Various Dialysis Machines Comparison Hemodialysis Units

 Hemodialysis Units Scope of this Product Comparison This Product Comparison covers single-patient hemodialysis units. Multipatient hemodialysis systems, disposable hemodialysis accessories, water-purification systems, and dialyzer reprocessors have been excluded. For information on similar devices, see the Product Comparisons titled Peritoneal Dialysis Units. These units are also called: artificial kidneys, dialysis machines, hemodialyzers, hemodialysis machines.

Purpose Hemodialysis units perform extracorporeal dialysis to replace the main activity of the kidneys in patients with impaired renal function, such as those with end-stage renal disease. The kidneys maintain the body’s fluid, electrolyte, and acid/base balance, counteracting the destabilizing influences of metabolic activity and a constantly changing external environment. Impaired kidney function causes the body to retain metabolic wastes and water. Hemodialysis therapy removes these, as well as ions and organic salts, from the bloodstream. Although it does not restore renal function or promote healing of the kidneys, it restores a reasonable state of health by partially performing renal functions, thereby minimizing further damage to other organs and physiologic systems.

Principles of operation Single-patient hemodialysis systems can be divided into three major components: the dialysate delivery system, the extracorporeal blood-delivery circuit, and the dialyzer. Blood is taken via the extracorporeal circuit, passed through a dialyzer for solute and fluid removal, and returned to the patient. Each system has its own monitoring and control circuits (see Figure 1).

Dialysate delivery system The delivery system prepares dialysate—a solution of purified water with an electrolyte composition similar to that of blood—and delivers it to the dialyzer. Dialysate acts to remove metabolic wastes from the blood and also acts as a source of ions to maintain the blood’s proper electrolyte and pH levels. Either acetate or bicarbonate concentrate is included in the dialysate as a buffering agent. Additional water is mixed into the dialysate to approximate normal bicarbonate ion blood concentrations.

UMDNS Information This Product Comparison covers the following device terms and product codes as listed in ECRI Institute’s Universal Medical Device Nomenclature System™ (UMDNS™): Hemodialysis Units [11-218]

5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA  Tel +1 (610) 825-6000  Fax +1 (610) 834-1275  Web www.ecri.org  E-mail [email protected]

Hemodialysis Units

Figure 1. Components of a typical hemodialysis unit.

To prevent short- and long-term toxic effects, incoming water must be treated to remove inorganic and organic contaminants, such as minerals and bacteria. Water-treatment systems typically use depth filtration, water softeners, activated carbon filtration, reverse osmosis (RO), and deionization (DI) to achieve the standard acceptable level of contaminants. Treated water enters the dialysis machine and usually passes through a heater and a deaerator before being mixed with the concentrate to form dialysate. Two types of proportioning systems are used to mix the water and concentrate: fixed-ratio controllers mix specific amounts of each, while servo-controlled systems monitor the conductivity of the dialysate and regulate the delivery of concentrate to satisfy specified conductivity and pH limits. The temperature of the dialysate is kept in the 34° to 42°C range to prevent excessive cooling or heating of the blood. The temperature and conductivity sensors can initiate alarms and divert the dialysate away from the dialyzer if the conductivity or temperature is not within specified limits. Some systems monitor other parameters, such as the pH, to determine dialysate status.

Extracorporeal blood circuit The external blood-delivery system (extracorporeal blood circuit) circulates a portion of the patient’s blood through the dialyzer and returns it to the patient. Usually, an artery and a vein in the patient’s arm are surgically joined for circulatory access; this junction is called an arteriovenous (AV) fistula. Bypassing capillary beds, where arterial blood pressure is markedly decreased, the blood entering the fistula maintains high pressure, causing the diameter of the vein to expand greatly. One or two large-bore needles can then be inserted into the enlarged vessel. The single-needle technique requires either a Y-connection and a controller to alternate withdrawal and infusion of blood or a special single-needle access catheter. Another technique for vascular access is the external AV shunt, which is made of Teflon and Silastic and connects to both a vein and an artery in the forearm or lower leg. It is used less often because of the risk of infection, thrombosis, and accidental dislodgment. A blood pump moves blood through the external tubing and dialyzer. As the pump draws blood into the extracorporeal circuit, it creates a partial vacuum that will draw air into the tubing if connections are not

