancement of Medical Instrumentation. Water for hemodialysis and related therapi
es. ANSI/AAMI 13959: 2014 Association for the Advancement of Medical Instrumentation, Arlington, VA,
2014.
19. Tao X, Hoenich N, Handelman SK, et al. Transfer of lowmolecular weight singlestranded DNA through
the membrane of a highflux dialyzer. Int J Artif Organs 2014; 37:529.
20. Schindler R, Beck W, Deppisch R, et al. Short bacterial DNA fragments: detection in dialysate and
induction of cytokines. J Am Soc Nephrol 2004; 15:3207.
21. Hasegawa T, Nakai S, Masakane I, et al. Dialysis fluid endotoxin level and mortality in maintenance
hemodialysis: a nationwide cohort study. Am J Kidney Dis 2015; 65:899.
22. Bommer J, Jaber BL. Ultrapure dialysate: facts and myths. Semin Dial 2006; 19:115.
23. Section IV. Dialysis fluid purity. Nephrol Dial Transplant 2002; 17 Suppl 7:45.
24. Ledebo I. Ultrapure dialysis fluidhow pure is it and do we need it? Nephrol Dial Transplant 2007; 22:20.
25. EDTNA/ERCA guidelines: technical section. EDTNA ERCA J 2002; 28:107.
26. Ray J. Microbiological monitoring of dialysis water systemswhich culture method? J Ren Care 2007;
33:66.
27. van der Linde K, Lim BT, Rondeel JM, et al. Improved bacteriological surveillance of haemodialysis
fluids: a comparison between Tryptic soy agar and Reasoner's 2A media. Nephrol Dial Transplant 1999;
14:2433.
28. Pass T, Wright R, Sharp B, Harding GB. Culture of dialysis fluids on nutrientrich media for short periods
at elevated temperatures underestimate microbial contamination. Blood Purif 1996; 14:136.
29. Bolasco P, Contu A, Meloni P, et al. Microbiological surveillance and state of the art technological
strategies for the prevention of dialysis water pollution. Int J Environ Res Public Health 2012; 9:2758.
30. International Organization for Standardization. Water for hemodialysis and related therapies. ISO 13959.
2014 International Organization for Standardization, Geneva, 2014.
31. Smeets E, Kooman J, van der Sande F, et al. Prevention of biofilm formation in dialysis water treatment
systems. Kidney Int 2003; 63:1574.
Topic 1900 Version 16.0
GRAPHICS
Reverse osmosis for water purification for hemodialysis
Schematic representation of reverse osmosis in which feed water, which is pumped, flows parallel to
the membrane. High pressure on the feed side of the membrane forces water across the membrane
to form the product water. Ions and other contaminants, which are rejected by the membrane,
accumulate in the remaining feed water and leave the membrane module as reject water. Locations
of gauges and meters for the online measurement of pressure, flow rate, conductivity and
temperature, and sampling points for offline measurements of contaminants are shown. The data
obtained with these gauges and meters are used to monitor the performance of the reverse osmosis
system.
Graphic 63776 Version 3.0
Formulae for calculating the performance characteristics
of a reverse osmosis unit for hemodialysis
* Feed flow rate = Product flow rate + Reject flow rate.
Maximum permissible residual disinfectant levels in drinking water and water
used in the preparation of dialysis fluid
Maximum permitted level in
Maximum permitted level in
water used for the preparation
drinking water (mg/L)
of dialysis fluid (mg/L)
Disinfectant
Chlorine 4 (as Cl 2 ) 0.1*
Chloramine 4 (as Cl 2 ) See footnote*
Chlorine dioxide 0.8 (as ClO 2 ) See footnote ¶
Disinfectant byproducts
Total trihalomethanes 0.08 Not specified

(TTHM) Δ
Haloacetic acids 0.06 Not specified

(HAA5) ◊
Chlorite 1 Not specified
Bromate 0.01 Not specified
* Total chlorine is defined as the sum free chlorine and combined chlorine. There is no direct method for the measurement
of chloramine. It is generally established by measuring total and free chlorine concentrations and calculating the
difference. When total chlorine tests are used as a single analysis, the maximum level for both chlorine and chloramine
should not exceed 0.1 mg/L. Since there is no distinction between chlorine and chloramine, this safely assumes that all
chlorine present is chloramine.
¶ There is little information about the potential toxicity of chlorine dioxide and its daughter products to hemodialysis
patients. A review of the literature yielded a single, historic report of 17 dialysis patients treated with water containing
0.02 to 0.08 mg/L of chlorite ions and no detectable chlorate ions, in whom hematologic changes were noted. [1]
Δ Total trihalomethanes are the sum of the concentrations of chloroform, bromodichloromethane, dibromochloromethane,
and bromoform.
◊ Haloacetic acids (five) are the sum of the concentrations of mono, di, and trichloroacetic acids and mono and
dibromoacetic acids.
Reference:
1. Ames RG, Stratton JW. Effect of chlorine dioxide water disinfection on hematologic and serum parameters of renal
dialysis patients. Arch Environ Health 1987, 42:280.
Suggested monitoring of water treatment system components and distribution
systems
Typical range of
Item to monitor What to monitor Typical interval ¶
values*
Sediment filter Pressure drop across the Based on the Daily

