Review

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Hemodialysis machine
technology: a global overview
Expert Rev. Med. Devices 7(6), 793–810 (2010)

Hans-Dietrich The market for hemodialysis machines, the background, the current products of manufacturers
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Polaschegg and the features of hemodialysis machines are described in this article. In addition to the
established companies and their products, Chinese manufacturers, and new developments for
Medical Devices Consultant,
Malerweg 12, A-9231 Koestenberg, home hemodialysis, are outlined based on publications available on the internet and patent
Austria applications. Here, a critical review of the state of the art questions the medical usefulness of
Tel.: +43 4274 4045 high-tech developments, compared with the benefits of more frequent and/or longer dialysis
hdp@aon.at
treatment with comparable simple machines.

Keywords : hemodialysis machines • hemodialysis manufacturers • hemodialysis markets

• home hemodialysis machines

Today’s hemodialysis machines are the result suffered from carpal tunnel syndrome and other
of a historical development going back to the amyloid deposits. Amyloid deposits are caused by
first home hemodialysis machines designed in b-2-microglobulin, a substance with a molecular
For personal use only.

1966 (Table 1) [1,2] . weight of approximately 12,000, which is poorly

These machines comprised of a proportioning
system for mixing acetate dialysate (the term ‘dia-
lysate’ is used throughout the manuscript for ‘dia-
lysing fluid’, as defined by IEC610601-2-16 ed3)
from a single concentrate and tap water, which was
degassed by the machine. Sodium acetate was used
as a buffer rather than sodium bicarbonate in order
to make proportioning technically simpler [3] .
The machines used low hydraulic-resistance
Kiil dialyzers, which could be operated with an
arterial-venous extra­corporeal circuit connected
directly to the Scribner shunt [4] . These machines
already comprised negative pressure monitors in
the dialysate circuit, an arterial pressure monitor
that served as a universal safety monitor, picking
up not only kinking of the line, but hypotension
caused by excessive ultrafiltration or blood loss
to the environment. Disinfection of the dialysate
circuit was performed with 85°C hot water.
During the following 10 years, the dialysis
device industry was built up in order to meet
the demand of the rapidly growing number of
patients. The Cimino fistula [5] and coil dialyzers
became available, which no longer allowed the
use of pump-less extracorporeal circuits.
At the end of the 1970s, several treatment
deficiencies became obvious. Uncontrolled
ultrafiltration and the use of the nonphysiologic
buffer acetate led to high rates of intradialytic
symptoms. In addition, most long-term patients
removed by hemodialysis. In Europe, it was rec-
ognized that these intradialytic symptoms were
less frequent with hemofiltration, and that fewer
patients suffered from amyloidosis, which was
believed to be the consequence of better high-
molecular-weight clearance and the use of sterile
replacement fluid with low endotoxin content.
Consequently, industry began to develop a new
generation of dialysis machines. Machines with
ultrafiltration control and bicarbonate dialysate
became available in the 1980s. In Europe, hemo­
diafiltration was developed in order to combine
the advantages of hemodialysis and hemofiltra-
tion. Cost was not a problem at this time and phar-
maceutical fluids were used for the hemo­filtration
part of the system. The technological basis of
today’s hemodialysis machines was established
during this period. Almost all of the advanced fea-
tures of today’s machines were invented or devel-
oped in the 1980s, although these features were
introduced in the late 1990s to the market (Table 1):
• Dialysate filtration for the production of ultra-
pure dialysate and online hemodiafiltration;
• Feedback control of physiologic parameters –
temperature, hematocrit and electrolytes;
• Online clearance measurement and Kt/V
(urea) calculation;
• Access recirculation and access flow measure-
ment.

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 Review Polaschegg

Table 1. Technical features of hemodialysis machines introduced to the market.

Technical features 1960–1969 1970–1979 1980–1989 1990–1999 2000–2009
Acetate dialysate + + + - -
Bicarbonate dialysate - - + + +
Dialysate concentration and ultafiltration profiles - - ~ + +
Dialysate filter - - - ~ +
Blood pumps - + + + +
Blood-leak detector + + + + +
Volumetric ultrafiltration control - - ~ + +
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Blood temperature control - - - + +

Blood–volume control - - - + +
Online clearance measurement - - - + +
Hemodiafiltration online - - ~ + +
Compliance with international safety standards - - ~ + +
- = absent; ~ = introduced; + = available.

Most of these new features are now common outside the USA, While the market leaders mostly ignored this development,
and are slowly being introduced within the USA. start-up companies in the USA took advantage of this oppor-
The first 10 years of the new millennium saw little progress tunity. Some failed, one succeeded (NxStage®) and others are
For personal use only.

from the established companies. Machines were beautified and
were equipped with powerful computers and large color screens.
Several processes were automatized and were simplified. From
a patient outcome perspective, the introduction of dialysate fil-
ters for producing ultrapure dialysate may have been the most
important contribution in Europe and Japan. The European
Renal Best Practice advisory board recommends the use of ultra-
pure dialysate if high-flux membranes are used [6] . However, the
advantages of ultrapure dialysate are not limited to high-flux
membranes. Passage of cytokine-inducing substances through
dialyzer membranes is not membrane flux-dependent, but is
membrane material-dependent [7–10] .
Online hemodiafiltration is heavily promoted by industry, but
hard clinical evidence for better patient survival is still lacking.
In the last 10 years, the medical community became aware that
the current methods of treatment are not improving patient survival
despite the use of more elaborate equipment. Treatment time had
been reduced in the previous decades from three-times per week
for 8 h, to three-times per week for 4 h or less. During this time,
the clinic in Tassin, France founded by Guy Laurent [11] , was still
treating patients for 8 h during the day or overnight using central
dialysate delivery systems and Kiil dialyzers as far as they were
still available. Although daily dialysis had been tried already [12–15] ,
it never became popular because of cost and time constraints. It
became more popular with the publication of the first results of
the Toronto group [16] , which demonstrated that daily dialysis was
feasible and cost-effective if performed overnight in the home. These
results demonstrated that longer and/or more frequent treatments
improve patient well-being and may improve survival. It is now
generally assumed that more frequent and/or longer treatment times
may be more important for patient survival than technology.
on the way. Several groups are working on portable machines,
and the idea of a wearable artificial kidneys has been revived as
well. The expected advantages of these machines compared with
conventional machines are: portability (weight less than 40 kg
as compared with 70–130 kg), less noise, no water treatment
required or separate dialysate production, ease of use, and multiple
use of the extracorporeal circuit including the dialyzer.
In the next 10 years, the established companies may not only
face competition from new start ups, but also from China, where
at least four companies offer machines with features very similar
to the older Fresenius generation of machines.
State-of-the-art machines primarily for maintenance dialysis in
the clinic are produced by the following companies:
• Europe: Bellco, B Braun, Fresenius, and Gambro
• USA: Fresenius USA
• Japan: JMS, Nikkiso, Nipro and Toray
• China: Chengdu Weilisheng Biotech, and Chongqing
Shanwaishan Science & Technology (Machines of these com-
panies are offered under different names by Tom Medical Sup-
plies [201] , Chongqing Tianhai, Jihua Medical Apparatus and
Instruments Co.).
An innovative dialysis machine primarily for the home market
is produced by NxStage in the USA.
The market
In 2009, 1,895,000 patients were treated by hemodialysis. More
than 50% of these patients were treated in the USA, EU and
Japan. Data were presented by Fresenius at the Annual General
Meeting, held on May 11, 2010, in Frankfurt, Germany [202] .

