the hygienic chain
TRANSCRIPT
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 1/16
The Hygienic ChainHow to opt imize dialysis fl uid purity
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 2/16
O ver the past decade we have learned much about dialy-
sis fluid contaminants and how they affect patients. We
have also discovered new ways to enhance fluid purity by
preventing the development of biofilm – colonies of micro-
organisms in an HD system that release toxins and resist
standard disinfection.
Evidence exists that monocyte activation and cytokineproduction occur from the transfer of bacterial by-products
into the blood during HD treatment. C onsequently, the
bacterial contamination of the dialysis fluid is a major factor
in HD bioincompatibility.
Further, a mounting body of scientific evidence suggests a
causal relationship between the microbial contamination of
HD fluids and the signs of chronic microinflammation seen
in dialysis patients. The adverse effects related to such
inflammation are significant and costly.
As result, standards and practice guidelines on water and
dialysis fluid purity are revised. The American A AM I asso-
ciation introduces action levels for bacteria and endotoxins
in water for dialysis to assure that corrective actions canbe initiated before exceeding the maximum levels estab-
lished by the standard (R D62:2001). The European Best
Practice G uidelines for Haemodialysis, issued 2002 by
ER A -EDTA , takes a further step by strongly recommending
the use of ultrapure quality for all dialysis applications to
minimize inflammation (EBPG IV.1 and IV.4.3).
Fluid Purity - a prerequisite to QualityDialysis Treatment.
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 3/16
M aintaining fluid purity means attending to the entire chain
of components and processes involved in HD – from water
treatment and concentrates to fluid distribution and HD
machines. We call this chain The Hygienic Chain.
And like any chain, it is only as strong as its weakest link.
This has never been more true than in the prevention of bio-
film. That is why G ambro has designed an entire HD system
to ensure optimal care while protecting your patients from the
hazards of biofilm every step of the way. From water treat-
ment and tubing to H D machines and concentrates, G ambro
offers a fully integrated solution.
We are pioneers in HD, and we have over a decade of expe-
rience in water treatment and fluid distribution systems spe-
cialized for HD units. In fact, we are the one company that
is able to provide every link in The Hygienic Chain. What’s
more, ours is the only system proven effective against biofilm
because every link is designed to resist microbial proliferation
and is fully integrated from R O unit to drain.
Water t reatment and
hot w ater fl ushing
HD mach ines and
dry concentrates
Tubing and inlets
The Hygienic Chain – a holistic approachto optimizing Dialysis Fluid Purit y
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 4/16
T he central component of the G ambro H ygienic Chain is
the G ambro C WP water treatment system. This system can
integrate an effective hot water flushing of the entire dis-
tribution loop. This way the entire pure water system gets
protected against biofilm formation.
T he CWP system is perfectly matched by our HD -machines
and other products like BiC art® , C leanC art® , U 8000 S
ultrafilter and the by G ambro recommended PEX tubing. A ll
designed to assure the highest hygienic standard for the
dialysis fluid.
Implementing The Hygienic C hain is an effective step for
avoiding treatment-related inflammation. As a result, the
effectiveness of erythropoietin can improve, morbidity may
be mitigated and the need for advanced medical care may
be reduced.
In the pages that follow, we hope to provide insight and
advice on how you can strengthen every link of the hygienic
chain to ensure optimal fluid quality for your patients.
Gambro Hygienic Chain Products
Avoiding treatment- related infl amm ation
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 5/16
How choosing the right water treatmentsystem can help prevent biofi lm
The first link in The Hygienic C hain is proper water treat-
ment. Treatment requirements vary according to the type of
water available in each municipality. What’s more, seasonal
variations in water quality exist within each municipality.
So it’s important to contact your municipal waterworks for
information on water quality and seasonal variations in your
area.
Typically, stages for water purification include pre-treatment,
softener, and reverse osmosis. While starting with a reliable
water treatment system is important, you should be mindful
that most of the microbiological contaminants found in H D
fluid are introduced further down the line, after the R O unit.
Purifying water only to have it contaminated downstream
makes little sense. T hat’s why part of your water treatment
strategy should include a plan for how you will prevent sub-
sequent contamination.
