Water Treatment For Hemodialysis, Including The Latest AAMI Standards - Document - Gale Academic OneFile

11/4/22, 12:06 Water treatment for hemodialysis, including the latest AAMI standards - Document - Gale Academic OneFile
Water treatment for hemodialysis, including the

latest AAMI standards
Author:
Rebecca L. Amato
Date:
Dec. 2001
From:
Nephrology Nursing Journal(Vol. 28, Issue 6)
Publisher:
Jannetti Publications, Inc.
Document Type:
Article
Length:
8,747 words
Abstract:
Inadequately purified water for hemodialysis (HD) treatments have

led to many documented patient
injuries and deaths. Although nurses may not
be servicing the water treatment system, they are
nonetheless responsible for
understanding all the clinical ramifications of water treatment for HD. This
article offers information on water treatment components used for HD
applications, including the latest
AAMI standards.
Full Text:
Goal:
To describe the function of the majority of the water treatment

components used for hemodialysis
applications.
Objectives:
1. List key components in a water treatment system for

hemodialysis patients.
2. Identify clinical manifestations in hemodialysis patients

exposed to inadequately purified water or
contaminated dialysate.
3. Discuss issues involved with the maintenance of a water

treatment system, the importance of water
quality monitoring, and bacterial
assays.
Many documented hemodialysis (HD) patient injuries and deaths are

associated with inadequately
purified water for the HD treatment. Table 1
describes potential clinical symptoms of using
inadequately purified water.
It is estimated that many more incidences go unreported because the
chronic
symptoms, like bone disease, can be insidious and relegated to problems
secondary to ESRD
unless a patient exhibits an acute or subacute reaction.
Nurses may not be servicing the water
treatment system, but nurses are
responsible for understanding all the clinical ramifications of water
treatment for hemodialysis and piecing together the entire picture. Although
historically the water
treatment system is the technicians' domain,
knowing the technical aspects in order to work together
is best for the
patients' ultimate well-being.
More than 90% of dialysate is water. The more pure the water, the
more accurate the dialysate
prescription delivered. Companies who sell water
purification devices are regulated by the Food and
Drug Administration (FDA).
Water treatment systems, dialysis machines, and ancillary devices are
mandated as Class II medical devices by the FDA. Class I encompasses loosely
regulated items such
as band-aids and tongue depressors; Class III
stringently regulates devices like high-flux
hemodialyzers and implantable
items such as pace makers.
https://go.gale.com/ps/i.do?p=AONE&u=googlescholar&id=GALE|A82511120&v=2.1&it=r&sid=AONE&asid=297a65f5 1/22
Water Supply
There are two sources of municipal water: surface water and ground
water. Surface water comes from
lakes, ponds, rivers, and other surface type
reservoirs. It is generally more contaminated with
organisms and microbes,
industrial wastes, fertilizers, and sewage. Ground water comes from
underground chambers such as wells and springs and is generally lower in
organic materials but
contains higher inorganic ions such as iron, calcium,
magnesium, and sulfate.
Public water systems process both types of water. They add

chemicals depending on the quality of the
supply water. By law, strict
guidelines must be adhered to as stated in the Safe Drinking Water Act.
This
law pertains to the maximum allowable level of contaminants in potable water.
Public water
systems are regulated by the Environmental Protection Agency
(EPA).
Municipal water suppliers use processed waste water from sewage

and industry for drinking water.
For example, waste from the manufacturing
process is metered into the waste water drain in
compliance with EPA and
other regulations. The waste water is distributed to a waste water plant
where it is run into large settling ponds and is treated with chemicals and
flocculants to remove the
contaminants. After the waste settles to the
bottom, the top layer of water is fed into a river or
reservoir that feeds
the municipal potable water facility. At the municipality, the water is
further treated
with flocculants, such as aluminum sulfate (alum), to remove
nonfilterable suspended particles
(colloidal matter); depth filtration to
remove filterable solids; chlorination/chloramination for
disinfection; and
fluoridation to prevent cavities. Ironically, most chemical additives have
unenforceable contaminant level goals; in other words, no citations are given
when a desired level is
violated. Table 2 gives maximum allowable levels of
contaminants in water by the Association for the
Advancement of Medical
Instrumentation (AAMI) and the EPA.
Water supply companies are mandated by the EPA to monitor and test
the water on a periodic basis.
Water can change from season to season and
even day to day. It has been reported that up to 48 of
our 50 states have
been out of compliance with the EPA Standards at any given time (Carpenter,
1991). This places an extra burden on the nephrology professionals to deliver
the purest water
feasible to persons on HD.
Why Water Purity is Important During HD
By the time water arrives at our faucets, it is deemed acceptable

to drink by the municipality and the
EPA; however, not acceptable to perform
HD. The average person drinks approximately two liters of
water a day,
whereas a dialysis patient is exposed to anywhere from 90 to 192 liters of
water per
treatment. In healthy individuals, the contaminants in water are
mainly excreted through the kidneys
and gastrointestinal (GI) system. HD
patients on the other hand, do not have functioning kidneys to
excrete the
waste products from this massive water (as dialysate) exposure. The blood is
separated
from the water by a semipermeable membrane, the dialyzer, that is
selective as far as size of
molecule but not contaminant specific.
This article reviews technical information sectioned into Feed

Water Components, Pretreatment
Components, Reverse Osmosis (RO) System,
Posttreatment Components and Distribution System.
Typically, not all the
components mentioned are on a water treatment system for hemodialysis. From
facility to facility, components will vary dependent upon incoming water
quality and philosophy of the
staff.
Feed Water Components
The AAMI recommends and the FDA and Health Care Financing
Administration (HCFA) dictate that all
water treatment devices be labeled
with: (a) the type of device; (b) the manufacturer name and
address with
phone number; (c) appropriate warnings for use; and (d) identifications to
prevent
improper connections. Flow schematics and diagrams should be
displayed in the water treatment
room and updated as necessary.
Back-flow preventer. All water treatment systems require a form of

back-flow prevention device. A
back-flow preventer prohibits the water in the
water treatment components from flowing back into the
potable drinking water
lines. This protects the drinking water from contamination with disinfectants
and
cleaners that are used in the water treatment system. Many other devices,
like air conditioners
connected to the drinking water supply, require
back-flow prevention in order to prevent back-
syphoning of anti-freeze and
other toxins.
Local plumbing codes dictate the type of back-flow preventer that

can be used and varies from area to
area. A device that creates an air gap,
such as break tank is considered a back-flow prevention device
and is
sometimes used on small portable RO machines. Back-flow preventers must be
installed by a
licensed plumber, and validated annually by a state authorized
licensed inspector.
Temperature blending valve. The temperature blending valve mixes

hot and cold water to a RO
membrane industry standard temperature of around
77 [degrees] F (25 [degrees] C). These valves
are widely used on large
central RO systems that tend to have cold incoming water. The colder the
source water, the less purified water the RO membrane will produce. Per 1
[degrees] F temperature
drop, the RO membrane produces 1.5% less purified
water (1 [degrees] C drop equals a 3%
decrease). For instance, an incoming
temperature of 50 [degrees] F would result in an approximate
loss of 40%
(product water flow).
An alternative to temperature blending when not practical, as in

single patient portable RO machines,
is the use of larger or more RO
membranes. The larger membrane surface area produces more
permeate water. If
blending hot and cold water together from a sink faucet, a temperature gauge
must
be in place with an audible alarm. Most RO membranes are heat intolerant
and can be destroyed with
temperatures above the manufacturer's
recommendations.
A temperature gauge with an audible and visual alarm should follow

temperature blending valves.
Temperature readings should be compared to an
independent meter and recorded at least daily.
Booster pump. The RO system requires a constant supply of water

flow and pressure in order to
operate successfully. Dialysis facilities
experience fluctuating or decreased incoming water pressure
and flow,
especially since back flow preventers and temperature blending valves
substantially lower
pressure. In order to compensate, a booster pump may be
placed after these devices. Booster pumps
should be followed by a pressure
gauge that is read and recorded daily.
Bladder tank. During cases of extreme low or intermittent to no

water flow, a bladder tank may be
coupled with a booster pump. A flexible
"bladder" on the inside of the tank maintains pressurized feed
water by cycling a diaphragm back and forth with pressurized water on the
bottom side and an air
charge on the top side.
A bladder tank should never be placed after the RO or deionization

