WWW.DEZMED.COM Comprehensive of Biomedical Engineering Site (www.dezmed.com) Apheresis Units Scope of this Product Comparison This Product Comparison covers mobile, automated apheresis units that collect specified blood components while reinfusing others along with replacement fluids. Machines that perform only plasmapheresis are also included. These devices are also called: hemapheresis units, blood cell processors, cell separators, leukapheresis units, continuous-flow centrifuges, and plasmapheresis units. Purpose Apheresis units automate the separation, collection, and reinfusion of blood components from healthy blood donors and from patients for therapeutic purposes. Desired components are collected, and the rest can be automatically returned to the donor or patient (along with replacement fluids). Apheresis systems can be used for (1) collection of blood products (i.e., donor collection), (2) exchange (removal and replacement) of substances, or (3) therapeutic removal of substances, or a combination of these applications. Automated apheresis can rapidly and efficiently obtain large quantities of specific components from a single donor. Blood components collected by apheresis can therefore reduce the risk of transfusion-transmitted infection by minimizing the number of donors needed to supply a particular component. In addition, for therapeutic purposes, a pathologic component or toxin can be removed from a patient and exchanged with a replacement fluid to treat the symptoms of a disease or disorder. Apheresis units use centrifugation and/or filtration to separate blood components. The method of separation depends on the product that is to be removed or collected from the blood. Two methods of apheresis are continuous and intermittent (discontinuous). Continuous apheresis requires two access sites in the patient—one for blood removal and one for blood return. Continuous apheresis may be contraindicated in some patients. Systems that use intermittent apheresis require only one access site; the blood is removed from the patient, processed, and then returned to the patient using the same site. Intermittent processing requires UMDNS Information a longer period of time than continuous apheresis. Filtration separates cellular components from the plasma based on their size. This Product Comparison covers the following device term and product code as listed in Apheresis is performed in various inpatient and outpatient ECRI’s Universal Medical Device settings, including hospitals, dialysis centers, blood banks, and Nomenclature System™ (UMDNS™): physician offices. For most procedures, apheresis takes no more Apheresis Units [16-405] than two hours. 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] to collect rare white and red blood cell antibodies. renal failure. In thrombocytapheresis. Many acute and chronic conditions have been reported to be successfully treated by therapeutic apheresis. and neurologic symptoms.Comprehensive of Biomedical Engineering Site (www.DEZMED. TTP causes thrombotic occlusion of small arteries and capillaries in organs. and to manufacture plasma derivatives. increased bleeding (because of a decrease in the number of platelets). who receive multiple transfusions and thus may have become alloimmunized to the HLAs on platelets. which are returned to the donor. and thrombotic thrombocytopenic purpura (TTP). and Rh immune globulin. Other treatments affected by therapeutic apheresis include red blood cell exchange for the treatment of sickle-cell disease and leukocyte removal for the treatment of disorders in which aggregates interfere with pulmonary and cerebral blood flow. white cells. Therapeutic apheresis has been useful as a part of treating certain immune-mediated disorders. plateletpheresis (also called thrombocytapheresis). which causes paralysis by an immunologically mediated demyelination of peripheral nerves. Human leukocyte antigen (HLA)-typed platelets can also be obtained for patients. It is used to collect plasma of a certain blood type to increase inventory. hepatitis immune globulin.com) Apheresis Units WWW. however. such as those with leukemia. which causes an antibodyassociated glomerulonephritis. Guillain-Barré syndrome. Other syndromes reported to be successfully treated by plasmapheresis include Goodpasture’s syndrome. platelets are removed from a donor and red cells. such as in patients with bone marrow failure or suppression caused by chemotherapy. Removal of these antibodies through plasmapheresis can provide dramatic. and leukapheresis. 2 ©2007 ECRI Institute. hemolytic anemia. and plasma are reinfused. Therapeutic lymphocytapheresis is the removal of the lymphocytes (also called mononuclear cells) to produce immunosuppression in conditions with an immune mechanism. Plasmapheresis is the separation of the plasma from the cellular components. plasma. and platelets into the donor. Apheresis donor platelet products are used to treat bleeding caused by thrombocytopenia. The neutrophils (granulocytes). Machines that are dedicated to plasma exchange automatically remove larger plasma volumes (usually for therapeutic purposes) and return predetermined amounts of plasma and replacement fluids. All Rights Reserved. there are few treatment methods that are universally accepted by the medical community because of the lack of randomized clinical trials to prove their efficacy. such as rheumatoid arthritis. most patients with myasthenia gravis develop antibodies against acetylcholine receptors (AChRs). systemic lupus erythematosus. a coagulation disorder that is thought to be immunologically mediated.COM Separation procedures performed on blood from healthy donors include plasmapheresis. . a type of white blood cell. Leukapheresis is the removal of the white blood cells and the reinfusion of red cells. is also treated with plasmapheresis. temporary clinical improvement. can be harvested to treat sepsis.dezmed. For example. and kidney transplant rejection. where the operator (usually a nurse.com) Apheresis Units Principles of operation WWW. and fresh frozen plasma. All Rights Reserved 3 .COM Apheresis machines are wheeled to the bedside or donor chair. and the desired layers are siphoned into collection bags.. Machines performing intermittent centrifugation draw blood. One manufacturer has an optical