The Hygienic Chain

How to optimize dialysis uid purity

Fluid Purity - a prerequisite to Quality Dialysis Treatment.

Over the past decade we have learned much about dialysis uid contaminants and how they affect patients. We have also discovered new ways to enhance uid purity by preventing the development of biolm colonies of microorganisms in an HD system that release toxins and resist standard disinfection. Evidence exists that monocyte activation and cytokine production occur from the transfer of bacterial by-products into the blood during HD treatment. Consequently, the bacterial contamination of the dialysis uid is a major factor in HD bioincompatibility. Further, a mounting body of scientic evidence suggests a causal relationship between the microbial contamination of HD uids and the signs of chronic microinammation seen in dialysis patients. The adverse effects related to such inammation are signicant and costly. As result, standards and practice guidelines on water and dialysis uid purity are revised. The American AAMI association introduces action levels for bacteria and endotoxins in water for dialysis to assure that corrective actions can be initiated before exceeding the maximum levels established by the standard (RD62:2001). The European Best Practice Guidelines for Haemodialysis, issued 2002 by ERA-EDTA, takes a further step by strongly recommending the use of ultrapure quality for all dialysis applications to minimize inammation (EBPG IV.1 and IV.4.3).

The Hygienic Chain a holistic approach to optimizing Dialysis Fluid Purity

Maintaining uid purity means attending to the entire chain of components and processes involved in HD from water treatment and concentrates to uid 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 biolm. That is why Gambro has designed an entire HD system to ensure optimal care while protecting your patients from the hazards of biolm every step of the way. From water treatment and tubing to HD machines and concentrates, Gambro offers a fully integrated solution.

Water treatment and hot water ushing

HD machines and dry concentrates

Tubing and inlets

We are pioneers in HD, and we have over a decade of experience in water treatment and uid distribution systems specialized for HD units. In fact, we are the one company that is able to provide every link in The Hygienic Chain. Whats more, ours is the only system proven effective against biolm because every link is designed to resist microbial proliferation and is fully integrated from RO unit to drain.

Gambro Hygienic Chain Products

The central component of the Gambro Hygienic Chain is the Gambro CWP water treatment system. This system can integrate an effective hot water ushing of the entire distribution loop. This way the entire pure water system gets protected against biolm formation. The CWP system is perfectly matched by our HD-machines and other products like BiCart, CleanCart, U 8000 S ultralter and the by Gambro recommended PEX tubing. All designed to assure the highest hygienic standard for the dialysis uid.

Avoiding treatment-related inammation

Implementing The Hygienic Chain is an effective step for avoiding treatment-related inammation. 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 uid quality for your patients.

Water treatment and

How choosing the right water treatment system can help prevent biolm
The rst link in The Hygienic Chain is proper water treatment. Treatment requirements vary according to the type of water available in each municipality. Whats more, seasonal variations in water quality exist within each municipality. So its important to contact your municipal waterworks for information on water quality and seasonal variations in your area. Typically, stages for water purication 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 HD uid are introduced further down the line, after the RO unit. Purifying water only to have it contaminated downstream makes little sense. Thats why part of your water treatment strategy should include a plan for how you will prevent subsequent contamination.

Heating unit

RO unit

RO unit

90C

min 85C

Regular hot water ushing of the entire uid distribution system, including HD machines, can prevent bio lm.

Biolm prevention
Of particular concern is the development of bio lm in the system. Bio lms are communities of micro - organisms living under a protective slime matrix. They form readily in aqueous environments, release toxins that contaminate dialysis uid, and, once established, are virtually impossible to remove. Bio lms 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.

Dialysis unit

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 bio lm out of your HD system is to prevent it from colonizing in the rst 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 sufcient; it should be performed on a regular basis without fail. Further, the entire uid path, all the way through the dialysis machines, needs to be dealt with.

Gambro has been developing water treatment systems tailored to the needs of HD clinics for over ten years. This CWP 100 by Gambro 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 ushing of the entire uid distribution system.

