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Transcript of Apheresis Units
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]
UMDNS Information
This Product Comparison covers the following device term and product code as listed in ECRI Institute’s Universal Medical Device Nomenclature System™ (UMDNS™):
Apheresis Units, Blood Donor [23-134]
Apheresis Units, Blood Donor, Platelet [23-135] Apheresis Units, Blood Donor, Plasma [23-136]
Apheresis Units, Therapeutic [23-137]
Apheresis Units, Therapeutic, Low-Density Cholesterol [23-139]
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.
Separation procedures performed on blood from healthy donors include plasmapheresis, plateletpheresis (also
called thrombocytapheresis), and leukapheresis. Plasmapheresis is the separation of the plasma from the cellular
components, which are returned to the donor. It is used to collect plasma of a certain blood type to increase
inventory; to collect rare white and red blood cell antibodies; and to manufacture plasma derivatives, hepatitis
immune globulin, and Rh immune globulin. 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.
In thrombocytapheresis, platelets are removed from a
donor and red cells, white cells, and plasma are reinfused.
Apheresis donor platelet products are used to treat bleeding
caused by thrombocytopenia, such as in patients with bone
marrow failure or suppression caused by chemotherapy.
Human leukocyte antigen (HLA)-typed platelets can also be
obtained for patients, such as those with leukemia, who
Apheresis Units
2 ©2008 ECRI Institute. All Rights Reserved.
receive multiple transfusions and thus may have become alloimmunized to the
HLAs on platelets.
Leukapheresis is the removal of the white blood cells and the reinfusion of
red cells, plasma, and platelets into the donor. The neutrophils (granulocytes),
a type of white blood cell, can be harvested to treat sepsis.
Many acute and chronic conditions have been reported to be successfully
treated by therapeutic apheresis; however, 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. Therapeutic apheresis has
been useful as a part of treating certain immune-mediated disorders. For
example, most patients with myasthenia gravis develop antibodies against
acetylcholine receptors (AChRs). Removal of these antibodies through
plasmapheresis can provide dramatic, temporary clinical improvement.
Guillain-Barré syndrome, which causes paralysis by an immunologically
mediated demyelination of peripheral nerves, is also treated with
plasmapheresis. Other syndromes reported to be successfully treated by
plasmapheresis include Goodpasture’s syndrome, which causes an antibody-
associated glomerulonephritis, and thrombotic thrombocytopenic purpura
(TTP), a coagulation disorder that is thought to be immunologically mediated.
TTP causes thrombotic occlusion of small arteries and capillaries in organs,
increased bleeding (because of a decrease in the number of platelets),
hemolytic anemia, renal failure, and neurologic symptoms.
Therapeutic lymphocytapheresis is the removal of the lymphocytes (also called mononuclear cells) to produce
immunosuppression in conditions with an immune mechanism, such as rheumatoid arthritis, systemic lupus
erythematosus, and kidney transplant rejection.
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.
Apheresis is performed in various inpatient and outpatient settings, including hospitals, dialysis centers, blood
banks, and physician offices. For most procedures, apheresis takes no more than two hours.
Principles of operation
Apheresis is performed either continuously or intermittently. 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 a longer
period of time than continuous apheresis.
Apheresis machines are wheeled to the bedside or donor chair, where the operator (usually a nurse or
technician) connects the sterile tubing sets, also called pheresis sets, to the patient or donor. As the patient’s blood
is pumped into the machine, an anticoagulant (e.g., acid citrate dextrose) is automatically added, and the blood
enters the chamber. Blood components are then separated using centrifugation and/or filtration. The method of
separation depends on the product that is to be removed or collected from the blood. Filtration separates cellular
components from plasma based on size. Centrifugation separates cellular components by density: the denser
layers (red blood cells) are separated from the less-dense layers (white blood cells, plasma), and the desired layers
are siphoned into collection bags. Optical sensors detect plasma-cell interfaces to minimize contamination from
other components. The centrifuge apparatus has inlet and outlet ports, as well as compartments to keep the
components separated. Compartmentalized bowls and tubular rotors are common centrifuge designs; some
Apheresis Units
©2008 ECRI Institute. All Rights Reserved 3
manufacturers also supply other types of centrifuge equipment for special separation procedures.
Plasmapheresis machines separate plasma from cellular components by pumping blood through a
microporous-membrane filter (similar to that used in a hemodialysis unit). The filter, which is typically a hollow-
fiber membrane with a pore size of 0.2 to 0.6 μm, contains numerous fibers that allow a large surface area for
filtration within a small space. Some plasmapheresis units combine filtration and centrifugation, while others
only centrifuge blood. The plasma is collected in a plastic bag, and plasma replacement fluids are automatically
infused into the patient to maintain appropriate intravascular volume and pressure. Replacement fluids can
include saline, normal serum albumin, plasma protein fraction, and fresh frozen plasma. Most apheresis units
automatically monitor the ratio of the volume of fluid reinfused to the volume of plasma removed. Some
machines allow the operator to select the percentage of fluids for automatic reinfusion (as a direct percentage of
the fluids removed).
