The Hygienic Chain. How to optimize dialysis fluid purity

Transcription

1 The Hygienic Chain How to optimize dialysis fluid purity

2 Fluid Purity a prerequisite to quality dialysis treatment Over the past three decades we have learned much about dialysis 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 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 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 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 (RD52:2004). The European Best Practice Guidelines for Haemodialysis, issued 2002 by ERA-EDTA, takes a further step by strongly recommending the use of ultrapure fluid quality for all dialysis applications to minimize inflammation (EBPG IV.1 and IV.4.3). 2

3 The Hygienic Chain a holistic approach to optimizing dialysis fluid purity Maintaining 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 biofilm. That is why Gambro 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 treatment and tubing to HD machines and concentrates, Gambro offers a fully integrated solution. Water treatment and hot water flushing HD machines and dry concentrates Tubing and inlets We are pioneers in HD with decades of experience in water treatment and fluid distribution systems specialized 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 RO unit to drain. 3

4 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 flushing of the entire distribution loop. This way the entire pure water system gets protection against biofilm formation. The CWP system is perfectly matched by our HD machines and other products like the BiCart cartridge, CleanCart cartridge, U 8000 S ultrafilter and Clean-PEX tubing, recommended by Gambro. All designed to assure the highest hygienic standard for the dialysis fluid. Avoiding treatment-related inflammation Implementing The Hygienic Chain is an effective step for avoiding treatmentrelated 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. 4

5 How choosing the right water treatment system can help prevent biofilm Water treatment and hot water flushing The first link in The Hygienic Chain is proper water treatment. 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 HD fluid are introduced further down the line, after the RO unit. Purifying water only to have it contaminated downstream makes little sense. That s why part of your water treatment strategy should include a plan for how to prevent subsequent contamination. 5

6 Heating unit RO unit min 85 C 90 C Regular hot water flushing of the entire fluid distribution system, including HD machines, can prevent biofilm. Biofilm prevention by proactive disinfection Of particular concern is the development of biofilm in the system. Biofilm is communities of microorganisms 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. 6

7 Dialysis unit Biofilm starts 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. 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. 7

8 Integrating reverse osmosis and hot water flushing The reverse osmosis unit should be well suited for to 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 fluid distribution system against biofilm formation. Gambro has decades of experience 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. Gambro has been developing water treatment systems tailored to the needs of HD clinics for over 30 years. CWP 100 systems by Gambro are available with either single- or double-reverse osmosis, have a built-in hot water tank, and are designed to perform daily unattended hot water flushing of the entire fluid distribution system. 8

9 How choosing the right HD machines and concentrates can enhance fluid purity HD machines and dry concentrates 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, complicated valves and chamber systems all increase the risk of contamination. That s because bacteria, yeast, fungi 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. 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. 9

10 HD machines designed for purity It 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. 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. Unfortunately, neither of these measures can provide adequate protection. 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. Many HD machines have complicated flow paths that favor microbial growth. Note 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 and enhance fluid purity. Note that Gambro machines can be drained and have no reservoirs where dialysis fluid can sit between treatments. 10

11 Dry bicarbonate cartridges easy, safe and hygienic Liquid bicarbonate concentrate is an excellent growth medium for bacteria. The introduction of even a single 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 the 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. The BiCart cartridge by Gambro is one such dry bicarbonate powder cartridge. Gambro was the first to offer this hygienic milestone and today over 200 million BiCart cartridges have been used around the globe, making it the world s most widely used dry bicarbonate. Automatic cleaning & disinfection The BiCart cartridge enables easy safe and hygienic preparation of dialysis fluid. Today the BiCart cartridge is an essential part of both The Hygienic Chain concept and Gambro s BiCart Select package that also includes SelectCart dry sodium chloride and SelectBag minor electrolytes. Further 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, the CleanCart C cartridge ensures that this fluid 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 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. 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. The CleanCart concept provides easy, safe and effective disinfections and cleaning. 11

12 Ultrafiltration of dialysis fluid Ultrafilters 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 derivatives 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 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 sterile single-use ultrafilter inserted in the infusion line, is the essential last safety barrier which makes it possible to achieve sterile substitution fluid (sterile equipment is necessary in order to produce sterile fluid). High quality concentrates A conc UF RO Ultrafilter 1 U 8000 S Ultrafilter 3 U 2000 Ultrafilter 2 U 8000 S The ULTRA system by Gambro, with its set-up of ultrafilters, provides ultrapure dialysis fluid and non-pyrogenic substitution fluid 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 precaution be taken to keep contaminants from entering the fluid system in the first place. A secure hygienic chain 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 ultrafilters and reduces the need for elaborate maintenance programs. 12

13 Tubing: a critical link in The Hygienic Chain Tubing and inlets 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 fluid 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 biofilm. Of particular concern are the machine s fluid inlet and the line that connects it to the central loop. These are the missing links in many hygienic chains. That is because neither the loop s nor the machine s disinfection routine include these areas. Such an omission leaves the entire system vulnerable to microbial contamination. 13

14 Preventive 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 coating the inner surfaces of fluid pipes. Since these microorganisms are securely fastened 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 as a reservoir of toxins that are constantly 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. Biofilm poses a real threat to tubing. Here the tubing has not beeen regularly flushed with hot water. Within two years biofilm is clearly evident. Gambro s automatic hot water flushing program stops biofilm before it starts. Here, Gambro s prophylactic hot water flushing 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. Gambro s PEX tubing resists heat, is flexible, tough, and chemically inert. 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. 14

15 A final word Fluid purity is a topic of increasing importance in HD treatment. With this brochure we hope to promote an 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 message, 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 product 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 preparation 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 to teach the highest quality dialysis treatment available. Ingrid Ledebo, Ph.D. Director Scientific Affairs Gambro Research & Development Contact Gambro If you are planning to update an existing clinic, call Gambro to see how we can work with your current equipment to maximize fluid quality and minimize the risk posed by biofilm. 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. 15

16 Partners in care HCEN1156_ Gambro Lundia AB... David, Ellen, Tom, Enrico, Beatriz. They are just a handful of the hundreds of thousands of men, women and children around the world who every day rely on our products and your care to survive kidney or liver conditions and enjoy a better life. Every step we take together, every improvement in care we make, touches lives and provides new hope to José, Xiuxiu, Vladimir, Fred, Jamila... Gambro the pioneer and leading innovator in dialysis therapy passionately committed to promoting life by advancing products, services and customer partnership within renal and hepatic care. Contact us at partner@gambro.com Gambro Lundia AB PO Box SE Lund Sweden Phone partner@gambro.com