Circulatory Assist Units, Intermittent Sequential Stockings, Compression Pneumatic
Circulatory Assist Units, Intermittent Sequential Stockings, Compression Pneumatic
Compression; Pneumatic
Scope of this Product Comparison
This Product Comparison covers intermittent pneumatic compression (IPC) devices intended for prevention of
deep vein thrombosis (DVT) and/or treatment of lymphedema in a clinical facility or in the home. It also covers
garments, such as pneumatic stockings (PSs) and antiembolic (elastic) stockings that are part of or accessories to
IPC devices.
These devices are also called: alternating-pressure control units,
pneumatic compression devices (PCDs), sequential compression
devices (SCDs), compression pumps, compression stockings.
Purpose
IPC units alternately apply and release pressure on a patient’s
arms, legs, or feet. They can be used to minimize venous stasis during
and immediately following surgery as well as during long periods of
immobility, such as for a bedridden patient. Such stasis puts certain
patients at risk for DVT, which can produce pulmonary embolism
(PE). DVT precedes PE in 9 out of 10 instances. Patients most likely to
be affected are those over age 40 who are undergoing hip or knee
surgery, major abdominal surgery, and/or intracranial neurosurgery.
Pregnant women are more likely to develop DVT than nonpregnant
women. Oral contraceptives and estrogen replacement therapy may also increase the risk of DVT, particularly
when combined with other risk factors such as smoking, hypertension, and obesity. Although there is no ideal
preventive measure, IPC treatment of the lower limbs and/or feet—either alone or combined with anticoagulant
therapy (e.g., heparin, warfarin, dextran) and antiembolic stockings—has been shown to be effective in
preventing DVT. IPC is a noninvasive treatment; its use promotes
venous emptying and mimics muscular activity that promotes the
release of plasminogen activator, which may guard against fibrinolytic UMDNS Information
shutdown.
This Product Comparison covers the following
Some pneumatic compression units are designed to treat chronic device terms and product codes as listed in
edema such as lymphedema, which is a condition caused by ECRI Institute’s Universal Medical Device
Nomenclature System™ (UMDNS™):
obstruction, destruction, or hypoplasia of lymphatic vessels and nodes
Circulatory Assist Units, Peripheral Compression,
and characterized by accumulation of fluid in a limb. Primary Intermittent [10-969]
lymphedema is a developmental abnormality and is usually a lifelong Circulatory Assist Units, Peripheral Compression,
Sequential [16-837]
condition. Secondary lymphedema can result from trauma, tumors, or Stockings, Compression [13-789]
surgery (e.g., oncologic surgery in which lymphatic nodes and vessels Stockings, Pneumatic [13-793]
have been removed). Lymphedema causes disfigurement (the affected
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]
Circulatory Assist Units, Intermittent; Sequential; Stockings, Compression; Pneumatic
limb can become several times its normal size); it causes the limb to become very heavy and puts the patient at
risk for bacterial and fungal infections. The affected limb may become painful and interfere with patient mobility.
Compression therapy can reduce the limb size so that its appearance is nearly normal. It can also be used to treat
patients with edema caused by many other conditions (e.g., postsurgical edema, dependent edema related to
pregnancy, edema related to leg ulcers or resulting from musculoskeletal injuries, chronic venous insufficiency).
IPC has also been reported to increase the healing rate of venous insufficiency ulcers.
Principles of operation
A typical IPC unit consists of one or more
garments that are wrapped around the limb to be
treated, tubing that connects the garments to the
pump, and a pump that provides air to inflate the
bladders within the garments. The timing cycle of
inflation and deflation as well as the bladder
inflation pressure is user-adjustable on some units
and fixed on others.
To operate any IPC device for DVT prophylaxis,
the garment is applied to the patient’s leg.
Garments typically cover the calf or calf and thigh;
foot garments are also used, but these are operated
at higher pressures than the calf or thigh garments.
Some IPC devices employ garments that have a
single bladder and apply a uniform pressure to the
treated limb when inflated. Other IPC devices use
garments with multiple bladders that compress the limb in a sequential, gradient fashion. In other words, the
highest pressure is applied first to the most distal bladder (e.g., ankle) and decreasing pressures are then applied
to the next most proximal bladder (e.g., calf, followed by thigh). The IPC device sustains the inflation pressure
briefly (also called the hold time, this time interval is adjustable on some units and fixed on others); all chambers
then deflate, and the cycle repeats.