794 Expert Rev. Med. Devices 7(6), (2010)

 Hemodialysis machine technology: a global overview Review

Most machines outside the USA offer

Table 2. Hemodialysis machines. Global market 2008.
optional or integrated means for online
Company Total machines (%) Machines installed 2008 (%) hemodiafiltration. This method was pio-
Fresenius 47 55 neered by Fresenius and Gambro and
based on two different safety philoso-
Gambro 15 12
phies [24] . The latest and highly advertised
Nikkiso 14 11 development in this field is the combina-
B Braun 5 8 tion of pre- and post-dilution mode, and
Toray 7 5 mid-dilution mode.
Conventional blood pressure monitors
Nipro 5 5
are a common accessory. Another com-
Others 7 4 mon accessory is a blood volume monitor
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Courtesy of Fresenius Medical Care – communication on request. (BVM). The BVM allows the measurement
of hemoglobin concentration during dialy-
The number of installed hemodialysis stations is estimated sis. It is assumed that this reflects the change of the circulating
to be 510,000, of which 66,000 were put on the market in blood volume, although this may not be exactly true [25,26] . The
2008 (Table 2) . Overall, the mean number of patients treated per BVM was first introduced to the market by HemaMetrics™
machine was 3.3. In Japan, 108,000 machines were used to treat (former name In-Line Diagnostics) [27,101] and Hospal [28,102] .
275,000 patients, of which 85% were bedside patients [17] . Taking Later, most dialysis machine manufacturers developed proprietary
into account that the prevalence of patients on dialysis in main- optical sensors with the exception of Fresenius, which is using an
land China is less than 3% of the prevalence of patients in Taiwan, ultrasound sensor [29,30,103] . So far, algorithms for ultrafiltration
the market for machines may increase to 100,000 machines per control, based on relative blood volume changes, reduce intra-
year in less than 10 years. dialytic symptoms only moderately [31,32] . Attempts to employ
blood-volume monitoring for dry-weight prescription did not lead
For personal use only.

Basic features of state-of-the-art dialysis machines to a final conclusion [33–36] . Recent work in this field focuses on
The basic requirements for safety and essential performance better understanding of plasma refilling [37–39] .
of hemodialysis machines are described by international stan- A device offered by Fresenius only is the blood temperature
dards [18,19] . In Europe, these standards are harmonized by the module (BTM) [104] . It allows the control of the patient’s body
EU. Harmonization means that these standards were assessed temperature and the measurement of thermal-energy transfer
for compliance with the essential requirements of the European between dialysis machine and the patient. The BTM was the first
Directive 93/42 (Medical Device Directive) [20] . The list of commercially available device for feedback control of a physio­
harmonized standards can be downloaded from the Eur-Lex logical parameter in dialysis. It measures the blood temperature
website [203] . noninvasively [40] in the arterial (withdrawal) line and the venous
Most features of state-of-the-art dialysis machines are reviewed (return) line. It allows the measurement of total (access + cardio­
in [21,22] . All machines comprise extracorporeal circuits with pulmonary) recirculation and uses this data to calculate the
rotary peristaltic blood pumps using two or three spring-loaded patient’s core temperature from the temperature measured in the
rollers and the monitors required by international standards: air arterial line. Stabilizing the body temperature helps to maintain
detector, venous clamp and venous pressure sensor. All have an vasoconstriction and blood pressure. The clinical efficacy has
anticoagulation (heparin) pump and an additional prepump arte- been demonstrated in a multicenter, randomized open trial [41] .
rial pressure sensor. Some have a third pressure sensor between The device also measures the thermal power and the total thermal
the blood pump and the dialyzer. energy balance for maintaining the body temperature constant.
The dialysate part of all single patient machines enables Although this information gives some indication regarding the
heating, degassing and mixing of at least two concentrates resting energy expenditure, it has not been used clinically so far.
with incoming water. Also commonly used are means for Electrolyte balancing [105] , online-clearance measure-
fluid balancing and safety monitors, which are required by ment [42,43,106–108] and the calculation of plasma conduct­ivity
safety standards. Dialysate concentration (commonly used, or plasma sodium [109] are offered by Fresenius and Gambro.
conductivity), temperature, net-fluid removal (commonly used Electrolyte balancing was invented to allow for a more precise esti-
are pressure sensors) and blood in dialysate. Most machines mate of the electrolytes transferred during dialysis. If performed
in Europe and Japan are equipped with dialysate filters for with ion-specific electrodes, its accuracy is at least ten-times better
the production of ultrapure dialysate [23] , and most machines than any calculation based on separate measurements with con-
allow the programed variation of dialysate concentration and ventional clinical chemical analyzers [44] . Online-clearance mea-
ultrafiltration with time (profiling). surement uses the basic concept of electrolyte balancing. Dialyser
All machines comprise means for disinfection of the dialysate clearance for solutes contained in fresh dialysate is calculated from
circuit with chemicals. Most machines also allow heat disinfection the difference between input and output concentrations at two dif-
or a combination of heat and chemicals. ferent dialysate input concentrations. Dialysate concentrations are