sensor that detects the concentration of platelets flowing through the collection line and also derives the current platelet yield in the collection bag. add anticoagulant. Some plasmapheresis units combine filtration and centrifugation. This type of pump holds a short length of tubing around rollers mounted on a rotor. The plasma is collected in a plastic bag. and types of solutions added). patient sex and weight. optical fluid-level detectors. and then reinfuse the remaining components through the same line (requiring one venipuncture). Replacement fluids can include saline. In addition. which is typically a hollow-fiber membrane with a pore size of 0. the operator can harvest specific components. and other settings.. plasma protein fraction.6 μm. Drip chambers are also commonly used with pumps to monitor flow. while others only centrifuge blood. Compartmentalized bowls and tubular rotors are common centrifuge designs. also called pheresis sets. centrifuge it to separate the components.g. In the chamber. and the blood enters the centrifugation chamber. the rollers occlude the tubing and force the fluid through the pheresis set. medical technologist. Rotary peristaltic pumps on apheresis units pump the blood from the patient or donor.Comprehensive of Biomedical Engineering Site (www. Some machines allow the operator to select the percentage of fluids for automatic reinfusion (as a direct percentage of the fluids removed). Apheresis units have a number of audiovisual alarms and displays to alert the operator to potentially life-threatening conditions. These features include pressure sensors and displays of the volume removed and volume reinfused. This monitor shines red and green monochromatic light through a cuvette that surrounds the line. or technician) connects the sterile tubing sets. and dry-heat fluid warmers. Other common features include ultrasonic air-bubble detectors.DEZMED.2 to 0. an anticoagulant (e. Most apheresis units automatically monitor the ratio of the volume of fluid reinfused to the volume of plasma removed. and reinfuse fluids. the operator enters certain information (e. As the rotor is turned at precise speeds by a motor drive.g. ©2007 ECRI Institute. some manufacturers also supply other types of centrifuge equipment for special separation procedures. during centrifuge operation). Some intermittent units reverse the inlet pump for reinfusion. plasma). to the patient or donor. as well as compartments to keep the components separated. Units that perform continuous centrifugation continually withdraw and process small volumes of blood and require two venipunctures to perform uninterrupted removal and return of blood components. centrifugation is used to separate components: the denser layers (red blood cells) are separated from the less-dense layers (white blood cells. volume to be reinfused). pump. pump speed.g. The centrifuge apparatus has inlet and outlet ports. With programmable units. normal serum albumin.. the light then passes through a lens to the detectors. The warmers help prevent hypothermia caused by infusing lowtemperature fluids. As the blood is pumped into the machine. and plasma replacement fluids are automatically infused into the patient to maintain appropriate intravascular volume and pressure. acid citrate dextrose) is automatically added. By adjusting controls (e. Plasmapheresis machines separate plasma from cellular components by pumping blood through a microporous-membrane filter (similar to that used in a hemodialysis unit).. and the machine runs the desired separation protocol by automatically controlling the centrifuge.g.dezmed. contains numerous fibers that allow a large surface area for filtration within a small space. Optical sensors detect plasma-cell interfaces to minimize contamination from other components. pump the components into collection bags. The filter. for centrifuge speed and time. each line has an automated clamp to stop flow at specified times during the procedure (e. especially when anticoagulated plasma is rapidly reinfused. hemorrhage. as well as the quality of blood products. Many tests are used or are being developed to monitor the safety of blood products. the anticoagulant causes decreased ionized calcium in the plasma. Food and Drug Administration (FDA). fever. If its concentration is not carefully monitored. These sets are usually less expensive and allow for more flexibility.Comprehensive of Biomedical Engineering Site (www. however. and collection bags. allowing five-day storage of platelets).dezmed. many of the serious transfusion errors that are reported to ECRI have been related to air embolism.DEZMED. but autocalculation of the anticoagulant. chills. which could lead to cardiac arrhythmia. Among other things. Hemolysis is often caused by a kink in the plastic tubing. In addition. Cost containment Most manufacturers offer closed. needles. needles. All Rights Reserved. anticoagulants. the collected products cannot be stored for as long (usually hours) because of the greater contamination 4 ©2007 ECRI Institute. Replacement fluids can produce allergic reactions. allergic reactions. such as vascular erosion and perforation. Careful monitoring of the extracorporeal blood volume is important in preventing hypovolemia and hypervolemia and their associated hypotension. Complications related to double-lumen venous catheter placement. Apheresis units should allow the anticoagulant ratio and replacement fluid balance to be set manually. hemolysis. disposable pheresis sets in which all the components are preattached (including saline solutions.COM There have been a few isolated reports on the failure of certain parts of apheresis machines. have also been documented. Despite the presence of air-bubble detectors in most apheresis units. Most deaths associated with therapeutic apheresis have been caused by cardiac arrest and respiratory failure in patients with serious illnesses. Purchase considerations ECRI recommendations Included in the accompanying comparison chart are ECRI’s recommendations for minimum performance requirements for apheresis units.S. and extracorporeal volume is preferred. Whenever blood or blood components are transfused. and a battery backup is preferred. Plasma is the component most often associated with transmission of diseases such as hepatitis and