Pressure-control mechanisms provided on some units allow the user to adjust the pressure directly by setting a
dial or indirectly by observing a pressure gauge while turning a dial. On others, the user selects the pressure by
programming the device. Available cuff pressures range from approximately 15 to 200 mm Hg. Typical DVT
prevention pressures using calf and thigh sleeves are around 30 to 45 mm Hg. For foot cuffs, this pressure is
around 130 to 180 mm Hg.
Most units intended to treat lymphedema apply sequential, gradient pressure using garments that have
multiple bladders. They usually provide higher pressures than those designed for DVT prevention and can be
applied to arms, legs, or amputee stumps. For example, one manufacturer’s treatment protocol for lymphedema
recommends applying pressure equal to the patient’s mean arterial pressure to the foot or hand. Each subsequent
chamber is inflated to a pressure that is a fixed amount less than that of the previous chamber.
Many compression units, typically those designed for DVT prevention, feature displays and alarms to alert
clinical personnel to excessive pressure, nonrelease of pressure, low pressure, kinked tubing, or other
malfunctions; some have mechanisms that vent pressure automatically if the cuff pressure rises above a set limit
or is maintained longer than the set time. Units that apply sequential, gradient compression typically indicate the
correct tubing connections to achieve the proper inflation sequence; the methods include color coding,
numbering, labeling with arrows, and physical conformation to prevent misconnection. Tubing connectors can be
friction (push on), spring-loaded valve, snap lock, or latch.
Garments for DVT prevention are usually for single-patient use; those for lymphedema treatment are typically
reusable. Construction material is usually a polyurethane and nylon combination or polyvinyl chloride (PVC).
Garment designs include types that slip over the patient’s limb as well as models that wrap around the limb and
close with hooks and loops, zippers, or Velcro fasteners. Pressure-release valves that permit quick deflation are
available on some manufacturers’ units; they are available more often on those units that cannot be easily opened
when inflated.
Some compression units are used with a graduated-compression (gradient) elastic stocking consisting of a
blend of cotton and nylon spandex; the stocking may be worn during or between treatments. Other suppliers
provide a light cotton liner to be worn under the pneumatic sleeve to absorb perspiration. One manufacturer’s
garment consists of an inflatable bladder that slips into a pouch in the front of an elastic stocking. When the
bladder is inflated, the stocking is stretched circumferentially, transmitting pressure to the calf. Another sleeve
design uses an inner lining of pliable polyurethane and an outer wall constructed of nonstretch nylon. When
inflated, the inner lining presses on the limb.
Reported problems
Contraindications for IPC therapy to prevent DVT include acute thrombosis, acute thrombophlebitis, acute
pulmonary edema, pulmonary embolism, congestive heart failure, and suspicion of recent DVT. Cardiac,
respiratory, renal, or hepatic diseases may be contraindications for lymphedema therapy.
Patient bruising and skin integrity problems have been reported with these devices. This may be caused by
garment sizing errors, improper garment placement, or if the garment has been reprocessed, an allergic reaction
to the cleaning chemicals used. It can also be caused by a pump malfunction, such as failure of the garment to
deflate. ECRI Institute is aware of one incident in which a device’s tubing set had been disconnected and then
reconnected incorrectly. The reversal of the tubing caused an incorrect inflation sequence, producing sustained
inflation and thereby injuring the patient. ECRI Institute recommends that staff regularly check all tubing for
leaks or loose ends. Some experts recommend discarding the entire set if a disconnected tube is found.
ECRI Institute is aware of reports of inadvertent attachment of sequential compression devices to needleless
Luer ports on intravenous (IV) administration sets, which can cause fatal air embolisms. ECRI Institute
recommends exclusive use of IPC devices with connectors that are not compatible with Luer connectors.
ECRI Institute also has investigated at least one case in which patient injury occurred when one chamber on a
multichambered cuff did not deflate. The pump monitored pressure in only one of cuff’s chambers and therefore
the pump’s alarm was not triggered.
If power cords do not have appropriate strain relief, power cords may become exposed. Units could lose
power if an unsecured strain relief has resulted in damage to the power cord wires; also, electric shock and fire
are associated risks, albeit remote ones. ECRI Institute recommends that facilities perform preventive
maintenance, including inspection of power cords and outlets.