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Hemodialysis Units absolutely tight. As a safety feature, air/foam detectors are employed to detect air in the blood line and prevent it from being pumped into the patient. External blood pressures are monitored on both venous and arterial lines; high- and low-pressure alarms turn off the blood pump if necessary. Because blood tends to clot when it comes into contact with foreign surfaces such as those in the tubing and dialyzer, heparin, an anticoagulant, is infused through a syringe pump aseptically connected to an infusion line in the arterial side of the blood circuit. The infusion pump can be set to deliver heparin at a predetermined rate. A drip chamber on the venous side of the blood circuit contains a clot-trapping filter to help prevent upstream clots and other debris from reaching the patient.

Dialyzer The dialyzer is a disposable component in which solute exchange, or clearance, takes place. There are three basic design configurations: coil, parallel plate, and hollow fiber. In all three, electrolytes, waste products, and water pass across a semipermeable membrane into a flowing stream of dialysate solution. By diffusion, osmosis, and ultrafiltration (UF), water and metabolites are exchanged between the blood and the dialysate. Concentration gradients cause waste products, such as urea and creatinine, to diffuse across the membrane from the blood to the dialysate. Electrolytes move in both directions to maintain equilibrium. Red and white blood cells and proteins are too large to pass through the pores in the membrane. UF by pressure gradient is the primary method of removing excess water from the blood through the semipermeable membrane. It occurs when water, a small molecule, is forced across the membrane by hydrostatic pressure—the primary UF mechanism in hemodialysis. Fluid removal is measured by the UF removal rate, which is automatically controlled in newer units. The use of high-flux dialysis, which typically shortens treatment time, has resulted from research with larger, high-efficiency dialyzers whose membranes’ increased surface areas and permeability permit higher fluidremoval rates than are possible with standard dialyzers. Development of thin-wall, hollow-fiber membranes has enhanced UF and clearance rates. Hemodialysis machines that are intended to be used with high-flux dialyzers must be capable of operating with transmembrane pressures (TMPs) approaching zero while maintaining adequate control of UF. However, the use of high-flux dialysis is still controversial: while the modality may permit faster treatment because of the very high UF rates, the adequacy of metabolic by-product clearance has not been well established. There has also been concern about the ability of bacteria or endotoxins to penetrate the membranes used in high-flux dialysis. Some hospitals use high-flux dialysis to treat drug overdoses and chemical poisonings because of its ability to filter the blood very rapidly. Another type of dialysis is continuous renal replacement therapy (CRRT). This type of therapy allows tighter control of volume transfer and more regular waste removal than intermittent treatment. CRRT is especially useful in patients who cannot tolerate the rapid volume loss associated with intermittent therapy; in unstable patients, such as those in the intensive care unit; and in patients undergoing cardiac surgery. Some conventional hemodialysis machines are now offering CRRT as an option.

Microprocessors Microprocessors in some units control alarms, sensors, and operating functions; allow for data storage; and interface with clinical databases. Data downloaded into a clinical database can be used to analyze information concerning a particular patient or machine, or it can be used to analyze treatments involving a number of patients and machines. Microprocessors also allow large amounts of information to be stored and analyzed during treatment. This includes calculating flow rate, duration of the session, total blood processed, and blood pressure. This data can then be analyzed and expressed in graph form or be sent to a central monitoring unit, such as the nurses’ station, where the data can be viewed and/or transferred to permanent medical records. It is also possible for home-

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Hemodialysis Units dialysis patients to be monitored at a remote location. However, remote adjustments to treatment are not yet possible.

Reported problems Infections are a leading cause of morbidity and mortality in chronic hemodialysis patients. For example, HBsAg (an indicator for the presence of hepatitis B virus) has been detected on various surfaces in hemodialysis centers, including dialysis-machine control knobs. Strict, specific policies and procedures designed to reduce infection risks should be implemented. These policies should address issues such as sterilization and disinfection, housekeeping, laundry, maintenance, waste disposal, isolation precautions, and universal precautions.

