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ECOLAND MEDICAL & WELLNESS CENTER,

INC.
DIALYSIS DEPARTMENT

Policies and Procedure on Treatment of Water for HD

Introduction:

 Quality of water contributes very significantly in acute


and long-term morbidity and prognosis.
 Dialysis Staff should have a fundamental understanding of
water treatment for hemodialysis
 All servicing maintenance, interventions, and changes to
the water treatment plant as a minimum shall be recorded
in an on-site log book.
 The worst way to hurt patients is through the water
system so it is expected that you know what is going on.
 Hemodialysis Patient Exposed to approximately 360L\week.
Kidneys unable to excrete toxic substances. Contaminants
directly exposed to blood via dialyzer membrane.

Procedure:
Water Treatment System
1. Feed Water Components: (Back-flow preventer, Temperature
blending valve, booster pump and raw water tank, acid
feed pump)
2. Pre-treatment section: (filters, activated carbon and
softener).
3. Treatment section: (reverse osmosis).
4. Post-treatment section: (microbial and UV filters or/and
deionization)
5. The distribution system: piping, valves, pumps, storage
tanks.

Acid Feed Pump

 By increasing the pH of the city water supply using lime


softening agents of Ca CO3 prevent leaching of lead,
copper from the piping system.
 Carbon tanks incoming water pH should be between 5-8.5
 A ph higher than 8.5 with chloramines present will cause
the carbon to be less adsorptive and the RO membrane
performance to degrade, resulting in poor water quality.
ECOLAND MEDICAL & WELLNESS CENTER,
INC.
DIALYSIS DEPARTMENT

Policies and Procedure on Treatment of Water for HD

Purification Process
Process Contaminant

Carbon Adsorption Chloramine, organics

Softener Calcium, Mg

Reverse osmosis Ionic contaminants, bacteria,


endotoxin
Deionization Ionic contaminants

Ultrafiltration Bacteria, Endotoxin

Multimedia depth Filter

 Large particulates of >10 microns such as dirt, are


removed by a multimedia depth filter.
 Floculants can clog the carbon and softener tanks,
destroy the RO pump, and foul the RO membrane
 Contain multiple layers of various sized rocks that trap
the large particles as the water filtered downward.

Carbon Tank

 Removes Chlorine and Chloramine


 These are high level oxidative chemicals. They are added
to municipal water systems to kill bacteria but they also
cause hemolysis.

Carbon filter

 As the input water flows down through the granular


activated carbon (GAC), solutes diffuse from the water
into the pores of the carbon and become attached to the
structure.
ECOLAND MEDICAL & WELLNESS CENTER,
INC.
DIALYSIS DEPARTMENT

Policies and Procedure on Treatment of Water for HD

 A 10-minute exposure time of the water through the carbon


tanks to reduce chlorine to at least 0.5mg/L and the
chloramine to be adsorbed to at least 0.1mg/L
 Synthetic Organic compounds such as herbicides pesticides
and industrial solvents will be adsorbed as well.

Water Softener

 Dissolved salts within in the water contribute to the


hardness of water, which can cause ‘hard deposits’ and
can foul the downstream WRO filter. Softeners function
to reduce this hardness by removing the salts, commonly
calcium and magnesium, by passing water through a
resin, exchanging them for sodium.
 ISO guidelines recommend a softener be used where feed
water has hardness in excess of 10 GPG (grains/gallon).
 softener is replaced every 3 – 5 yrs.
 The Softener needs regenerating on a routine basis with
concentrated NaCl Solution (brine)before the resin
capacity is used up
 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

Calcium carbonate Classification

0-60 mg/L Soft

61-120 mg/L Moderately Hard

121-180 mg/L Hard

Greater than 180 mg/L Very Hard

Reverse osmosis System


ECOLAND MEDICAL & WELLNESS CENTER,
INC.
DIALYSIS DEPARTMENT

Policies and Procedure on Treatment of Water for HD

 RO overcomes natural osmosis by forcing feed water under


pressure thru a semi-permeable water under pressure thru
a semi permeable membrane leaving contaminants behind
(ions, organics)
 90 to 99 percent of ionic compounds and >95 percent of
nonionic contaminants, also it is an effective barrier
against microbiological contaminants, including bacteria,
viruses and endotoxin.