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 Review Polaschegg
usually measured by conductivity cells. It has been demonstrated
that the ‘ionic’ clearance, which is the mean value of the clearance of
all ions in the dialysate, reflects urea clearance. From the measured
clearance and the treatment time registered by the dialysis machine,
Kt can be calculated. For calculation of Kt/V, which is a commonly
used measurement for the dialysis dose, independent information
regarding the total body water of the patient is required. An alterna-
tive method for measuring Kt/V online is the continuous measure-
ment of uremic solutes in the dialysate. Rather elaborate devices for
continuous measurement of urea were manufactured by Baxter [45]
and Gambro [46] , but are no longer on the market. More recently,
the availability of light-emitting diodes for the ultraviolet (UV)
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range allows a relatively simple measurement of UV-absorbing ure-
mic toxins and other substances diffusing from the patient’s plasma
into spent dialysate. Although these substances are different from
urea, the removal kinetic is first order as well, which allows the
direct calculation of Kt/V for these substances, which can then be
converted into Kt/V for urea. No information regarding the total
body water of the patient is required. In case the dialyzer function
deteriorates during dialysis, dialysate measurement of uremic solutes
would be false positive, which means that a high Kt/V value would
be calculated, although the true Kt/V is lower than anticipated at
start. Combining online clearance measurement with continuous
measurements in the spent dialysate can ameliorate this problem.
For personal use only.
The latest machines of the leading manufacturers allow the
transfer of data between dialysis machines and central computers
via a network. Some machines also store data on patient cards.
Unfortunately, these data outputs are not compatible because no
standard exists.
Fresenius
Fresenius Medical Care AG & Co KGaA is an affiliation of
Fresenius SE and a vertical integrated dialysis company producing
all products required for hemodialysis, but also operating dialysis
clinics worldwide (Figure 1) . It is the clear market leader in this
field. The rise of this company is partially due to the continuity
of its technical-oriented management, and by the continuity of
the core technology for dialyzers and machines.
The machine technology evolved from the 2008 series of
machines [110] , which began with the concept of an autoclaveable
machine that was later abandoned because of technical problems.
This series of machines was based on a modular concept allowing
the individual positioning of a blood pump and air detector mod-
ule and also allowed the addition of two more modules. By 1983,
the technological problems with the machine were solved and the
A2008C (C stood for ‘chemical disinfection’) was successful on
the German market. After first contact in 1984 with the small
company Seratronics, in Concord (CA, USA), Fresenius USA was
established. The first machines were sold in the USA in 1985.
Parallel to this development, the A1008D was developed in
1983–1985. This machine was the first worldwide machine com-
plying with the new hemodialysis devices standard [19] (now IEC
60601-2-16). It was also the first Fresenius machine comprising
a microprocessor for the automatic test of the protective system
and a battery backup for the extracorporeal circuit.
796
Another development in this period was a bedside monitor
(2008BSS) that was sold in the USA and in France (Tassin).
The A2008D machine was only sold in the USA between 1987
and 1990. It used the blood circuit modules of the A1008D.
The A2008E introduced in 1990 was an enhancement of
the A2008D.
Fresenius USA presented an alternative cost-efficient machine
in 1992 – the 2008H, which was based on the bedside station
2008BSS. The 4008 machine was developed in the Fresenius fac-
tory in Schweinfurt, Germany, and put on the market in 1994.
At this time, the 2008H made by Fresenius USA was already well
established on the US market. The additional features of the 4008
were not accepted by the US market. Since then, Fresenius USA
sells machines developed and manufactured in the USA. The
current version is the 2008K2, for which the touch panel of the
2008K was abandoned because of a patent dispute with Baxter,
which is not fully resolved, although the US patent department
has recently made an important decision in this case [204] .
The 2008K2 comprises online-clearance measurement [42,47,107] .
This method is also used for measuring access flow [48,49,111] .
The machine can be fitted optionally with a dialysate filter, the
BTM and BVM. The low-flow option allows the machine to be
used for sustained low-efficiency dialysis. In principle, machines
sold by Fresenius USA were always upgradeable or retrofitable,
which was an important sales argument during the initial years
of this company.
For home hemodialysis, the 2008K is offered in a smaller cabinet
(same size as the A2008C).
Outside the USA, Fresenius still offers two versions of the
4008 machine. The 4008H is still available, but the demand
for the smaller 4008S (S = small) is dominant. The main dif-
ference is the width of the cabinet. Both machines comprise
a modular extracorporeal circuit with blood pump, heparin
pump and air detector as standard modules, and BTM, BVM
and blood pressure module as options. Online hemodiafiltra-
tion is available as an option as well. Recently, the 4008S-classic
was put on the market, which is a nonmodular basic machine
with limited options.
The latest models, the 5008 and 5008S, break with the previ-
ous design. These machines are no longer modular in the sense
that easy upgrades in the field are possible. These machines
incorporate most of the ideas patented by Fresenius during
the last 20 years. Although this is not backed by adverse safety
reports for the previous models, changes in the hydraulics were
sometimes justified by safety in the accompanying patent appli-
cations. Compared with the previous model, the user interface
has been considerably improved, although no relevant treat-
ment features have been added. The improvements comprise of
a state-of-the-art touch screen (the dispute regarding Baxter’s
European patent 0668793 is ongoing after it had been granted
in 2000 and revoked in 2006), three new peristaltic pumps
allowing a more easy loading of the tubing, an air-free arterial
pressure sensor [112] and a cover for the extracorporeal circuit.
Many additional valves and sensors have been added to detect
leaks, prevent user errors and allow the operation with central
Expert Rev. Med. Devices 7(6), (2010)
 Hemodialysis machine technology: a global overview Review

concentrate delivery systems, and dry and liquid bicarbonate

concentrates. This additional comfort has boosted the weight of
the machine from 92 kg for the 4008H to 135 kg. The number
of valves has been increased from 29 to 58, and the number
of components listed in the legend to the hydraulic diagram
increased from 112 to 154.
Like most machines put on the market in the last few years, many
service functions, such as priming of the extracorporeal system,
system test, disinfection and monitoring functions, are controlled
by the machine, which reduces the workload for the nurses.
The company emphasizes the environmental aspects of the
5008, which are based on reduced water and energy consump-
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tion. This is achieved with the AutoFlow function, which adapts

the dialysate flow to the effective blood flow [113] , and a new
heat exchanger.
The GENIUS® hemodialysis machine is a unique batch type
device originally developed by the late Dr Tersteegen [50,114] . It is
remarkable because of its simplicity. Clinical results are at least
comparable with conventional systems. Because the dialysate is
prepared as batch from powder and water, the ionic composition
of the dialysate can be adjusted with greater accuracy compared
with conventional systems.
The GENIUS was developed originally as an integrated system
with multiple use of the extracorporeal systems, including the dia-
For personal use only.

lyzer [51,115] , Fresenius is not offering this feature. The GENIUS

is now promoted for sustained low-efficiency dialysis treatment
of acute renal failure [52,53] .

Gambro
Founded by the hemodialysis pioneer Nils Alwall and the investor
Holger Crawford in the early 1960s, Gambro soon developed into
an important player in the field (Figure 2) . Gambro acquired Hospal
in 1987, which was a joint venture between Rhone-Poulenc and
Sandoz. In 1990, Gambro took over the US company Cobe,
another pioneer of hemodialysis machines.
The dialysis machines offered today still reflect the history. The
classical Gambro machine line includes the still-popular AK200
ULTRA™ S, which historically goes back to the AK10 from 1977
and the AK100 Ultra from 1993.
Figure 1. Fresenius 5008, as shown at the European Renal
The Hospal Integra was introduced from 1994. The Innova Association–European Dialysis and Transplant Association
is the Hospal version of the Phoenix machine, which adopted conference 2008, in Barcelona, Spain. The machine comprises
technology from Cobe. The Phoenix is currently sold in the USA. three pumps allowing for single-needle dialysis and online
The recently launched ARTIS machine uses technology from hemodiafiltration. A dedicated blood tubing system allows for
all predecessors. Gambro pioneered the use of dry concentrates air-free prepump pressure measurement, measurement of blood
volume changes and blood temperature. Electrolyte clearance can
that are converted to liquid concentrates by continuous dissolution be measured periodically, which is used for the online calculation
before being added to water in order to produce dialysate. The of Kt/V and plasma sodium. The elaborate hydraulic system allows
basic patent was revoked in Europe after opposition by almost all connection to central concentrate supply systems, as well as use of
other dialysis machine manufacturers [116] . In Australia, Gambro dry and liquid concentrates.
won a patent dispute against Fresenius [205] . After the success of
the BiCart®, Gambro also introduced the SelectCart® for sodium The AK200 line of machines is primarily promoted for online
chloride, which may gain importance in the future because it offers hemodiafiltration or hemofiltration. The AK96 is a basic machine
the chance for precise dialysate sodium control. For regular dialysis, promoted for home-hemodialysis.
this combination of dry concentrates is supplemented by a liquid The Hospal branch of Gambro developed monitors for
concentrate that contains the remaining ions and glucose, but it is blood volume changes (Hemoscan™) [56,57] online measure-
also possible to infuse these electrolytes to the blood directly [54,55] . ment of dialysance (Diascan™) [58] and dialysate sampling