Rotary peristaltic pumps on apheresis units pump the blood from the patient or donor, pump the components
into collection bags, add anticoagulant, and reinfuse fluids. Some intermittent units reverse the inlet pump for
reinfusion. This type of pump holds a short length of tubing around rollers mounted on a rotor. As the rotor is
turned at precise speeds by a motor drive, the rollers occlude the tubing and force the fluid through the pheresis
set. Drip chambers are also commonly used with pumps to monitor flow. In addition, each line has an automated
clamp to stop flow at specified times during the procedure (e.g., during centrifuge operation).
By adjusting controls (e.g., for centrifuge speed and time, pump speed, and types of solutions added), the
operator can harvest specific components. With programmable units, the operator enters certain information (e.g.,
patient sex and weight, volume to be reinfused), and the machine runs the desired separation protocol by
automatically controlling the centrifuge, pump, and other settings.
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. Other common features include ultrasonic air-bubble detectors, optical fluid-level detectors, and dry-
heat fluid warmers. The warmers help prevent hypothermia caused by infusing low-temperature fluids. 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. This monitor shines red and green monochromatic
light through a cuvette that surrounds the line; the light then passes through a lens to the detectors.
Reported problems
There have been a few isolated reports on the failure of certain parts of apheresis machines, such as the pump
rotor. With regular inspection and maintenance, these problems can be minimized.
Citrate toxicity is a common problem during apheresis, especially when anticoagulated plasma is rapidly
reinfused. If its concentration is not carefully monitored, the anticoagulant causes decreased ionized calcium in
the plasma, which could lead to cardiac arrhythmia.
Air embolism is a risk associated with most transfusion procedures. Despite the presence of air-bubble
detectors in most apheresis units, many of the serious transfusion errors that are reported to ECRI Institute have
been related to air embolism. Complications related to double-lumen venous catheter placement, such as vascular
erosion and perforation, have also been documented. Other problems, such as hemolysis, have been associated
with kinked tubing or poorly connected sets.
Whenever blood or blood components are transfused, there is a risk of infection. Plasma is the component
most often associated with transmission of diseases such as hepatitis and AIDS. Many tests are used or are being
developed to monitor the safety of blood products. To ensure the health of donors and recipients, as well as the
quality of blood products, many guidelines for apheresis have been published by organizations such as the
American Association of Blood Banks (AABB) and the U.S. Food and Drug Administration (FDA).
Apheresis Units
4 ©2008 ECRI Institute. All Rights Reserved.
Purchase considerations
ECRI Institute recommendations
Included in the accompanying comparison chart are ECRI Institute’s recommendations for minimum
performance requirements for apheresis units. Apheresis units should allow the anticoagulant ratio and
replacement fluid balance to be set manually, but autocalculation of the anticoagulant, replacement volume, and
extracorporeal volume is preferred. Units should have monitors and/or alarms, and a battery backup is preferred.
Facilities should ensure that the apheresis unit supplier will provide implementation support and that
technicians are properly trained. Standardizing to the same models can minimize the time and costs involved in
training and in inspection and preventive maintenance.
Cost containment
Most manufacturers offer closed, disposable pheresis sets in which all the components are preattached
(including saline solutions, anticoagulants, needles, and sample collection bags) to increase the useable life of the
blood products (e.g., allowing five-day storage of platelets). Open sets usually include unconnected tubing,
needles, and collection bags. These sets are usually less expensive and allow for more flexibility; however, the
collected products have a shorter useable life (usually hours) because of the greater contamination risk associated
with open sets. Some closed sets have sterile-barrier filters that allow users to provide their own intravenous and
anticoagulant solutions.
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. Therefore, a
purchase decision should be based on issues such as life-cycle cost (LCC), local service support, discount rates
and non-price-related benefits offered by the supplier, and standardization with existing equipment in the
department or hospital (i.e., purchasing all apheresis units from one supplier).
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. For example, hospitals can use LCC analysis techniques to examine the
cost-effectiveness of leasing or renting equipment versus purchasing the equipment outright. Because it examines
the cash-flow impact of initial acquisition costs and operating costs over a period of time, LCC analysis is most
useful for comparing alternatives with different cash flows and for revealing the total costs of equipment
ownership. One LCC technique—present value (PV) analysis—is especially useful because it accounts for
inflation and for the time value of money (i.e., money received today is worth more than money received at a
later date). 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. The PV is calculated using the annual cash outflow, the dollar discount factor (the cost
of capital), and the lifetime of the equipment (in years) in a mathematical equation.
The following represents a sample five-year PV/LCC analysis for an apheresis unit.
Present Value/Life-Cycle Cost Analysis
Assumptions
Operating costs are considered for years 1 through 7
Dollar discount factor is 3.5%
Inflation rate for disposables is 3%
The following analysis is based on 200 apheresis procedures performed in one year. Depending on hospital
size and apheresis demand, this figure can vary significantly.
Apheresis Units
©2008 ECRI Institute. All Rights Reserved 5
Capital Costs
Apheresis unit = $60,000
Total Capital Costs = $60,000
Operating Costs
Cost for disposable pheresis sets = $16,000/year
Cost for replacement fluids = $26,000/year
Total Operating Costs = $42,000/year
Support Costs
Cost for service contract = $3,500/year, years 2 through 7
Cost for quality-control tests = $200/year, years 2 through 7
Total Support Costs = $3,700/year, years 2 through 7
PV = ($367,422)
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, the initial acquisition cost is only a fraction of the total
cost of operation over five years. Therefore, rather than making a purchase decision based solely on the
acquisition cost of an apheresis unit, buyers should consider operating costs over the lifetime of the equipment.
