a project report on

A TRAINING REPORT
ON
DIALYSIS-KEY TO A LONG LIFE
Submitted in partial fulfillment for the award of degree of
BACHELOR OF TECHNOLOGY
IN
BIOMEDICAL ENGINEERING
Under the Supervision of:
Under the Supervision of:
Mr. Sanjeev Kumar
Area Technical Manager-North
Fresenius Medical Care (India) Pvt. Ltd.
Mr. Ravish Garg
Assistant Professor (BME)
GJUS&T, Hisar
Submitted By:
PRAVEEN KUMAR
Roll No.- 0814117
VIIITh Semester
Biomedical Engineering
Department of Biomedical Engineering
Guru Jambheshwar University of
Science & Technology, Hisar
(2008-2012)
2
ACKNOWLEDGEMENT
An industrial training is a golden opportunity for learning and self development. The submission
of this report give me an opportunity to convey my gratitude to all those who help me rich a
stage where I have immense confidence to launch my carrier in the competitive world.
This training is an acknowledgement to the intensity drive and technical competence of many
persons who have contributed to it. I consider myself very lucky and honored to have so many
wonderful people lead me through in completion of this project. I would like to express my
gratitude to the Technical Department for providing me all the help and support in completion
of my project. The project would not have taken its present shape without their guidance and
valuable time.
My grateful thanks to Mr. Sanjeev Kumar, Area Technical Manager-North who in spite of
being extraordinary busy with his duties, took time to hear, guide and keep me on the correct
path. I do not know where I would have been without him. A humble ‘Thank You’ sir.
Ms. Medha Mathur, HR Department monitored my progress and arranged all facilities to
make life easier. I choose this moment to acknowledge her/his contribution gratefully.
Mr. Ravish Garg, Assistant Professor, Department of Bio-Medical Engineering, whose
patience I have probably tested to the limit. He was always so involved in the entire process,
shared his knowledge, and encouraged me to think. Thank You, Dear sir.
I would like to thanks Dr. R. K. Gupta, Head, T&P cell, G. J. U. S. & T., Hisar, Haryana for
his efforts and help provided to me to get such an excellent opportunity.
Last but not the least there were so many who shared valuable information that helped in the
successful completion of this project. I would like to thank to my family, my friends, because
their love, affection and wishes remain with me throughout my academic carrier and successfully
completion of my project.
PRAVEEN KUMAR
(0814117)
3
DECLARATION
I hereby declare that this is an original report based on my own work of study during the
training. I also ensure that the information enclosed here will not be disclosing to anyone and
will only be submitted to the University for the completion of the degree.
Date:
Place:
Praveen Kumar
4
5
Index
Sr. No.
Topic
Page No.
Abstract
6
Introduction
7
1
Kidney
9
2
Dialysis
14
3
Dialysis Machine
30
4
Accessories
49
5
Data Sheets
72
6
Infection Control
84
7
Myths & Facts
104
8
Indian Economy & Dialysis
109
9
Fresenius Medical Care
117
10
References
120
6
ABSTRACT
The kidneys have important roles in maintaining health. When healthy, the kidneys maintain the
body's internal equilibrium of water and minerals (sodium, potassium, chloride, calcium,
phosphorus, magnesium, sulfate). Those acidic metabolism end-products that the body cannot
get rid of via respiration are also excreted through the kidneys. The kidneys also function as a
part of the endocrine system, producing erythropoietin and calcitriol. Erythropoietin is involved
in the production of red blood cells and calcitriol plays a role in bone formation.
When you are diagnosed with kidney failure, you need some sort of renal replacement therapy some sort of therapy that replaces your kidney function. There are plenty of options. In effort to
help those people, we have come up with an idea of DIALYSIS.
Dialysis is an imperfect treatment to replace kidney function because it does not correct the
endocrine functions of the kidney. Dialysis treatments replace some of these functions through
diffusion (waste removal) and ultrafiltration (fluid removal).
7
INTRODUCTION
It’s an interesting thing about molecules – they’re adventurous. They want to go places. But –
and they’re very serious about this - it’s really important for them to spread themselves around
evenly; they want to travel with their friends, or not at all. If they see a place where they’re
under-represented, over across yonder semi-permeable membrane for example, (Montana,
maybe), well, off they’re gonna go, until there’s just as many over there across the border in
Montana as there are over here in Idaho. Wyoming may be. Nice, compulsive little ICUpersonality molecules – so cute.