(DI) on the purified water
distribution side of the system. There is a
possibility of retention of chemicals in the air-charged side of
the tank if
it should fail. The pre and post pressures of the bladder tank should be
monitored and
recorded daily.
Pretreatment Components
Acid injection metering device. New lower lead and copper

regulations for drinking water were
mandated in 1996 by the EPA. In order to
meet the more stringent guidelines, water suppliers have
answered by
increasing the pH of the city water supply using lime softening agents or
calcium
carbonate. These chemicals prevent leaching of lead, copper, and
other metals from the city and
residential piping systems.
In order for the RO to operate properly and carbon tanks to remove

chlorine/chloramine effectively, the
ideal incoming water pH should be
between 5-8.5. In many areas the pH is higher than 8.5, so an acid
injection
system may be incorporated into the design of the pretreatment, especially
with the presence
of chloramine. A pH higher than 8.5 with chloramine present
will cause the carbon to be less
adsorptive and the RO membrane performance

to degrade (Leuhmann, Keshaviah, Ward, Klein, &
Thomas, 1989).
Acid injection devices meter a small amount of a strong acid, such

as muriatic also known as
hydrochloric (HCl), or sulfuric acid, into the feed
water stream. Some facilities have switched to
weaker, safer acids like
acetic and ascorbic acids, but much more of the solution is needed to alter
the
pH downward.
Acid injection systems must be placed before the multimedia depth

filter. The lower pH will cause
dissolved metals like aluminum and some salts
in the feed water to precipitate. The depth bed filter
will catch most of the
precipitated particles.
Acid injection systems must be continuously monitored by an inline

pH monitor with an audible and
visual alarm. The system must be checked
against an independent pH device at least daily. Both
readings should be
recorded. While pH meters are useful, they tend to drift and need frequent
calibration. All Material Safety Data Sheets (MSDS) and Occupational Safety
and Health
Administration (OSHA) requirements must be followed for the safe
handling of the acid.
Multimedia depth filter. Large particulates of 10 microns or

greater that cause the supply water to be
turbid -- such as dirt, silt,
colloidal matter (suspended matter) -- are removed by a multimedia filter,
sometimes referred to as a depth bed filter. Foulants can clog the carbon and
softener tanks, destroy
the RO pump, and foul the RO membrane.
Many source waters, in spite of their apparent clarity, carry a

large amount of suspended particulate
matter that can adversely affect
pretreatment and RO performance. A silt density index (SDI) test
measures and
evaluates how rapidly a screen becomes clogged on a particular water source.
Most
RO membrane manufacturers recommend that feed water SDI not exceed a
value of 5.0.
Multimedia filters contain multiple layers of various sized rocks

ranging from sand to gravel that
literally trap the large particles as the
water is filtered downward. The first layer is usually composed of
anthracite
coal, followed by layers of garnet, sand, then gravel. All the tiers are
constructed of different
sized media so that not all the particulates are
collected at the top but rather distributed through the
media bed, a
phenomenon known as depth filtration. By using a stratified bed, increasingly
smaller
particles are captured, the entire bed is used, and the filter is not
rapidly clogged.
An automatic multimedia filter is back-washed on a preset time

schedule (when the system is not in
use) so that the media is cleansed and
renewed regularly. By redirecting the water flow upward
(backwashing), the
tightly packed bed is lifted so that the lighter material floats to the top
and out to
drain. The media, chosen for its size and density, then resettles
in its ordered layers when the process
is complete.
Multimedia filters should be back-washed at frequent intervals,

how often depends on the amount of
particulates in the supply water. Pressure
gauges on the inlet and outlet of the tank monitor pressure
drop (delta
pressure) and are read and recorded at least daily to monitor clogging of the
filter bed.
When these gauges display a difference of 8 PSI or greater, it is
time to backwash. Also, the clock on
the head of the tank should be read and
recorded daily. Compare the time on the tank head to the
time on a wristwatch
(they should be the same). Situations such as power failures can reset the
backwash time to occur during patient runs. No patient harm would occur, but
patients' treatments
would be delayed as the RO would have no water
flow.
Water softener. Softeners work on an ion exchange basis. The resin

beads within the tank have a high
affinity for the cations calcium and
magnesium (both divalent) present in the source water and release
two sodium
ions (monovalent) for one calcium or magnesium captured. High levels of
calcium and
magnesium in the supply water cause the water to be hard.
Hardness is measured in grains per gallon
(grain literally taken from the
precipitate left from evaporated water being the size of a grain of wheat)
or
mg/ml and is generally expressed as CaC[O.sub.3] (calcium carbonate) for
uniformity purposes. To
a lesser degree, softeners will remove other
polyvalent cations such as iron.
Water containing calcium and magnesium form scale deposits on the

RO membrane and eventually
foul the membrane. Once mineral deposits form on
the RO membrane, the percent rejection
(membrane performance) and product
water quality, measured as total dissolved solids (TDS),
conductivity, or
resistivity, decline. Mineral scale can become permanent and decrease the
life
expectancy of the RO membrane if not cleaned. Some source waters can
foul an RO membrane in
hours, turning it literally to stone.
However, sodium chloride does not deposit scale on the RO

membrane. So, a softener is placed
before the RO and the DI to protect the RO
membrane or to extend the life of the DI depending on
which primary form of
water purification exists.
Softeners are sized in grains of capacity; 1 cubic foot (cu. ft.)

of resin equals 30,000 grains of
hardness exchange capability. A source water
analysis that states the level of CaC[O.sub.3] is
important in determining
the size of the softener. A formula can be used to calculate how long the
softener will last before needing regeneration.
Decreased softener resin life may occur if exposed to detrimental

levels of chlorine or chloramine in
the incoming water. Therefore, the
softener can be placed after the carbon tank if the incoming
chlorine/chloramine levels dictate. Softeners are also placed before the
carbon tank, on the
chlorinated/chloraminated water side in order to impede
microbial growth, decreasing the bacterial
bioburden to the RO membrane.
The softener needs regenerating on a routine basis with

concentrated sodium chloride solution (brine)
before the resin capacity is
used up. Also, like multimedia filters, during normal operation, the water
flows downward through the resin and tightly packs the resin beads. Before
the regeneration process,
the resin is backwashed to loosen the media and
clean any particulates from the tank. After the
backwashing step, the brine
solution is drawn into the tank to regenerate the resin. The calcium and
magnesium are forced off the resin beads even though they possess a stronger
bond than sodium
because they are overwhelmed by the amount of sodium ions.
Next, the excess salt solution is rinsed
out of the tank.
Regeneration is usually performed every day the softener is used

at a time when the water treatment
system is not in use. Most dialysis
facilities use a permanent softener that incorporates a brine tank
and
control head that executes the automatic regeneration cycle. According to the
AAMI standard,
automatically regenerated softeners should be fitted with a
regeneration lock-out device to prevent the
regeneration process during
patient treatments (AAMI, 2001).
Portable exchange softeners (softeners that are regenerated

off-site) are sometimes used in areas
that regulate the amount of sodium and
chloride discharged to drain. In this case, the softener tank will
be
replaced on a routine basis and will not have a control head or brine tank.
They may also be used
on single patient portable systems in acute dialysis
for quick turn-around and ease.
A hardness test on the effluent softened water should be done, at