Water treatm ent and
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 6/16
Biofi lm preventionOf particular concern is the development
of biofilm in the system. Biofilms are com-
munities of micro-organisms living under
a protective slime matrix. They form
readily in aqueous environments, release
toxins that contaminate dialysis fluid, and,
once established, are virtually impossible
to remove.
Biofilms start when bacteria encounter
a solid surface. They form a temporary
bond to the surface and begin to multiply.
Soon, they start developing a protective
polysaccharide slime coat that forms a
permanent bond with the surface.
Heat ing uni t RO uni t RO uni t
R egular hot water flushing of the entire fluid distribution system, including H D machines, can prevent biofilm.
90°C
min 8 5°C
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 7/16
Once the slime layer is in place, the
microbes are, in all practical senses,
impervious to both heat and chemical
disinfection.
The only proven way to keep biofilm out
of your HD system is to prevent it from
colonizing in the first place. That means
eradicating all bacteria in the system
before they have the time to develop a
protective slime layer. A random schedule
of disinfection is not sufficient; it should
be performed on a regular basis without
fail. Further, the entire fluid path, all the
way through the dialysis machines, needs
to be dealt with.
Dialysis unit
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 8/16
Integrating reverse osmosisand hot water fl ushing The reverse osmosis unit should
be well suited for the specialized
needs of the HD clinic. Its rejection
of electrolytes as well as bacteria
and bacterial products should be
highly effective and reliable.
Beyond that, investing in a reverse
osmosis unit designed with an inte-
grated hot water unit can protect
the entire fluid distribution system
against biofilm formation.
Gambro has over a decade of expe-
rience designing and installing
water systems specifically for HD.
This experience has helped us
design a water system that prevents
the formation of biofilm and is
simple to operate. The integrated
heat function by Gambro means
that hot water can be regularly
flushed through the entire fluid
path, all the way to and including
the fluid pathways inside HD
machines. This makes the Gambro
CWP system a complete and highly
effective tool to prevent microbial
infestation.
G ambro has been developing water treatment systems tailored to the needs of HD clinics for
over ten years. T his CWP 100 by G ambro is available with either single- or double-reverse
osmosis, has a built-in hot water tank, and is designed to perform daily unattended hot
water flushing of the entire fluid distribution system.
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 9/16
How choosing the right HD machines andconcentrates can enhance fl uid purity
The next link in The Hygienic Chain is the HD machine. While
most major brands of HD machines would appear to perform
HD equally well, their hygienic performance can vary greatly.
As a result, the machines themselves can be a significant
source of contamination.
Design elements like long flow paths, dead ends, compli-
cated valves and chamber systems all increase the risk of
contamination. That’s because bacteria, yeast, fungus and
other microbes thrive in still fluid. Dead ends cause stagnant
fluid zones and are often difficult to reach with disinfectants.
The same can be said of areas where the flow rate is low.
C omplicated valves allow microbes to hide and chamber
systems can double as bacterial incubators between treat-
ments. The use of liquid bicarbonate concentrates adds to
this risk.
HD machines and
dry concentrates
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 10/16
HD machines designed for purityIt’s easy to distinguish between an
HD machine that is designed for
purity and one that is not.
Open any Gambro machine and
compare it to other HD machines
in your clinic.
Many HD machines have complicated flow paths that favor microbial growth.
N ote the numerous valves, low flow areas, and holding tanks where fluid can sit
between treatments.
From their inception, Gambro HD machines have been designed to resist microbes andenhance fluid purity. N ote that G ambro machines can be drained and have no reservoirs
where dialysis fluid can sit between treatments.
Note the simplified flow path in
the Gambro machine. This ensures
an even flow rate throughout the
entire fluid path, giving microbes
nowhere to hide during heat or
chemical disinfection. You’ll also
note that the Gambro machine has
no reservoirs where dialysis fluid
can sit between treatments.
Microbe-friendly flow path design
often results in biofilm inside the
HD machine. If that happens, one
must rely on disinfection to kill the
microbes or the dialysis membrane
to keep contaminants away from
the patient’s blood stream. Unfor-
tunately, neither of these measures
can provide adequate protetion. The
slime which covers the microbes is
extremely robust, able to withstand
both heat and chemicals. What’s
more, many of the bacterial by-
products released from the biofilm
are clearly small enough to pass
freely through any dialysis membrane.