That’s the basic idea behind “diffusion across a concentration gradient”. Why can’t these people
just speak English? If there’s too much molecules over here on this side, and not hardly none of
‘em over on that side, why then, they’re just gonna get up and go over across there – it’s what
they do, as the Great Physicist decreed, way back there in the Bang.
Of course the membrane has to have holes in it to let ‘em through, right? Just the right size holes
too, ‘cause ya don’t wanna be losing your albumins and all, or your red cells, know what I’m
sayin’, yo?
The term dialysis is derived from the Greek word dialusis meaning to separate (dia meaning
through, and lysis meaning loosening or splitting). In medicine, Dialysis is a procedure that
replaces the normal functions of the kidney by removing metabolic waste products through
diffusion and hydraulic pressure gradients. Use of an artificial semipermeable membrane
(hemodialyzer) or a natural semipermeable membrane (peritoneum) allows passage of some
molecules while passage of other molecules is restricted. Molecules that can move through
8
membrane move from the area of higher concentration to the area of lower concentration. The
dialysate is a combination of treated water and electrolyte concentrates used with the dialysis
machine and system. Dialysis may be used for those with an acute disturbance in kidney function
(acute kidney injury, previously acute renal failure), or progressive but chronically worsening
kidney function–a state known as chronic kidney disease stage 5 (previously chronic renal failure
or end-stage kidney disease). The latter form may develop over months or years, but in contrast
to acute kidney injury is not usually reversible, and dialysis is regarded as a "holding measure"
until a renal transplant can be performed, or sometimes as the only supportive measure in those
for whom a transplant would be inappropriate. Dialysis is hazardous for the patient and for the
staff that take care of the patient.
Dialysis treatment is accomplished by two primary mechanisms, hemodialysis (HD) and
peritoneal dialysis (PD). HD utilizes an artificial dialyzer for removal of metabolic waste
products and PD uses the patient’s peritoneal cavity and membranes.
Dialysis can be hazardous for the patient as venous access and insertion of foreign bodies can
increase risk of infection. Also the patient might be exposed to exogenous microorganisms or to
endotoxin from contaminants in the water used to prepare dialysis. Personnel that care for the
patient are at risk of occupational exposure to blood-borne pathogens as patients requiring
dialysis can have a high prevalence of blood-borne diseases. Reuse of syringes and other
breakdowns in infection control resulted in transmission of HIV to 39 patients at two dialysis
centers in Egypt.
9
Chapter-1
Kidney
10
WHAT DO KIDNEYS DO?
The kidneys are bean-shaped organs, each about the size of a closed fist. They are located near
the middle of the back. The kidneys are sophisticated reprocessing machines. Every day, a
person’s kidneys process about 200 liters of blood to sift out about 2 liters of waste products and
extra water. The wastes and extra water become urine, which flows to the bladder through tubes
called ureters. The bladder stores urine until releasing it through urination.
Wastes in the blood come from the normal breakdown of active tissues, such as muscles, and
from food. The body uses food for energy and self-repairs. After the body has taken what it
needs from food, wastes are sent to the blood. If the kidneys did not remove them, these wastes
would build up in the blood and damage the body.
In addition to removing wastes, the kidneys release three important hormones:
-
Erythropoietin, or EPO, which stimulates the bone marrow to make red blood cells.
Renin, which regulates blood pressure.
Calcitriol, the active form of vitamin D, which helps maintain calcium for bones and for
normal chemical balance in the body.
When kidneys do not work as expected, the functions they are supposed to be performing are
impaired. The most important function of the kidneys is to remove wastes from the body. When
the kidneys do not work as well as they should, the wastes in the body are not removed
effectively.
This build up of wastes in the body is harmful for the body.
11
WHY DO KIDNEYS SHUT DOWN?
Remember all that stuff about pre-renal, intra-renal, and post-renal. They describe the three main
ways that kidneys get hurt. The fourth way is toxicity.