a minimum, once a day and
recorded. However, to determine the efficacy of the
softener, it is best to test the softened water twice
a day; once in the
morning to determine that the softener did regenerate and once at the end of
the
day to prove that the softener performed adequately all day. Hardness
tests should be less than 2
grains per gallon (gpg) hardness (35 mg/L) and
performed on "fresh" water, not water that has sat in
the tank all
night. Start the water treatment system approximately 15 minutes (shorter
interval for
portable systems) prior to drawing the sample. If the hardness
test reads above 2 gpg, the softener
may need regenerating before use. Check
the timer in the control head to see that it displays the
correct time, and
read and record the pressure gauges pre and post softener daily.
Brine tank. The brine tank contains salt pellets and water to
create the super saturated salt solution
used for softener regeneration.
Fifteen pounds of salt is required to regenerate one cubic foot of resin
(30,000 grain capacity). Only refined, pellet shaped salt should be used in
dialysis applications (FDA,
1996). Other salts (e.g., rock salt) may contain
too many impurities, such as dirt.
The salt level in the brine tank should be inspected daily and
maintained as needed. As long as there
is undissolved salt present, the
solution is considered supersaturated. Ascertain that a "salt
bridge"
has not formed in the tank by tapping on the top of the salt in
the tank. If a salt bridge has formed, the
softener will not regenerate to
full capacity and would not soften for the expected duration of time.
Record
the level of the water and salt daily.
Carbon tanks. Chlorine and chloramine are added to the city water
supply for disinfection purposes. In
drinking water, these additives allow us
to drink the water with minimal risk of becoming ill from a
parasite or
pathogenic bacteria. However, there are some drawbacks to the disinfectants
themselves.
For instance, chlorine can combine with other organic chemicals
to form trihalomethanes, a
carcinogenic. For this reason, chloramine, a
combined chlorine that cannot combine with other
chemicals, has become the
major disinfectant of drinking water over the past 15 years. But, as
compared
to chlorine, it takes a longer contact time with the carbon to be adsorbed.
Since the
initiation of chloramine use, there have been more reported
incidents of hemolysis and related
symptoms in patients due to chloramine
exposure than compared with chlorine, though chlorine is
harmful also.
Beside the deleterious effects in patients, both chlorine and

chloramine are not removed by RO and
actually damage the thin film-type RO
membranes. Therefore they must be removed before the RO
system. Furthermore,
chloramine must be removed before DI because there is a possibility that
carcinogenic nitrosamines may develop if non-carbon filtered water enters the
DI bed (Kirkwood,
Dunn, Thomasson, & Simenhoff, 1981).
Carbon filtration, often referred to as granular activated carbon

(GAC), will remove chlorine and
chloramine that are almost always present in
the source water through a chemical process termed
adsorption. As the input
water flows downward through the GAC, solutes diffuse from the fluid into the
pores of the carbon and become adsorbed or attached to the structure. As a
side benefit, along with
chlorine and chloramine, many other low molecular
weight organic chemicals such as herbicides,
pesticides, and industrial
solvents will be adsorbed.
GAC can be made from different organic material such as bituminous

coal, coconut shells, peach pits,
wood, bone, and lignite that have been
exposed to excessive temperatures (pyrolysis). It is then acid
washed to
remove the ash and to etch the carbon to increase the porosity and therefore
the
adsorbency of the GAC. All carbon used for dialysis should be acid
washed, especially carbon derived
from bone, wood, or coal, as these tend to
leach metals such as aluminum when they are not acid
washed and exposed to
water.
GAC is rated in terms of an "iodine number," which

measures the ability to adsorb low molecular
weight, small organic substances
like iodine and subsequently, chlorine and chloramine. The higher
the iodine
number, the more chlorine and chloramine will be adsorbed. An iodine number
of 900 or
greater is recommended for the removal of chlorine and chloramine.
It would be ideal to have a
chlorine or total chlorine rating for carbon, but
it is not a trade practice. Peroxide number is another
rating system that is
closely associated with the carbon's ability to adsorb chlorine and
chloramine.
According to AAMI, when other forms of non-iodine rated carbons
are used, the manufacturer should
supply validation for the removal of
chlorine and chloramine (AAMI, 2001).
Another rating system that is pertinent to dialysis is the

abrasion number, which reflects the ability of
activated carbon to withstand
degradation -- the higher the number, the more resistant to breakdown.
Since
there is frequent backwashing associated with carbon used for dialysis, a
durable carbon such
as acid washed bituminous coal should be considered.
AAMI (2001) recommends the use of virgin carbon and not carbon
that has been reburned by the
manufacturer. Carbon is used in many, more
toxic applications than dialysis and can be recycled and
reburned by vendors.
Reburnt or reprocessed carbon can retain impurities that may be toxic to
patients. It is recommended that a GAC mesh size of 12 x 40 or smaller is
used in order to obtain a
larger surface area, but not too small, or flow
will be impeded through the tank (Luehmann et al.,
1989).
An appropriate exposure time of the water flow through the carbon

tank is imperative in order for the
chlorine and chloramine to be adsorbed
adequately. The contact time can be measured using the
input flow rate (Q) in
gallons per minute (gpm) and the amount of the carbon media in cu. ft. (V)
and is
expressed as empty bed contact time (EBCT).
EBCT = V x 7.48 / Q
A minimum of 10 minutes EBCT is recommended by AAMI (2001) for the

removal of both chlorine and
chloramine. Two tanks in a series configuration,
with the first tank feeding into the second tank, is the
suggested set-up,
one as the worker and one for back-up with each tank having at least 5
minutes
EBCT.
According to AAMI and the FDA, portable single patient systems are
exempt from this standard since
one-to-one monitoring typically exists and 10
minute EBCT is not practical (AAMI, 1998; FDA, 1996).
Therefore, smaller
tanks may be substituted along with more frequent total chlorine testing. One
caveat -- small carbon cartridge type filters should not be used alone, they
have minimal EBCT for
adsorption and are not appropriate for high flow rates.
GAC has an exhaustion point where its adsorption capability stops.

When this occurs, chlorine and
chloramine break-through will occur. New
carbon must be flushed thoroughly to remove the ash and
carbon fines (small
pieces of carbon) that will damage the RO membrane. AAMI and FDA recommend
rotating the second GAC tank to the first position, and placing the rebedded
tank in the second
position (AAMI, 2001; Luehmann et al., 1989). However, the
safest technique is to rotate the carbon
tanks out on a routine basis before
breakthrough occurs, for example every 6 months. Carbon is a
conducive medium
for bacteria to proliferate and will cause undue bioburden stress on the RO
membrane. Over time, RO membranes can "grow through" with bacteria
and contaminate the product
water side (White & Layman, 1991).
The AAMI Standard (1998, 2001) has established maximum allowable

levels for chlorine of 0.5 mg/L
and 0.1 mg/L for chloramine. A test for total
chlorine, which tests for both "free" chlorine and
"combined" chlorine or chloramine, should be performed on fresh
effluent exiting the first tank a
minimum of once a day (AAMI, 2001). The
safest practice is to test before every patient shift. If
breakthrough is
detected from the first tank, a test after the second tank should be done.
Assuming
the second test is negative, patient runs can be initiated if the
first tank is replaced within a reasonable
time, for instance 24 hours. In
addition, hourly testing for total chlorine should be performed on the
second
tank.
Bypass valves placed on the piping to carbon tanks that allow the
feed water to completely bypass the
carbon tanks without being carbon
filtered are unsafe and not recommended.
With a standard DPD (N, N-diethyl-p-phenylenediamine) test, the

difference between the "free"
chlorine and "total
chlorine" is considered the chloramine content, since there is no test
that isolates
chloramine. When total chlorine tests are used as a single
analysis (e.g., test strips), 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 (AAMI,
2001).
Even if chloramines are not normally present in the water supply,