Water purification Adequate water purification is essential in hemodialysis. The quality and composition of tap water varies from location to location; water that is considered safe for drinking is often dangerous for hemodialysis. A long-term dialysis patient is exposed to 450 liters of water per week, which is almost 50 times the amount ingested by healthy people; as a result, trace amounts of elements in tap water may approach toxic levels in dialysis patients. Chloramines, which are added to tap water to inhibit bacterial growth, have been known to cause hemolysis. Aluminum in tap water has been cited as a possible cause of illnesses such as dialysis encephalopathy, bone disease, and anemia; iron can move across the dialyzer membrane and cause excessive iron storage in the liver; copper can cause anemia and metabolic acidosis; and excess lead can result in neurologic damage. Standards have been established for the quality of water used in hemodialysis systems, but there is still some question regarding what constitutes a harmful level of impurity. Researchers are discovering that many components currently being removed by the purification system and by the dialyzer membrane, such as zinc, are important to body metabolism. Vitamin therapy is often prescribed for dialysis patients. Water used for dialysis should be tested periodically. The monitoring frequency depends on the water treatment used. The guidelines established by the Centers for Medicare & Medicaid Services recommend that centers using RO or DI devices sample for maximum allowable levels of chemical contaminants in water. Guidelines for facilities using other water-treatment methods recommend sampling at least every three months and at times of expected high levels of contamination.

Automated disinfection Some hemodialysis machines have an alarm to indicate failure to draw in disinfectant during an automated disinfection cycle. However, there have been incidents in which disinfectant was not drawn into the machine and the alarm failed to indicate this problem. Ensuring sufficient disinfectant uptake during automated disinfection is critical to patient health. During a typical automated disinfection cycle, the hemodialysis machine is connected to a container of disinfectant. An internal pump draws the disinfectant into the machine, where the internal components are disinfected. If the hemodialysis machine does not take up an adequate amount of disinfectant, bacteria may proliferate inside the machine. When dialysate comes in contact with the interior of an inadequately disinfected machine, bacteria will mix with the dialysate solution. Endotoxins, the components of dead bacteria or excretions of live bacteria, may pass through the semipermeable membrane of the dialyzer and enter the patient’s blood, potentially causing a pyrogenic reaction. Over time, repeated exposure to endotoxins may affect a dialysis patient’s health.

Dialysate Operator error in preparing the dialysate is possible. While acetate was once the preferred ingredient for all dialysis patients, bicarbonate dialysis has become a common alternative because of superior posttreatment comfort. Bicarbonate dialysis requires mixing treated water with the critical ratio of two concentrates, acid and

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Hemodialysis Units bicarbonate. Because conductivity reflects the total ionic content of the dialysate but does not measure its actual composition, fatal errors in pH balance can bypass alarms by satisfying conductivity requirements. Extreme care should be taken in mixing dialysate and in attaching dialysate containers to the proper inlet ports on the machine. As a precaution, dialysate should be checked for both pH and conductivity before each dialysis treatment. Bicarbonate buffers are susceptible to contamination from bacteria that require the salt in bicarbonate concentrate for growth. Techniques that can retard bacterial growth in bicarbonate media should be followed when preparing dialysate concentrate.