filter manufacturer's instructions
or measurements of
system performance
Sediment filter Backwash cycle timer Daily

backwashing cycle setting
Cartridge filter Pressure drop across the Based on the Daily

filter manufacturer's instructions
or measurements of
system performance
Water softener Residual hardness of Hardness as specified by Daily

product water the manufacturer of the
reverse osmosis equipment
Water softener brine tank Level of undissolved salt in Daily

tank
Water softener Regeneration cycle timer Daily

regeneration cycle setting
Carbon beds Productwater total ≤0.1 mg/L of total chlorine Daily

chlorine between the beds
Chemical injection system Level of chemical in the Based on the Daily (continuous

reservoir, injector function, manufacturer's instructions monitoring is preferable)
value of the controlling or measurements of
parameter (eg, pH) system performance
Reverse osmosis Product water conductivity, Based on the Daily (continuous

TDS, or resistivity and manufacturer's instructions monitoring is preferable)
calculated rejection or measurements of
system performance
Reverse osmosis system Product and reject flow Based on the Daily (continuous

rates, and calculated manufacturer's instructions monitoring is preferable)
recovery or measurements of
system performance
Deionizer Product water resistivity or Resistivity ≥1 Continuous monitoring

conductivity megaohm/cm; conductivity
≤1 microSiemens/cm
Endotoxinretentive filters Pressure drop across the Based on the Daily

filter at a fixed flow rate or manufacturer's instructions
productwater flow rate at or measurements of
a fixed pressure drop system performance
Dialysis water storage Bacterial growth and Total viable microbial count Monthly, or as defined by

tanks endotoxins less than action level the results of the validation
(typically 50 CFU/mL); process for storage tanks
endotoxin less than action supplying a central dialysis
level (typically 0.125 fluid delivery system
EU/mL)
Water distribution piping Bacterial growth and Total viable microbial count Monthly, or as defined by

system endotoxins less than action level the validation process
(typically 50 CFU mL); results
endotoxin less than action
level (typically 0.125
EU/mL)
UV irradiators Energy output and/or the Based on the Monthly
lamp lifespan manufacturer's instructions
or measurements of
system performance
Ozone generators Concentration in the water Facility should define an During each disinfection

contact time and residual acceptable operating range
ozone after disinfection based on the
manufacturer's instruction
or system performance
Hot water disinfection Temperature and time of Facility should define an During each disinfection

system exposure of the system to acceptable operating range
hot water based on the
manufacturer's instructions
or measurements of
system performance
Chemical disinfection Concentration of germicide Facility should define an During each disinfection

systems in water and contact time acceptable operating range
based on the
manufacturer's instruction
or measurements of
system performance
TDS: total dissolved solids; CFU: colony forming units; EU: endotoxin units; UV: ultraviolet.
* It is not possible to specify universally acceptable operating ranges for each device listed since some of the specifications
will be system specific.
¶ The actual interval for monitoring, testing, cleaning, and/or disinfection should be based on the results of the validation
process and ongoing trend analysis.
Courtesy of Nicholas Hoenich, PhD.
Suggested monitoring frequency of water and dialysis fluid
Typical range of
Item to monitor What to monitor Typical interval
values
Feed water Chemical contaminant Yearly, but more frequently

levels if trend analysis
demonstrates variability
Product water Chemical and microbiologic As defined by the AAMI [1] Six monthly, or more

contaminant levels frequently if trend analysis
demonstrates variability
Standard dialysis fluid Bacterial growth and Total viable microbial count Monthly, rotated among

endotoxin concentration less than action level machines so that each
(typically 50 CFU/mL); machine is tested at least
endotoxin less than action once per year, and
level (typically 0.25 different machines are
EU/mL) sampled on each occasion
Ultrapure dialysis fluid Bacterial growth and Total viable microbial count Before the first use to