chloramines can form naturally from
chlorine combining with ammonia from
decomposing vegetation. Chloramine may also be added
unexpectedly to the
source water, especially those municipal suppliers using surface water.
Therefore,
always test for total chlorine and never just free chlorine alone.
Channeling of the GAC is a common problem because water tends to

flow in the path of least
resistance. Carbon will also filter debris from the
water, and compaction of the carbon will create
smaller carbon fines.
Biological fouling is another inherent problem with GAC because it is an
organic
medium, and with the chlorine and chloramine removed from the water,
bacteria grow. These
phenomena cause the carbon surface area to be underused.
Therefore, carbon tanks are
backwashed on a routine basis to
"fluff" the bed, clean the debris out, and expose unused sides of
the
carbon. Backwashing does not regenerate the carbon when it is exhausted,
it simply exposes unused
sides of the carbon. If the carbon tank cannot be
backwashed, the carbon media should be changed
on a more frequent basis.
Monitor the pre and post GAC tank pressures and check the setting
of the control head clock and
record daily. Testing the effluent for
chlorine/chloramine break-through must be done at minimum daily,
but before
every patient shift is safest. Document when the tanks have been exchanged or
re-bedded,
and include the grade of carbon used and rinse time of the tank
performed.
Reverse Osmosis (RO) Systems
Prefilter. Prefilters are particulate filters positioned after all

the pretreatment and immediately before
the RO pump and RO membrane. Carbon
fines, resin beads, and other debris exiting the pretreatment
destroy the
pump and foul the RO membrane. Typically, prefilters range in pore size from
3-5 microns.
Two gauges monitor the inlet versus the outlet pressures across
the filter. If the delta pressure
increases by eight over new filter pressure
differential, the filter is clogged and needs replacement.
Prefilters are
inexpensive insurance against damaging more expensive items downstream in the
system. Therefore, changing them on a routine basis before the pressure
differential indicates is good
practice. Inspect the filter's center
tube for soiling. If dirt is present, the prefilter was overburdened and
should have been replaced sooner. AAMI (2001) standards dictate that the
housing of the pre filter
should be opaque to deter algae growth.
RO pump and motor. The RO pump increases water pressure across the
RO membrane to increase
both product water flow and rejection characteristics
of the RO membrane. RO systems typically
operate between 200-250 PSI.
It is important that RO pumps are made of high-grade stainless

steel, inert plastics, and carbon
graphite-wetted parts. Brass, aluminum, and
mixed metal pumps will leach contaminants into the
water and are not
compatible with peracetic acid type disinfectants. Operating RO pumps dry
will
cause irreparable damage. Monitor RO pump discharge pressure
continuously and record daily.
RO membranes. The RO membrane is the heart of the system. It

produces the purified water through
RO. RO is just that, it is the opposite
of osmosis. Osmosis is a naturally occurring phenomenon
involving the flow of
water from a less concentrated compartment (e.g., nonsalty side) to the more
concentrated compartment (e.g., salty side) across a semi-permeable membrane
to equilibrate the
two solutions. In reverse osmosis, concentrated water is
forced to flow in the opposite or unnatural
direction across a semipermeable
membrane by means of high pressure. Natural osmotic flow is
overcome and pure
water passes through the membrane leaving the dissolved solids (salts,
metals,
etc.) and other constituents behind on the concentrated side.
Dependent upon how much product
water is needed, the RO system will have one
or more RO membranes.
RO membranes reject dissolved inorganic elements such as ions of

metals, salts, and chemicals and
organics including bacteria, endotoxin, and
viruses. Rejection of charged ionic particles ranges from
95-99%, whereas
contaminants such as organics that have no charge are rejected at a greater
than
200 molecular weight cut-off. Ionic contaminants are highly rejected

compared to neutrally charged
particles, and polyvalent ions are more readily
rejected than monovalent ions.
Thin film (TF) RO membranes made of polyamide (PA) are the most
common type used in HD. These
RO membranes are made with a thin, dense,
semipermeable membrane over a thick porous
substructure for strength and
spiral wound around a permeate collecting tube. The spiral design
allows for
a large surface area in a small space.
TF RO membrane will degrade when exposed to oxidants such as

chlorine/chloramine and, therefore,
must be preceded by carbon tanks. Care
must be taken with the use of peracetic acid products used
for disinfection,
as they will oxidize the RO membrane if used above a 1% dilution or if iron
deposits
reside on the RO membrane.
The colder the incoming water, the more resistant it is to cross

the RO membrane, thereby decreasing
purified water production. Adequate
pretreatment, pH, and cleanliness of the RO membrane surface
also influence
performance of the membrane.
TF membranes have a wide pH tolerance of 2-11; however, the

optimum pH range for membrane
performance is between 5.0-8.5. High alkalinity
also enhances scaling of the RO membrane surface.
Scale deposits such as calcium and magnesium salts and silt

composed of colloidal matter, metals
such as iron, and organics and dirt will
accumulate on and eventually foul the RO membrane. Routine
cleaning and
disinfection will insure proper functioning and will extend the life of the
RO membrane
and reduce the bacterial growth in the system that can harm
patients.
Cleaning the RO, on at least a quarterly basis, will strip the

scale and silt build-up. High pH cleaners
remove the silt slime layer and low
pH cleaners remove the mineral scale build-up.
Disinfection regimens vary widely, but it is recommended at least

monthly for the entire system, from
RO to dialysis machines (Amato, 1995;
Bland et al., 1989). With storage tank systems, weekly
disinfection of the
tank and distribution loop is recommended. For portable RO systems, weekly
disinfection should be performed, or whenever there is down-time for more
than 48 hours (Amato,
1995).
RO membrane performance is measured by percent rejection, and

final product water quality can be
measured by either conductivity in
micro-siemens/cm or total dissolved solids (TDS) displayed as
mg/L or parts
per million (PPM). AAMI recommends both percent rejection and water quality
monitors
be used. They should be continuously displayed with audible and
visual alarms with set points that
can be heard in the patient care area.
Percent rejection alone only measures membrane performance.
For example, if
the source water is relatively pure, containing 100 PPM dissolved solids
(metals, salts)
and the percent of those dissolved solids that are rejected
to waste is equal to 95%, the final water
quality would display 5 TDS mg/L or
PPM. However, if the source water had as much as 500 PPM and
the percent
rejection continued to be 95%, the final water quality would then be 25 PPM.
In each
scenario, the percent rejection is the same 95%, but the final water
quality is significantly different. An
AAMI analysis in either case must be
done to indicate whether the water is suitable for dialysis or
needs further
purification.
An AAMI chemical analysis must be performed at minimum once a year

to validate the removal of
contaminants by the water treatment system. Some
states require more frequent testing such as twice
a year (Texas Department
of Health, 1996). The AAMI sample should be drawn after all the
posttreatment
components in the most distal portion of the distribution loop. The system
must operate
within AAMI parameters at all times, so it is suggested to test
quarterly with season changes. An
additional AAMI analysis should be done if
the percent rejection falls by 5-10% and/or the water
quality degrades by
doubling of the salt passage (AAMI, 1998; Luehmann et al., 1989) and it is
unable
to be recovered through cleaning or repair (e.g., membrane
replacement) of the RO system. It is
required by AAMI and FDA that if a

predetermined set-point for water quality is violated, that the RO
system
should shut off or the product water from the RO divert to drain. The
physician should be
notified to continue treatments (AAMI, 2001; FDA, 1996).
Small portable RO systems are exempt from
the shut-off or divert-to-drain
standard since one-to-one monitoring usually exists (FDA, 1996), but the
physician still should be notified.
AAMI has determined maximum allowable levels of contaminants that