Purchase considerations
ECRI Institute recommendations
Included in the accompanying comparison chart are ECRI Institute’s recommendations for minimum
performance requirements for IPC devices.
Since compression devices are designed to assist in the circulation of blood by pumping the venous system,
pressures that stop arterial blood flow are counterproductive to optimal refilling of the veins. Applied pressures
should be as low as possible—between 30 and 60 mm Hg for the calf (varies per body part)—and not more than
200 mm Hg as a rule. The IPC device should provide a sufficient period of deflation to allow for venous refilling
(e.g., 20 seconds), and some type of display is needed as a method of measuring and communicating pressure and
duration.
ECRI Institute recommends purchasing pumps that monitor actual pressures in the garments and that have a
real-time pressure display rather than only a set-pressure display. Units that are equipped with overpressure,
kinked tubing and low-pressure alarms are preferred, as are those that automatically vent if a failure-to-deflate
condition occurs. The unit should make troubleshooting these alarms easy for clinicians and be comfortable for
patients (e.g., pumps are not noisy or disruptive). A power switch is also recommended to quickly discontinue
operation in an emergency.
Other considerations
While studies show that using IPC devices provides better protection against DVT than not using any
prevention method at all, when it comes to comparing the different variations of IPC devices, the answers are less
clear. There is no conclusive evidence in the literature that definitively states that one type of IPC device is more
effective at reducing DVT than another. Therefore it is not clear whether uniform compression or sequential-
gradient compression is better, or whether a calf garment is better than a calf-thigh garment.
Other considerations include making sure that the device has adequate safety features, that it is easy to use,
and that it is comfortable for the patient. The patient population to be treated also affects the decision on which
device to purchase. For instance, if the patient population will consist of many patients with leg casts, an IPC
device that offers foot compression would be a good choice. Another consideration is whether it is possible to
standardize products from a single vendor to simplify garment purchase as well as pump service and repair. This
can be accomplished with an all-in-one pump that can deliver multiple modes of therapy (e.g., foot, calf/thigh) or
with different devices from a single supplier (e.g., one pump for foot compression and another for calf/thigh
compression). Clinician and patient compliance have been shown to be beneficial for IPC therapy because the
devices tend to be used correctly for longer periods. Pumps with lower operational noise levels may also help to
achieve better compliance.
Cost containment
The price of the pump unit is a one-time expenditure that may not be significant when compared with the cost
of disposable garments. Suppliers may offer discounts on pumps when a large number of disposables are
ordered; negotiating efforts should also focus on the cost of these disposable garments at the time of purchase,
because their cost is significant over the useful life of the pump. In addition, purchasers may want to compare the
cost of single-patient-use garments with the cost of sterilizing reusable garments.
Stage of development
As early as 1972, there is a reference to using a pneumatic intermittent pump connected to a legging to prevent
DVT by compressing the calf muscle. The development of compression units has continued the initial design
while adding programmability and safety features, such as overpressure alarms and shutoff devices. Sequential-
gradient compression units were developed in the late 1970s. Use of IPC devices gained popularity after 1986,
when the National Institutes of Health (NIH) Consensus Development Conference on the Prevention of Venous
Thrombosis and Pulmonary Embolism endorsed them as an effective means of DVT prevention.
Attention is being directed toward improving comfort, closure mechanisms, and overall convenience of use in
an attempt to increase patient compliance with physician orders. Several manufacturers offer pumps with
optional battery packs so that therapy can be applied during patient transport. One manufacturer is using
“vascular refill detection,” which uses air plethysmography to evaluate individual patient’s refill times instead of
a set deflation time.
Bibliography
Amarigiri SV, Lees TA. Elastic compression stockings for prevention of deep vein thrombosis. Cochrane Database
Syst Rev 2000;(3):CD001484.
Clagett GP, Anderson FA Jr, Levine MN, et al. Prevention of venous thromboembolism. Chest 1992 Oct;102(4
Suppl):391S-407S.
Comerota AJ, Katz ML, White JV. Why does prophylaxis with external pneumatic compression for deep vein
thrombosis fail? Am J Surg 1992 Sep;1643:265-8.
ECRI Institute. Fatal air embolism caused by the misconnection of medical device hoses to needleless Luer ports
on IV administration sets [hazard report]. Health Devices 2004 Jun;33(6):223-5.