Dialyzer reuse Occasional instances of bacterial and hepatitis B infection have been reported in hospital dialysis units. While technical improvements in materials and disinfection procedures have improved the safety of dialyzer reuse, this practice continues to be controversial. For example, if inadequately disinfected, tubing and dialyzer membranes can harbor infection-causing organisms. Infestation may also be caused by contaminated water used to rinse and clean the dialyzers and prepare germicide used in disinfection or sterilization. With repeated use, there is a higher risk of membrane damage, allowing organisms to pass into the bloodstream. Hazards exist with certain kinds of reprocessing systems: toxic reactions to formaldehyde fumes have been reported in dialysis unit operators, and trace amounts of disinfectant may remain in the dialyzer after reprocessing, exposing the patient to potentially harmful levels of the agent during dialysis. Ideally, dialyzers labeled “single use” or “disposable” should be discarded after their initial use; this practice eliminates the danger of microbial and/or disinfectant contamination and ensures an efficient dialysis treatment. However, financial considerations have forced many hospitals and clinics to reuse many kinds of disposables, and the reuse of dialyzers is now a widespread practice. Additionally, reprocessed dialyzers may offer patients some benefits, such as reducing the incidence of “first-use syndrome”—an allergic reaction to a new, unprocessed dialyzer—which is experienced by some patients. U.S. Food and Drug Administration regulations now require manufacturers of reusable dialyzers to recommend at least one method for reprocessing. Guidelines, such as those proposed by the Association for the Advancement of Medical Instrumentation, should be closely followed to ensure safe dialyzer reprocessing. In addition, dialysis unit operators and patients should be fully informed about the adverse health effects of exposure to particular disinfectants (e.g., formaldehyde).

Other problems Allergic or anaphylactic reactions in response to device materials and the mode of dialyzer sterilization have been reported; improving the biocompatibility of components by the reduction of, for example, plasticizer and trace-metal leaching is a major concern of researchers and manufacturers. In addition, ethylene oxide, the most common sterilant used in dialyzer manufacturing, has been shown to cause allergic reactions; in response, some manufacturers are using gamma radiation and steam sterilization. The rapid fluid removal caused by high-efficiency dialyzers can produce strong hypotensive reactions in patients who suffer from severe cardiovascular disease or who have retained more than 5 kg of fluid between dialysis treatments (this retained fluid must be removed to maintain proper electrolyte concentrations, pH, and blood pressure). The cardiovascular systems of these patients cannot compensate for the sudden and extreme loss of fluid volume from the blood; consequently, blood pressure falls sharply. Dialysis disequilibrium syndrome is experienced by the majority of people undergoing treatment on a standard dialysis unit. Symptoms range from mild attacks of malaise and drowsiness to convulsions, coma, and death; the suspected cause is, again, the inability of the vascular system to adjust to the change in fluid volume during dialysis. Problems can also result from the use of hemodialysis catheters and blood lines. If a hemodialysis catheter

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Hemodialysis Units separates from a patient’s venous blood line, the patient can suffer an air embolism or quickly lose a large amount of blood. FDA has received reports of incidents in which hemodialysis catheters have separated, leaked, cracked, torn, or broken, leading to air embolism, infection, blood loss, the need for additional surgery, or death. Alarms may not sound if a catheter separates from the venous blood line, FDA says, increasing the need for regular monitoring. FDA also recommends that healthcare workers use the indicated vascular access site for hemodialysis only and that they make sure the catheter site remains visible during treatment, removing sheets and blankets if necessary.

Purchase considerations ECRI Institute recommendations Included in the accompanying comparison chart are ECRI Institute’s recommendations for minimum performance requirements for hemodialysis units. The main considerations when choosing a hemodialysis unit are patient safety and device effectiveness. Temperature should be monitored by the dialysate delivery system, and an alarm should sound if temperatures above 41°C are reached, as blood exposed to higher temperatures can be damaged. TMP should also be monitored, and the unit should alarm if the TMP falls below 0. This drop in TMP may lead to reverse UF, allowing fluids and toxins to filter back into the blood. The hemodialysis unit should monitor UF removal rates with an accuracy of ±10% of set volume. In addition, the unit must have air/foam and conductivity detectors to minimize patient risk when blood is circulated in the extracorporeal blood circuit. In order to minimize the chances of infection, heat or chemical disinfection should be available and utilized. ECRI Institute recommends that users follow the manufacturer’s disinfection instructions.