Once again, (and as always, “with a lot of lies thrown in”), this stuff isn’t that hard. Just think of
where the urine comes from, and where it goes:
Pre-renal stuff has to do with
the blood supply arriving to the
kidney, here… at the artery.
Intra-renal: bad things are
happening within the structure
of the kidney – ATN, that kind
of thing.
Post renal stuff happens here,
where the urine is trying to flow
out towards the outside world…
12
Pre-renal:
In front of the kidney, the urine is coming from the bloodstream – before it reaches the kidney.
Most often the problem is simply that there isn’t enough blood volume in front of the kidney –
reaching it. The patient is dry.
Remember the BUN/creatinine ratio thing. Not too hard. Put the BUN over the creatinine, like
so: 10 /1.0 – so you could call that ten to one.
Now try this one: 100 /1.0 – a hundred to one. This one is “way” dry – the patient’s kidneys are
working, you know that because the creatinine is still normal (won’t be for long!). But the BUN
is, as we say in MA, wicked high – meaning not an excess of BUN so much as a loss of water.
This patient might have a hematocrit of 50 – it’s not that she has too many red cells, but that
she’s lost a lot of the water that they should be floating around in.
Intra-renal:
Inside the kidney, where the urine is being made. The kidney itself has “taken a hit” – in our
patients this usually the evil ATN: Acute Tubular Necrosis, usually from hypotension. I hate it
when that happens. It turns out that kidneys are very sensitive creatures; they don’t tolerate
being insulted (“Stupid kidney!”), and they fail if they’re underperfused for any serious length of
time. It varies, but sometimes it seems that an elderly patient who becomes hypotensive for 20
minutes will develop kidney failure.
Probably related; it seems as though some patients with hypertension at baseline don’t make
much urine at what we would consider normal MAPs, but turn into Niagara Falls when their
pressure rises – maybe for the hour when you were doing their bath. The interpretation put on
this is usually that these people are the ones with renal artery stenosis: their kidneys are used to
seeing a higher perfusion pressure most of the time, and even though they’re not failing yet,
exactly, they’re still not doing their stuff at what they think are hypotensive pressures. Makes
sense, in that a vasculopath with bad coronaries may have bad renes for the same reason. I think
it was in “The Tennis Partner” that I read Abraham Varghese’s description of feeling a patient’s
radial arterial pulse, and trying to intuit how much diffuse vasculopathy she might have from the
feel of the radial’s stiffness. That’s real doctoring!
Post Renal:
After the kidney – enough blood got there, the urine got made okay, but now it’s having trouble
getting out, after the kidney. Maybe a ureter is blocked (oof – I know about that one!), maybe the
urethra is blocked. Flush the foley!
13
TYPES OF KIDNEY DISEASES - ACUTE AND CHRONIC
Acute - It means a sudden reduction in the kidney function due to reduced blood supply
following dehydration due to conditions like gastroenteritis, heart attack, blood loss etc. If the
underlying disease is not rapidly corrected, the patient may die. On the contrary if the underlying
disease is corrected, the patient recovers fully and may require only temporary dialysis.
Chronic - The most important cause of this is diabetes in middle aged or the elderly population.
High blood pressure is also an important reason and can add with diabetes to produce a bad
outcome. Both the above conditions affect the kidney slowly over the years.
The body can adapt itself till ninety percent of the kidney is damaged and hence the patients do
not have any symptoms. The detection is done by laboratory testing of the urine and blood.
Albumin leak is the earliest parameter warning of kidney damage. Subsequently the urea and
creatinine rise in the blood indicates the severity of the kidney failure. It is unfortunate that still
many patients are being detected at this stage and not at the early stage of albumin leak when
corrective measures can be taken. An important marker of possible kidney damage in a diabetic
individual is reduced vision due to retinopathy.
Another curse of modern development is the excessive in take of drugs for example pain killers,
so called tonics and various other unstudied alternate or native medical preparations. Over a long
period of time, these drugs tend to damage the kidney. Needless to say patients are often
asymptomatic and only after a careful laboratory evaluation is the kidney disease deducted.
14
Chapter-2
Dialysis
15
STARTING INDICATIONS OF DIALYSIS
The decision to initiate dialysis or hemofiltration in patients with renal failure depends on several
factors. These can be divided into acute or chronic indications.