can safely be in water before
causing patient harm (see Table 2). Usually, RO
systems can meet the AAMI standards on drinking
water that meets the EPA
guidelines. Sometimes, double-pass RO, product water of one RO is fed
into
another RO, is used for extra purification.
RO systems, RO pumps, and dialysis machines all require a minimum

flow rate and pressure to
operate properly without damage. Pressure gauges
typically measure the inlet water supply, pump,
reject water, or waste and
product pressures, and are displayed as pounds per square inch (PSI). On
larger central RO systems, flow monitors indicate the actual water flow in
gpm of the inlet, reject or
waste, and product streams.
All gauges and flow meters should be within manufacturer's

specifications and recorded daily. Water
quality conductivity or TDS should
be within normal limits for the location, checked against an
independent
device, and recorded at least daily. Percent rejection should be within
acceptable
operating limits and documented daily. While it is true for all
measurements on a water treatment
system, it is especially important to
include the expected parameters for water quality on the log sheet.
Trend
analysis is also vital for documenting water treatment systems. It allows the
user to be more
proactive, seeing a problem arising, rather than
"putting out fires."
Posttreatment Components
Deionization (DI). Sometimes DI is required to polish the water

when RO alone cannot reduce the
contaminants to within AAMI standards. Also,
facilities many times use DI as an emergency back-up
to the RO and may have
the DI tanks "dry" or offline.
DI contains resin beads that remove both cations and anions from
water in exchange for hydroxyl
(OH) and hydrogen (+H) ions. The ions released
combine to form pure water ([H.sub.2]O). Particles
without a charge are not
removed by DI, as they are with RO. In fact, the DI retains all the ions it
has
accumulated until it reaches an exhaustion point. Before this occurs, the
tank must be exchanged for
a new one. If a DI is used past the point of
exhaustion, it will start to dump the captured ions in mass
quantities, the
weakly attracted ions like aluminum and fluoride go first. There have been
injuries and
deaths reported with the improper use of DI, therefore, it is
imperative to assure the safest set-up is in
place (Luehmann et al., 1989).
DI tanks can be either dual bed or mixed-bed varieties. Dual bed

type are tanks that contain either all
cation or all anion resin beads and
require two tanks, one of each, in series to remove ions from the
water.
Mixed-bed deionizers contain both positive and negative charged resins in one
tank and
produce a higher quality of water than dual beds. Dual beds may be
used as long as they are followed
by at least one mixed-bed tank. Like
softeners, DI has a finite capacity, 1 cubic foot of DI resin equals
8,000
grains exchange capability. When the bed is exhausted, it must, according to
AAMI and FDA, be
replaced with medical (or potable water) designated resins
(AAMI, 2001; FDA, 1996; Luehmann et al.,
1989). DI is used for many
industrial applications, such as chrome plating factories, which can leave
the resin full of toxins and heavy metals. These industrial resins could harm
patients and should be
regenerated separately from dialysis resins. Further,
the tanks should be disinfected at the time of
regenerating to prevent
pyrogenic episodes in patients (AAMI, 2001).
DI can actually degrade the product water in terms of bacteria and

endotoxin content because DI resin
is a conducive environment for bacteria.
Further, bacteria and endotoxin have no charge and are left
undisturbed by
DI. AAMI (2001) and FDA (1996) recommend that DI be followed by
ultrafiltration (UF),
which removes both bacteria and endotoxin.
Carbon filtration is mandatory before DI, otherwise carcinogenic

nitrosamines can develop when water
that is not carbon filtered contacts the
resin beads (Kirkwood et al., 1981; Luehmann et al., 1989).
AAMI and FDA dictate that DI should be monitored continuously with

a temperature compensated
audible and visual resistivity alarm that should be
heard in the patient care area. If more than one DI
tank is in use, the final
tank should have the more sophisticated alarm, the preceding tanks may have
simple indicator lights. Since DI can exhaust and dump its retained ions, it
is recommended that two
tanks be used in a series configuration, one as the
worker and one as back-up. Also, it is required for
DI to have a
divert-to-drain mechanism for deteriorating water quality events (AAMI, 2001;
FDA, 1996;
Luehmann et al., 1989).
Resistivity, which is the opposite of conductivity, should

continuously read above 1 meg-ohm/cm and
be recorded at least daily along
with pre and post tank pressures. DI tanks should be exchanged on a
routine
basis even if the resin is not near exhaustion due to the microbiological
fouling potential.
Distribution System
Storage tanks. RO distribution systems can be grouped into two

categories, direct feed and indirect
feed. A direct feed system
"directly" delivers the product water from the RO unit to the loop
for
distribution. Unused product water can be recirculated before the RO unit
for conservation reasons.
An indirect feed system involves a storage tank
that accumulates the product water and delivers it to
the distribution loop.
Unused portions of the product water are recirculated back into the storage
tank.
The RO unit will stop and start filling the tank by receiving signals
from the high and low level switches
on the storage tank.
According to AAMI and FDA, storage tanks should be made of inert

materials that do not contaminate
the purified water, and the bottoms should
be conical shaped for complete emptying. The size of the
tank should be in
proportion to meet the facilities peak demands, no larger. Tight fitting lids
and
hydrophobic submicron vent filters inhibit air borne microbes from
entering the tank (AAMI, 2001;
FDA, 1996; Luehmann et al., 1989). A spray bar
mechanism that continuously washes down the
inside of the tank prevents
stagnant areas that can grow bacteria.
In both direct and indirect scenarios, it is important to obtain

good scrubbing velocities to inhibit the
adhesion and growth of bacteria. The
recommended minimum velocity for direct feed systems
measured at the
"end" of the loop with everything connected drawing water (dialysis
machines, reuse,
bicarbonate container filling, etc.) or peak demand, is at
least 1.5 feet per second. Indirect feed
systems should minimally be 3 feet
per second at peak demand.
Storage tanks require recirculation pumps made of inert

nonleaching materials that can meet the
challenge of the higher velocities.
An aggressive and frequent disinfection program should be
established
whenever a storage system is employed. Many facilities disinfect the
distribution system
on a weekly basis.
Ultraviolet irradiator (UV). UV is a low pressure mercury vapor

lamp enclosed in a quartz sleeve that is
required to emit a germicidal 254 nm
wavelength and provide a dose of radiant energy of 30
milliwatt-
sec/[cm.sup.2] in order to kill bacteria (AAMI, 2001). The UV is
able to penetrate the cell wall of the
bacteria and alter the DNA to either
kill it or render it unable to replicate.
It is possible for some species of bacteria to become resistant to

UV irradiation. Also, UV does not
destroy endotoxin, and it may even increase
the level as a result of the destruction of the bacteria cell
wall where
endotoxins harbor. Therefore, UV should be followed, at some point, by
ultrafiltration. Bio
film, a protective slime coating that bacteria secrete,
will also reduce the effectiveness of UV.
Regular maintenance of the UV device includes continuous

monitoring of radiant energy output that
activates an audible and visual
alarm, replacing the lamp at least annually, and routine cleaning of the
quartz sleeve.
Submicron and ultrafiltration. A submicron filter reduces the

level of bacteria in the final product water,
whereas an ultrafilter removes
both bacteria and endotoxin. Both are membrane filters that can be
cross flow
types with a feed stream and reject stream or a dead-ended design with one
stream. The
housing should be opaque to inhibit algae growth.
When using submicron and ultrafilters, AAMI (2001) recommends they

are validated for medical use.
In the industry, there are "nominal"
and "absolute" ratings for UF and submicron filters. Absolute
ratings are more appropriate for dialysis applications. Also, filters that
are not for medical use may
contain preservatives that require up to 500
gallons of water to rinse thoroughly. One incident in New
York in 1989 was
caused by using a commercially available, non-medical filter. Sodium azide, a
desiccant and preservative, was inadequately rinsed from the filter and
caused nine patients life-
threatening hypotension, blurred vision, abdominal
pain, headache, and loss of consciousness shortly
after treatments began
(FDA, 1989).
Since ultrafilters have tighter pores, they inherently have low