General devices. Health Devices Inspection and Preventive Maintenance System Procedure no. 438
Ground-resistance testing [User Experience Network™]. Health Devices 1993 Feb;22(2):96.
Intermittent Compression Units [inspection and preventive maintenance procedure].
BiomedicalBenchmark. Procedure no. 491-20081015-01.
Intermittent pneumatic compression devices [evaluation]. Health Devices 2007 Jun;36(6):177-204.
Flam E, Berry S, Coyle A, et al. Blood-flow augmentation of intermittent pneumatic compression systems used for
the prevention of deep vein thrombosis prior to surgery. Am J Surg 1996 Mar;171(3):312-5.
Fordyce MJ, Ling RS. A venous foot pump reduces thrombosis after total hip replacement. J Bone Joint Surg Br
1992 Jan;74(1):45-9.
Kaboli P, Henderson MC, White RH. DVT prophylaxis and anticoagulation in the surgical patient. Med Clin North
Am 2003 Jan;87(1):77-110, viii.
Lachmann EA, Rook JL, Tunkel R, et al. Complications associated with intermittent pneumatic compression. Arch
Phys Med Rehabil 1992 May;73(5):482-5.
McCulloch JM, Marler KC, Neal MB, et al. Intermittent pneumatic compression improves venous ulcer healing.
Adv Wound Care 1994 Jul;7(4):22-4, 26.
Mitchell JR. Epidural analgesia masking a malfunctioning pneumatic compression device. Anaesthesia 2005
Feb;60(2):207-8.
Murakami M, McGill TL, Cindrick-Pounds L, et al. Deep venous prophylaxis in trauma: improved compliance
with a novel miniaturized pneumatic compression device. J Vasc Surg 2003 Nov;38(11):923-6.
Ollendorf DA, Vera-Llonch M, Oster G. Cost of venous thromboembolism following major orthopedic surgery in
hospitalized patients. Am J Health-Sys Pharm 2002 Sep;59(9):1750-4.
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9, 757.
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Cardiovasc Surg 1988 Jan-Feb;29(1):37-41.
Salzman EW, McManama GP, Shapiro AH, et al. Effect of optimization of hemodynamics on fibrinolytic activity
and antithrombotic efficacy of external pneumatic calf compression. Ann Surg 1987 Nov;206(5):636-41.
Werbel GB, Shybut GT. Acute compartment syndrome caused by a malfunctioning pneumatic-compression boot:
a case report. J Bone Joint Surg Am 1986 Dec;68(9):1445-6.
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Supplier Information
AIRCAST
DJO LLC [452204]
1430 Decision St
Vista, CA 92081-8553
Phone: (760) 727-1280, (800) 336-6569 Fax: (760) 734-3595, (800) 936-6569
Internet: http://www.donjoy.com
E-mail: [email protected]
ALBAHEALTH
Albahealth LLC Div Encompass Medical [101010]
201 St Germain Ave PO Box 100
Valdese, NC 28690-0100
Phone: (828) 879-6500, (800) 533-8930 Fax: (828) 879-6595
Internet: http://www.albahealth.com
E-mail: [email protected]
BIO COMPRESSION
Bio Compression Systems Inc [160973]
120 W Commercial Ave
Moonachie, NJ 07074
Phone: (201) 939-0716, (800) 888-0908 Fax: (201) 939-4503
Internet: http://www.biocompression.com
E-mail: [email protected]
BOESL
Boesl Medizintechnik GmbH [172857]
Charlottenburger Allee 13
Aachen D-52068
Germany
Phone: 49 (241) 900770 Fax: 49 (241) 9007710
Internet: http://www.boesl-med.de
E-mail: [email protected]
C-BOOT
C-Boot Ltd [453759]
Building 30 MATAM PO Box 15051
Haifa IL-31905
Israel
Phone: 972 (4) 8503030 Fax: 972 (4) 8503131
Internet: http://www.c-boot.com
E-mail: [email protected]
CENTROMED
Centromed Ltd [179523]
Anglo House Wotton Road Kingsnorth Industrial Estate
Ashford TN23 6LN
England
Phone: 44 (1233) 635353 Fax: 44 (1233) 635351
Internet: http://www.centromed.com
E-mail: [email protected]
CHATTANOOGA
Chattanooga Group A DJO Co [101154]
4717 Adams Rd PO Box 489
Hixson, TN 37343-4001