AIDS. To ensure the health of donors and recipients.g. which can be prevented by careful observation. hypotension. and sample collection bags) to increase storage capacity (e. Standardizing to the same models can minimize the time and costs involved in training and in inspection and preventive maintenance. User training for apheresis is an important issue. venous access difficulties.com) Apheresis Units Reported problems WWW. clotting. replacement volume. there is a risk of infection. these guidelines outline specific criteria for potential blood donors.. Adverse reactions to apheresis include faintness and/or nausea. Units should have monitors and/or alarms. With regular inspection and maintenance. Open sets usually include unconnected tubing. Citrate toxicity is a common problem during apheresis. many guidelines for apheresis have been published by organizations such as the American Association of Blood Banks (AABB) and the U. and cardiac arrhythmias. Air embolism is a risk associated with most transfusion procedures. such as the pump rotor. these problems can be minimized. the hydroxyethyl starch (HES) and steroids that are used to increase the sedimentation and yield of granulocytes can also cause toxic reactions with repeated use. . years 2 through 5 Total Support Costs = $3. hospitals can use LCC analysis techniques to examine the cost-effectiveness of leasing or renting equipment versus purchasing the equipment outright.000 Total Capital Costs = $35.000/year Support Costs Cost for service contract = $3. years 2 through 5 PV = ($256. One LCC technique—present value (PV) analysis—is especially useful because it accounts for inflation and for the time value of money (i. discount rates and non-price-related benefits offered by the supplier. Depending on hospital size and apheresis demand. For example. LCC analysis is most useful for comparing alternatives with different cash flows and for revealing the total costs of equipment ownership.e.000/year Total Operating Costs = $42.COM risk associated with open sets. years 2 through 5 Cost for quality-control tests = $200/year. Capital Costs Apheresis unit = $35. a purchase decision should be based on issues such as life-cycle cost (LCC). Because it examines the cash-flow impact of initial acquisition costs and operating costs over a period of time. Present Value/Life-Cycle Cost Analysis Assumptions Operating costs are considered for years 1 through 5 Dollar discount factor is 3. and the lifetime of the equipment (in years) in a mathematical equation.200/year.000/year Cost for replacement fluids = $26. Some closed sets have sterile-barrier filters that allow users to provide their own intravenous and anticoagulant solutions. and standardization with existing equipment in the department or hospital (i.500/year.5% Inflation rate for a full-service contract is 3% Inflation rate for disposables is 3% The following analysis is based on 200 apheresis procedures performed in one year. purchasing all apheresis units from one supplier). The cost of disposables and replacement fluids is an important consideration when purchasing an apheresis unit because these components can represent a significant expense over the useful life of the device. the dollar discount factor (the cost of capital)..com) Apheresis Units WWW.e. Conducting a PV/LCC analysis often demonstrates that the cost of ownership includes more than just the initial acquisition cost and that a small increase in initial acquisition cost may produce significant savings in long-term operating costs. An LCC analysis can be used to compare high-cost alternatives and/or to determine the positive or negative economic value of a single alternative.528) ©2007 ECRI Institute. money received today is worth more than money received at a later date). The PV is calculated using the annual cash outflow.Comprehensive of Biomedical Engineering Site (www. All Rights Reserved 5 . Therefore. local service support.. this figure can vary significantly.000 Operating Costs Cost for disposable pheresis sets = $16. The following represents a sample five-year PV/LCC analysis for an apheresis unit.DEZMED.dezmed. 20(1112):1347-52. Plasmapheresis in intensive care. Standards for blood banks and transfusion services. For further information on PV/LCC analysis. All Rights Reserved. Intensive Care World 1990 Jun. drug therapy). pilot study. Additional service contract discounts may be negotiable for multiple-year agreements or for service contracts that are bundled with contracts on other apheresis units in the department or hospital. Stage of development Further research is being performed on therapeutic apheresis units that remove specific subcellular components from plasma (without centrifugation) to treat diseases. Esteve-Comas M. readers should contact ECRI’s SELECT™ group. ECRI recommends that.com) Apheresis Units WWW. lymphocytes have been harvested from patients and incubated with interleukin-2. such as immunoglobulin M (IgM) autoantibodies. As a guideline. These lymphokine-activated killer cells are then reinfused into the patient.Comprehensive of Biomedical Engineering Site (www. immune complexes. full-service contracts typically cost approximately 8% of the apheresis unit’s purchase price.g. Granulocyteapheresis in steroid-dependent inflammatory bowel disease: a prospective. Aliment Pharmacol Ther 2004 Dec. Several of these techniques use special affinity columns containing adsorbents that selectively remove a pathogenic substance by chemical or antigen-antibody reactions as the plasma is pumped through the column.. to maximize bargaining leverage. open. Intensive Care World 1990 Mar. In cancer immunotherapy research. non-Hodgkin’s lymphoma. 23rd ed. Recent studies have begun to examine how apheresis technology may be used as an effective treatment for inflammatory bowel disease. Domenech E. the initial acquisition cost is only a fraction of the total cost of operation over five years. such as melanoma. hospitals negotiate pricing for service contracts before the system is purchased. 