For further information on PV/LCC analysis, customized analyses, and purchase decision support, readers
should contact ECRI Institute’s SELECTplus™ group.
ECRI Institute recommends that, to maximize bargaining leverage, hospitals negotiate pricing for service
contracts before the system is purchased. As a guideline, full-service contracts typically cost approximately 8% of
the apheresis unit’s purchase price. 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. 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. This technique has been applied in patients with
hypercholesterolemia to remove low-density lipoprotein (LDL). 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.g., diet, drug therapy). Special filters such as cryofilters have also been used to remove macromolecules, such as
immunoglobulin M (IgM) autoantibodies, immune complexes, and lipids. Recent studies have begun to examine
how apheresis technology may be used as an effective treatment for inflammatory bowel disease.
In cancer immunotherapy research, lymphocytes have been harvested from patients and incubated with
interleukin-2, a lymphokine manufactured by T cells that is important in the immune response. These
lymphokine-activated killer cells are then reinfused into the patient. While there are many serious side effects of
this type of immunotherapy, the therapy has been useful in treating a number of cancers, such as melanoma, non-
Hodgkin’s lymphoma, and colorectal carcinoma.
Apheresis Units
6 ©2008 ECRI Institute. All Rights Reserved.
Bibliography
American Association of Blood Banks (AABB) Standards Committee. Standards for blood banks and transfusion
services. 23rd ed. Bethesda (MD): AABB; 2005.
Hart GK. Plasmapheresis in intensive care, part 1 of 2: history, techniques and complications. Intensive Care World
1990 Mar;7(1):21-5.
Hart GK. Plasmapheresis in intensive care, part 2 of 2: indications for plasmapheresis and plasma exchange in the
intensive care unit. Intensive Care World 1990 Jun;7(2):80-4.
Legallais C, Moriniere P, Wojcicki JM, et al. A high selectivity cascade filtration technique for LDL- cholesterol
and Lp(a) removal. Artif Organs 1995; 19(9):887-95.
Malchesky PS, Koo AP, Roberson GA, et al. Apheresis technologies and clinical applications: the 2002
international apheresis registry. Ther Apher Dial 2004 Apr;8(2):124-43.
Quillen K, Magarace L, Flanagan J, et al. Vascular erosion caused by a double-lumen central venous catheter
during therapeutic plasma exchange. Transfusion 1995 Jun;35(6):510-2.
Simon T, Lee EJ, Heaton CA, et al. Storage and transfusion of platelets collected by an automated two-stage
apheresis procedure. Transfusion 1992 Sep; 32(7):624-8.
Tindall RS, ed. Therapeutic apheresis and plasma perfusion. New York: Alan R. Liss; 1982.
U.S. Congress, Office of Technology Assessment. Health technology case study 23: the safety, efficacy, and cost
effectiveness of therapeutic apheresis. Washington (DC): U.S. Congress, Office of Technology Assessment;
1983 Jun.
Whayne TF Jr., Zielke JC, Dickson LG, et al. State of the art treatment of the most difficult low density lipoprotein
(LDL) cholesterol problems: LDL apheresis. J Ky Med Assoc 2002 Dec;100(12):535-8.
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 Medical Industries Sdn Bhd B Braun International Asia Pacific Operations [183765]
Bayan Lepas Free Industrial Zone PO Box 880
Penang 10810
Malaysia
Phone: 60 (4) 8203100 Fax: 60 (4) 6433750
Internet: http://www.bbraunap.com
E-mail: [email protected]
B Braun Melsungen AG [178137]
Lindberghstrasse 12
Puchheim/Muenchen D-34212
Germany
Apheresis Units
©2008 ECRI Institute. All Rights Reserved 7
Phone: 49 (89) 8394090 Fax: 49 (89) 83940943
Internet: http://www.bbraun.com
E-mail: [email protected]
CARIDIAN BCT
CaridianBCT Inc [453484]
10811 W Collins Ave
Lakewood, CO 80215
Phone: (303) 232-4357, (877) 339-4228
Internet: http://www.caridianbct.com
E-mail: [email protected]
FENWAL
Fenwal Inc [452143]
25212 W Illinois Rt 120
Round Lake, IL 60073
Phone: (800) 333-6925, (800) 766-1077
Internet: http://www.fenwalinc.com
E-mail: [email protected]
HAEMONETICS
Haemonetics Corp [102265]
400 Wood Rd
Braintree, MA 02184-9114
Phone: (781) 848-7100, (800) 537-2802 Fax: (781) 848-5106
Internet: http://www.haemonetics.com
E-mail: [email protected]
Haemonetics (Hong Kong) Ltd [194764]
Suite 1314 13/Fl Two Pacific Place 88 Queensway
Hong Kong
People's Republic of China
Phone: 852 28689218 Fax: 852 28014380
Internet: http://www.haemonetics.com
E-mail: [email protected]
Haemonetics SA [183754]
Signy Centre rue des Flecheres boite postale 262
Signy 2 CH-1274
Switzerland
Phone: 41 (22) 3639011 Fax: 41 (22) 3639054
Internet: http://www.haemonetics.com
E-mail: [email protected]
Haemonetics (UK) Ltd [183766]
5 Ashley Drive
Bothwell G71 8DA
Scotland
Phone: 44 (1698) 819700 Fax: 44 (1698) 811811
Internet: http://www.haemonetics.com
E-mail: [email protected]
KURARAY MEDICAL
Kuraray Medical Inc [174106]
Apheresis Units
8 ©2008 ECRI Institute. All Rights Reserved.