Phone: (423) 870-2281, (800) 592-7329 Fax: (423) 875-5497
Internet: http://www.chattgroup.com
E-mail: [email protected]
COVIDIEN
Covidien (US) [452294]
15 Hampshire St
Mansfield, MA 02048
Phone: (508) 261-8000, (800) 346-7197
Internet: http://www.covidien.com
ECOLAB
Ecolab Inc [312330]
370 Wabasha Ave
St Paul, MN 55102-2233
Phone: (651) 293-2233, (800) 352-5326 Fax: (651) 293-2092
Internet: http://www.ecolab.com
E-mail: [email protected]
EUREDUC
Eureduc [172391]
35 rue des Broderies
Coignieres F-78310
France
Phone: 33 (1) 34610161 Fax: 33 (1) 34614061
Internet: http://www.eureduc.tm.fr
E-mail: [email protected]
FMT
FMT Medizintechnik GmbH [233585]
Abtsberg 19
Bamberg D-96049
Germany
Phone: 49 (951) 51166 Fax: 49 (951) 51167
Internet: http://www.fmt-medizintechnik.de
E-mail: [email protected]
HUNTLEIGH HEALTHCARE
Huntleigh Healthcare Ltd A Getinge Group Co [272792]
310-312 Dallow Road
Luton LU1 1TD
England
Phone: 44 (1582) 413104
Internet: http://www.arjohuntleigh.com
E-mail: [email protected]
ITO
ITO Co Ltd [156029]
3-3-3 Toyotama-Minami Nerima-ku
Tokyo 176-8605
Japan
Phone: 81 (3) 39944619 Fax: 81 (3) 39941465
Internet: http://www.itolator.co.jp/english
E-mail: [email protected]
KCI
Kinetic Concepts Inc [102816]
8023 Vantage Dr
San Antonio, TX 78230-4726
Phone: (210) 255-6812, (800) 275-4524 Fax: (210) 255-6987
Internet: http://www.kci1.com
E-mail: [email protected]
Internet: http://www.mcsmed.com
E-mail: [email protected]
MEDMARK TECHNOLOGIES
MedMark Technologies LLC [451356]
724 H West Rt 313 Dublin Pk
Perkasie, PA 18944
Phone: (215) 249-1540 Fax: (215) 249-1029
Internet: http://www.medmarktechnologies.com
E-mail: [email protected]
MEGO AFEK
Mego Afek [157010]
Kibbutz Afek IL-30042
Israel
Phone: 972 (4) 8784277 Fax: 972 (4) 8784148
Internet: http://www.lympha-press.com
E-mail: [email protected]
MJS HEALTHCARE
MJS Healthcare Ltd [187060]
Barton Industrial Estate Faldo Road
Barton MK45 4RT
England
Phone: 44 (1582) 882959 Fax: 44 (1582) 882176
Internet: http://www.mjshealthcare.com
E-mail: [email protected]
NOVAMEDIX
Novamedix Services Ltd An Orthofix Co [186680]
Viscount Court South Way Walworth
Andover SP10 5NW
England
Phone: 44 (1264) 334212 Fax: 44 (1264) 334007
Internet: http://www.novamedix.com
E-mail: [email protected]
TALLEY MEDICAL
Talley Group Ltd [149093]
Abbey Park Industrial Estate Premier Way
Romsey SO51 9DQ
England
Phone: 44 (1794) 503500 Fax: 44 (1794) 503555
Internet: http://www.talleygroup.com
E-mail: [email protected]
Note: The data in the chart derives from suppliers’ specifications and have not been verified through
independent testing by ECRI Institute or any other agency. Because test methods vary, different products’
specifications are not always comparable. Moreover, products and specifications are subject to frequent changes.
ECRI Institute is not responsible for the quality or validity of the information presented or for any adverse
consequences of acting on such information.
When reading the chart, keep in mind that, unless otherwise noted, the list price does not reflect supplier
discounts. And although we try to indicate which features and characteristics are standard and which are not,
some may be optional, at additional cost.
For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the
conversion to U.S. dollars to facilitate comparison among models. However, keep in mind that exchange rates change
often.
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The information in Product Comparisons comes from a number of sources: medical and biomedical
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distributor in USA.
Model Footnotes
Data Footnotes