2005.7(2):80-4. Therefore. and lipids. the therapy has been useful in treating a number of cancers. Apheresis is currently used to help reduce LDL concentrations in coronary heart disease patients who have had difficulty lowering LDL levels by other means (e. . Hart GK.COM Other costs not included in the above analysis that should be considered for budgetary planning include those associated with the following: Apheresis unit stand Transport case Utilities As illustrated by the above sample PV/LCC analysis. Hart GK. part 1 of 2: history. While there are many serious side effects of this type of immunotherapy. and purchase decision support. This technique has been applied in patients with hypercholesterolemia to remove low-density lipoprotein (LDL). customized analyses. et al. techniques and complications. buyers should consider operating costs over the lifetime of the equipment. Bibliography American Association of Blood Banks (AABB) Standards Committee. Special filters such as cryofilters have also been used to remove macromolecules. a lymphokine manufactured by T cells that is important in the immune response. diet. part 2 of 2: indications for plasmapheresis and plasma exchange in the intensive care unit.7(1):21-5. Hinojosa J.DEZMED. 6 ©2007 ECRI Institute. and colorectal carcinoma. Bethesda (MD): AABB. Plasmapheresis in intensive care.dezmed. rather than making a purchase decision based solely on the acquisition cost of an apheresis unit. Am J Clin Pathol 1988 Sep. et al. Seidel D.90(3):300-2. Plasmapheresis during pregnancy. Wojcicki JM. A high selectivity cascade filtration technique for LDLcholesterol and Lp(a) removal.76(3 Pt 1):451-7.com E-mail: inquiry@bbraun. ed. Flanagan J. Lee EJ. 1983 Jun. All Rights Reserved 7 . Whayne TF Jr. Liss. Heaton CA.S. U.S.com E-mail: info@bbraun. Bowes WA. 19(9):887-95. J Ky Med Assoc 2002 Dec. Koo AP. Malchesky PS. Therapeutic apheresis and plasma perfusion. et al. Yamaji K. Zielke JC. Yamane S. Obstet Gynecol 1990 Sep. Ther Apher 1998 May.com ©2007 ECRI Institute. Eur J Clin Invest 1991 Aug. Current therapeutic apheresis technologies for inflammatory bowel disease. Evaluation of safety and cholesterol-lowering effects during the first 12 months.Comprehensive of Biomedical Engineering Site (www.2(2):105-8. WWW. Schuff-Werner P. Moriniere P. et al. 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. and cost effectiveness of therapeutic apheresis. Armstrong VW.35(6):510-2. Tindall RS. Artif Organs 1995.bbraun. Watson WJ. et al. efficacy. Vascular erosion caused by a double-lumen central venous catheter during therapeutic plasma exchange.21(4):375-83. Office of Technology Assessment.com B Braun Medical Industries Sdn Bhd B Braun International Asia Pacific Operations [183765] Bayan Lepas Free Industrial Zone PO Box 880 10810 Penang Malaysia Phone: 60 (4) 8203100 Fax: 60 (4) 6433750 Internet: http://www. an angiographically assessed trial on the role of LDL-apheresis in the secondary prevention of coronary heart disease. I. Dickson LG. Washington (DC): U. Transfusion 1995 Jun. Fukunaga K. Apheresis technologies and clinical applications: the 2002 international apheresis registry.100(12):535-8.dezmed. 32(7):624-8. 1982. Transfusion 1992 Sep. New York: Alan R. Katz VL. et al.COM Mintz PD. Storage and transfusion of platelets collected by an automated twostage apheresis procedure. et al. Quillen K. Roberson GA. State of the art treatment of the most difficult low density lipoprotein (LDL) cholesterol problems: LDL apheresis. Congress..8(2):124-43. Health technology case study 23: the safety. Congress.com) Apheresis Units Legallais C. The HELP-LDL-apheresis multicentre study. A prospective comparison of platelet collection with the CS-3000™ blood cell separator using the closed system and open system kits. Office of Technology Assessment.DEZMED. Ther Apher Dial 2004 Apr.bbraunusa. Supplier information B Braun B Braun Medical Inc. Magarace L. Simon T. DEZMED.com Gambro KK [287972] Acropolis Tokyo 9th Floor 6-29 Shin-ogawamachi Shinjuku-ku Tokyo 162-0814 Japan Phone: 81 (3) 52273220 Fax: 81 (3) 52273254 Internet: http://www. A Sorin Group Co [157140] via Statale 12 Nord 86 I-41037 Mirandola MO Italy Phone: 39 (0535) 29811 Fax: 39 (0535) 25229 Internet: http://www.com Baxter Baxter Healthcare Corp.dideco.com E-mail:
[email protected] B Braun Melsungen AG.bbraun.com Dideco Dideco SpA.Comprehensive of Biomedical Engineering Site (www.com Gambro BCT Inc [374111] 10810 W Collins Ave Lakewood CO 80215 Phone: (303) 232-6800 (877) 339-4228 Fax: (303) 231-4160 Internet: http://www.com E-mail:
[email protected] E-mail: gambrobct@gambrobct. MedTech Div [138485] Postfach 1120 D-34209 Melsungen Germany Phone: 49 (5661) 712778 Fax: 49 (5661) 713689 Internet: http://www.com E-mail:
[email protected]) Apheresis Units WWW.it E-mail:
[email protected] Haemonetics Haemonetics (Hong Kong) Ltd [194764] Suite 1314 13/Fl Two Pacific Place 88 Queensway Hong Kong People’s Republic of China 8 ©2007 ECRI Institute.gambrobct. .dezmed. Transfusion Therapies [426357] Rt 120 and Wilson Rd Round Lake IL 60073 Phone: (847) 948-2000 (888) 229-0001 Fax: (888) 229-0030 Internet: http://www. All Rights Reserved.it Gambro BCT Gambro BCT Europe NV/SA [374112] Ikaroslaan 41 B-1930 Zaventem Belgium Phone: 32 (2) 7150590 Fax: 32 (2) 7210770 Internet: http://www. kuraray. Need to know more? For further information about the contents of this Product Comparison.jp Note: The data in the charts derive from suppliers’ specifications and have not been verified through independent testing by ECRI or any other agency.com Haemonetics SA [183754] Signy Centre rue des Flecheres boite postale 262 CH-1274 Signy 2 Switzerland Phone: 41 (22) 3639011 Fax: 41 (22) 3639054 Internet: http://www. +1 (610) 834-1275 (fax).co. ECRI is not responsible for the quality or validity of the information presented or for any adverse consequences of acting on such information.com Haemonetics (UK) Ltd [183766] 5 Ashley Drive Bothwell Strathclyde G71 8DA Scotland Phone: 44 (1698) 819700 Fax: 44 (1698) 811811 Internet: http://www.com Haemonetics Corp [102265] 400 Wood Rd Braintree MA 02184-9114 Phone: (781) 848-7100 (800) 225-5242 Fax: (781) 848-5106 Internet: http://www. Because test methods vary. different products’ specifications are not always comparable. When reading the charts.COM Phone: 852 2868 9218 Fax: 852 2801 4380 Internet: http://www. unless otherwise noted. Products and specifications are subject to frequent changes.jp E-mail: tomoko_inoue@kuraray. 5265.DEZMED.com) Apheresis Units WWW. some may be optional.haemonetics.com Kuraray Medical Kuraray Medical Inc [174106] Ote Center Building 1-1-3 Otemachi Chiyoda-ku Tokyo 100-8115 Japan Phone: 81 (3) 67011000 Fax: 81 (3) 67011005 Internet: http://www. And although we try to indicate which features and characteristics are standard and which are not. keep in mind that.com E-mail:
[email protected]. at additional cost.com E-mail:
[email protected] E-mail:
[email protected] (e-mail). ext. All Rights Reserved 9 . Last updated August 2006 ©2007 ECRI Institute. contact the HPCS Hotline at +1 (610) 825-6000.dezmed. the list price does not reflect supplier discounts.co. or
[email protected] of Biomedical Engineering Site (www.haemonetics.com E-mail: sales@haemonetics. in the Healthcare Product Comparison System does not constitute the endorsement or approval of the product’s quality.S. The appearance or listing of any item. nor do they own stock in medical device companies. As pioneers in this science for nearly 40 years. ECRI Institute and its employees accept no royalties. Many of the words or model descriptions appearing in the Healthcare Product Comparison System are proprietary names (e. Agency for Healthcare Research and Quality. gifts.DEZMED. The appearance of any name without designation as proprietary should not be regarded as a representation that is not the subject of proprietary rights. visit http://www.Comprehensive of Biomedical Engineering Site (www. specifications from product literature.. All Rights Reserved. or commissions from the medical device industry. correspondence and discussion with manufacturers and distributors. The Healthcare Product Comparison System accepts no advertising and has no obligations to any commercial interests. dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and therapeutic capital equipment more effectively in support of improved patient care. ECRI Institute marries experience and independence with the objectivity of evidence-based research. 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. For more information. healthcare processes. finder’s fees. 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. a nonprofit organization. About ECRI Institute ECRI Institute. devices. WWW.g.dezmed.ecri. The information and photographs published in Product Comparisons appear at no charge to manufacturers. and drug technology. a nonprofit organization. 10 ©2007 ECRI Institute. and ECRI Institute’s Problem Reporting System. ECRI Institute respects and is impartial to all ethical medical device companies and practices.com) Apheresis Units Policy Statement The Healthcare Product Comparison System (HPCS) is published by ECRI Institute.COM The information in Product Comparisons comes from a number of sources: medical and biomedical engineering literature. they have not been tested by ECRI Institute’s clinical and engineering personnel and are largely unconfirmed. risk and quality management.000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement.org. even though no reference to this fact may be made. trademarks). While these data are reviewed by qualified health professionals. or of claims made for it by the manufacturer. Employees engage in no private consulting work for the medical device industry. performance. or the use of a photograph thereof. procedures. More than 5. . or value. com) WWW.Comprehensive of Biomedical Engineering Site (www.DEZMED.COM Apheresis Units Product Comparison Chart ©2007 ECRI Institute. All Rights Reserved 11 .dezmed. buffer. 60-120 min NA NA NA NA 2 RBC. These specifications continue onto the next page. separation and collection chamber EXTRACORPOREAL VOLUME. 17 G needles.dezmed.DEZMED. System Worldwide Yes Yes Filtration NA Continuous AMICUS 4R4580 Worldwide Yes1 Yes2 Centrifugation 3. plasma collection. tubing.P. 0-90 Inlet/return. mL/min Double 0-200 PUMPS Inlet. preservative and saline solutions.com) Apheresis Units Product Comparison Chart WWW. 1 L saline. ©2007 ECRI Institute. all other necessary kit components Cassettes. (2) donor.280 Continuous. mL ANTICOAGULANT RATIO WARMER. (1) plasma.COM MODEL B BRAUN BAXTER BAXTER WHERE MARKETED FDA CLEARANCE CE MARK (MDD) SEPARATION METHOD CENTRIFUGE. anticoagulant. return ALYX Worldwide Yes Yes Centrifugation 4. intermittent VENOUS ACCESS INLET RATE. systemspecific filters and solutions. recirculation. double 0-150.E. 25-28 min (average) NA None specified 60 min NA NA NA Concurrent with platelets Concurrent with platelets None specified Plasma separator. plasma. All Rights Reserved. two 1. one 800 mL plasma transfer pack. intermittent draw/return Single 50-100.Comprehensive of Biomedical Engineering Site (www. circulation. PRP This is the first of two pages covering the above model(s). 1 sample pouch. . (1) inprocess.L.000 mL platelet storage containers. mononuclear cell NA NA NA NA NA NA NA NA LDL. inlet/centrifuge. anticoagulant. 1 unit RBC with concurrent plasma NA NA Plateletpheresis. rpm FLOW TYPE H. automatic preferred Preferred NA LDL fibrinogen. lipoprotein (a) Single. filtration. 1 L anticoagulant. temperature APPLICATIONS Donor collection Exchange Therapeutic removal TIME Platelets Lymphocytes Granulocytes Monocytes RBC Plasma Other PHERESIS SET Open 12 Closed ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Apheresis Unit Manual required.500 Continuous processing. (1) anticoagulant 195 NA (heparin) 110 1:11 205-209 Yes By dialysis NA NA LDL apheresis 2 units RBCs. auto-adjusting and programmable max 5 total. tubing set None None None 2 RBC and RBC/Plasma kits have pre-connected anticoagulant. August 2006 Not specified Not specified Not specified Meets requirements of TUV. centrifuge temperature. weigh scales and auto cuff Single-needle venousaccess platelet collection. imbalance detectors Not specified Yes.5 x 20. plasma return. temperature (in dialysis module) Air. All Rights Reserved 13 . separation. ultrasonic air-bubble and fluid-level detectors.8) 396 x 160 x 142 (156 x 62. saline is separated and spiked via a functionally-closed lead in European kits. pump pressure. both include on-site service and parts Immediate Included January to December Automated. centrifuge door. cm (in) LINE POWER.P. ©2007 ECRI Institute.8 x 52. service and parts Not specified Not specified Not specified Lease: life of lease.E. pressures. donor data Not specified Not specified Not specified Not specified 99. ECRI Institute assumes