flows and high delta pressures across
the membrane. They will decrease flow
velocity in the loop if not designed and staged properly.
Alternatively,
ultrafiltration gives added benefit and extra protection when placed at
points of use such
as the reuse water, the bicarbonate fill station, the
dialyzer pre-rinse device, and inside dialysis
machines on the dialysate
itself (Cappelli, 1991).
Submicron and ultrafilters, even though they remove microbes, are

targets for bacterial infestation if
not routinely disinfected or replaced.
The pressure differentials should be monitored continuously and
documented at
least daily.
Distribution piping systems. Though there continues to be some

water treatment systems that have
nonreturning lines that go to drain, a
continuous loop design is recommended by AAMI. No dead-ends
or multiple
branches should exist in the distribution system, as these are places for
bacteria biofilm to
grow.
Highly purified water is very aggressive and will leach metals and
chemicals it comes in contact with.
Polyvinyl chloride (PVC) is the most
common piping material used in the USA because of its low cost
and relatively
inert nature. Other substances that may be used, but not limited to, are
high-grade
stainless steel, polypropylene, polyvinylidene fluoride (PVDF),
and glass. No copper, brass, aluminum,
or other toxic substances should be
used in the piping.
The inner surface of the joint connections should be as smooth as

possible to avoid microbiological
adhesion, such as chamfered connections,
and the use of simple wall outlets with the shortest
possible fluid path and
minimum pipe fittings are recommended (AAMI, 2001; Luehmann et al., 1989).
Flow velocity should be evaluated quarterly and the loop visually

inspected for incompatible materials
that may have been inadvertently added.
Have loop repairs performed by personnel or reputable
plumbers and all
materials used inspected for compatibility. Disinfection should always follow
any
invasive repair to the system.
Bacteria and endotoxin testing. At a minimum, bacterial levels

should be tested monthly at the points
where all dialysis systems connect to
the loop. This includes reuse systems, dialysis machines,
bicarbonate filling
stations, etc. Bacteria levels shall not exceed 200 colony forming units/ml
(CFU/ml)
with an action level of 50 CFU/ml.
The AAMI (2001) standards state: "Water samples for bacteria

testing shall be collected at a point
where water enters the equipment used
to prepare concentrates, dialysate, reprocessing of
hemodialyzers, or any
other point where product water is dispensed. Samples shall be assayed within
30 minutes of collection, or immediately stored at 4-6 [degrees] C and
assayed within 24 hours of
collection. Total viable counts (standard plate
counts) shall be obtained using the membrane filter
technique, which can
include commercial water testing devices, or spread plates. The calibrated
loop
technique shall not be used. Incubation is at 35-37 [degrees] C and
colonies shall be counted after 48
hours of incubation. Product water shall
not contain a total viable microbial count >200 CFU/ml" (p.
RO62).
Dialysate samples should be taken at the end of the day from the
dialysate exiting the dialyzer and
assayed in the same way as above. In no
case should the dialysate sample be greater than 2000
CFU/ml. All dialysis
machines should be sampled on a monthly basis.
Dialysis professionals should understand that the above mentioned

bacteria testing measures may
underestimate the bacterial burden in the water
system due to the nature of biofilm (AAMI, 2001). The
required testing
methods may not show all organisms that can grow in the system because
testing
measures for plank-tonic (free floating) bacteria and not sessile
(attached) bacteria. Therefore, it is
highly recommended to disinfect on a
routine aggressive basis and not just when an unacceptable
microbial count
dictates. Keep in mind that sterile water is not made in hemodialysis. With
large
amounts of downtime (system off), biofilm will grow even with bacteria
results stating "no growth."
Occasional scrape or swab samples of
storage tanks and piping may be more helpful for indicating
biofilm.
Endotoxin testing is now suggested by AAMI for all water used for
hemodialysis purposes. In no case
shall the endotoxin level exceed 2.0 EU as
tested by the Limulus Amoebocyte Lysate (LAL) assay,
and action must be taken
when the level exceeds 1.0 EU/ml.
Quite a number of research papers concluded that long-term effects

of endotoxin and other cell
fragments from gram negative bacteria exposure in
dialysis patients results in chronic inflammatory
responses. Therefore, AAMI
has taken a step toward more strict standards emphasizing the
importance of
endotoxin testing. Chronic endotoxin exposure from dialysate, at a level
lower than that
which causes a pyrogenic reaction (temperature spike, chills,
rigors, hypotension, etc.), can stimulate
the pro and anti-inflammatory
activities resulting in decreased transferrin, increased Beta-2
microglobulin
amyloidosis leading to carpal tunnel syndrome, and accelerated
atherosclerosis
(Canaud, Bosc, Leray, Morena, & Stec, 2000). C-reactive
proteins from the acute phase inflammatory
response predict mortality and
morbidity in hemodialysis patients and have been linked to malnutrition,
resistance to EPO, and increased cardiovascular risk (Panichi et al., 2000).
Summary
Understanding water treatment system operation, the nuances of

patient reactions, and
communicating with technicians and community water
suppliers, nephrology nurses can contribute
immensely to long-term, positive
patient outcomes.
The Philadelphia Incident
Even though there have been many more recent incidences with
chloramine poisoning of patients, the
most noted example remains the
"Philadelphia Incident" of 1987 because it is multifaceted.
Initially, a
nurse in the facility noticed an unusually large number of
routine hematocrits were lower than normal.
Patients also complained of
headaches, malaise, and were hypotensive. After 2-3 days of symptoms,
it
became apparent that chloramines were the culprit causing hemolysis.
Forty-four patients out of 107
required transfusions, and 10 were sent to the
emergency department for additional treatment.
Fortunately, thanks to careful
clinical monitoring, no patients died during this event (Ackerman, 1988;
FDA,
1988).
Upon further investigation, it was discovered that the water