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 Review Polaschegg
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For personal use only.
Figure 2. Gambro ARTIS in hemodialysis mode. The machine
uses a dedicated blood tubing system already used by previous
machines of Gambro. It offers online hemodiafiltration and
various feedback control modes based on the measurement of
blood volume changes and electrolyte clearance. It calculates
Kt/V and ionic balance. Single-needle treatment uses one pump
only. It offers dialysate preparation with dry NaCl concentrate,
which allows for precise adjustment of the dialysate sodium
concentration.
Image courtesy of Gambro, Stockholm, Sweden.
(Quantiscan™). These monitors are used for feedback control
of physiological parameters: Hemocontrol™ [59,60] for net-fluid
removal and dialysate composition based on online measure-
ment of blood volume changes (Diascan). Diacontrol, for plasma
sodium control, employs the online clearance measurement
798
principle (Diascan) to calculate plasma conductivity, which is a
surrogate for plasma sodium [61,62] .
The latest dialysis machine ARTIS has been designed for easy
use. Once finished, it will combine all options offered by the
Gambro and Hospal machines, which may justify the weight of
approximately 130 kg and 900 pages of instructions for use. It
uses a cassette type blood circuit originally developed by Cobe,
and recently improved by Hospal [117,118] .
Nikkiso
Nikkiso is a company working in several technological fields
(Figure 3) . The medical division is only one out of four divisions,
but the hemodialysis machine technology benefits from the
know-how of the highly specialized pump division. Nikkiso is
the market leader with machines in Japan, where bedside sta-
tions connected to central dialysate delivery systems account
for approximately 88% of the approximately 110,000 dialysis
monitors [17,63] . The central dialysate delivery system consists of
a water treatment module, which also supplies individual dialysis
machines (DBB-26). Dialysate concentrate is mixed from powder
and water by powder-mixing systems (DRY-1 or DRY-11A), and
the concentrate is mixed volumetrically with water by the central
mixing station (DAB-E series). Dialysate is supplied to consoles
(DCS-26, DCS-73) that also contain dialysate bypass valves.
Disinfection of the complete dialysate system is controlled by
the central unit. According to Nikkiso, central dialysate delivery
systems are also sold to Taiwan and Vietnam.
Nikkiso Medical moved to Europe with the dialysis machine
DBB-03, which was designed for the German market. Some
features indicate that the design was influenced by the dialysis
machine from B Braun. The company has recently acquired Mesys,
a German company making the Aquarius dialysis machines for
intensive care. This device is distributed by Edwards, which was
recently taken over by Baxter. Nikkiso also started assembly of
dialysis machines for Europe, and possibly the USA, in a fac-
tory in Hannover, Germany. In the USA, Nikkiso has already
achieved 510-k clearance through DaVita 2003. More recently,
Nikkiso received 510-k clearance for the model DBB-06. It may
be speculated that this device will be distributed by Baxter in the
USA and possibly elsewhere. Current models are the DBB-05
with optional online hemodiafiltration and a more cost-effective
version DBB-06 without online hemodiafiltration.
The online hemodiafiltration system of the DBB-05 employs
a dialysate filter that is tested prior to each dialysis, similar to the
Fresenius approach, and a disposable substitution filter similar
to the Gambro approach. The company introduced the DBB-
07 machine at the recent European Dialysis and Transplant
Association/European Renal Association conference in Munich,
Germany, in May 2010. This machine now uses a hemodiafiltra-
tion system comparable with Fresenius and B Braun Avitum,
which employs two multiple-use filters that are both tested prior
to dialysis. The machines comprise of an optical hemoglobin sen-
sor for blood volume and dialysate sodium control, but no online
clearance measurement. Unlike competitive systems, the hemo-
globin monitor does not require a special blood tubing system.
Expert Rev. Med. Devices 7(6), (2010)
 Hemodialysis machine technology: a global overview Review

The company also emphasizes the hygienic design of the dialysate

coupling. The dialysate filter uses the polyester–polymer–alloy
(PEPA) membrane with a superior endotoxin rejection ratio com-
pared with polysulfone membranes because of the higher absorp-
tion capacity [64] .

B Braun Avitum
The 100-year old family owned company B Braun began the pro-
duction of hemodialysis machines in 1968 (Figure 4) . The dialysis
activities are now bundled in B Braun Avitum. Like Fresenius,
it is a vertical-organized business including all dialysis products
and the operation of dialysis clinics worldwide.
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The dialysis machine, Dialog plus, has been upgraded

recently with new components and state-of-the-art electron-
ics, without changing the machine design. Besides the usual
standard features, it comprises a post-pump-pressure transducer
in the extracorporeal circuit, and an online hemodiafiltration
system similar to the Fresenius one with one dialysate filter
and one substitution filter. A unique feature is the recently
developed Adimea sensor, which measures the absorption of
UV light in spent dialysate at 285 nm [65,66] . Absorption at
this wavelength is mostly from uric acid [67] . Nevertheless, the
slope of the concentration versus time allows the calculation
of Kt/V (urea), which is the recognized standard for measur-
For personal use only.

ing dialysis dose. The principle was demonstrated in 1980 [68] .

A free-standing device measuring UV absorption in dialysate
is offered by LDiamon AS (Tallinn, Estonia) [119] . While the
sensor of the B Braun machine is similar or identical to the
LDiamon system, the software is a proprietary development of
B Braun Avitum [120] .

Bellco
The company, founded in 1972, was taken over from Sorin by
private equity firms in 2008. The company has traditionally
served niche markets and has pioneered several developments
that have been taken over by others or may become important
in the future. The Bellco Unimat® was the first monitor with a
disposable hydraulic circuit.
The use of a differential mass flowmeter based on the Coriolis
principle was another innovation of Bellco. This principle is
now used in the Gambro ARTIS machine, which is produced
by Gambro-Dasco (Medolla, Italy), situated right opposite the
Bellco factory in Mirandola.
Bellco has pioneered paired-filtration dialysis, which combines
a high-flux membrane for filtration and a low-flux membrane for Figure 3. Nikkiso DBB05, as shown at the European Renal
dialysis in a single filter. Since the filtrate is removed separately, Association–European Dialysis and Transplant Association
it can be used for online ana­lysis of the constituents that reflect conference 2008, in Barcelona, Spain. The machine uses two
peristaltic pumps, of which one is used either for double-pump
plasma concentration [69] . single-needle treatment or, alternatively, for online
Bellco has also promoted online regeneration of filtrate as an hemodiafiltration treatment. A hemoglobin sensor for blood
alternative to online hemodiafiltration. This system, however, volume control is optionally available. Kt/V is calculated online
does not offer medical advantages [70] or cost advantages. The based on treatment prescription data and blood flow.
state-of-the-art machine Formula® Therapy also offers standard
online hemodiafiltration and mid-dilution hemodiafiltration with Toray
a special filter [71] . The low volume of the dialysis fluid circuit Toray Medical is a member of the diversified Toray group. In dialy-
may reduce time during set-up and disinfection of the machine. sis, the company is known worldwide primarily for its dialyzers.