Ote Center Building 1-1-3 Otemachi Chiyoda-ku
Tokya 100-8115
Japan
Phone: 81 (3) 67011000 Fax: 81 (3) 67011005
Internet: http://www.kuraray.co.jp
E-mail: [email protected]
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. 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.
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 February 2009
Apheresis Units
©2008 ECRI Institute. All Rights Reserved 9
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
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Many of the words or model descriptions appearing in the Healthcare Product Comparison System are
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name without designation as proprietary should not be regarded as a representation that is not the subject of
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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 nearly 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.
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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.
Apheresis Units
10 ©2009 ECRI Institute. All Rights Reserved.
Product Comparison Chart
MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1
B BRAUN CARIDIAN BCT CARIDIAN BCT
Apheresis Units H.E.L.P. System COBE Spectra Spectra Optia
WHERE MARKETED Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes, for therapeutic plasma exchange (TPE) only
CE MARK (MDD) Yes Yes Yes, for TPE and mononuclear cell (MNC) collections only
SEPARATION METHOD Filtration Centrifugation Centrifugation
CENTRIFUGE, rpm NA 400-2,400 ±5% 3,000
FLOW TYPE Continuous Continuous Continuous
VENOUS ACCESS Double Single, double Double
INLET RATE, mL/min 0-200 Up to 150 0-142
PUMPS Inlet, anticoagulant, plasma collection, buffer, circulation, filtration, return
Inlet, anticoagulant, collect/replace plasma
Inlet, anticoagulant, remove/plasma, collect/replace, return
EXTRACORPOREAL VOLUME, mL 195 Variable, depending on
tubing set used Variable, depending on tubing set used
ANTICOAGULANT RATIO Manual required, automatic preferred
NA (heparin) Varies Varies
WARMER, temperature Preferred By dialysis Optional Optional
APPLICATIONS Donor collection LDL apheresis Plateletpheresis, concurrent
plasma, WBC collection, bone marrow processing
MNC (donor and patient)
Exchange NA Therapeutic plasma exchange, RBC exchange
TPE
Therapeutic removal LDL fibrinogen, lipoprotein (a)
Cytoreduction No
TIME Platelets NA Configurable, 100 min
(default) NA
Lymphocytes NA Configurable; time x TBV (volume processed)
Configurable; time x TBV (volume processed)
Granulocytes NA 7 L NA Monocytes NA Configurable; time x TBV
(volume processed) Configurable; time x TBV (volume processed)
RBC NA RBCX end point based on FCR or volume processed, not configurable
NA
Plasma NA TPE, plasma volume exchanged
TPE, plasma volume exchanged
Other LDL, 60-120 min None specified None specified
PHERESIS SET Open Plasma separator, system-
specific filters and solutions, tubing set
Single-/dual-needle plasma exchange, red cell exchange, WBC collection, bone marrow process
Dual-needle TPE exchange set
Closed None Sets for 7-day platelet storage, single-needle 7-day platelet storage, and single- and dual-needle Leukoreduction System platelets, auto PBSC, functionally closed WBC
Functionally closed collection set for MNC collection
These specifications continue onto the next two pages.
Apheresis Units
©2008 ECRI Institute. All Rights Reserved 11
Product Comparison Chart
MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1
B BRAUN CARIDIAN BCT CARIDIAN BCT
Apheresis Units H.E.L.P. System COBE Spectra Spectra Optia
REPLACEMENT FLUID BALANCE
Manual required, automatic preferred
NA 75-150%, default 100% 84-114% (normal mode), 75-125% (caution mode)
PROGRAMS None Mononuclear cell collections and removal, therapeutic plasma exchange, RBC exchange, single-/dual-needle platelet collection, single-needle therapeutic plasma exchange, granulocyte collection, bone marrow processing, auto PBSC, lymphoplasma exchange
TPE and MNC
MONITORS/ALARMS Required Pre-/postpump inlet, circulation, heparin, pre-/postpump filtration, plasma return, venous lines, ultrasonic air-bubble and fluid-level detectors; conductivity, flows, pressures, temperature (in dialysis module)
Centrifuge and access/return-pressure sensors, inlet and return-air detector, AC fluid-level detector, collect concentration, monitor, RBC detector, warning, operator attention, shutdown alarms, fluid-leak detector
Centrifuge and inlet/return-pressure sensors, reservoir air/fluid level sensors, anticoagulant fluid detector, replacement fluid detector, RBC detector, warning, operator attention, shutdown alarms, fluid-leak detector, automated tubing set safety checks, automated interface management, tubing set type detector
DATA MANAGEMENT Patient data Not specified Not specified Not specified Autocalculation Not specified
Anticoagulant Preferred Not specified Not specified Not specified Replacement volume Preferred Not specified Not specified Not specified Extracorporeal volume Preferred Not specified Not specified Not specified
WEIGHT, kg (lb) 99.7 (219.8) 177 (389) 92 (202)
H x W x D, cm (in) 396 x 160 x 142 (156 x 62.5 x 56)
148 x 70 x 71 (58.3 x 27.6 x 28)
116 x 52.7 x 81.3 (46 x 20.7 x 32)
LINE POWER, VAC 100/110/120/220/240 100/115/220/240 100-240 Power, W Not specified 800-960, depends on input
voltage 960-1,000, depends on input voltage
BATTERY BACKUP Preferred Not specified Smart Socket Not specified
PURCHASE INFORMATION
List price Not specified (units are leased with disposables agreement)
$65,000 $70,000
Open set Not specified Not specified Not specified Closed set Not specified Not specified Not specified
Warranty 1 year, service and parts 1 year, service and parts 1 year, service and parts Delivery time, ARO Not specified Not specified Not specified Training Not specified Included Included Fiscal year Not specified January to December January to December
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
Apheresis Units
12 ©2009 ECRI Institute. All Rights Reserved.