no liability for decisions made based on this data.DEZMED.3 (38.1 x 81.Comprehensive of Biomedical Engineering Site (www. August 2006 1These recommendations are the opinions of ECRI Institute's technology experts. mononuclear cell Inlet. venous lines. air/fluid detector.dezmed. VAC Power. ARO Training Fiscal year OTHER SPECIFICATIONS LAST UPDATED Supplier Footnotes B BRAUN BAXTER BAXTER H. kg (lb) H x W x D.5 x 32) 100/115/200-240 Not specified Yes Not specified Not specified Not specified 1 year. automatic preferred Required Preferred Preferred Preferred Preferred Delivery time. optical sensor. W BATTERY BACKUP PURCHASE INFORMATION List price Open set Closed set Warranty ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Apheresis Unit Manual required. pre/postpump filtration.5 x 56) 100/110/120/220/240 Not specified Not specified Yes Yes IVD instead of ECV 24 (53) 33 x 46 x 53 (13 x 18 x 21) Not specified Not specified Not specified 156 (345) 97. System NA ALYX Yes AMICUS 4R4580 Yes None 2 RBC.7 (219. Model Footnotes Data Footnotes 1BK960005.COM MODEL REPLACEMENT FLUID BALANCE PROGRAMS MONITORS/ALARMS DATA MANAGEMENT Patient data Autocalculation Anticoagulant Replacement volume Extracorporeal volume WEIGHT. double-needle venousaccess platelet collection. integrated leukoreduction. leak. August 2006 90-264 250 Yes Not specified Not specified Not specified By region Not specified Included Not specified Meets requirements of IEC 60601-1-1 and EMI standards. purchase: 1 year. conductivity. circulation. flow. RBC/plasma Pre-/postpump inlet. interface detector. jumbo concurrent plasma. flows.L. 2CE0123. humidity.com) Apheresis Units Product Comparison Chart WWW. fluid. overspill. heparin.and return-line pressure monitor. COM MODEL BAXTER Autopheresis-C A-200 : A201 : A-401 Worldwide Not specified Not specified Rotating member filtration 3. time x TBV (volume processed) 7L Configurable. plateletpheresis. needle. mL ANTICOAGULANT RATIO WARMER. 14 ©2007 ECRI Institute. collect/replace plasma ~200 240 170 Yes NA Yes 36°C control 1:8-1:16 Optional Variable. RBCs Leukapheresis. double 0-85 Inlet. plasma. separation and collection containers Soft belt. 60 min. auto PBSC. plasma collection Worldwide. time x TBV (volume processed) RBCX end point based on FCR or volume processed. WBC collection. tubing. anticoagulant Worldwide Yes Yes Centrifugation 400-2. single-needle 7-day platelet storage. RBCs Therapeutic removal NA Lymphocytes. tubing. 100 min (default) Configurable. plateletpheresis. therapeutic. bacteriologic filter WHERE MARKETED FDA CLEARANCE CE MARK (MDD) SEPARATION METHOD CENTRIFUGE. double 0-100 Inlet. concurrent plasma. stem cell collection. granulocytes Lymphocytes. return. red cell exchange. two 1 L PL732/PL304 packs. 90 min Anticoagulant. anticoagulant. functionally closed WBC This is the first of two pages covering the above model(s). tubing.900 Continuous Single. bags. bone marrow processing Therapeutic plasma exchange.DEZMED.dezmed. 1 sample pouch. anticoagulant. 120-180 min. RBC exchange Cytoreduction Configurable. . WBC collection. depending on tubing set used Varies Optional Plasmapheresis Leukapheresis. anticoagulant. plasma volume exchanged None specified Single-/dual-needle plasma exchange. tubing. mononuclear cell Exchange NA Plasma. collection BAXTER CS-3000 Plus DIDECO EXCEL PRO GAMBRO BCT COBE Spectra Worldwide Not specified Not specified Centrifugation 550-1. RBC. tubing.400 ±5% Continuous Single. bags Anticoagulant. not configuration TPE. and singleand dual-needle LeukoReduction System platelets. 1 L anticoagulant. tubing. These specifications continue onto the next page. rpm FLOW TYPE VENOUS ACCESS INLET RATE.600 Continuous. intermittent Single. mL/min PUMPS EXTRACORPOREAL VOLUME. needle. temperature APPLICATIONS Donor collection TIME Platelets PHERESIS SET Open Closed Plateletpheresis. collection and storage containers Monitor box. collection and storage containers Monitor box. except USA Not specified Yes Centrifugation 800-1. 1 L saline. platelets NA 75 min 60 min Lymphocytes NA 100-180 min NA Granulocytes Monocytes NA NA 100-175 min 120-180 min NA NA RBC NA NA NA Plasma 35 min (600 mL) NA NA Other None specified None specified Stem cells. bone marrow process Sets for 7-day platelet storage.600 Intermittent Single 0-150 Inlet. separation/collection containers Soft belt. collection.com) Apheresis Units Product Comparison Chart WWW. All Rights Reserved. 1 600/800 mL PL146 transfer pack.Comprehensive of Biomedical Engineering Site (www. bone marrow stem cell and peripheral stem cell collection Plasma. two 17 G needles. double Up to 150 Inlet. PEX. granulocytes. plasma exchange. inlet and return-air detector. fluid-leak detector Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified 47. fluid-level and fluid-interface detectors Mononuclear cell collections and removal.380 200 (441) [98. W LAST UPDATED Supplier Footnotes Model Footnotes Data Footnotes ©2007 ECRI Institute. level detectors. 186] x 64 x 93 ([39. granulocyte collection. cascade filtration. and lymphocyte collection. Not specified On-site January to December All procedures can be carried out in single. 230 (180-260) 350 315 (694. air/fluid detector. depends on input voltage Smart Socket $20.8 cm (33").000 Not specified Not specified 1 year $65. VAC Power. optical interface detector Inlet-.7 x 43. lymphoplasma exchange Centrifuge and access/return-pressure sensors. and blockedline pressure monitor. plasma exchange. fluidlevel and interface detectors. single-/dualneedle platelet collection. TUV. service. or 8 special procedures Platelet. return-. default 100% Plasmapheresis collection 8 standard procedures: platelet. platelet and red blood cell collection. collect concentration.com) Apheresis Units Product Comparison Chart WWW. service and parts $45. blood-loss detector. granulocyte. imbalance detectors Inlet pressure.3 x 27.dezmed. cm (in) LINE POWER. RBC exchange. August 2006 Not specified $118 $155-165 6 months.and return-line pressure monitor. Meets requirements of BSI. and UL. certified by GLEM and TUV. special plasma exchange.8 x 17 x 10.8 x 142 (24 x 38.Comprehensive of Biomedical Engineering Site (www. single-needle therapeutic plasma exchange. and travel Not specified Not specified Not specified Meets requirements of CSA.COM MODEL BAXTER Autopheresis-C A-200 : A201 : A-401 NA BAXTER CS-3000 Plus DIDECO EXCEL PRO GAMBRO BCT COBE Spectra Yes Automatic 75-150%. humidity. warning.7 (105) 169. AC fluid-level detector. platelet and plasma. bone marrow processing.2 (66. CSA. imbalance detector.5 x 56) 100/115/200/210/220/230/240 1.6 x 28) 100/115/220/240 800-960. centrifuge temperature.3) 115 (90-130).2 x 26. bubble detectors. 