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 Review Polaschegg
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For personal use only.
Figure 4. B Braun Avitum: Dialog plus, as shown at the
European Renal Association–European Dialysis and
Transplant Association conference 2008, in Barcelona,
Spain. The machine employs two peristaltic pumps, of which the
second one can be used either for single-needle treatment with
the cross-over method or, alternatively, for online
hemodiafiltration. It offers a fuzzy logic control of the
ultrafiltration rate based on the patient’s blood pressure which is
measured periodically using a conventional blood pressure
monitor. The optionally available Adimea monitor measures the
optical absorption in the dialysate in the UV range. It is used to
calculate Kt/V. For hematocrit and oxygen saturation
measurement the Crit-line Monitor from Hemametrix can be
connected to the machine.
800
Toray was the pioneer of ultrafiltration control with balancing
chambers in Japan. The TR-FX2 machine is a standard, no-frills
hemodialysis machine, which can optionally be equipped with a
dialysate filter. The TR-8000 ‘YUGA’ offers most of the features
of European machines, including online hemodiafiltration option-
ally, but no heat disinfection and physiological controllers. It is
offered outside the USA and Europe, although the machine is
shown at conferences in Europe.
Nipro
Nipro is a specialized medical devices and drug company with
a focus on dialysis equipment, and one of the large suppliers for
fistula needles and dialyzers. The Nipro SURDIAL machine
was occasionally shown at European exhibitions, but is sold
mostly in Asia and South America. The machine features dis-
crete bargraphs and digital monitors rather than a full screen.
The company emphasizes the volumetric balancing system,
which does not require a separate ultrafiltration pump. The
machine does not offer heat disinfection and dialysate pro-
duction from dry concentrates. The Nipro Surdial 55 offers a
rotatable touch screen.
The Diamax machine additionally offers dialysate filtration
and heat disinfection.
The SURDIAL X machine was shown at the 2010 European Renal
Association–European Dialysis and Transplant Association (ERA/
EDTA) conference. This machine now offers heat disinfection, and
also allows the use of dry bicarbonate concentrate.
JMS
Japan Medical Supply (JMS) is a medical company with activities
in infusion technology, blood collection, heart–lung machines
and dialysis. Outside Japan the company is best known as a lead-
ing supplier of fistula needles. Although the company announces
single-patient machines on the website, information is only
available on a fully automated central dialysate delivery system
GC-110N with bed-side monitors. It comprises dialysate filtration
and allows automatic priming of the dialyzer by dialysate back-
filtration [72,121] . The same principle is also used for backflushing
of blood and for rapid infusion during dialysis.
Chinese manufacturers
The information below was retrieved from the internet. No user
reports in English language have been found.
Four manufacturers of hemodialysis machines have been
identified:
• Chengdu Weilisheng Biotech (Chengdu, China) offers a
machine, WT2008B. Not only the name, but also the design,
is similar to the older Fresenius product 4008B. No specification
was available on the internet or by request;
• Chongqing Tianhai Medical Equipment Co. (Chongqing,
China), founded 1995, sells the dialysis machine MR-100M.
The specification reveals that this is a basic machine but offer-
ing heat disinfection, which indicates German rather than
Japanese influence;
Expert Rev. Med. Devices 7(6), (2010)
 Hemodialysis machine technology: a global overview Review

• Jihua Medical Apparatus and Instruments Co. (GuangZhou,

China), founded 2000 as joint venture between the JiNan
university and the GuangDong Medical Group. The develop-
ment of the hemodialysis machine JH-2000 was finished in
2004. The company is fully certified by the notified body Det
Norske Veritas (DNV) from Norway (a certification company
with focus on maritime technologies). The JH-2028 is an
upgraded machine with sodium and ultrafiltration profiling.
Kt/V function (supposedly a calculation rather than measure-
ment), adjustable bicarbonate concentration, battery backup,
dialysate filter and network connection are options. The dial-
ysis machine bears the CE mark since 2007. This machine
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was shown on the Allmed booth at the ERA/EDTA confer-

ence exhibition in 2007 in Barcelona, Spain under the name
‘Mondial 100’;
• An alternative version, the JHM-2028 double-pump LCD
hemodialysis machine, is offered as the ‘Pristina’ machine by
Allmed, which was shown at the 2010 ERA/EDTA conference.
This machine differs minimally from the JHM-2028, which
was shown on the Jihua booth, together with the Aiso-3038
machine. The 3038 and 4048 versions allow hemodiafiltration
with pharmaceutical fluids used as substitution fluid.
Apparently these machines were closely modelled after the 4008
For personal use only.

machine of Fresenius. Even the description of the sodium and

ultrafiltration profiles are a near-copy of the 4008 manual.
Chongqing Shanwaishan Science & Technology Co. offers a
series of machines:
• The SWS-4000A comprises sodium and ultrafiltration profiles,
Kt/V calculation, heat disinfection and battery backup;
• The SWS-4000B comprises a second peristaltic pump for
hemodiafiltration with pharmaceutical replacement fluids;
• The SWS-4000 also allows online hemodiafiltration;
• All machines have a comparably low weight of approximately
60 kg.
The return of home hemodialysis
Although only a small number of patients were receiving home
hemodialysis in the 1980s, some doctors were convinced that
this is the only way for offering patients longer and/or more
frequent treatment, which is believed to improve survival rates
and patient well-being. Patients in Tassin were treated for 8 h,
three-times a week in the clinic, but most home patients in Tassin
dialysed every other day or night. The market leaders neglected
the field. Only in recent years have standard machines been
slightly modified for home-hemodialysis: The Fresenius 2008K
‘Baby K’ and Gambro AK96. Dedicated machines were devel-
oped or are being developed by small companies [73] . Some are
already on the market.
Aksys
In the 1990s, Zbylut Twardowsky designed a machine with
a reusable (extended use) extracorporeal circuit and dialyzer,
Figure 5. NxStage® System One (on top) home unit on
PureFlow™ SL dialysis preparation and storage device. The
treatment device uses a cassette system that integrates the blood
and dialysate flow circuit. Dialysate is produced from a single dry
concentrate containing lactate rather than bicarbonate.
Alternatively, the system can be operated using bags with
pharmaceutically produced dialysate. This is the preferred method
in the intensive care unit, but can also be used in the home or
while travelling.
Image courtesy of NxStage, MA, USA.
with the goal to reduce the workload for the patient [74,122] . A
group of people from Baxter’s Renal Division founded Aksys,
a venture-backed company that later went public. The approval
of the Aksys PHD® system [75] for marketing was originally
anticipated for 1996, but it took 6 more years until the company
could announce US FDA clearance. In the same year, 2002,
Aksys achieved the CE mark and reported the first treatment
in the UK. Although clinical reports were positive [76,77] , the
company eventually failed financially and was winded down in
January 2007. Aksys has demonstrated successfully that home-
hemodialysis with extended use of the extracorporeal circuit
is possible [123,124] . In addition, they have demonstrated the
practicability of priming by backfiltration through the dialyzer
membrane, which had been proposed before.

