the hygienic chain

7/28/2019 The Hygienic Chain

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The Hygienic ChainHow to opt imize dialysis fl uid purity



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.



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



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



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



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



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



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.



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



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.



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.



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.



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



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.



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.



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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

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