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 11/16
Dry bicarbonate cartridges
– easy, safe and hygienicLiquid bicarbonate concentrate is an
excellent growth medium for bacteria.
The introduction of even a singlemicrobe into the liquid can result in
explosive bacterial growth. And the
more steps involved in delivering the
bicarbonate concentrate to the machine,
the higher risk of contamination. In
fact, in systems using a central supply of
liquid bicarbonate concentrate, contami-
nation cannot be avoided.
The simple answer is the use of a dry
bicarbonate powder cartridge. Hermeti-
cally sealed and ready for on-line prepa-
ration as needed, there is no chance
for contamination to occur between
preparation and use. BiCart® by Gambro
is one such dry bicarbonate powder
cartridge. Gambro was the first to offer
this hygienic milestone and today over
BiCart® enables easy safe and hygienic preparation of dialysis fluid.
Today BiC art® is an essential part of both The Hygienic Chain concept
and Gambro’s BiC art Select® package that also includes SelectCart®
dry sodium chloride and SelectBag® minor electrolytes.
Automatic cleaning & disinfectionFurther in the pursuit of purity, citric
acid and sodium carbonate powders
are used to decalcify and clean the
machine’s fluid paths. Since liquid
citric acid provides an excellent
growth medium for microbes, Clean-
Cart® C ensures that this fluid is pre-
pared by the machine as needed, with
no time for contamination. Just pressthe disinfection button and place the
cartridge in the holder. The machine
takes care of the rest, initiating heat
disinfection in combination with a
decalcification or cleaning.
Ease of disinfection is a factor that is
often overlooked with regard to fluid
purity. Simply put, the easier and/or less
time consuming it is to disinfect, the
more regularly it is likely to be done.The CleanCart® concept provides easy, safe andeffective disinfections and cleaning.
100 million BiCart units have been used
around the globe, making it the world’s
most widely-used dry bicarbonate.
With that in mind, Gambro has
designed an HD system that disinfects
the entire fluid path — from water
treatment to HD machine to drain
— automatically, every day, during
non-dialysis hours.
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 12/16
RO
A
conc
UF
Ultrafi ltration of dialysis fl uidUltrafilters may also be used to
strengthen The Hygienic Chain.
Inserting a U 8000 S ultrafilter in
the dialysis fluid line significantly
reduces levels of bacterial deriva-
tives in the fluid. More ultrafilters
are required to prepare on-line
substitution fluid for HDF or HF.
To assure sterile equivalent and
non-pyrogenic fluid in all cases, the
The ULTRA system by Gambro, with it s set- up of ultrafi lters , provides ultrapure dialysis fl uid and non- pyrogenic subs titu -tion fl uid for HDF or HF.
Extra purity and security
While the ULTRA system is highly
efficient at removing contaminants
from the dialysis fluid, prudence
would suggest that every precau-
tion be taken to keep contaminants
from entering the fluid system in the
first place. A secure hygienic chain
Ultrafi lter 3U 2000
Ultrafi lter 2U 8000 S
Ultrafi lter 1U 8000 S
High qual i tyconcentrates
ULTRA system by Gambro uses a
set-up of three ultrafilters. The first
one is to assure that ultrapure water
feeds the machine’s interior — a
requirement for all on-line systems.
The second one prepares ultrapure
dialysis fluid. The last one, a single-
use ultrafilter inserted in the infu-
sion line, is the essential last safety
barrier.
adds an extra measure of purity and
security to the ULTRA system. In
addition, ensuring cleaner fluid from
the start prolongs the life of the
ultrafilter and reduces the need for
elaborate maintenance programs.
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 13/16
Tubing: a critical link in The Hygienic Chain
If the water treatment system and HD machines are ade-
quately equipped to prevent contamination, there is only
one source left. T hat is, the tubing that runs throughout
the clinic connecting all the machines to their fluid source.
This crucial link in T he Hygienic Chain is perhaps the most
important because it is so often found to be the source of contamination due to the growth of biofilm.
O f particular concern are the machine´s fluid inlet and
the line that connects it to the central loop. T hese are the
missing links in many HD systems. T hat’s because neither
the loop’s disinfection routine nor the machine’s include
these areas. Such an omission leaves the entire system
vulnerable to microbial contamination.