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 Review Polaschegg
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Figure 6. Xcorporeal’s Portable Artificial Kidney concept
study, as presented in 2008. The company is out of business.
The intellectual property has been taken over by Fresenius. It is
likely that Fresenius will combine this technology with the
technology of RenalSolutions. The device combines the
advantages of the NxStage® System One disposable cassette with
the dialysate regeneration of Renal Solutions.
For personal use only.
Before going out of business, Aksys announced an agree-
ment with DEKA for the development of the next-generation
machine (Figure 7) [206] . This development will be discussed
later (DEKA).
The initial success of Aksys on the financial market and the
medical success of the Toronto group [16] with nocturnal home
hemodialysis motivated others to design dialysis machines suitable
for home hemodialysis.
So far, one company succeeded in spite of financial losses, thanks
to the unique design of the dedicated home hemodialysis machine.
NxStage®
The company was founded in 1998 as QB Medical, Inc., and
later changed its name to NxStage Medical, Inc. The company
has manufacturing plants in Mexico, Germany and Italy for
the production of the machine, dialyzers and the disposable
fluid cassette (Figure 5) . The company has never made a profit
and has accumulated losses of approximately US$276 mil-
lion [207] . Recently, NxStage® has established a partnership with
Asahi Kasei Kuraray Medical. Asahi provides NxStage with
US$40 million of debt financing, and NxStage gains access to
the Asahi polysulfone membrane.
NxStage has recently closed distribution agreements with
European dealers (Kimal in the UK, Dirinco in the Netherlands).
Asahi is a potential partner for distribution in Asia.
The NxStage System One concept was originally modeled after
the well-established peritoneal dialysis cyclers; dialysis using phar-
maceutical dialysate or hemofiltration replacement fluid supplied in
bags. Unlike previous hemodialysis/hemo­filtration machines using
this concept, the System One uses disposable volumetric balancing
chambers rather than scales for fluid balancing. This allows for
802
easier handling of the waste, which can be dumped directly into
the drain [78,125] . Volumetric fluid balancing is well established with
standard dialysis machines, and disposable systems have been used
before [126,127] .
Both the extracorporeal circuit and the dialysate/filtration cir-
cuit are integrated into a single cassette system. Balancing cham-
bers made from flexible bags and conventional tubing is used in
combination with rotary peristaltic pumps. The dialyzer is inte-
grated into the cassette system, but cassettes without integrated
dialyzer are also available. This makes the setup of the system
less complicated compared with standard machines, although the
priming process is still not fully automatic. Air has to be removed
manually with a syringe [208,209] .
Apparently the company has hoped that the increased cost for
six treatments per week will be reimbursed [79] , which is not yet
the case today.
In order to offer a more cost-effective treatment, an add-
on system for producing dialysate onsite was developed. The
PureFlowTM SL device, which received FDA clearance in 2006,
produces a batch of high-purity dialysate that can be used for up
to three treatments. Water is purified by a disposable cartridge
using ion exchange, carbon adsorption and filtration, but not
reverse osmosis. Typical cartridge use time is 6 weeks. The batch
is produced in a disposable bag that contains the concentrate,
which contains lactate rather than bicarbonate [80] . Batch prepa-
ration time is approximately 7 h. Separation of dialysate prepara-
tion from dialysate use allows the use of a low-flow water treat-
ment system [128] . The use of a prefilled bag for batch preparation
of dialysate has been described before [129] . One disadvantage
of all batch-type dia­lysate machines is energy consumption for
heating because, unlike with conventional systems, the energy
is not recuperated with heat exchangers. This may be a concern
outside the USA.
RenalSolutions, a wholly owned subsidiary of
Fresenius Medical Care
The company has a long history that goes back to the 1970s
when CCI Life Systems introduced the REDY® (REcirculating
DYalysis) machine. Before Fresenius took over in 2007 for
US$190 million [210] , the technology was owned by Organon
Teknika (1983), followed by Gambro (1992) and SORB
technology (1999). In 2001, SORB Technology merged with
RenalSolutions. The company has developed the Allient ®
Sorbent Hemodialysis System, which employs the slightly
improved REDY sorbent cartridges for dialysate regenera-
tion [81,82] . The machine comprises a disposable dialysate cir-
cuit that requires only 6 l of tap water for priming. Tap water
can be used because the sorbent cartridge, which contains ion
exchange material and activated charcoal, exchanges the ions in
tap water for sodium, and adsorbs chloramines and endotoxins.
The extracorporeal system comprises a unique pneumatic-driven
blood pump that can also be used for single-needle dialysis [130] .
No clinical activities have been reported recently. This may be
related to problems with the blood pump [211] . The machine is
no longer advertised on the website.
Expert Rev. Med. Devices 7(6), (2010)
 Hemodialysis machine technology: a global overview
Xcorporeal
Xcorporeal developed a portable dialysis machine and a wear-
able artificial kidney between 2006 and 2009. The company
was created through mergers with or transitions from other
companies [212] . The business plan from 2006 [213] estimated
that clinical trials would begin 2008. The company ran out of
money, sold the intellectual property to Fresenius and went out
of business in March 2010. The company showed models of the
portable machine at various shows [214] . The portable dialysis
machine was shown in two versions: a device for in-center use,
which is compared with the PrismaFlex® from Gambro; and a
device for home use. The device consists of a fluid-part contain-
Expert Review of Medical Devices Downloaded from informahealthcare.com by Nyu Medical Center on 11/30/14
ing weight scale, heater, conductivity sensor and a disposable bag
that is initially filled with 6 l of tap water. A disposable cassette
system similar to the NxStage cassette [131,132] is inserted into the
console unit that also houses the microprocessor control unit and
a touch screen. Dialysate is regenerated using the principle pio-
neered by the REDY machine. Apparently, the design attempts
to combine the advantages of the NxStage System One and the
Renal Systems Allient.
DEKA
DEKA, named after its founder and famous inventor, Dean
Kamen, began the development of a home hemodialysis machine
For personal use only.
as part of a collaboration with Aksys (Figure 8) . During this ini-
tial phase, Aksys tried to raise money and presented the goal of
this development [215] . According to this presentation the new
machine, will provide all the advantages of the first-generation
Aksys machine, while being smaller, lighter, quieter, transport-
able and more reliable. The cost to manufacture, install and
maintain will be lower. After Aksys went out of business, Baxter
announced a collaboration with DEKA and the company HHD,
LLC which owns some intellectual property [216] . DEKA and
HHD applied for several patents that apparently describe the
new home hemodialysis machine. Two patents [133,134] allow
some insight. Both, the dialysate and the blood system are oper-
ated with pneumatic pumps and valves that are powered by a
detachable power unit. The extracorporeal system is integrated
in a cassette system that can be easily inserted behind doors.
The system also allows for extended use of the extracorporeal
system. One advantage of extended use of the extracorporeal
system is the lower space requirement at home for disposables
and biologic waste.
Quanta
Quanta Fluid Solutions is a spin-off of IMI vision, the dedicated
