Water For DialysisCertain contaminants in water
supplies can cause severe complications in dialysis patients. If the
water used for preparing dialysate and or reuse purposes, or the
dialysate itself, exceeds the allowable limit for bacteria and
endotoxins, the dialysis patient can exhibit clinical signs such as
shaking chills, fever, hypotension, myalgias, nausea and vomiting
(pyrogenic reactions), and possibility sepis. The onset of these
symptoms usually occurs one to two hours after initiation of the
treatment.
Sophisticated water purification systems we provide to purify water; to
a level determined to be safe for the patients. And the critical piece
of equipment in these water purification systems is the reverse osmosis
(RO) plant.
The basic components of an RO system are the pre-filter, a pump, and
membrane elements. The membrane elements are placed in stainless steel
or FRP housings, which are then manifolded together. Water purification equipmentThe raw city water is fed through a
back-washable sand filter followed by water softener. sand filter
removes the suspended solids and softener removes calcium and magnesium
ions. Softeners also remove small amounts of iron.
After the softener, activated carbon filter is employed to remove
chloramine, chlorine, and trace organics. It is important to keep the
chloramine or chlorine in the system up to this point in order to
minimize the chance of bacterial growth.
5 micron Cartridge filter is employed to remove particles greater than
5 microns to protect the RO membranes.
Next comes the RO machine, which typically removes 90% to 95+ % of the
dissolved salts. RO also removes bacteria and pyrogens as well as 99+ %
of organic molecules over 200 daltons in molecular weight. In some
cases where the raw water has a very high level of dissolved solids, a
second RO machine in series or an ion exchange unit after the RO may be
used to lower the dissolved solids level to an acceptable number. What level of water quality is necessary for dialysis?The Association for the Advancement
of Medical Instrumentation (AAMI) has set forth water standards as
guidelines for dialysis centers to follow. These standards list maximum
levels for ions found in water as well as for heavy metals and bacteria. AAMI Water Standards
CONTROL OF BACTERIAThe goal of disinfection is to
prevent and control the colonization of microorganisms, and a well
designed water purification system and delivery loop is the first step
in achieving this prevention.
In order to prevent stagnation--a cause of bacterial grrowth--the
distribution piping in direct-feed systems (those with no storage
tanks) must have a velocity of at least 1.5 ft/sec, and in indirect
feed systems (those with storage tanks present), at least 3 ft/sec. It
should be a continuous fast flowing loop design with no dead ends,
rough joints, or unused branches in the piping. The connections linking
the product water to the dialysis machine should be accessible, minimal
in length, and have a positive shutoff valve to prevent air from being
drawn up into the loop. If a storage tank is present, it should be
small in size in order to produce turbulent flows. It should also have
a dish or conical shaped bottom for complete drainage, and have an
airtight lid with a bacteria filter. The incorporation of an internal
spray mechanism will also prevent water from stagnating on the exposed
surfaces.
Bacterial monitoring for the purpose of validating frequency and
efficacy of disinfection is crucial and should be performed correctly
and routinely. Strategies for controlling bacterial colonization
include regular, simultaneous disinfection of the entire RO unit, the
delivery loop, and the hemodialysis machines, as well as limiting
"downtime" and ensuring that the system and distribution piping are
well designed in the first place. Many different disinfectants exist
and may be appropriate for RO systems. It is important to vary the
disinfectants used in order to obtain different results such as biofilm
removal and reduction of specific microorganisms. AAMI AND FDA RECOMMENDATIONSAAMI and FDA standards state that 200
cfu/ml (colony forming units/ml) is the maximum bacterial concentration
allowable in the product water used for dialysis purposes. The AAMI
standard also expounds that the total microbial count in proportioned
dialysate should not exceed 2,000 cfu/ml. Additionally, according to
the standards, voluntary endotoxin (lipopolysaccharide) levels in the
water used for reuse should not exceed 1 ng/ml or 5 EU (endotoxin
units) as demonstrated by the Limulus amebocyte lysate (LAL) assay.
AAMI recommends that bacterial monitoring should be performed once a
moth on the RO product water and dialysate. More frequent bacterial
monitoring should be performed if the system is opened for any reason,
if a new piece of equipment has been incorporated, or if the results of
the water or dialysate cultures exhibit higher than allowable counts. |