Other considerations If only one or two units are being purchased to supplement existing stock, then staff familiarity and experience with a particular manufacturer’s machines can be an important factor. In general, clinicians will require less training on and will be more comfortable with new models from a manufacturer whose equipment they are currently using. Clinical engineers would also benefit from the experience gained in servicing earlier models from the same manufacturer. An additional advantage is that the components of the new machines may be identical to those of earlier models, reducing the need to store additional parts and thereby simplifying inventory. Facilities that need units for limited chronic or acute care applications not requiring recent innovations (e.g., variable sodium, regular or profiled UF control), as well as facilities considering units for home use, may realize cost savings by purchasing earlier models. Machines acquired for home dialysis must be easy to operate, incorporating good human factors design. Because power, water pressure, and temperature may not be as well regulated in homes as in hospitals and most dialysis centers, factors such as limited acceptable ranges of supply voltage and water temperature become issues in selecting a unit. Reliability is of special concern for machines that are to be used in the home because there is usually no backup unit or repair technician available; if the unit ceases to function in the middle of treatment, the consequences can be serious. Home-dialysis training programs are available for patients, their relatives, and caregivers. Most hemodialysis units accept various brands of disposable accessories (e.g., tubing sets, bags). However, some units require the use of proprietary disposables, which can increase the operational costs per procedure. Facilities with multiple hemodialysis units should make sure that all units can accept the same brands of disposables. Some suppliers will offer discounts on disposables when they are purchased in bulk quantities. Disposables are a significant operating cost, which can vary greatly depending on supplier discounts and incentives. ECRI Institute’s PriceGuide™ service benchmarks the price for single-use medical products.

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Hemodialysis Units PriceGuide compares your hospital’s current pricing data with the national or regional average and lowest recorded prices paid. For more information, contact ECRI Institute.

Stage of development Clinicians and researchers are seeking ways to improve the quality of life for patients with renal failure, especially when transplantation is not a feasible alternative. One trend is toward prescription dialysis, in which the dialysate is fine-tuned to the individual needs of the patient. Manufacturers have responded by offering variable and programmable systems, which allow individualized patient therapy. Although it has drawbacks, the reuse of single-use dialyzers for the same patient (see Reported Problems), is widely practiced, as hospitals and treatment centers have found it increasingly necessary to maximize use of their equipment and resources. Because dialyzer reuse significantly lowers the cost per treatment, safe and effective methods for recycling dialyzers are in great demand, and a number of companies have emerged that develop and manufacture dialyzer reprocessing machines. Formaldehyde was formerly the most common disinfectant, but because of safety concerns on the part of the Occupational Safety and Health Administration, it is now rarely used. Disinfectants such as sodium hypochlorite and peracetic acid are currently used. Test kits that detect trace amounts of disinfectant are available with reprocessors. The future of home dialysis may include single-patient hemodialysis machines that can incorporate dialyzer reprocessors. While medical research is attempting to define the limits of the shortest, most efficient dialysis procedure, technological development is following a parallel course. Smaller, lighter, battery-powered units are being designed that can dialyze almost as quickly as the high-efficiency models. Almost completely automatic, these machines contain microprocessors that monitor and control all the unit’s sensors, alarms, and operating functions. One manufacturer has developed a dialysis system that incorporates an intradialytic blood-volume monitor for hemodynamic surveillance. Much research has been performed to study the benefits of daily, or at least more frequent, dialysis. This has led to an increased interest in home dialysis. Some patients prefer home dialysis because of the added scheduling flexibility it allows. Companies are now working to develop safer and easier-to-use hemodialysis units for home use. Frequent dialysis treatments more closely resemble the natural function of the kidneys, which continuously filter blood to remove toxins and excess fluids. Patients who undergo short daily treatments or longer nocturnal sessions can avoid the peak-and-valley effects caused by intermittent dialysis. This regimen may also more efficiently rid the body of middle-weight molecules, which seem to be the cause of long-term complications of dialysis. Home units that treat water before sessions, as well as dialyzers that can be used for the same patient for up to one month without reprocessing, are in development. Researchers are trying to produce a biocompatible, infection-proof synthetic material that can be molded into tubing, implanted in large vessels, and attached to the extracorporeal blood circuit for use as a permanent access channel to the blood. This artificial vessel is necessary to extend the length of time that patients can receive dialysis treatment because veins and arteries become thrombosed after repeated damage to their walls and because blood flow is diminished; continued puncturing of these vessels could cause their collapse or result in the formation of emboli. Advancement in membrane technology is also under way. Researchers are trying to create more efficient and more biocompatible membranes for use during dialysis. Research into new synthetic materials, as well as bioartificial membranes, is being conducted. One technology involves the incorporation of cultured renal tubular cells and glomerular cells layered onto a synthetic membrane. The cultured cells will allow hemodialysis units not only to filter toxins and excess fluid out of blood, but also to replace some of the kidney’s metabolic and endocrine functions.