innovation unit of IMI plc, and has apparently raised US$24 mil-
lion for the development of a home hemodialysis machine using
an all-disposable cassette system for the dialysate circuit as well
as for the blood circuit. The cassette system consists essentially of
two hard plastic platens, which form the contours of all pumps,
valves and conduits. These platens are covered by flexible sheets
that are deformed by actuators. Water is heated and degassed sepa-
rately [135,136] . The basic concept of a disposable system formed
by two flexible sheets was already described by Lichtenstein [137] .
www.expert-reviews.com
Review
Figure 7. Aksys PHD-2 model as presented in Security and
Exchange Commission filings from October 4, 2006 [215] . It
may be assumed that this model is similar to the DEKA machine
under development.
Home dialysis plus
The company intends to develeop a lightweight (14 kg) home
hemodialysis machine [217] with a microchannel dialyzer [218] ,
employing Microtechnology-based Energy, Chemical &
Biological Systems (MECS) technology.
The engineering knowledge of this company includes former
coworkers of Drake and Willock, a pioneering company of hemo­
dialysis, which was later acquired by Althin Medical (CA, USA),
which was then acquired by Baxter. This know-how is complemented
by Kevin Drost, Director of the Center for MECS [219] .
Introduction to the market was originally estimated for 2010.
The company was not ready to provide any technical information
or information regarding funding, but funding of US$50 million
from private investment was announced in June 15, 2010 [220] .
Expert commentary
Companies
The rise and fall of the established companies in the field is related
to the qualification of the management. It is possible for scientists
to understand the medical aspects of dialysis, and learn the finan-
cial and marketing aspects of business. The opposite is not neces-
sarily the case. Financial people have a much greater difficulty in
learning the medical and scientific aspects of dialysis.
Fresenius, during it’s ascend from a small family-owned com-
pany to the world market leader, was always managed by scien-
tists and engineers. This will change in the next few years, and
may become a problem when making major technical decisions
regarding the future.
In the 1990s, Gambro changed ownership and management,
and moved headquarters from Lund to Stockholm. Management
moved away from the real life of research and manufacturing.
In these years, Gambro lost the leadership in dialysis. Shortly
after the second fraud settlement with the US government
[221] , Gambro divested its US clinics to DaVita [222] . Technical
803
 Review Polaschegg
516 23
516
172
518 172
174
514
519 519
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510
53
53
518
14
518 513
517
Figure 8. Interior view of the DEKA machine according to
US patent application US20100051529 with inserted blood
circuit cassette: 14 = dialyzer, 23 = blood pump,
513 = clamp [133] . This patent application describes a device with
cassettes for the extracorporeal system and the dialysate fluid
path. All valves and pumps are pneumatically operated. The
extracorporeal system is designed for extended use (multiple use)
For personal use only.
in the home.
problems and noncompliance with the FDA resulted in an import
ban for all products produced in the Gambro–Dasco factory in
Mirandola, Italy [223] . Gambro never managed to integrate fully
the various acquisitions, and still sells two technically diverse
lines of dialysis machine products. It is highly questionable if
Gambro will regain its former strength.
Nikkiso, a company well established in Japan, has not yet
been very successful in Europe. This may change with the new
DBB-07, and if the Japanese management transfers more design
responsibility to the German factory. Nikkiso has recently received
FDA 510-k clearance for the DBB-06 machine in the USA. The
company is not able to develop this market by itself. Most likely,
they will team up with Baxter. Nikkiso has missed the chance to
introduce the cost-efficient central dialysate delivery system to
the USA and Europe.
B Braun is an ‘old fashioned’, German-controlled company,
which is growing slowly and steadily. Thus, no revolutionary
movement can be expected.
The other Japanese and Chinese manufacturers will look for
markets outside the USA and Europe. Dialysis machines con-
stitute only a fraction of the total costs of dialysis, and require
substantial efforts for training and maintenance. The motivation
to buy such machines even at a lower price will be limited in
Europe and the USA.
Baxter will most likely re-enter the market with a home hemo-
dialysis machine developed by DEKA, and possibly with Nikkiso
as partner in the USA and elsewhere. So far, Baxter has failed in
the hemodialysis machine market, although the companies that
were acquired by Baxter produced competitive machines at the
804
time of acquisition. It is questionable if the peritoneal dialysis
oriented sales organization will be able to sell the much more
demanding home hemodialysis system.
Technology
Over the last 20 years, machines of the leading companies
became increasingly elaborate, larger and heavier. Feedback
control of physiological parameters has reduced intradialytic
symptoms, and has improved the well-being of patients. It also
has made life easier for nurses. Online hemodiafiltration has
improved biochemical markers, but this was not accompanied by
an improvement of patient survival, although a survival advan-
tage is claimed by some papers [70,83–86] . Data from the Fresenius
network published in abstract form and claiming a reduction of
the mortality risk of 37% was never published in a peer-reviewed
journal [87] . So far, all published work is retrospective [88–90] .
The Turkish hemodiafiltration study: a comparison of post-
dilution online Hemodiafiltration and Hemodialysis [224] , which
is supported by Fresenius and is now complete, may help to
clarify this issue. No results were presented at the recent ERA/
EDTA conference held in June 2010, but may be made known
at the American Society for Nephrology conference, to be held
in November, 2010.
Although online measurement of treatment parameters such
as clearance, and the calculation of Kt/V and plasma sodium,
is heavily promoted by the leading manufacturers, all warn
about the use of these parameters for adjusting treatments.
Precise sodium control may become more important as the
result of new insights into sodium homoeostasis [91] , which may
increase the interest in feedback-controlled dialysate sodium
adjustment.
The Hospal-Cobe line of machines of Gambro, as well as the
5008 machines of Fresenius, use dedicated blood lines, which
are produced only by the manufacturer of the machine. The
risk related to the dependence on a single source may deter some
customers who are aware of recent problems related to propri-
etary extracorporeal circuits [92] . In one case, machines were
changed because of problems with the proprietary blood tubing
system [93] .
In the absence of any new concept that reduce mortality within
the frame of conventional treatment, of 4 h, three-times per week,
machine development has focused on the improvement of the user
interface. Although progress has been made, machines are still far
from being user-fault tolerant.
Assuming that high-tech hemodiafiltration with a conven-
tional treatment schedule of 4 h, three-times per week reduces
mortality, one may wonder why low-tech but long-term treat-
ment (central dialysate delivery, low flux dialyzer) like in
Tassin [11] , achieved extraordinary results. It is likely that
treatment time and good medical care is more important than
flux and clearance. If this is indeed the case, then the current
130 kg heavy flagships of the market leaders may become the
overengineered dinosaurs of hemodialysis that will be replaced
by cost-efficient machines for the clinic and small dedicated
machines for the home.
Expert Rev. Med. Devices 7(6), (2010)
 Hemodialysis machine technology: a global overview Review