Ion exchange deionizers (DI)

 DI use a two-stage process to remove virtually all ionic


material remaining in pretreated water.
 Two types of synthetic resins are used; one to remove
positively charged ions (cations) and another to remove
negatively charged ions (anions).
 Although deionizers produce water of very high purity
with respect to ionic contaminants, they do not remove
microbiological contaminants.
 Therefore, it is necessary to incorporate bacterial
control equipment after the application of deionizer.

Ultraviolet filter

 The mechanism of microorganism destruction is currently


believed to be that ultraviolet causes molecular
rearrangements in DNA and RNA, which in turn blocks
replication.
 As the UV kills the bacteria, it may increase the level
of endotoxins a result of the destruction of the gram-
negative bacteria (endotoxin producing) cell wall

Distribution System

 RO distribution system: direct feed and indirect feed


ECOLAND MEDICAL & WELLNESS CENTER,
INC.
DIALYSIS DEPARTMENT

Policies and Procedure on Treatment of Water for HD

 Direct feed: directly delivers the product water from the


loop for distribution
 Indirect feed: involves a storage tank that accumulates
the product water and delivers to the distribution loop
 Unused portions are recirculated back into the storage
tank

Microbiological aspects of fluid system design

 Use of a recirculation-type system


 Avoidance of dead ends and dead space areas,
 Use of materials compatible with the planned methods of
disinfection
 Storage tank should be cleaned and disinfected.
 The disinfection program could prevent the formation of
biofilm, which can become difficult to eradicate.

Ultrapure dialysis solution

 Decrease CRP and IL-6


 Improves response to EPO
 Promotes better nutrition
 Reduces plasma levels of B-2 microglobulin
 Slow loss of residual renal function
 Lowers cardiovascular morbidity
 Bacteria level below 0.1 cfu/ml and endotoxin level 0.03
EU/ml

Water Treatment Unit

 TDS and conductivity daily


 Microbiological culture and endotoxin assay. Monthly
 Chemical assay every 6 months
 There is no limit for RO product TDS/conductivity.
 Values that are acceptable in one location may not be
acceptable in another location.
 TDS in some areas of 50 ppm is acceptable.
ECOLAND MEDICAL & WELLNESS CENTER,
INC.
DIALYSIS DEPARTMENT

Policies and Procedure on Treatment of Water for HD

 A slight change in the amount of fluoride injected into


the water can cause the RO product water to go less than
a 1 ppm TDS increase.

Bacterial Monitoring:

 The maximum level of bacteria in water used to prepare


dialysis fluid must not exceed the AAMI standard of 100
CFU. The AAMI action level is 50 CFU
 An action level is defined as a point when measures must
be taken to correct the potential source to remain in
compliance with AAMI standards.

Endotoxin Standard

 The maximum level of endotoxin in water used to prepare


dialysis fluid must not exceed the AAMI standard of 0.25
Endotoxin Units/ml (EU/ml)

Contaminant Maximum Test Methodology


Concentration mg/L
Calcium 2 (0.1 mEq/L) EDTA or Atomic
absorption

Magnesium 4 (0.3 mEq/L ) Atomic Absorption

Potassium 8 (0.2 mEq/L) Atomic Absorption


or Flame
Photometric
Sodium 70 (3.0 mEq/L) Atomic Absorption
or Flame
Photometric
Antimony 0.006 Atomic Absorption
(platform)

Arsenic 0.005 Atomic Absorption


(gaseous hydride)
Barium 0.10 Atomic Absorption
(electrothermal)
Beryllium 0.0004 Atomic Absorption
ECOLAND MEDICAL & WELLNESS CENTER,
INC.
DIALYSIS DEPARTMENT

Policies and Procedure on Treatment of Water for HD

(platform)

Cadmium 0.001 Atomic Absorption


(electrothermal)
Chromium 0.014 Atomic Absorption
(electrothermal)
Lead 0.005 Atomic Absorption
(electrothermal)
Mercury 0.0002 Flameless Cold
Vapor (Atomic
Absorption)
Selenium 0.09 Atomic Absorption
(gaseous or
electrothermal)
Silver 0.005 Atomic Absorption
(electrothermal)
Aluminum 0.01 Atomic Absorption
(electrothermal)
Chloramines 0.10 DPD Ferrous
Titrimetric Method