Indications for dialysis in the patient with Acute Kidney Injury are summarized with the
vowel acronym of "AEIOU":
1. Acidemia from metabolic acidosis in situations in which correction with sodium
bicarbonate is impractical or may result in fluid overload.
2. Electrolyte abnormality, such as severe hyperkalemia, especially when combined
with AKI.
3. Intoxication, that is, acute poisoning with a dialyzable substance. These
substances can be represented by the mnemonic SLIME: Salicylic Acid, Lithium,
Isopropanol, Magnesium-containing laxatives, and Ethylene Glycol.
4. Overload of fluid not expected to respond to treatment with diuretics.
5. Uremia complications, such as pericarditis, encephalopathy, or gastrointestinal
bleeding.

Chronic Kidney Injury indications for dialysis:
1. Symptomatic renal failure
2. Low Glomerular Filtration Rate (GFR) (RRT often recommended to commence at
a GFR of less than 10-15 mls/min/1.73m2). In diabetics, dialysis is started earlier.
3. Difficulty in medically controlling fluid overload, serum potassium, and/or serum
phosphorus when the GFR is very low.
16
HISTORY OF DIALYSIS
Dialysis is referred to as "selective diffusion." Diffusion is the movement of material from higher
concentration to lower concentration through a given membrane. Selective diffusion is diffusion,
but depending on the membrane, some material will move across the membrane and some
material will not. Thomas Graham, Chairman of Chemistry at University College, London, first
discovered this idea of selective diffusion. Thomas Graham's work with vegetable parchment led
to his observation that it acted like a semipermeable membrane. Graham later came to call this
discovery, 'dialysis'. Dialysis is a Greek word meaning "loosening from something else".
Year
Discovery
1913
Abel, Rowntree, and Turner devised an apparatus for the dialysis of blood.
1943
Kolff and Berk developed the first clinically successful hemodialyzer.
1948
Skeggs-Leonards developed the parallel plate
countercurrent flow of blood and dialyzing fluid.
1956
Travenol developed the first twin-coil disposable dialyzer unit.
1956
Hollow fiber kidneys were developed in the United States.
1956
Gambro began production of disposable parallel plate dialyzers in Europe.
1960
Kiil developed a simpler countercurrent flow method with parallel flow.
dialyzer,
utilizing
Dr. Willem Kolff, a Dutch physician, constructed the first working dialyzer in 1943 during the
Nazi occupation of the Netherlands. Due to the scarcity of available resources, Kolff had to
improvise and build the initial machine using sausage casings, beverage cans, a washing
machine, and various other items that were available at the time. Over the following two years,
Kolff used his machine to treat 16 patients suffering from acute kidney failure, but the results
were unsuccessful. Then, in 1945, a 67-year-old comatose woman regained consciousness
following 11 hours of hemodialysis with the dialyzer, and lived for another seven years before
dying of an unrelated condition. She was the first-ever patient successfully treated with dialysis.
Early stage dialyzers consisted of cellulose tubing wrapped around a small drum. The drum was
then partially emerged in a bath of dialysate. The dialysate usually consisted of a saline solution
only. As the drum was hand cranked, the blood was propelled through the cellulose tubing;
causing a diffusion of materials from blood to dialysate and from dialysate to blood (Fig 1).
17
Fig: 1
As technology has advanced so has the development of dialyzers. Dialyzers use motors to pump
the blood and dialysate. Maintaining pressure upon the blood in the veins is accomplished by
using microprocessors and transducers to maintain a constant pressure across the body and
dialyzer. The blood and dialysate flow through high-tech plastic composite tubing. Unlike in the
past, the dialysate consists of more than just saline. The dialysate can consist of sodium chloride,
sodium bicarbonate or sodium acetate, calcium chloride, potassium chloride, and magnesium
chloride.
18
PRINCIPLE OF DIALYSIS
Dialysis works on the principles of the diffusion of solutes and ultrafiltration of fluid across a
semi-permeable membrane. Diffusion describes a property of substances in water. Substances in
water tend to move from an area of high concentration to an area of low concentration. Blood
flows by one side of a semi-permeable membrane, and a dialysate, or special dialysis fluid, flows
by the opposite side. A semipermeable membrane is a thin layer of material that contains holes
of various sizes, or pores. Smaller solutes and fluid pass through the membrane, but the
membrane blocks the passage of larger substances (for example, red blood cells, large proteins).