Five-year view
No clinical evidence exists yet that would demand a change of
technology. For this reason, no dramatic changes or new devel-
opments can be expected. 10 years ago, Polaschegg attempted
a 10-year view in the future [94] . Although this view was based
on already existing or patented technology, only a few of the
predictions are slowly becoming evident in the market. Some of
the predictions 10 years ago are still candidates:
• Introduction of online hemodiafiltration in the USA incase
reliable studies confirm the marketing-driven preliminary
results claiming a survival benefit;
Expert Review of Medical Devices Downloaded from informahealthcare.com by Nyu Medical Center on 11/30/14
slow down the growth of conventional dialysis, because only 20%
of patients are believed to be candidates for home hemodialysis;
• Use of dialysis regeneration for home hemodialysis. This will
include the already existing sorbent systems based on REDY,
but also novel sorption materials for direct removal of urea and
nanomaterials with higher adsorption capacities;
• Wearable artificial kidneys will be developed in the next
5 years, but it is unlikely that this will have any impact on the
market within this period. None of the systems that were
tested or proposed in the past few years have solved or even
attempted the problem of safe disconnection and reconnection

• Further automation of the hemodialysis process employing
feedback control, which may reduce the frequency of user errors
and increase the efficacy by optimizing blood flow;
• Integration of the dialysis units, which already exist to a limited
extent, may become more widespread and may use more pow-
erful programs for trend ana­lysis of patient-related data. Can-
didates are: access pressure for access surveillance; pressure/flow
data for catheter surveillance; body temperature and energy
balance for metabolic data; plasma sodium and electrolyte bal-
ances for better control of the nonosmolar sodium pool; and
blood volume data for dry weight changes;
For personal use only.
by the patient. Only a minor percentage of patients will accept
a wearable device weighing approximately 0.5–2 kg without
the possibility of disconnecting it for a few hours. However,
these wearable devices will make the community aware that
dialysis can be efficient and simple, which may cause a reversal
of the trend to ever more complicated and heavier machines.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any
organization or entity with a financial interest in or financial conflict with
the subject matter or materials discussed in the manuscript. This includes

• An increase of home hemodialysis use, thanks to new patient-user employment, consultancies, honoraria, stock ownership or options, expert
friendly machines. A limiting factor is the lack of training facili- testimony, grants or patents received or pending, or royalties.
ties. The increased use of home hemodialysis will only moderately No writing assistance was utilized in the production of this manuscript.

Key issues
• A single manufacturer controls more than 50% of the hemodialysis machine market. Three European and three Japanese companies
control more than 95% of the market.
• Recent, sophisticated developments in hemodialysis technology have not improved patient outcome.
• The claimed benefits of online hemodialfiltration have not been supported by randomized controlled trials.
• The medical community increasingly convinced that more frequent and/or longer hemodialysis time is more important.
• Current flagship dialysis machines may be the dinosaurs of hemodialysis, doomed to die out.
• Leading companies have relaunched simpler machines.
• Chinese companies emerge on the market. The technology used is a close copy of the older generation of the market leader’s device.
• Home hemodialysis machines based on new technologies are developed by start-up companies.
• Baxter plans a relaunch of its hemodialysis machine business.
• Fresenius acquires know-how for home hemodialysis machines.

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 Hemodialysis machine technology: a global overview Review

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www.expert-reviews.com 809
 Review Polaschegg

Appendix: Company addresses

Company addresses and websites.

Company Company address Company website
abbreviation
Allmed Allmed Medical GmbH, Karl-Marx-Street 23, 01109 Dresden, Germany www.allmedgrp.com
Baxter Baxter International Inc, One Baxter Parkway, Deerfield, IL 60015-4625, USA www.baxter.com
Bellco Bellco s.p.a. Via Camurana, 1 I-41037 Mirandola, Italy www.bellco.net
B Braun B Braun Avitum AG, Schwarzenberger Weg 73–79, D-34212 www.bbraun.com
Expert Review of Medical Devices Downloaded from informahealthcare.com by Nyu Medical Center on 11/30/14

Melsungen, Germany
Chengdu Chengdu Weilisheng Bioscience Technology Co Ltd, 2F.Block C, JiuXing http://nv6qi784.en.busytrade.
Weilisheng Avene 6. High-Tech Zone Chengdu, Sichuan 610041, China com
Chongqing Chongqing Shanwaishan Science & Technology Co Ltd, 67 3rd Road ke-yuan, http://en.swskj.com
Shanwaishan Hi-tech zone, Chongqing, 400041, China
Chongqing Tianhai Chongqing Tianhai Medical Equipment Co Ltd, D2–5 Jinguoyuan, High New Area, www.c-thme.com
Shiqiaopu, Jiulongpo, Chongqing, 400039, China
DaVita DaVita Inc. 1551 Wewatta Street, Denver, CO 80202, USA www.davita.com
DEKA DEKA Research @ Development Corp. Technology Center, 340 Commercial Street, www.dekaresearch.com
Manchester, NH 03101-1108, USA
Edwards Edwards Lifesciences, One Edwards Way, Irvine, CA 92614, USA www.edwards.com
For personal use only.

Fresenius Fresenius Medical Care AG Co KGDaA, Else-Kröner-Street 1, D-61346 Bad Homburg, www.fmc-ag.com
Germany
Fresenius USA Fresenius Medical Care North America (FMCNA) Headquarters, 920 Winter Street, www.fmcna.com
Waltham, MA 02451–1457, USA
Gambro Gambro, Head Office, Regeringsgatan 29, S-103 91 Stockholm, Sweden www.gambro.com
HemaMetrics HemaMetrics, 695 N. 900 W, Kaysville, UT 84037-4118, USA www.hemametrics.com
Home Dialysis Plus Home Dialysis Plus, Ltd., 2828 SW Corbett Avenue, Suite 114, Portland, OR 97201, www.homedialysisplus.com
USA
Hospal HOSPAL Headquarters, Gambro Renal Products, Ikaroslaan 61, www.hospal.com
Zaventem 1930, Belgium
IMI vision IMI Vision, Tything Road, Arden Forset Ind. Est., Alcester, Warwickshire www.imivision.com
B49 6EU, UK
JMS JMS Co, Ltd. Overseas Department 12–17, Kako-Machi, Naka-Ku, Hiroshima www.jms.cc
730–8652, Japan
Jihua Jihua Medical Apparatus and Instruments Co., Ltd., 7F, Building D, Gaopu Road, www.ji-hua.cn
GaoTang Region, TianHe District, Guangzhou, China
LDIAMON LDIAMON AS, Tammsaare tee 118d, EE-12918 Tallinn, Estonia www.ldiamon.eu
Medisystems Medisystems, a NxStage® Company, Corporate Headquarters, 439 South Union www.medisystems.com
Street, 5th Floor, Lawrence MA 01843, USA
Nikkiso Nikkiso Co Ltd, 43-2, Ebisu 3-Chome, Shibuya-Ku, Tokyo, Japan-150–8677 www.nikkiso.co.jp
Nipro Nipro Corporation, Head Office, 3–9–3 Honjo-Nishi Kita-Ku, Osaka, Japan-531–8510 www.nipro.co.jp
NxStage® NxSTAGE Medical, Inc. 439 South Union Street, 5th Floor, www.nxstage.com
Lawrence, MA 01843, USA
Quanta Fluid Quanta Fluid Solutions, Tything Road, Alcester B49 6EU, UK www.quantafs.com
Solutions
Renal Solutions Renal Solutions, 770 Commonwealth Drive, Suite 101, Warrendale PA 15086, USA www.renalsolutionsinc.com
Toray Toray Medical Company Limited, Head Office, Toray Building 5F, 8–1, Mihama www.toray-medical.com
1-chome, Urayas, Chiba, Japan-279–8555

810 Expert Rev. Med. Devices 7(6), (2010)