endotoxins in the ultrapure <0.1 CFU/mL; endotoxin validate the system and
dialysis fluid as it enters <0.03 EU/mL monthly thereafter
the dialyzer Bacterial growth and
endotoxin tests are not
necessary if the system is
fitted with a bacteria and
endotoxinretentive filter
validated by the
manufacturer and operated
and monitored according to
the manufacturer's
instructions
The actual interval for monitoring, testing, cleaning, and/or disinfection should be based on the results of the
validation process and ongoing trend analysis.
AAMI: Association for the Advancement of Medical Instrumentation; CFU: colonyforming units; EU: endotoxin units;
ANSI: American National Standards Institute; ISO: International Organization for Standardization.
References:
1. Association for the Advancement of Medical Instrumentation. Water for hemodialysis and related therapies.
ANSI/AAMI/ISO 13959. 2009 Association for the Advancement of Medical Instrumentation, Arlington, VA 2011.
Courtesy of Nicholas Hoenich, PhD.
Water contaminants and resulting symptoms among hemodialysis patients
Contaminant Symptoms of toxicity
Aluminum Neurologic deterioration, encephalopathy, bone disease, anemia
Bacteria and Pyrogenic reaction, such as hypotension, fever, nausea, and vomiting
endotoxin
Calcium Nausea and vomiting, muscle weakness, hypertension
Chloramine Hemolysis, anemia, methemoglobinemia
Copper Nausea, chills, hemolysis
Fluoride Bone disease (chronic exposure); pruritus, chest pain, nausea, cardiac arrest (acute exposure
to high concentrations)
Lead Abdominal pain, muscle weakness, peripheral neuropathy, subtle cognitive changes
Magnesium Nausea and vomiting, muscle weakness
Nitrates Nausea and vomiting, hypotension, methemoglobinemia
Sodium Hypertension
Sulfate Nausea and vomiting, metabolic acidosis
Zinc Anemia
Individual symptoms associated with water contaminants among hemodialysis
patients
Symptom of toxicity Contaminants
Abdominal pain Lead
Anemia Aluminum, chloramine, copper, zinc
Bone disease Aluminum, fluoride (chronic exposure)
Cardiac arrest Fluoride (acute exposure to high concentrations)
Chest pain Fluoride
Chills Copper
Cognitive changes Lead
Death Aluminum, bacteria, chloramine, endotoxin, fluoride
Encephalopathy Aluminum
Fever Bacteria, endotoxin
Hemolysis Chloramine, copper, nitrates
Hypertension Calcium, sodium
Hypotension Bacteria, endotoxin, nitrates
Metabolic acidosis Low pH, sulfate
Methemoglobinemia Chloramine, nitrates
Muscle weakness Calcium, lead, magnesium
Nausea and vomiting Bacteria, calcium, copper, endotoxin, fluoride, low pH,
magnesium, nitrates, sulfate, zinc
Neurologic deterioration Aluminum
Peripheral neuropathy Lead
Pruritus Fluoride
Data from: Dialysis water pretreatment for incentre and satellite haemodialysis units in NSW: A set of guidelines. NSW
Renal Services Network 2008.
Contributor Disclosures
Nicholas Hoenich, PhD Nothing to disclose Richard A Ward, PhD Consultant/Advisory Boards: Baxter
Healthcare [Hemodialysis devices]. Steve J Schwab, MD Nothing to disclose Alice M Sheridan,
MD Nothing to disclose
Contributor disclosures are reviewed for conﬂicts of interest by the editorial group. When found, these are
addressed by vetting through a multi-level review process, and through requirements for references to be
provided to support the content. Appropriately referenced content is required of all authors and must
conform to UpToDate standards of evidence.
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Chlorine 4 (as Cl 2 ) 0.1*

Chloramine 4 (as Cl 2 ) See footnote*

Chlorine dioxide 0.8 (as ClO 2 ) See footnote ¶

Total trihalomethanes 0.08 Not specified

Haloacetic acids 0.06 Not specified

Bromate 0.01 Not specified

Sediment filter Pressure drop across the Based on the Daily

Sediment filter Backwash cycle timer Daily

Cartridge filter Pressure drop across the Based on the Daily

Water softener Residual hardness of Hardness as specified by Daily

Water softener brine tank Level of undissolved salt in Daily

Water softener Regeneration cycle timer Daily

Carbon beds Product­water total ≤0.1 mg/L of total chlorine Daily

Chemical injection system Level of chemical in the Based on the Daily (continuous

Reverse osmosis Product water conductivity, Based on the Daily (continuous

Reverse osmosis system Product and reject flow Based on the Daily (continuous

Deionizer Product water resistivity or Resistivity ≥1 Continuous monitoring

Endotoxin­retentive filters Pressure drop across the Based on the Daily

Dialysis water storage Bacterial growth and Total viable microbial count Monthly, or as defined by

Water distribution piping Bacterial growth and Total viable microbial count Monthly, or as defined by

UV irradiators Energy output and/or the Based on the Monthly

Ozone generators Concentration in the water Facility should define an During each disinfection

Hot water disinfection Temperature and time of Facility should define an During each disinfection

Chemical disinfection Concentration of germicide Facility should define an During each disinfection

Feed water Chemical contaminant Yearly, but more frequently

Product water Chemical and microbiologic As defined by the AAMI [1] Six monthly, or more

Standard dialysis fluid Bacterial growth and Total viable microbial count Monthly, rotated among

Ultrapure dialysis fluid Bacterial growth and Total viable microbial count Before the first use to

Conﬂict of interest policy

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Carbon beds Productwater total ≤0.1 mg/L of total chlorine Daily

Endotoxinretentive filters Pressure drop across the Based on the Daily