This replicates the filtering process that takes place in the kidneys, when the blood enters the
kidneys and the larger substances are separated from the smaller ones in the glomerulus.
The two main types of dialysis, hemodialysis and peritoneal dialysis, remove wastes and excess
water from the blood in different ways. Hemodialysis removes wastes and water by circulating
blood outside the body through an external filter, called a dialyzer, that contains a semipermeable
membrane. The blood flows in one direction and the dialysate flows in the opposite. The
counter-current flow of the blood and dialysate maximizes the concentration gradient of solutes
between the blood and dialysate, which helps to remove more urea and creatinine from the
blood. The concentrations of solutes (for example potassium, phosphorus, and urea) are
undesirably high in the blood, but low or absent in the dialysis solution, and constant
replacement of the dialysate ensures that the concentration of undesired solutes is kept low on
this side of the membrane. The dialysis solution has levels of minerals like potassium and
calcium that are similar to their natural concentration in healthy blood. For another solute,
bicarbonate, dialysis solution level is set at a slightly higher level than in normal blood, to
encourage diffusion of bicarbonate into the blood, to act as a pH buffer to neutralize the
metabolic acidosis that is often present in these patients. The levels of the components of
dialysate are typically prescribed by a nephrologist according to the needs of the individual
patient.
In peritoneal dialysis, wastes and water are removed from the blood inside the body using the
peritoneal membrane of the peritoneum as a natural semipermeable membrane. Wastes and
excess water move from the blood, across the peritoneal membrane, and into a special dialysis
solution, called dialysate, in the abdominal cavity which has a composition similar to the fluid
portion of blood.
19
TYPES OF DIALYSIS
There are three primary and two secondary types of dialysis: hemodialysis (primary), peritoneal
dialysis (primary), hemofiltration (primary), hemodiafiltration (secondary), and intestinal
dialysis (secondary).
1. Hemodialysis
In hemodialysis, the patient's blood is
pumped through the blood compartment
of a dialyzer, exposing it to a partially
permeable membrane. The dialyzer is
composed of thousands of tiny synthetic
hollow fibers. The fiber wall acts as the
semipermeable membrane. Blood flows
through the fibers, dialysis solution flows
around the outside of the fibers, and water
and wastes move between these two solutions.
The cleansed blood is then returned via the
circuit back to the body. Ultrafiltration occurs
by increasing the hydrostatic pressure across
the dialyzer membrane. This usually is done
by applying a negative pressure to the
dialysate compartment of the dialyzer.
fig: Hemodialysis Schematic
This pressure gradient causes water and
dissolved solutes to move from blood to
dialysate, and allows the removal of several
liters of excess fluid during a typical 3- to
5-hour treatment. In the US, hemodialysis
treatments are typically given in a dialysis
center three times per week (due in the US to
Medicare reimbursement rules); however, as of
2007 over 2,500 people in the US are dialyzing
at home more frequently for various treatment
lengths. Studies have demonstrated the clinical benefits of dialyzing 5 to 7 times a week, for 6 to
8 hours. This type of hemodialysis is usually called "nocturnal daily hemodialysis", which a
20
study has shown a significant improvement in both small and large molecular weight clearance
and decrease the requirement of taking phosphate binders. These frequent long treatments are
often done at home while sleeping, but home dialysis is a flexible modality and schedules can be
changed day to day, week to week. In general, studies have shown that both increased treatment
length and frequency are clinically beneficial.
Access for Hemodialysis
In order to be dialyzed there must be a way to connect your circulatory system to the artificial
kidney machine. This connection is called a vascular access and initially requires minor surgery.
The fistula is created by a surgical procedure which attaches a vein to an artery in an arm. This
increases the amount of blood that flows through the vein which in turn causes the vein to
enlarge. The larger size of the blood vessel allows two needles to be inserted for treatment.