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Hemodialysis Units Bibliography Arnow PM, Bland LA, Garcia-Houchins S, et al. An outbreak of fatal fluoride intoxication in a long-term hemodialysis unit. Ann Intern Med 1994 Sep 1;121(5):339-44. Boag JT. Hemodialysis equipment. Dial Transplant 1996 Oct;25(10):697-9. Building a better stop-gap—vascular access for dialysis. Start Up 2003 Apr;8(4):8-10. “Burned out bulb” contributed to dialysis patient death. Biomed Saf Stand 1995 Mar 15;25(5):38. CDC advises cohorting to prevent outbreaks: staff segregated also a key. Hosp Infect Control 1995 Jul;22(7):89-90. Cummings NB, Klahr S, eds. Chronic renal disease: causes, complications and treatment. New York: Plenum; 1985. Dialysis centers hit by bloodborne outbreaks. Hosp Infect Control 1995 Jul;22(7):87-9. ECRI. Ensuring sufficient disinfectant uptake during automated disinfection for hemodialysis machines [hazard report]. Health Devices 2004 Aug;33(8):296-7. Continuous renal replacement therapy: The real story [guidance article]. Health Devices. 2001 Jul;30(7):248-55. Hemodialysis units. Health Devices Inspection and Preventive Maintenance System. Procedure no. 413. Spurious ECG signals during hemodialysis [hazard report]. Health Devices. 2002 Mar; 31(3): 112-3. Feldman HI, Kinosian M, Bilker WB, et al. Effect of dialyzer reuse on survival of patients treated with hemodialysis. JAMA 1996 Aug 28;276(8):620-5. Ghezzi PM, Sanz-Moreno C, Gervasio R, et al. Technical requirements for rapid high-efficiency therapy in uremic patients. Paired filtration-dialysis (PFD) with a two-chamber technique. Trans Am Soc Artif Intern Organs 1987 Jul-Sep;33(3):546-50. Hakim RM, Depner TA, Parker TF 3rd. Adequacy of hemodialysis. Am J Kidney Dis 1992 Aug;20(2):107-23. Hornberger JC, Garber AM, Chernew ME. Is high-flux dialysis cost-effective? Int J Technol Assess Health Care 1993 Winter;9(1):85-96. Luehmann DA, Keshaviah PR, Ward RA, et al. Water treatment for hemodialysis. U.S. Department of Health and Human Services; 2002. Meers C, Morton AR, Toffelmire EB. Dialysis access morbidity with high-efficiency dialysis. Dial Transplant 1993 Jun;22(6):324-5, 329, 352. Neiberger R, Schwalbe M, Pena D, et al. Cause of death for children on chronic dialysis: a 20-year analysis. Dial Transplant 1995 Feb;24(2):78, 80-1, 91. Neto MC, Manzano SI, Canziani ME, et al. Environmental transmission of hepatitis B and hepatitis C viruses within the hemodialysis unit. Artif Organs 1995 Mar;19(3):251-5. Paolini F, Mancini E, Bosetto A, et al. Hemoscan: a dialysis machine-integrated blood volume monitor. Int J Artif Organs 1995 Sep;18(9):487-94. Parker TF 3rd. Technical advances in hemodialysis therapy. Semin Dial 2000 Nov-Dec;13(6):372-7. Pru CE, Cuervo C, Ardila M, et al. Hepatitis C transmission through dialysis machines. ASAIO J 1994 JulSep;40(3):M889-91. Rudnick JR, Arduino MJ, Bland LA, et al. An outbreak of pyrogenic reactions in chronic hemodialysis patients associated with hemodialyzer reuse. Artif Organs 1995 Apr;19(4):289-94.