Product Comparison Chart
MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1
B BRAUN CARIDIAN BCT CARIDIAN BCT
Apheresis Units H.E.L.P. System COBE Spectra Spectra Optia
OTHER SPECIFICATIONS Meets requirements of TUV. Smart Socket uses lithium energy cell to retain RAM data for ≥10 years. Meets requirements of BSI, CSA, JIS, TUV, and UL.
Meets requirements of BSI, CSA, JIS, TUV, and UL.
UMDNS CODE(S) 23134, 23135, 23136, 23137, 23139
23134, 23135, 23136, 23137, 23139
23134, 23135, 23136, 23137, 23139
23134, 23135, 23136, 23137, 23139
LAST UPDATED February 2009 February 2009 February 2009
Supplier Footnotes 1These recommendations are the opinions of ECRI Institute's technology experts. ECRI Institute assumes no liability for decisions made based on this data.
Model Footnotes
Data Footnotes
Apheresis Units
©2008 ECRI Institute. All Rights Reserved 13
Product Comparison Chart
MODEL CARIDIAN BCT FENWAL FENWAL FENWAL Trima Accel Automated
Blood Collection ALYX AMICUS Autopheresis-C
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Not specified
CE MARK (MDD) Yes Yes Yes Not specified
SEPARATION METHOD Centrifugation Centrifugation Centrifugation Rotating member filtration
CENTRIFUGE, rpm 3,000 4,500 3,280 3,600
FLOW TYPE Continuous Continuous processing, intermittent draw/return
Continuous, intermittent Intermittent
VENOUS ACCESS Single Single Single, double Single
INLET RATE, mL/min 0-142 50-100, auto-adjusting and programmable max
0-150, 0-90 0-150
PUMPS Inlet, anticoagulant, platelet, plasma, return
5 total, (2) donor, (1) in-process, (1) plasma, (1) anticoagulant
Inlet/return, inlet/centrifuge, anticoagulant, plasma, recirculation, PRP
Inlet, anticoagulant, return, collection
EXTRACORPOREAL VOLUME, mL Variable, depending on
tubing set used 110 205-209 ~200
ANTICOAGULANT RATIO 6:13.7 1:11 Yes Yes
WARMER, temperature NA NA NA NA
APPLICATIONS Donor collection Platelets, plasma and RBC
products in any combination, including double RBC collections
2 units RBCs, 1 unit RBC with concurrent plasma
Plateletpheresis, mononuclear cell
Plasmapheresis
Exchange NA NA NA NA Therapeutic removal NA NA NA NA
TIME Platelets ≤150 min, based on donor
TBV, platelet count, machine configuration
NA 60 min NA
Lymphocytes NA NA NA NA Granulocytes NA NA NA NA Monocytes NA NA NA NA RBC ≤150 min, based on donor
TBV, HCT, machine configuration
2 RBC, 25-28 min (average) Concurrent with platelets NA
Plasma ≤150 min, based on donor TBV, HCT, machine configuration
NA Concurrent with platelets 35 min (600 mL)
Other None specified None specified None specified None specified
PHERESIS SET Open None None None Anticoagulant, needle,
tubing, collection and storage containers
Closed Sets for 5-day platelet storage and 42-day RBC storage: platelet, plasma, RBC set with or without TLR filter, plasma, RBC set with or without TLR filter
2 RBC and RBC/plasma kits have preconnected anticoagulant, preservative, and saline solutions, all other necessary kit components
Cassettes, tubing, 1 L saline, 1 L anticoagulant, 17 G needles, 1 sample pouch, two 1,000 mL platelet storage containers, one 800 mL plasma transfer pack, separation and collection chamber
Anticoagulant, needle, tubing, collection and storage containers
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
Apheresis Units
14 ©2009 ECRI Institute. All Rights Reserved.