Because this may cause discomfort, the skin can be anaesthetized with Novocain. These needles
are connected to tubes which go to and from the artificial kidney machine. A graft also provides
access to the patients circulatory system. When a graft is used, synthetic material is inserted to
form a connection between an artery and a vein. The advantage of the graft and fistula, which
both require minor surgery, is that they are under the skin and therefore less prone to infection
than an external shunt. They do require two needle sticks each time dialysis is performed.
Sometimes a person must start dialysis before a permanent access can be created. In this case, a
catheter may be inserted into a vein in your chest, neck or leg to gain access to the circulatory
system. A catheter may also be used if the patient has used up all other possible sites for a fistula
or graft. The advantage of a catheter is that no needles need to be inserted. The disadvantages are
numerous, including the possibility of infection and clotting.
2. Peritoneal Dialysis
In peritoneal dialysis, a sterile solution containing glucose is
run through a tube into the peritoneal cavity, the abdominal body
cavity around the intestine, where the peritoneal membrane
acts as a partially permeable membrane. The peritoneal membrane
or peritoneum is a layer of tissue containing blood vessels that lines
and surrounds the peritoneal, or abdominal, cavity and the internal
abdominal organs (stomach, spleen, liver, and intestines). The
dialysate is left there for a period of time to absorb waste products,
and then it is drained out through the tube and discarded. This cycle
or "exchange" is normally repeated 4-5 times during the day,
(sometimes more often overnight with an automated system).
Each time the dialysate fills and empties from the abdomen is
fig: Schematic Diagram of
called one exchange.
Peritoneal Dialysis
21
A dwell time means that the time of dialysate stay in patient's
abdominal cavity—wastes, chemicals and extra fluid move from
patient's blood to the dialysate across the peritoneum. A drain
process is the process after the dwell time, the dialysate full with
waste products and extra fluid is drained out of patient's blood.
Ultrafiltration occurs via osmosis; the dialysis solution used
contains a high concentration of glucose, and the resulting osmotic
pressure causes fluid to move from the blood into the dialysate. As
a result, more fluid is drained than was instilled. Peritoneal
dialysis is less efficient than hemodialysis, but because it is
carried out for a longer period of time the net effect in terms of
removal of waste products and of salt and water are similar to
hemodialysis. Peritoneal dialysis is carried out at home by the patient. Although support is
helpful, it is not essential. It does free patients from the routine of having to go to a dialysis clinic
on a fixed schedule multiple times per week, and it can be done while travelling with a minimum
of specialized equipment.
Access for Peritoneal Dialysis
Access for peritoneal dialysis is gained via a flexible hollow tube, called a catheter, which is
surgically implanted through the wall of the abdomen into the abdominal cavity. This catheter is
usually permanent, but may be replaced as needed. A potential problem with peritoneal dialysis
is peritonitis, an infection of the lining membrane of the peritoneal cavity. The exchanges of
dialysis fluid must be performed using sterile technique in order to prevent this type of infection.
Depending on the way peritoneal dialysis is performed it is described in two different ways:


Continuous Ambulatory Peritoneal Dialysis (CAPD)
Continuous Cycling Peritoneal Dialysis (CCPD)
Continuous Ambulatory Peritoneal Dialysis
Continuous Ambulatory Peritoneal Dialysis (CAPD) is self administered and machine free.
CAPD exchanges are performed in a clean, private location where the patient is comfortable. The
process of exchanging the dialysis fluid is repeated every 4 to 6 hours during the day, with each
exchange taking approximately 30 minutes (10 minutes to introduce and 20 minutes to drain the
dialysate). Each day, the final dialysis is performed right before the patient goes to bed at night.
Since the patient is continually dialyzing, there are usually fewer dietary restrictions. CAPD
provides mobility for the patient, and thus an improved quality of life. The details of an exchange
are as follows: Fluid that has been dwelling in the peritoneal cavity needs to be removed so fresh
fluid may be infused and the blood cleansing process can continue. The catheter is attached to a
Y SET. This Y set has a drain bag on one end and a fresh bag of dialysate on the other. For
22
outflow, the empty bag is placed on the floor and the used fluid is allowed to drain into it by
gravity. When the bag is full, the line is opened clamped and the inflow line is opened. For
inflow, the two liter bag of dialysate is raised above the patients shoulder and the fresh, warm
dialysate is infused by gravity. When that bag is empty, the inflow line is closed and the Y set
and bags are removed and discarded. The patient then resumes normal activity until it is time for
another exchange.