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Hemodialysis Units Stuart M. The high cost of kidney failure. Start Up 2003 Apr;8(4):23-33.

Supplier information B BRAUN B Braun Medical Inc A B Braun Group Co [171733] 824 Twelfth Ave PO Box 4027 Bethlehem, PA 18018-0027 Phone: (610) 691-5400, (800) 227-2862 Fax: (610) 691-2202 Internet: http://www.bbraunusa.com E-mail: [email protected] B Braun Melsungen AG [178137] Lindberghstrasse 12 Puchheim/Muenchen D-34212 Germany Phone: 49 (89) 8394090 Fax: 49 (89) 83940943 Internet: http://www.bbraun.com E-mail: [email protected] B Braun Medical (France) [178337] 204 avenue du Marechal Juin boite postale 331 Boulougne Cedex F-92107 France Phone: 33 (1) 41105300 Fax: 33 (1) 41105399 Internet: http://www.bbraun.fr E-mail: [email protected]

BELLCO Bellco SpA A Sorin Group Co [331072] via Camurana 1 Mirandola (MO) I-41037 Italy Phone: 39 (053) 529111 Fax: 39 (053) 529407 Internet: http://www.bellcospa.it E-mail: [email protected]

FRESENIUS Fresenius Medical Care Co KGaA [454270] Else-Kroener-Strasse 1 Bad Homburg D-61352 Germany Phone: 49 (6172) 6080 Fax: 49 ( 6172) 60802294 Internet: http://www.fresenius.de E-mail: [email protected] Fresenius Medical Care North America [312187] 920 Winter St Waltham, MA 02451-1457 Phone: (781) 699-9000, (800) 662-1237 Internet: http://www.fmcna.com E-mail: [email protected]

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Hemodialysis Units GAMBRO Gambro Americas [372119] 14143 Denver West Pkwy Lakewood, CO 80401 Phone: (303) 232-6800, (800) 525-2623 Internet: http://www.usa-gambro.com E-mail: [email protected] Gambro AB [139296] Box 7373 Stockholm S-103 91 Sweden Phone: 46 (8) 6136500 Fax: 46 (8) 6112830 Internet: http://www.gambro.com Gambro KK [287972] Acropolis Tokyo 9/Fl 6-29 Shin-ogawamachi Shinjuku-ku Tokyo 162-0814 Japan Phone: 81 (3) 52273220 Fax: 81 (3) 52273254 Internet: http://www.gambro.com Gambro Pty Ltd [305714] Suite 2 Level 4 62 Norwest Boulevarde Baulkham Hills 2153 Australia Phone: 61 (2) 88523700 Fax: 61 (2) 96341375 Internet: http://www.gambro.com

HOSPAL Gambro Hospal Ltd Sub Gambro AB [418672] Lundia House Ermine Business Park Huntingdon PE29 6XX England Phone: 44 (1480) 444000 Fax: 44 (1480) 434084 Internet: http://www.gambro.co.uk Hospal AG [331103] Dornacherstrasse 8 Basle CH-4008 Switzerland Phone: 41 (61) 2721323 Internet: http://www.hospal.com

NIKKISO Nikkiso Co Ltd [150938] 3-43-2 Ebisu Shibuya-ku Tokyo 150-8677 Japan Phone: 81 (3) 34433711 Fax: 81 (3) 34734963 Internet: http://www.nikkiso.co.jp/english

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Hemodialysis Units TORAY Toray Industries Inc [137952] Toray Building 1-1 Nihonbashi-Muromachi 2-chome Chuo-ku Tokyo 103-8666 Japan Phone: 81 (3) 32455111 Fax: 81 (3) 32455555 Internet: http://www.toray.co.jp Toray International America Inc [452114] 140 Cypress Station Dr Suite 210 Houston, TX 77090 Phone: (281) 587-2299, (800) 662-1777 Fax: (281) 587-9933 Internet: http://www.torayusa.com/medical E-mail: [email protected] Toray Industries Inc (Europe) [418643] 3rd Floor Old Park Lane London W1K 1AD England Phone: 44 (20) 76637760 Fax: 44 (20) 76637770 Internet: http://www.toray.com