Product Comparison Chart
MODEL CARIDIAN BCT FENWAL FENWAL FENWAL Trima Accel Automated
Blood Collection ALYX AMICUS Autopheresis-C
REPLACEMENT FLUID BALANCE
80-120%, default 100%; configurable on or off; only available with plasma/RBC set
Yes Yes NA
PROGRAMS Collection of platelets, platelets with plasma, platelets with RBC, platelets with plasma and RBC, plasma with RBC, plasma (volumes up to 1L), RBC, double RBC, collection of high concentration platelets with automatic addition of storage solution
2 RBC, RBC/plasma Single-needle venous-access platelet collection, double-needle venous-access platelet collection, jumbo concurrent plasma, mononuclear cell
Plasmapheresis collection
MONITORS/ALARMS Centrifuge and access/return-pressure reservoir air/level sensors, anticoagulant detector, RBC spillover detector, fluid-leak detector, independent control and safety systems with advisory, alert, and alarms
Air, separation, overspill, fluid, leak, centrifuge door, pump pressure, flow, weigh scales and auto cuff
Inlet- and return-line pressure monitor, air/fluid detector, interface detector, optical sensor, centrifuge temperature, humidity, imbalance detectors
Inlet- and return-line pressure monitor, air/fluid detector, optical interface detector
DATA MANAGEMENT Patient data Not specified Yes, donor data Not specified Not specified Autocalculation
Anticoagulant Not specified Yes Not specified Not specified Replacement volume Not specified Yes Not specified Not specified Extracorporeal volume Not specified IVD instead of ECV Not specified Not specified
WEIGHT, kg (lb) 84 (185) 24 (53) 156 (345) 47.7 (105)
H x W x D, cm (in) 106 x 52.7 x 81.3 (41.9 x 20.7 x 32)
33 x 46 x 53 (13 x 18 x 21) 97.8 x 52.1 x 81.3 (38.5 x 20.5 x 32)
169.7 x 43.2 x 26.2 (66.8 x 17 x 10.3)
LINE POWER, VAC 100-240 90-264 100/115/200-240 115 (90-130), 230 (180-260) Power, W 700 250 Not specified 350
BATTERY BACKUP Not specified Yes Yes 12 V
PURCHASE INFORMATION
List price $84,105 Not specified Not specified $20,000-30,000 Open set NA Not specified Not specified $80-90 Closed set NA Not specified Not specified Not specified
Warranty 1 year, service and parts Lease: life of lease; purchase: 1 year; both include on-site service and parts
By region 1 year, service and parts
Delivery time, ARO Not specified Immediate Not specified Not specified Training Included Included Included Not specified Fiscal year January to December January to December Not specified Not specified
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
Apheresis Units
©2008 ECRI Institute. All Rights Reserved 15
Product Comparison Chart
MODEL CARIDIAN BCT FENWAL FENWAL FENWAL Trima Accel Automated
Blood Collection ALYX AMICUS Autopheresis-C
OTHER SPECIFICATIONS Meets requirements of CSA Class I, type BF equipment.
Automated, integrated leukoreduction; saline is separated and spiked via a functionally-closed lead in European kits.
Meets requirements of IEC 60601-1-1 and EMI standards.
Model A-200 is column mounted with front-locking casters, 3 pumps with 4 clamps; model A-401 folds to 83.8 cm (33 in). Meets requirements of CE, CSA, EMC, and UL.
UMDNS CODE(S) 23134, 23135, 23136, 23137, 23139
23134, 23135, 23136, 23137, 23139
23134, 23135, 23136, 23137, 23139
23134, 23135, 23136, 23137, 23139
LAST UPDATED February 2009 February 2009 February 2009 February 2009
Supplier Footnotes
Model Footnotes
Data Footnotes
Apheresis Units
16 ©2009 ECRI Institute. All Rights Reserved.