Continuous Cycling Peritoneal Dialysis
Continuous Cycling Peritoneal Dialysis (CCPD) is very similar to CAPD, however, in this case,
the exchanges are performed at night while the patient sleeps. To facilitate this process the
patient is hooked up to an automatic cycling machine. This machine makes several evenly
spaced exchanges during the night and a final one just before the patient gets up in the morning.
During the day either one exchange or no exchanges are made. An advantage of CCPD is that the
likelihood of infection caused by improper handling of the dialysis equipment is reduced. With
only one hook-up per day rather than four or five there is less chance that the patient will
introduce some bacteria into the peritoneal cavity; thus the likelihood of peritonitis is reduced.
On the other hand, it is necessary for the patient to be attached to a machine during the night
hours while the CAPD patient remains totally machine free.
3. Hemofiltration
Hemofiltration is a similar treatment to hemodialysis, but it makes use of a different principle.
The blood is pumped through a dialyzer or "hemofilter" as in dialysis, but no dialysate is used. A
pressure gradient is applied; as a result, water moves across the very permeable membrane
rapidly, "dragging" along with it many dissolved substances, including ones with large molecular
weights, which are not cleared as well by hemodialysis. Salts and water lost from the blood
during this process are replaced with a "substitution fluid" that is infused into the extracorporeal
circuit during the treatment. Hemodiafiltration is a term used to describe several methods of
combining hemodialysis and hemofiltration in one process.
4. Hemodiafiltration
Hemodialfiltration is a combination of hemodialysis and hemofiltration. In theory, this technique
offers the advantages of both hemodialysis and hemofiltration.
23
5. Intestinal Dialysis
In intestinal dialysis, the diet is supplemented with soluble fibers such as acacia fiber, which is
digested by bacteria in the colon. This bacterial growth increases the amount of nitrogen that is
eliminated in fecal waste. An alternative approach utilizes the ingestion of 1 to 1.5 liters of nonabsorbable solutions of polyethylene glycol or mannitol every fourth hour.
6. Home Dialysis
Yes, it is possible to dialyze at home! Home dialysis offers a lot of advantages:




Dialyze at your own convenience
No need to adhere to center schedules and timings
Be completely independent
Get better dialysis
There are two ways you can dialyze at home:


Peritoneal Dialysis
Home Hemodialysis
Peritoneal dialysis is almost always done at home. You can find out more about peritoneal
dialysis here.
Hemodialysis can be done at home too! You will need to make an initial investment however.
You will need the following:



Hemodialysis machine
Reverse Osmosis based water treatment plant
Additional electrical wiring and plumbing
To start with, you will also need to have a technician who comes home to help you do the
treatment. Gradually, however, you can learn the ropes and eventually do everything on your
own or with the help of a partner who can be your spouse, a parent, a sibling etc.
Unfortunately, home hemodialysis has not caught on too much in India and there are only a
24
handful of people doing hemodialysis at home. There is no training available yet for this.
However, it is definitely possible and offers a lot of benefits over dialyzing at a hospital or a
center.
One major benefit of dialyzing at home is that you can dialyze more frequently with ease.
Research shows that hemodialysis, when done more frequently, over longer durations and more
gently (at low pump speeds and ultrafiltration rates) is much better for the body overall in terms
of both short term and long term outcomes.
It is hardly practical to go to a hospital or center every day of the week for long hours. This is
much easier when done at home. So, this kind of 'optimal dialysis' is much more doable if you
dialyze at home.
It is extremely important however, to get your doctor's buy-in before switching to home hemo.
This modality, though closest to ideal, may not be suited to you. Talk to your nephrologist about
this and get his/her consent before you consider switching.
25
PD versus HD
Here are a few aspects to consider while deciding on which modality to adopt:
Diet and fluid restrictions:
With Peritoneal Dialysis, there are generally fewer diet and fluid restrictions as compared to
hemodialysis.
Travel:
It is generally easier to travel with PD since you can carry your supplies with you. With hemo
travel is possible but you can travel for short periods and come back in time for your next session
or you can travel to a place where there is a hospital or center that offers dialysis.