Total Chlorine 0.50 DPD Ferrous


Titrimetric Method

Copper 0.10 DPD Ferrous


Titrimetric Method

Fluoride 0.20 Ion Selective


Electrode Method

Nitrate (as N) 2.00 Cadmium Reduction


Method
Thallium 0.002 Atomic Absorption
(platform)
Zinc 0.10 Atomic Absorption
(direct aspiration)
Association for the Advancement of Medical Instrument.
Dialysate for hemodialysis (ANSIA/AAMI RD52:2004). Arlington
(VA). American National Standard. 2004

WATER TREATMENT UNIT


ECOLAND MEDICAL & WELLNESS CENTER,
INC.
DIALYSIS DEPARTMENT

Policies and Procedure on Treatment of Water for HD

A program of improvement should begin immediately if


routine monitoring demonstrates that concentrations of
chemical contaminants exceed the maximum allowable limits of
AAMI.
Disinfection
General

 Disinfection schedules should be designed to prevent


bacterial proliferation, rather than being designed to
eliminate bacteria once they have proliferated to an
unacceptable level (i.e. above the action level)
 A proper disinfection strategy is to be preventive and
this should be applied from the start of operation.
 Disinfection of the distribution piping systems.
 1- Chemical disinfection
 2- Hot water disinfection When used to control
proliferation (minimum distribution loop 60 oC)
 Heat disinfection will not remove established biofilms,
but is convenient, requires little rinse time and can
thus be used more often to prevent biofilm formation. An
occasional chemical disinfection might still be
necessary.

Testing of samples

 Testing of water samples shall be carried out by trained


and accredited persons or accredited laboratories.
 The Dialysis department shall maintain records of persons
who have been trained and accredited and full details of
accredited laboratories.
 The records shall be maintained within the dialysis unit.

Sample Collection

 Water sample sites


 Samples are to be taken at outlets of the water
distribution system.
ECOLAND MEDICAL & WELLNESS CENTER,
INC.
DIALYSIS DEPARTMENT

Policies and Procedure on Treatment of Water for HD

 Prior to sampling, the inside of the outlet can be


disinfected, especially if no hemodialysis machine is
attached. The reason for such disinfection is that, over
time, residual water in an outlet will support microbial
growth. The Disinfection can be made by flushing the
inside of outlet with 70% ethanol or iso-propanol. A
sterile cotton swab wetted with alcohol can also be used.
Exposure time is to be >15s.
 It is sufficient to let out enough water to rinse off the
alcohol (200ml to 500ml) prior to sampling
 Alternatively, hoses can be disconnected from the tap and
the taps opened and allowed to flush for 2 min to 3 min
before aseptically collecting a sample.
 Sample for cultivation and endotoxin analysis: Sample
volume 5ml to 1000ml or volume as specified by the
laboratory.

Sample Collection

 Dialysis fluid samples


 Dialysis fluid samples should be collected from a
sampling port prior to the dialyzer. The sample port
should be designed to minimize the likelihood of
contaminating the sample and should be capable of being
effectively disinfected.
 Dialysis machines are equipped with dialysis fluid sample
ports that can be accessed using a syringe. These sample
ports may be disinfected with 70% ethanol or iso-propanol
and allowed to air dry.
 A sterile syringe (20ml or larger) should then be used to
aspirate dialysis fluid out of and into the port before
filling the syringe. The filled syringe should then be
discarded and a fresh sample of dialysis fluid collected
using a new sterile syringe.
ECOLAND MEDICAL & WELLNESS CENTER,
INC.
DIALYSIS DEPARTMENT

Policies and Procedure on Treatment of Water for HD

 Sample for cultivation and endotoxin analysis: Sample


volume 5ml to 1000ml or a volume as specified by the
laboratory. Containers for samples to be cultured should
be sterile and containers for samples to be cultured
should be sterile and containers for samples to be tested
for endotoxins should be sterile and endotoxin free.

Storage of samples

 Heterotrophic plate count


 Storage of samples
 Microbial analysis of water and dialysis fluid samples
should be conducted as soon as possible after collection
to avoid unpredictable changes in the microbial
population. If samples cannot be analyzed within 4 hr. of
collection, follow the laboratory instructions for
shipping. Samples intended for colony counts should not
be frozen
 Storage of samples for endotoxin analysis may be
different from what is given above, provided the complete
procedure follows the manufacturer’s instructions for use
of the LAL assay.

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