Product Comparison Chart
MODEL FENWAL HAEMONETICS HAEMONETICS HAEMONETICS CS-3000 Plus CCS Cymbal MCS+ LN 8150
WHERE MARKETED Worldwide Japan Asia, Europe, USA USA
FDA CLEARANCE Not specified No Yes Yes
CE MARK (MDD) Not specified No Yes No
SEPARATION METHOD Centrifugation Centrifugation Centrifugation Centrifugation
CENTRIFUGE, rpm 550-1,600 3,000-7,000 5,500 7,000 default
FLOW TYPE Continuous, intermittent Intermittent Intermittent Intermittent
VENOUS ACCESS Single, double Single Single Single
INLET RATE, mL/min 0-85 20-100 50-80 20-100
PUMPS Inlet, anticoagulant, plasma collection
3 2 3
EXTRACORPOREAL VOLUME, mL 240 15-500 <390 <690
ANTICOAGULANT RATIO Yes 1:8-1:16 1:12, 1:16 1:12-1:16
WARMER, temperature 36°C control NA NA NA
APPLICATIONS Donor collection Leukapheresis,
plateletpheresis, mononuclear cell
Plateletpheresis; with or without concurrent plasma, leukoreduction, plasmapheresis
Red cell apheresis, 2 units RBCs with optional in-process leukoreduction
RBC apheresis; 2 units RBCs, 2 units RBCs leukocyte-reduced, or 1 unit RBCs and 400-550 mL concurrent plasma
Exchange Plasma, RBCs NA NA NA Therapeutic removal Lymphocytes, granulocytes Granulocytes and peripheral
blood stem cells removed NA NA
TIME Platelets 75 min Target-dependent NA NA Lymphocytes 100-180 min Target-dependent NA NA Granulocytes 100-175 min Target-dependent NA NA Monocytes 120-180 min Target-dependent NA NA RBC NA NA 2 RBC, 30-40 min 2 RBC, 35 min; RBCP, 25
min Plasma NA 45 min NA NA Other None specified None specified None specified None specified
PHERESIS SET Open Monitor box, tubing,
separation/collection containers
None None None
Closed Monitor box, tubing, 1 L saline, 1 L anticoagulant, two 17 G needles, 1 sample pouch, 1 600/800 mL PL146 transfer pack, two 1 L PL732/PL304 packs, separation and collection containers
Platelets, platelets with leukocyte reduction, plasma, therapeutic removals and stem cells
2 RBC RBCP, 2 RBC, 2 RBC-F
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
Apheresis Units
©2008 ECRI Institute. All Rights Reserved 17
Product Comparison Chart
MODEL FENWAL HAEMONETICS HAEMONETICS HAEMONETICS CS-3000 Plus CCS Cymbal MCS+ LN 8150
REPLACEMENT FLUID BALANCE
Yes NA Optional Yes
PROGRAMS 8 standard procedures: platelet, granulocyte, and lymphocyte collection; plasma exchange; special plasma exchange; lympho/plasma exchange; single venous-access platelet collection; baseline cell collection; or 8 special procedures
Platelets, plasma, component therapies (peripheral blood stem cells, granulocytes)
2 RBC using SAG-M (42-day storage), single needle, variable absolute RBC collection, allogenic, therapeutic or autologous processing
2 RBC using AS-3 (42-day storage), RBCP using AS-3 (42-day storage), single needle, variable absolute RBC collection, allogeneic or autologous processing
MONITORS/ALARMS Inlet-, return-, and blocked-line pressure monitor; fluid-level and interface detectors; centrifuge temperature, humidity, imbalance detectors
4 air detectors, 2 pressure monitor, 2 spill sensors, 2 separation sensors, self-regulating flow, automated and pulsing cuff
3 air detectors, 2 pressure monitors, 2 separation sensors, self-regulating flow, automated and pulsing cuff
4 air detectors, 2 pressure monitors, spill sensor, 2 separation sensors, self-regulating flow, automated and pulsing cuff
DATA MANAGEMENT Patient data Not specified Not specified Not specified Not specified Autocalculation
Anticoagulant Not specified Not specified Not specified Not specified Replacement volume Not specified Not specified Not specified Not specified Extracorporeal volume
Not specified Not specified Not specified Not specified
WEIGHT, kg (lb) 315 (694.6) 26.3 (56) 13 (29) 26.3 (56)
H x W x D, cm (in) 61 x 97.8 x 142 (24 x 38.5 x 56)
68.5 x 56.5 x 56.5 (27 x 22.3 x 22.3)
30.5 x 28 x 51.6 (12 x 11 x 20)
67.5 x 55 x 55 (26.5 x 21.5 x 21.5)
LINE POWER, VAC 100/115/200/210/220/230/240 100/220 110/220 110/220 Power, W 1,380 Not specified Not specified Not specified
BATTERY BACKUP No No Yes No
PURCHASE INFORMATION
List price Not specified Not specified Not specified Not specified Open set $118 Not specified Not specified Not specified Closed set $155-165 Not specified Not specified Not specified
Warranty 6 months, service, parts, and travel
1 year, service, parts, travel 1 year, service, parts, travel 1 year, service, parts, travel
Delivery time, ARO Not specified Immediate Immediate Immediate Training Not specified Available Available Available Fiscal year Not specified April to March April to March April to March
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
Apheresis Units
18 ©2009 ECRI Institute. All Rights Reserved.
Product Comparison Chart
MODEL FENWAL HAEMONETICS HAEMONETICS HAEMONETICS CS-3000 Plus CCS Cymbal MCS+ LN 8150
OTHER SPECIFICATIONS Meets requirements of CSA. Haemocalculator; stand and transport case; advanced user interface; smartcard technology.
Stand and transport case; advanced user interface; optional battery operation; DTS (data transfer system).
Stand and transport case; advanced user interface.