requirements for the facility had increased,
and a water vendor added more RO
membranes without increasing the size of the pretreatment
carbon to
accommodate the higher flow rate. The staff person monitoring the system
recorded the
chloramine levels accurately as they climbed to toxic levels
(AAMI maximum level is 0.1 mg/L); but the
staff member was not aware that
this was a dangerous situation and did not report it to a supervisor.
Furthermore, no written policy was in place regarding the testing of total
chlorine levels and double
checks with signatures were not standard
procedure. Also, the staff erroneously believed that
backwashing the carbon
tank would regenerate the tank (Ackerman, 1988; FDA, 1988). This incident
illustrates the need for educating staff, choosing reputable medical water
vendors, having proper
policies and procedures in place, and reevaluating the
entire system if anything is changed.
Table 1
Signs and Symptoms and Possible Water
Contaminant-Related Causes
Symptom Possible Water Contaminants
Anemia Al, chloramines, Cu, Zn
Bone Disease Al, FL
Hemolysis Cu, nitrates, chloramines
Hypertension Ca, Na
Hypotension Bacteria, endotoxin, nitrates
Metabolic acidosis Low pH, sulfates
Neurological deterioration Al
Nausea and vomiting Bacteria, Ca, Cu, endotoxin, low pH, Mg,
nitrates, sulfates, Zn
Death Al, Fl, endotoxin, bacteria, chloramine
Note: Revised from Food and Drug Administration (FDA). (1989). A
manual on water treatment. Washington, DC: FDA.
Table 2
AAMI and EPA Maximum Allowable Levels of Contaminants in Water
EPA maximum for
drinking water (mg/L)
Contaminant 2000 (condensed list)
Calcium Not regulated
Magnesium Not regulated
Potassium Not regulated
Sodium Not regulated
Antimony 0.006
Arsenic 0.005
Barium 2
Beryllium 0.004
Cadmium 0.005
Chromium 0.10
Lead 0.015 **
Mercury 0.002
Selenium 0.05
Silver 0.10 *
Aluminum 0.05-0.2 *
Chloramines 4.0 *
Free Chlorine 4.0 *
Copper 1.3 **
Fluoride 4.0
Nitrate (as Nitrogen) 10
Sulfate 250 *
Thallium 0.002
Zinc 5 *
Bacteria HPC Bacteria: 500 cfu/ml
Coliform bacteria: 0 ***
Endotoxin Not regulated
AAMI maximum
concentration for
Contaminant dialysis water (mg/L)
Calcium 2 (0.1 mEq/L)
Magnesium 4 (0.3 mEq/L)
Potassium 8 (0.2 mEq/L)
Sodium 70 (3.0 mEq/L)
Antimony 0.006
Arsenic 0.05
Barium 0.10
Beryllium 0.0004
Cadmium 0.001
Chromium 0.014
Lead 0.005
Mercury 0.0002
Selenium 0.09
Silver 0.005
Aluminum 0.01
Chloramines 0.10
Free Chlorine 0.50
Copper 0.10
Fluoride 0.20
Nitrate (as Nitrogen) 2.0
Sulfate 100
Thallium 0.002
Zinc 0.10
Bacteria 200 cfu/ml
(action level 50 cfu/ml)
Endotoxin 2 EU/ml
(action level 1 EU/ml)
Lowest concentration
associated with
Contaminant dialysis toxicity (mg/L)
Calcium 88
Magnesium
Potassium
Sodium 300
Antimony New to AAMI 2001
Arsenic
Barium
Beryllium New to AAMI 2001
Cadmium
Chromium
Lead
Mercury
Selenium
Silver
Aluminum 0.06
Chloramines 0.25
Free Chlorine
Copper 0.49
Fluoride 1.0
Nitrate (as Nitrogen) 21
Sulfate 200
Thallium New to AAMI 2001
Zinc 0.2
Bacteria 200 cfu/ml
Endotoxin 5 EU/kg/body weight
* Unenforceable maximum contaminant level goal (Secondary Standard)
** Action level at 90th percentile
*** 95% of the samples (all positive results must be resolved)
Note: HPC = heterotrophic plate count; EU = endotoxin unit
From: Association for the Advancement of Medical Instrumentation
(AAMI). (1998). Volume 3: Dialysis. Hemodialysis systems, RD5-1992.
Arlington, VA: Author. (Revised 2001 to reflect new standards)
References
Ackerman, R.A. (1988, March). The Philadelphia incident.

Contemporary Dialysis and Nephrology, pp.
27-28, 33.
Amato, R.L. (1995). Disinfection of an RO: Clearing the issues.

Dialysis and Transplantation, 24(5),
244-249, 258.
Association for the Advancement of Medical Instrumentation (AAMI).

(2001). Volume 3: Hemodialysis
systems. ANSI/AAMI RD62-2001. Arlington, VA:
Author.
Association for the Advancement of Medical Instrumentation (AAMI).

(1998). Volume 3: Dialysis.
Hemodialysis systems. RD5-1992. Arlington, VA:
Author.
Bland, L.A., & Favero, M.S. (1989). Microbial control

strategies for hemodialysis systems. Plant,
Technology & Safety
Management Series, 3, 30-36.
Canaud, B., Bosc, J.Y., Leray, H., Morena, M., & Stec, F.
(2000). Microbiologic purity of dialysate:
Rationale and technical aspects.
In Chronic inflammation in hemodialysis (pp. 34-47). Switzerland: S.
Karger
AG.
Cappelli, G. (1991, December). Dialysate contribution to

bio-incapatability in hemodialysis: The effect
of microbial contamination.
Contemporary Dialysis & Nephrology, pp. 20-22.
Carpenter, B., Hedges, S.J., Crabb, C., Reilly, M., & Bounds,
M.C. (1991, July 29). Is your water safe?
U.S. News and World Report, pp.
48-55.
Food and Drug Administration (FDA). (1988, February 19). FDA

Safety Alert: Chloramine
contamination of hemodialysis water supplies.
Rockville, MD: Author.
Food and Drug Administration (FDA). (1989, March, 15). FDA Safety
Alert: Sodium azide
contamination of hemodialysis water supplies. Rockville,
MD: Author.
Food and Drug Administration (FDA). (1996). FDA premarket approval

guidelines fir hemodialysis
water treatment systems. Rockville, MD: Author.
Kirkwood, R.G., Dunn, S., Thomasson, L., & Simenhoff, M.L.

(1981). Generation of the precarcinogen
dimethylnitrosamine (DMNA) in
dialysate water. American Society fir Artificial Internal Organs
Transactions, 27, 168-171.
Luehmann, D., Keshaviah, P., Ward, R., Klein, E., & Thomas, A.
(1989). A manual on water treatment
for hemodialysis. Rockville, MD: FDA.
Panichi, V., Migliori, M., De Pietro, S., Taccola, D., Bianchi,

A.M., Norpoth, M., Giovannini, L., Palla,
R., & Tetta, C. (2000).
C-reactive protein as a marker of chronic inflammation in uremic patients.
Chronic inflammation in hemodialysis, pp. 17-24. Switzerland: S. Karger AG.
Texas Department of Health. (1996, July 26). End state renal

disease facilities: Rules and standards,
25 TAC 117.1-117.85. Austin: Author.
White, D., & Layman, R. (1991, September,). Reverse osmosis

element design evolution and its
effects on improving water quality for
hemodialysis. Contemporary Dialysis and Nephrology, 20-25,
50.
Water Treatment for Hemodialysis INcluding the Latest AAMI

Standards
By Rebecca L. AMato, BSN, RN, CNN Posttest -- 3.0 Contact Hours
Posttest Questions
(See posttest instructions on the answer form, next page)

Nephrology Nursing Journal would like to
acknowledge Patricia B. McCarley,
MSN, RN, ACNP CNN, for contributing the questions to this CE
posttest.
1. Persons on hemodialysis are
exposed to approximately how
many liters of water during a dialysis
treatment?
A. 25 liters.
B. 100 liters.
C. 250 liters.
D. 500 liters.
2. Effluent water from the softener
should be checked for hardness

and indicate less than 2
grains/gallon (or 35 mg/l) at least
A. before each patient shift.
B. after the water system is on 30
minutes.
C. twice a day, in the morning and
at the end of the day.
D. A hardness test is not needed
after a softener.
3. Reverse osmosis (RO) membranes

can prevent all except
A. hemolysis caused by chloramines.
B. febrile reactions caused by bacteria.
C. hypotension caused by endotoxins.
D. nausea and vomiting caused by
calcium
4. The Association for Advancement
of Medical Instrumentation
(AAMI) recommendation for
empty bed contact time (EBCT) in
the carbon tank for the removal of
chlorine and chloramine is at
least
A. 1 minute.
B. 5 minutes.
C. 10 minutes.
D. 15 minutes.
5. Which type of carbon is most
appropriate for use in a
hemodialysis water treatment
system?
A. Acid washed, virgin granular
activated carbon (GAC) with a
900 or higher iodine number.
B. Reburnt, granular activated

carbon with a 500 or lower
iodine number.
C. Non-acid washed, recycled
carbon with a 900 or lower
iodine number.
D. Acid washed, reburnt carbon

with 500 or higher iodine number.
6. Total chlorine tests for both free
chlorine and combined chlorine