Integrating reverse osmosis and hot water 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 integrated hot water unit can protect the entire uid distribution system against bio lm formation. Gambro has over a decade of experience designing and installing water systems specically for HD. This experience has helped us design a water system that prevents the formation of bio lm and is simple to operate. The integrated heat function by Gambro means that hot water can be regularly ushed through the entire uid path, all the way to and including the uid pathways inside HD machines. This makes the Gambro CWP system a complete and highly effective tool to prevent microbial infestation.

HD machines and dry concentrates

How choosing the right HD machines and concentrates can enhance 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 signicant source of contamination. Design elements like long ow paths, dead ends, complicated valves and chamber systems all increase the risk of contamination. Thats because bacteria, yeast, fungus and other microbes thrive in still uid. Dead ends cause stagnant uid zones and are often difcult to reach with disinfectants. The same can be said of areas where the ow rate is low. Complicated valves allow microbes to hide and chamber systems can double as bacterial incubators between treatments. The use of liquid bicarbonate concentrates adds to this risk.

HD machines designed for purity

Its 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 ow paths that favor microbial growth. Note the numerous valves, low ow areas, and holding tanks where uid can sit between treatments.

From their inception, Gambro HD machines have been designed to resist microbes and enhance uid purity. Note that Gambro machines can be drained and have no reservoirs where dialysis uid can sit between treatments.

Note the simplied ow path in the Gambro machine. This ensures an even ow rate throughout the entire uid path, giving microbes nowhere to hide during heat or chemical disinfection. Youll also note that the Gambro machine has no reservoirs where dialysis uid can sit between treatments. Microbe-friendly ow path design often results in bio lm 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 patients blood stream. Unfortunately, neither of these measures can provide adequate protetion. The slime which covers the microbes is extremely robust, able to withstand both heat and chemicals. Whats more, many of the bacterial byproducts released from the bio lm are clearly small enough to pass freely through any dialysis membrane.

Dry bicarbonate cartridges easy, safe and hygienic

Liquid bicarbonate concentrate is an 100 million BiCart units have been used excellent growth medium for bacteria. around the globe, making it the worlds The introduction of even a single most widely-used dry bicarbonate. microbe 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, contamination cannot be avoided. The simple answer is the use of a dry bicarbonate powder cartridge. Hermetically sealed and ready for on-line preparation 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 rst to offer this hygienic milestone and today over

BiCart enables easy safe and hygienic preparation of dialysis uid. Today BiCart is an essential part of both The Hygienic Chain concept and Gambros BiCart Select package that also includes SelectCart dry sodium chloride and SelectBag minor electrolytes.

Automatic cleaning & disinfection

Further in the pursuit of purity, citric acid and sodium carbonate powders are used to decalcify and clean the machines uid paths. Since liquid citric acid provides an excellent growth medium for microbes, CleanCart C ensures that this uid is prepared by the machine as needed, with no time for contamination. Just press the disinfection button and place the cartridge in the holder. The machine takes care of the rest, initiating heat disinfection in combination with a decalcication or cleaning. Ease of disinfection is a factor that is often overlooked with regard to uid purity. Simply put, the easier and/or less time consuming it is to disinfect, the more regularly it is likely to be done. With that in mind, Gambro has designed an HD system that disinfects the entire uid path from water treatment to HD machine to drain automatically, every day, during non- dialysis hours.

The CleanCart concept provides easy, safe and effective disinfections and cleaning.

Ultraltration of dialysis uid

Ultra lters may also be used to strengthen The Hygienic Chain. Inserting a U 8000 S ultra lter in the dialysis uid line signicantly reduces levels of bacterial derivatives in the uid. More ultra lters are required to prepare on-line substitution uid for HDF or HF. To assure sterile equivalent and non-pyrogenic uid in all cases, the ULTRA system by Gambro uses a set-up of three ultra lters. The rst one is to assure that ultrapure water feeds the machines interior a requirement for all on-line systems. The second one prepares ultrapure dialysis uid. The last one, a singleuse ultra lter inserted in the infusion line, is the essential last safety barrier.