UMDNS CODE(S) 23134, 23135, 23136, 23137, 23139
23134, 23135, 23136, 23137, 23139
23134, 23135, 23136, 23137, 23139
23134, 23135, 23136, 23137, 23139
LAST UPDATED February 2009 February 2009 February 2009 February 2009
Supplier Footnotes
Model Footnotes
Data Footnotes
Apheresis Units
©2008 ECRI Institute. All Rights Reserved 19
Product Comparison Chart
MODEL HAEMONETICS HAEMONETICS KURARAY MEDICAL MCS+ LN 9000 PCS2 KPS-8800Ce
WHERE MARKETED Worldwide, except Japan Asia, Europe, USA Asia
FDA CLEARANCE Yes Yes No
CE MARK (MDD) Yes Yes No
SEPARATION METHOD Centrifugation Centrifugation Membrane filtration
CENTRIFUGE, rpm 3,000-7,000 2,000-8,000 NA
FLOW TYPE Intermittent Intermittent Continuous
VENOUS ACCESS Single Single Double
INLET RATE, mL/min 20-100 20-100 10-220
PUMPS 3 2 Blood, plasma, drain, anticoagulant
EXTRACORPOREAL VOLUME, mL 15-500 15-500 Plasma exchange 232 mL;
plasma (double) filtration 366 mL
ANTICOAGULANT RATIO 1:8-1:16 1:16 Yes
WARMER, temperature NA NA Yes, 36-45°C
APPLICATIONS Donor collection Plateletpheresis, double
RBC apheresis, RBC and concurrent plasma collection, platelets and concurrent RBC collection, plasmapheresis; optional concurrent plasma, leukoreduction, volume replacement
Plasmapheresis Plasma exchange, plasma (double) filtration, plasma perfusion, direct hemoperfusion
Exchange Plasma, single/double access, column compatible
NA Plasma
Therapeutic removal Mononuclear cells, thrombocytes, leukocytes, granulocytes
NA Plasma components
TIME Platelets Target-dependent NA NA Lymphocytes Target-dependent NA NA Granulocytes Target-dependent NA NA Monocytes Target-dependent NA NA RBC 2 RBC, 35 min; RBCP, 25
min NA NA
Plasma 45 min 45 min; 35 min with EXPRESS feature
3 L plasma filtration, ~2.5 hr, includes preparation time
Other None specified None specified None specified
PHERESIS SET Open Plasma exchange, plasma
collection Plasma Plasma separator, plasma
fractionator, plasma perfusion cartridge, tubing set, hemoperfusion cartridge
Closed Platelets, RBCP, 2 RBC, platelet and RBC, FFP, PBSC; all sets with optional integrated leukoreduction
Plasma (Europe) None
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
Apheresis Units
20 ©2009 ECRI Institute. All Rights Reserved.
Product Comparison Chart
MODEL HAEMONETICS HAEMONETICS KURARAY MEDICAL MCS+ LN 9000 PCS2 KPS-8800Ce
REPLACEMENT FLUID BALANCE
Optional Optional Equal to drain
PROGRAMS Platelets (single donor, double-unit, optional concurrent plasma, optional concurrent RBC, optional volume replacement), plasma exchange, component therapies (mononuclear cells, granulocytes), 2 RBC and RBCP collections, PPP and FFP
Plasma, plasma with saline replacement, plasma with concurrent-source leukocytes (USA only)
Autopriming function (plasma exchange, plasma filtration, plasma perfusion), linkage function with centrifuge cell separator (plasma filtration, plasma perfusion)
MONITORS/ALARMS 4 air detectors, 2 pressure monitors, spill sensor, 2 separation sensors, self-regulating flow, automated and pulsing cuff
4 air detectors, 2 pressure monitors, spill sensor, 2 separation sensors, self-regulating flow, automated and pulsing cuff
Monitors: treatment information, instant and accumulated flow rates (blood inlet, plasma, drain), pressures (arterial, venous, second filter, TMP), elapsed treatment time, alarms for arterial, second filter, venous, and transmembrane pressure; air bubble; heparin; temperature; connection of tubing; others
DATA MANAGEMENT Patient data Not specified Not specified Not specified Autocalculation
Anticoagulant Not specified Not specified Not specified Replacement volume Not specified Not specified Not specified Extracorporeal volume Not specified Not specified Not specified
WEIGHT, kg (lb) 26.3 (56) 26.3 (56) 70 (154)
H x W x D, cm (in) 68.5 x 56.5 x 56.5 (27 x 22.3 x 22.3)
68.5 x 56.5 x 56.5 (27 x 22.3 x 22.3)
125 x 56 x 57 (49 x 22 x 22.5)
LINE POWER, VAC 100/220 110/220 110/220 Power, W Not specified Not specified 350 VA
BATTERY BACKUP No No No
PURCHASE INFORMATION
List price Not specified Not specified ~$50,000 Open set Not specified Not specified $200 Closed set Not specified Not specified NA
Warranty 1 year, service, parts, travel 1 year, service, parts, travel 1 year, service and parts Delivery time, ARO Immediate Immediate 3 months Training Available Available At extra charge Fiscal year April to March April to March April to March
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
Apheresis Units
©2008 ECRI Institute. All Rights Reserved 21
Product Comparison Chart
MODEL HAEMONETICS HAEMONETICS KURARAY MEDICAL MCS+ LN 9000 PCS2 KPS-8800Ce
OTHER SPECIFICATIONS Haemocalculator; stand and transport case; advanced user interface; smartcard technology; optional saline replacement.
Stand and transport case; advanced user interface.
Displays in English and Japanese; combination system with centrifuge cell separator (plasma filtration, plasma perfusion).
UMDNS CODE(S) 23134, 23135, 23136, 23137, 23139
23134, 23135, 23136, 23137, 23139
23134, 23135, 23136, 23137, 23139
LAST UPDATED February 2009 February 2009 February 2009
Supplier Footnotes
Model Footnotes
Data Footnotes