Tubing and inlets
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 14/16
Preventative maintenance The effectiveness of all other purity
precautions is seriously reduced if the
tubing is home to thriving communities
of bacteria and other microorganisms
that are found in biofilm. Sometimes this
film can be observed with the naked eye
as a creamy yellowish deposit coatingthe inner surfaces of fluid pipes. Since
these microorganisms are securely
fasted to the walls of the tubing, they
are not floating in the fluid and therefore
will not be revealed by CFU counts of
the fluid. Nonetheless, they serve
Often over looked, tubing can be the cr i t ica l weak l ink in many hygienic chains. Gambro’s PEXtubing resists heat, is fl exible, tough, and chemically inert.
Biofi lm poses a real threat to tubing. Here thetubing has not b eeen regular ly fl ushed wit h hotwater . Within t wo years biofi lm is c lear ly ev ident.
Gambro’s automat ic hot wat er fl ushing program stopsbiofi lm before i t s t ar ts . Here, Gambro’s prophylactic hotwater fl ushing of the tubing results in a sur f ace that is as
c lean two years later as the day i t was inst al led.
as a reservoir of toxins that are con-
stantly leached into the system.
While biofilm is virtually impossible
to remove, it can be prevented from
establishing a presence. Prevention
with daily prophylactic disinfection
is the only known answer. That is,daily circulation of hot water through
the entire fluid circuit in your clinic.
It’s not difficult. In fact, the Gambro
system can perform this daily routine
automatically during non-dialysis
periods.
Tubing The choice of tubing is important.
There are many requirements placed on
HD system tubing. It should be tough,
flexible, heat resistant, chemically
inert, and have a smooth inner surface.
Meeting all these requirements, our
PEX tubing is ideally suited for the
specialized demands of the HD clinic.
It’s tough yet easily bendable and can
be installed in long sections without
joints. This is important because joints
favor the growth of biofilm. All in all,
PEX tubing offers an advantage over
any other type of tubing, including
electro-polished stainless steel.
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 15/16
Contact Gambro
If you are planning an update to an
existing clinic, call Gambro to see how
we can work with your current equip-
ment to maximize fluid quality and
minimize the risk posed by biofilm.
Leif Smeby
Senior Vice President
Corporate Research
Fluid purity is a
topic of increas-
ing importance
in HD treatment.
With this bro-
chure we hope
to promote an
A fi nal word
approach we call The Hygienic Chain
concept. Our aim is to demonstrate the
importance of fluid purity and explain
how we achieve it. As part of that mes-sage, I would like to express Gambro’s
dedication to The Hygienic Chain
concept as a way to better serve you
and your patients.
The Hygienic Chain concept has been
a guiding principle in Gambro’s prod-
uct design for decades. It is reflected
in a string of Gambro innovations like
hygienic fluid path design in our HD
machines, on-line heat disinfection,
on-line preparation of bicarbonate
from dry powder, and on-line prepara-
tion of HF/HDF infusion fluid — all
Gambro firsts. It is also reflected in
our product range, which provides
a complete hygienic chain solution.
Gambro can provide every link in the
hygienic chain from water treatment
to ultrafilters.
If you are considering replacing your
water treatment system, now is the
time to make your clinic’s hygienic
chain even stronger. I hope that the
ideas presented in the booklet will help
you and your patients with the highest
quality dialysis treatment available.
Sincerely,
If you are planning a new HD clinic,
we recommend that you consider estab-
lishing a fully integrated hygienic chain
from the start. Your Gambro representa-
tive would be happy to consult with you.
7/28/2019 The Hygienic Chain
http://slidepdf.com/reader/full/the-hygienic-chain 16/16
H C E N 1 1 5 6
©
2 0 0 3 .
0 9 .
R e v .
2 .
G a m b r o L u n d i a A B .
2 0 0 1
J u n e .
P r i n t e d b y E l a n d e r
s S k o g s G r a fi s k a A B .
G ambro Lundia AB
International M arketing
B ox 10101, S E-220 10 Lund
Sweden.
Tel +46 46 16 90 00
Fax + 46 46 16 96 97
www gambro com