Note: The data in the charts derive from suppliers’ specifications and have not been verified through independent testing by ECRI Institute or any other agency. Because test methods vary, different products’ specifications are not always comparable. Moreover, products and specifications are subject to frequent changes. ECRI Institute is not responsible for the quality or validity of the information presented or for any adverse consequences of acting on such information. When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier discounts. And although we try to indicate which features and characteristics are standard and which are not, some may be optional, at additional cost. For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the conversion to U.S. dollars to facilitate comparison among models. However, keep in mind that exchange rates change often.

Need to know more? For further information about the contents of this Product Comparison, contact the HPCS Hotline at +1 (610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or [email protected] (e-mail). Last updated August 2009

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Hemodialysis Units

Policy Statement The Healthcare Product Comparison System (HPCS) is published by ECRI Institute, a nonprofit organization. HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and therapeutic capital equipment more effectively in support of improved patient care. The information in Product Comparisons comes from a number of sources: medical and biomedical engineering literature, correspondence and discussion with manufacturers and distributors, specifications from product literature, and ECRI Institute’s Problem Reporting System. While these data are reviewed by qualified health professionals, they have not been tested by ECRI Institute’s clinical and engineering personnel and are largely unconfirmed. The Healthcare Product Comparison System and ECRI Institute are not responsible for the quality or validity of information derived from outside sources or for any adverse consequences of acting on such information. The appearance or listing of any item, or the use of a photograph thereof, in the Healthcare Product Comparison System does not constitute the endorsement or approval of the product’s quality, performance, or value, or of claims made for it by the manufacturer. The information and photographs published in Product Comparisons appear at no charge to manufacturers. Many of the words or model descriptions appearing in the Healthcare Product Comparison System are proprietary names (e.g., trademarks), even though no reference to this fact may be made. The appearance of any name without designation as proprietary should not be regarded as a representation that is not the subject of proprietary rights. ECRI Institute respects and is impartial to all ethical medical device companies and practices. The Healthcare Product Comparison System accepts no advertising and has no obligations to any commercial interests. ECRI Institute and its employees accept no royalties, gifts, finder’s fees, or commissions from the medical device industry, nor do they own stock in medical device companies. Employees engage in no private consulting work for the medical device industry.

About ECRI Institute ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for over 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, healthcare processes, devices, procedures, and drug technology. ECRI Institute is one of only a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. For more information, visit http://www.ecri.org.

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Hemodialysis Units

Product Comparison Chart

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Hemodialysis Units Product Comparison Chart MODEL

ECRI INSTITUTE'S RECOMMENDED SPECFICATIONS1 Basic Hemodialysis Units

WHERE MARKETED FDA CLEARANCE CE MARK (MDD) DIALYSATE DELIVERY Proportioning system Comfort control, °C Temperature alarm limits, °C Conductivity range, mS/cm Flow, mL/min Transmembrane pressure, mm Hg Rx dialysis Bicarbonate Sodium therapy Ultrafiltration removal rate, L/hr pH monitor BYPASS INDICATOR BLOOD CIRCUIT Arterial pressure, mm Hg Venous pressure, mm Hg Blood pump range, mL/min Heparin pump range, mL/hr DISINFECTION Method DISPLAY TYPE DISPLAYED PARAMETERS Dialysate pressure Transmembrane pressure Conductivity Flow rate

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B BRAUN

BELLCO

BELLCO

Dialog+ Worldwide Yes Yes

Formula Worldwide No Yes

Formula 2000 Worldwide No Yes

Balance chamber

Volumetric by ceramic pumps; system servocontrolled 35-39 34, 40

Volumetric by ceramic pumps; system servocontrolled 35-39 34, 40 12.1-15.7 total conductivity, 2.4-3.6 partial conductivity (3 mS/cm), 4-6 partial conductivity (5 mS/cm) 300, 500, 800 -300, +400, adjustable

33-40 ±1 from set value 11-17

Alarm if