UF
A conc

High quality concentrates

RO

Ultralter 3 U 2000

Ultralter 1 U 8000 S

Ultralter 2 U 8000 S The ULTRA system by Gambro, with its set-up of ultralters, provides ultrapure dialysis uid and non-pyrogenic substitution uid for HDF or HF.

Extra purity and security

While the ULTRA system is highly efcient at removing contaminants from the dialysis uid, prudence would suggest that every precaution be taken to keep contaminants from entering the uid system in the rst place. A secure hygienic chain adds an extra measure of purity and security to the ULTRA system. In addition, ensuring cleaner uid from the start prolongs the life of the ultra lter and reduces the need for elaborate maintenance programs.

Tubing and inlets

Tubing: a critical link in The Hygienic Chain

If the water treatment system and HD machines are adequately equipped to prevent contamination, there is only one source left. That is, the tubing that runs throughout the clinic connecting all the machines to their uid source. This crucial link in The Hygienic Chain is perhaps the most important because it is so often found to be the source of contamination due to the growth of biolm. Of particular concern are the machines uid inlet and the line that connects it to the central loop. These are the missing links in many HD systems. Thats because neither the loops disinfection routine nor the machines include these areas. Such an omission leaves the entire system vulnerable to microbial contamination.

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 biolm. Sometimes this lm can be observed with the naked eye as a creamy yellowish deposit coating the inner surfaces of uid pipes. Since these microorganisms are securely fasted to the walls of the tubing, they are not oating in the uid and therefore will not be revealed by CFU counts of the uid. Nonetheless, they serve as a reservoir of toxins that are constantly leached into the system. While bio lm 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 uid circuit in your clinic. Its not difcult. In fact, the Gambro system can perform this daily routine automatically during non- dialysis periods.

Bio lm poses a real threat to tubing. Here the tubing has not beeen regularly ushed with hot water. Within two years bio lm is clearly evident.

Gambros automatic hot water ushing program stops bio lm before it starts. Here, Gambros prophylactic hot water ushing of the tubing results in a surface that is as clean two years later as the day it was installed.

Often overlooked, tubing can be the critical weak link in many hygienic chains. Gambros PEX tubing resists heat, is exible, tough, and chemically inert.

Tubing
The choice of tubing is important. There are many requirements placed on HD system tubing. It should be tough, exible, 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. Its tough yet easily bendable and can be installed in long sections without joints. This is important because joints favor the growth of bio lm. All in all, PEX tubing offers an advantage over any other type of tubing, including electro -polished stainless steel.

A nal word
Fluid purity is a topic of increasing importance in HD treatment. With this bro chure we hope to promote an approach we call The Hygienic Chain concept. Our aim is to demonstrate the importance of uid purity and explain how we achieve it. As part of that message, I would like to express Gambros 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 Gambros product design for decades. It is reected in a string of Gambro innovations like hygienic uid path design in our HD machines, on-line heat disinfection, on-line preparation of bicarbonate from dry powder, and on-line preparation of HF/HDF infusion uid all Gambro rsts. It is also reected in our product range, which provides a complete hygienic chain solution. Gambro can provide every link in the hygienic chain from water treatment to ultra lters. If you are considering replacing your water treatment system, now is the time to make your clinics 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,

Leif Smeby Senior Vice President Corporate Research

Contact Gambro
If you are planning an update to an existing clinic, call Gambro to see how we can work with your current equipment to maximize uid quality and minimize the risk posed by bio lm. If you are planning a new HD clinic, we recommend that you consider establishing a fully integrated hygienic chain from the start. Your Gambro representative would be happy to consult with you.

Gambro Lundia AB International Marketing Box 10101, SE-220 10 Lund Sweden. Tel +46 46 16 90 00 Fax +46 46 16 96 97 www.gambro.com

HCEN1156 2003. 09. Rev. 2. Gambro Lundia AB. 2001 June. Printed by Elanders Skogs Graska AB.