3 pumps with 4 clamps. and UL. therapeutic plasma exchange. Meets requirements of IEC 601-1. kg (lb) H x W x D. operator attention.000 $80-90 Not specified 1 year. shutdown alarms. EMC. single venousaccess platelet collection. Not specified Included January to December Smart Socket uses lithium energy cell to retain RAM data for ≥10 years. August 2006 April 2001 December 2007 REPLACEMENT FLUID BALANCE PROGRAMS MONITORS/ALARMS DATA MANAGEMENT Patient data Autocalculation Anticoagulant Replacement volume Extracorporeal volume WEIGHT. leukocyte. lympho/plasma exchange. parts. auto PBSC.DEZMED.000 Not specified Not specified 1 year.000-50. ARO Training Fiscal year OTHER SPECIFICATIONS Not specified Not specified Not specified Model A-200 is column mounted with front-locking casters. granulocyte. service and parts Delivery time.or double-needle mode. peripheral blood stem cell/bone marrow stem cell collection. model A-401 folds to 83. 73] x 25 x 37) 100/110/230 ±10% 500 VA BATTERY BACKUP PURCHASE INFORMATION List price Open set Closed set Warranty 12 V No Nonrechargable 177 (389) 148 x 70 x 71 (58.000-30. RBC detector. JIS. All Rights Reserved 15 . Meets requirements of CE. reinfusion pressure. CSA. baseline cell collection.6) 61 x 97. platelet procedure Inlet. monitor. based on donor TBV. platelets with leukocyte reduction. mL ANTICOAGULANT RATIO WARMER. HCT.com) Apheresis Units WWW. plasma volume exchanged Other PHERESIS SET Open Closed None This is the first of two pages covering the above model(s). collect/replace. plasma. depending on tubing set used Varies Optional Variable.000 Intermittent Single 20-100 3 Yes Centrifugation 5. machine configuration ≤150 min.000-7.COM Product Comparison Chart MODEL GAMBRO BCT Spectra Optia WHERE MARKETED FDA CLEARANCE Worldwide Yes (for therapeutic plasma exchange only) Yes Centrifugation 3.7 NA 15-500 <390 1:8-1:16 NA 1:12. All Rights Reserved. temperature APPLICATIONS Donor collection Exchange Therapeutic removal TIME Platelets GAMBRO BCT Trima Accel Automated Blood Collection Worldwide Yes HAEMONETICS CCS HAEMONETICS Cymbal Japan No Europe No Yes Centrifugation 3. with or without concurrent plasma. machine configuration None specified None specified None specified Dual-needle TPE None None In development Sets for 7-day platelet storage and 42-day RBC storage: platelet. mL/min PUMPS EXTRACORPOREAL VOLUME. other applications in development In development NA Lymphocytes Granulocytes Monocytes RBC In development In development In development In development Plasma TPE. platelet count. based on donor TBV. depending on tubing set used 6:13.DEZMED. 16 ©2007 ECRI Institute.000 Continuous Double 0-142 Inlet. including double RBC collections NA Plateletpheresis.Comprehensive of Biomedical Engineering Site (www. anticoagulant. return No Centrifugation 3. machine configuration NA NA NA ≤150 min. remove/plasma. plasma. anticoagulant. rpm FLOW TYPE VENOUS ACCESS INLET RATE. plasma and RBC products in any combination.dezmed. 2 units RBCs NA NA NA Granulocytes and peripheral blood stem cells removed NA Target-dependent NA NA NA NA NA NA NA NA NA NA 2 RBC. plasma Therapeutic plasma exchanged.500 Intermittent Single 50-80 2 Variable. These specifications continue onto the next page. RBC set with or without TLR filter. . based on donor TBV. platelet. return CE MARK (MDD) SEPARATION METHOD CENTRIFUGE. 30-40 min None specified ≤150 min. 1:16 NA In development Platelets. HCT. leukoreduction Red cell apheresis. RBC set with or without TLR filter Therapeutic removals and stem cells Platelets. plasma.000 Continuous Single 0-142 Inlet. W BATTERY BACKUP PURCHASE INFORMATION List price Open set Closed set Warranty Delivery time.7 x 32) 100-240 960-1. automated interface management. anticoagulant fluid detector. DTS (data transfer system). 2 pressure monitor. service and parts Not specified Included January to December Meets requirements of BSI. double RBC. column pressure sensor. reservoir air/fluid level sensors. depends on input voltage Not specified Not specified Not specified Not specified 84 (185) 106 x 52. RBC. All Rights Reserved 17 . tubing set type detector DATA MANAGEMENT Patient data Autocalculation Anticoagulant Replacement volume Extracorporeal volume WEIGHT. component therapies (peripheral blood stem cells. advanced user interface.5 x 28 x 51. ARO Training Fiscal year OTHER SPECIFICATIONS LAST UPDATED Supplier Footnotes Model Footnotes Data Footnotes GAMBRO BCT Trima Accel Automated Blood Collection 80-120%. 2 spill sensors.5 x 56. plasma (volumes up to 1L). replacement fluid detector.5 (27 x 22. selfregulating flow.3 (56) 68. VAC Power. service. service and parts Not specified Included January to December Meets requirements of CSA Class I. configurable on or off. anticoagulent detector. 2 separation sensors.7 x 81. allogenic. smartcard technology. platelets with plasma.3) 100/220 22 Not specified Not specified Not specified 13 (29) 30. optional battery operation. Not specified Not specified Not specified 1 year.dezmed. warning. and UL. granulocytes) 2 RBC using SAG-M (42day storage). $78. plasma.365 NA NA 1 year. cm (in) LINE POWER.000 Not specified Not specified 1 year. plasma with RBC.6 (12 x 11 x 20) 110/220 22 Not specified No Yes $70. JIS. 75-125% (caution mode) PROGRAMS TPE. automated and pulsing cuff 3 air detectors. type BF equipment.COM Product Comparison Chart MODEL GAMBRO BCT Spectra Optia REPLACEMENT FLUID BALANCE 84-114% (normal mode). only available with plasma/RBC set Collection of platelets. RBC detector.DEZMED. alert and alarms HAEMONETICS CCS HAEMONETICS Cymbal NA Optional Platelets. independent control and safety systems with advisory. service. self-regulating flow. 2 pressure monitors. August 2006 ©2007 ECRI Institute.3 (41. single needle variable absolute RBC collection.com) Apheresis Units WWW. operator attention. TUV. parts.3 x 22.3 (41. travel Immediate Available April to March Stand and transport case. travel