(chloramine) should be performed
on fresh effluent exiting
the first carbon tank at minimum
of how often and when?
A. Daily before turning on the

water treatment system.
B. Daily after the water system
has run for 15 minutes.
C. Monthly at the end of each
patient shift.
D. Monthly when drawing water
cultures.
7. It is recommended that you clean
the RO membranes with high and

low pH cleaners
A. weekly.
B. monthly.
C. quarterly.
D. annually.
8. A chemical analysis is recommended
by the AAMI to determine
if water is suitable for hemodialysis.
Minimally, it should be done
at least
A. annually.
B. quarterly.
C. monthly.
D. weekly.
9. Coupled with the water quality chemical
analysis, the RO membrane performance
(percent rejection) and
water quality monitors (conductivity,
TDS) determine whether the water
meets the AAMI standards on a routine
basis. When would it be necessary
to perform another AAMI analysis?
A. When the salt passage triples
and water quality is not
improved by disinfection.
B. When the salt passage doubles
and the water quality is not
improved by cleaning.
C. When the percent rejection
increases and the conductivity
falls.
D. When the resistivity is greater
than 1 meg-ohm/cm and the
TDS falls.
10. The safest set up for the use of
deionizer (DI) tanks is
A. one DI tank containing medical
grade resin with a single light
display for resisitivity.
B. two tanks containing commercial
grade resin in series with a
single light display for resistivity.
C. one tank containing commercial
grade resin with an audible

and visual temperature compensated
resistivity alarm.
D. two tanks containing medical
grade resin in series with an
audible and visual temperature-compensated
alarm.
11. It is recommended that DI tanks
be followed by
A. submicron filter.
B. ultrafilter.
C. ultraviolet irradiation (UV).
D. particulate filtration.
12. To impede microbial growth the

minimum velocity in the piping
system with a storage tank during
peak demand is
A. 3 ft/sec measured at the end of
the loop.
B. 3 ft/sec feeding into the loop.
C. 1.5 ft/sec measured at the end
of the loop.
D. 1.5 ft/sec feeding into the loop.
13. Proper storage tank design
should include a conical shaped
bottom storage tank with
A. a loose-fitting lid and a large
storage capacity in case of

emergency.
B. a tight-fitting lid and storage
capacity to meet peak demand.
C. a tight-fitting lid and storage
capacity to dialyze one shift of
patients.
D. storage tanks are prohibited in
most states.
14. Ultraviolet irradiation (UV) should
be followed by ultrafiltration (UF)
because the UV light
A. encourages the growth of bacteria.
B. destroys bacteria, releasing the
endotoxins.
C. causes biofilm formation.
D. causes hemolysis of red blood
cells.
15. The nurse knows that dialysate

amplifies bacterial growth in the
system. Testing for bacterial
growth in dialysate should be
from dialysate samples
A. entering the dialysis machine
at the end of the day.
B. exiting the dialysis machine at
the beginning of the day.
C. entering the dialyzer at the
beginning of the day.
D. exiting the dialyzer at the end of
the day.
16. Several patients in the clinic

show a hyporesponse to Epogen.
All causes are ruled out and you
suspect a chronic inflammatory

response in the affected patients.
A possible cause to investigate
would be
A. high levels of sodium.
B. low levels of endotoxin.
C. high levels of aluminum.
D. low levels of calcium.
17. Patients experience what symptoms
when exposed to hard water
(calcium and magnesium)?
A. Hyperkalemia.
B. Hemolysis.
C. Nausea and vomiting.
D. Hypotension.
18. Several of the patients began to
experience the following symptoms:
cyanosis, hypotension, and
vomiting. You suspect contamination
of the water with
A. nitrates.
B. iron.
C. aluminum.
D. fluoride.
19. The DI tanks become exhausted
in a dialysis clinic. It is imperative
to replace them to prevent
A. hemolysis.
B. death.
C. hypotension.
D. metabolic acidosis.
Rebecca L. Amato, BSN, RN, CNN, is Director of Education,

Osmonics/ZyzaTech Water Systems,
Kent, WA; and a member of the Renal Disease
and Detoxification Board of AAMI. She is a past
President for the ANNA
Greater Puget Sound Chapter and past Chair for the Corporate/ Government
SIG.
Amato, Rebecca L.
Copyright: COPYRIGHT 2001 Jannetti Publications, Inc.

http://www.ajj.com
Source Citation (MLA 9th Edition)

Amato, Rebecca L. "Water treatment for hemodialysis, including the latest AAMI standards."
Nephrology Nursing Journal, vol. 28, no. 6, Dec. 2001, pp. 619+. Gale Academic OneFile,
link.gale.com/apps/doc/A82511120/AONE?u=googlescholar&sid=bookmark-
AONE&xid=297a65f5. Accessed 11 Apr. 2022.
Gale Document Number: GALE|A82511120

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11/4/22, 12:06 Water treatment for hemodialysis, including the latest AAMI standards - Document - Gale Academic OneFile

Water treatment for hemodialysis, including the

Inadequately purified water for hemodialysis (HD) treatments have

To describe the function of the majority of the water treatment

1. List key components in a water treatment system for

2. Identify clinical manifestations in hemodialysis patients

3. Discuss issues involved with the maintenance of a water

Many documented hemodialysis (HD) patient injuries and deaths are

Public water systems process both types of water. They add

Municipal water suppliers use processed waste water from sewage

Why Water Purity is Important During HD

By the time water arrives at our faucets, it is deemed acceptable

This article reviews technical information sectioned into Feed

Feed Water Components

Back-flow preventer. All water treatment systems require a form of

Local plumbing codes dictate the type of back-flow preventer that

Temperature blending valve. The temperature blending valve mixes

An alternative to temperature blending when not practical, as in

A temperature gauge with an audible and visual alarm should follow

Booster pump. The RO system requires a constant supply of water

Bladder tank. During cases of extreme low or intermittent to no

A bladder tank should never be placed after the RO or deionization

Acid injection metering device. New lower lead and copper

In order for the RO to operate properly and carbon tanks to remove

adsorptive and the RO membrane performance

Acid injection devices meter a small amount of a strong acid, such

Acid injection systems must be placed before the multimedia depth

Acid injection systems must be continuously monitored by an inline

Multimedia depth filter. Large particulates of 10 microns or

Many source waters, in spite of their apparent clarity, carry a

Multimedia filters contain multiple layers of various sized rocks

An automatic multimedia filter is back-washed on a preset time

Multimedia filters should be back-washed at frequent intervals,

Water softener. Softeners work on an ion exchange basis. The resin

Water containing calcium and magnesium form scale deposits on the

However, sodium chloride does not deposit scale on the RO

Softeners are sized in grains of capacity; 1 cubic foot (cu. ft.)

Decreased softener resin life may occur if exposed to detrimental

The softener needs regenerating on a routine basis with

Regeneration is usually performed every day the softener is used

Portable exchange softeners (softeners that are regenerated

A hardness test on the effluent softened water should be done, at

Beside the deleterious effects in patients, both chlorine and

Carbon filtration, often referred to as granular activated carbon

GAC can be made from different organic material such as bituminous

GAC is rated in terms of an "iodine number," which

Another rating system that is pertinent to dialysis is the

An appropriate exposure time of the water flow through the carbon

A minimum of 10 minutes EBCT is recommended by AAMI (2001) for the

GAC has an exhaustion point where its adsorption capability stops.

The AAMI Standard (1998, 2001) has established maximum allowable

With a standard DPD (N, N-diethyl-p-phenylenediamine) test, the

Even if chloramines are not normally present in the water supply,

Channeling of the GAC is a common problem because water tends to

Reverse Osmosis (RO) Systems

Prefilter. Prefilters are particulate filters positioned after all

It is important that RO pumps are made of high-grade stainless

RO membranes. The RO membrane is the heart of the system. It

RO membranes reject dissolved inorganic elements such as ions of

200 molecular weight cut-off. Ionic contaminants are highly rejected

TF RO membrane will degrade when exposed to oxidants such as

The colder the incoming water, the more resistant it is to cross

TF membranes have a wide pH tolerance of 2-11; however, the