Immediate Available April to March Stand and transport case.000.9 x 20. RBC spillover detector. collection of high concentration platelets with automatic addition of storage solution Centrifuge and access/return-pressure reservoir air/level sensors.5 x 56. automated and pulsing cuff Not specified Not specified Not specified Not specified Not specified Not specified Not specified 92 (202) 106 x 52. parts. automated tubing set safety checks.9 x 20. advanced user interface.7 x 81. default 100%. therapeutic or autologous processing 4 air detectors. fluid-leak detector. kg (lb) H x W x D. CSA. platelets with RBC.7 x 32) 100-240 700 Not specified Not specified Not specified 26.Comprehensive of Biomedical Engineering Site (www. 2 separation sensors. shutdown alarms. other applications in development MONITORS/ALARMS Centrifuge and inlet/returnpressure sensors. platelets with plasma and RBC. December 2007 December 2007 August 2006 Not specified Not specified Not specified 1 year. fluid-leak detector. thrombocytes. 2 RBC. 2 RBC-F Platelets. volume replacement Plasmapheresis Plasma exchange. These specifications continue onto the next page. except Japan Yes Yes Centrifugation 3. plasma (double) filtration. leukocytes. or 1 unit RBCs and 400-550 mL concurrent plasma NA NA Plasma Therapeutic removal NA Plasma. includes preparation time None specified None Therapeutic removals. tubing set. direct hemoperfusion Exchange RBC apheresis.Comprehensive of Biomedical Engineering Site (www. plasma perfusion. drain.COM MODEL WHERE MARKETED FDA CLEARANCE CE MARK (MDD) SEPARATION METHOD CENTRIFUGE.500 Intermittent Single 20-100 2 KURARAY MEDICAL KPS-8800Ce Asia No No Membrane filtration NA Continuous Double 10-220 Blood. plasma fractionator. All Rights Reserved.5 hr. granulocytes NA Plasma components NA NA NA NA 2 RBC.000 default Intermittent Single 20-100 3 HAEMONETICS MCS+ LN 9000 Worldwide. Europe.DEZMED. anticoagulant EXTRACORPOREAL VOLUME. . ~2. mL/min PUMPS HAEMONETICS MCS+ LN 8150 USA Yes No Centrifugation 7. rpm FLOW TYPE VENOUS ACCESS INLET RATE. 2 units RBCs leukocyte-reduced. 2 units RBCs. mononuclear cells Plasma RBCP. RBCP.000-7.000-7. 36-45°C Plateletpheresis. column compatible Mononuclear cells. plasma exchange.com) Apheresis Units Product Comparison Chart WWW. hemoperfusion cartridge None This is the first of two pages covering the above model(s).000 Intermittent Single 20-100 3 HAEMONETICS PCS2 Asia. plasma perfusion cartridge. 35 min. platelets with leukocyte reduction Plasma (Europe) ANTICOAGULANT RATIO WARMER. mL <690 15-500 15-500 1:12-1:16 NA 1:8-1:16 NA 1:16 NA Plasma exchange 232 mL. plasma. optional concurrent plasma. leukoreduction. temperature APPLICATIONS Donor collection TIME Platelets Lymphocytes Granulocytes Monocytes RBC Plasma Other PHERESIS SET Open 18 Closed Plasma separator. USA Yes Yes Centrifugation 2.dezmed. ©2007 ECRI Institute. single/double access. 25 min NA Target-dependent NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA 45 min None specified None specified None specified 3 L plasma filtration. plasma (double) filtration 366 mL Yes Yes. parts.3 (56) 68. temperature.5 x 56. plasma perfusion).000 $200 NA 1 year.5) 110/220 350 VA No Not specified Not specified Not specified 1 year.dezmed. second filter.5 x 56. automated and pulsing cuff Monitors: treatment information. plasma with saline replacement. 2 pressure monitors. singleneedle variable absolute RBC collection. pressures (arterial. smartcard technology.Comprehensive of Biomedical Engineering Site (www. advanced user interface. alarms for arterial. instant and accumulated flow rates (blood inlet. linkage function with centrifuge cell separator (plasma filtration.DEZMED. selfregulating flow. Not specified Not specified Not specified 1 year.COM REPLACEMENT FLUID BALANCE PROGRAMS MONITORS/ALARMS DATA MANAGEMENT Patient data Autocalculation Anticoagulant Replacement volume Extracorporeal volume WEIGHT. connection of tubing. August 2006 August 2006 August 2006 ~$50.3 x 22.5 x 21. All Rights Reserved 19 . elapsed treatment time.5 x 21. advanced user interface. plasma exchange (single/double access. optional saline replacement. advanced user interface.5) 110/220 550 No Not specified Not specified Not specified 26. spill sensor. travel Immediate Available April to March Stand and transport case. service. parts. second filter. granulocytes) 4 air detectors. plasma.3) 110/220 550 No Not specified Not specified Not specified 70 (154) 125 x 56 x 57 (49 x 22 x 22.5 x 56. double-unit. August 2006 ©2007 ECRI Institute. 2 pressure monitors. parts. optional concurrent plasma.3) 100/220 550 No Not specified Not specified Not specified 26. 2 spill sensors. service.5 x 55 x 55 (26. travel Immediate Available April to March Stand and transport case.3 (56) 67. plasma perfusion). automated and pulsing cuff Platelets (single donor. service. W BATTERY BACKUP PURCHASE INFORMATION List price Open set Closed set Warranty Delivery time.5 x 56. allogeneic or autologous processing Plasma. service and parts 3 months At extra charge April to March Displays in English and Japanese. VAC Power. selfregulating flow. others Not specified Not specified Not specified Not specified Not specified Not specified Not specified 26. drain). venous.3 x 22.5 (27 x 22. selfregulating flow. 2 separation sensors. travel Immediate Available April to March Stand and transport case. component therapies (mononuclear cells.com) Apheresis Units Product Comparison Chart MODEL WWW. RBCP using AS-3 (42-day storage). and transmembrane pressure. column compatible). plasma perfusion) 4 air detectors. ARO Training Fiscal year OTHER SPECIFICATIONS LAST UPDATED Supplier Footnotes Model Footnotes Data Footnotes HAEMONETICS MCS+ LN 8150 Yes HAEMONETICS MCS+ LN 9000 Optional HAEMONETICS PCS2 Optional KURARAY MEDICAL KPS-8800Ce Equal to drain 2 RBC using AS-3 (42-day storage). plasma with concurrent-source leukocytes Autopriming function (plasma exchange.3 (56) 68. 2 pressure monitors. spill sensor. cm (in) LINE POWER. kg (lb) H x W x D. air bubble. automated and pulsing cuff 4 air detectors. 2 separation sensors. 2 separation sensors. heparin. TMP).5 (27 x 22. combination system with centrifuge cell separator (plasma filtration. optional volume replacement). venous. Not specified Not specified Not specified 1 year. plasma filtration.