Treatment process:
PD is considered to be less risky as a process because there is no blood going out of your system
as in hemo. Also, PD offers continuous dialysis whereas hemo is intermittent.
Cost:
PD is usually more expensive than hemo.
Body Art!!!
In PD, you will need to have a catheter (tube) inside your stomach the outer part of which will be
outside your body. The tube is usually wrapped in a small pouch that is fastened around your
stomach. With hemo, you will need to get a fistula which may look like a swelling on your arm
or wherever the fistula is made. In case of a jugular catheter you will have a couple of small
tubes usually near your neck.
Infection:
The chances of catching infections are high on PD. If proper washing techniques and sterile
procedures are not followed, it is possible that you may catch bacterial infections which may lead
to having to remove the PD catheter. In hemodialysis, it is possible that you may catch infections
if the proper washing procedures are not followed especially during reprocessing of the dialyser
and tubes.
26
Both hemodialysis and CAPD has its advantages and disadvantages. These are as follows:



With Hemodialysis one has top travel to a hospital for the procedure on an average three
to four time a week and stay for at least 6 to 8 hr during the dialysis, whereas with CAPD
this can be done safely at home. However one has to do it daily and three to four times in
a day the fluid exchange has to take place using sterile precautions. It also means having
to store a supply of CAPD fluid boxes at home.
In hemodialysis there is a necessity to prick the skin with two needles each time you go
for the dialysis where with CAPD this is not the case.
With CAPD because it is done daily the fluid and food restrictions are a little less
rigorous compared to hemodialysis where the restrictions are more.
Both type of dialysis has also personal preferences. It is best to talk to a few patients in the
dialysis unit and discuss the procedure before committing to any one in particular. However one
must remember they are both equally effective.
27
AFTER EFFECTS OF DIALYSIS
ADVANTAGES OF DIALYSIS
1. Remove metabolic wastes and toxins: such as creatinine, urea, uric acid, and so on.
2. Regulate water balance: dialysis can get rid of excess water in blood so as to relieve edema.
3. Adjust acid-base balance: patients with Chronic Kidney Disease suffer from different
severity of acid poisoning, and dialysis can adjust acid-base balance though removing
excessive acid or base substances.
4. Regulate electrolyte balance: dialysis can decrease some mineral substances in blood to
relieve some symptoms like hyperkalemia, hyperphosphatemia and so on.
5. The last one but the most important advantage is to set aside time for other pathological
treatments and to supply clean treatment environment.
DISADVANTAGES OF DIALYSIS
1. Without pathological treatment effects:
Dialysis is just a replacing treatment method. It replaces the damaged kidneys to get rid of
wastes and toxins out of body. As for the pathological treatment of kidney lesion, it is not
effective. If patients with severe kidney disease like Uremia, it will delay the treatment of
disease. as a result, patients have to take kidney transplant.
2. Various complications:
Dialysis can induce many complications which can be divided into two types—immediate
complications and distant complications.
The former ones include hypotension, hyoxemia, cardiac tamponade and son on.
The later ones include hypertension, left heart insufficiency, pericarditis, pulmonary edema
and so on.
Therefore, although dialysis has immediate effects to superficial symptoms, it is just
replacing treatment can not be regarded as real treatment method. If patients with severe
disease, it is possible for patients to lose best chance of treatment.
28
HOW TO DEAL WITH COMPLICATIONS OF DIALYSIS?
Due to the declining of kidney function, there are many metabolic wastes and toxins
accumulated in blood. Dialysis is called artificial kidney which can replace kidneys to discharge
these wastes out of blood. Dialysis is necessary for patients with Kidney Failure while dialysis
will cause some complications. Here are some tips to deal with the complication during dialysis.
Hypotension
1. Causes: The first reason causing hypotension is the decreasing of effective blood volume.
The second reason is the decreasing ability of vasoconstriction. The third one is the
decreasing of cardiac output. It means the blood out from heart is decrease. The fourth one
is poor biocompatibility of dialysis membrane.
2. Tips for Hypotension: When patients with Kidney Failure have discomfort in chest, vomit
and nausea, they should lie on the back and keep feet is higher than head as to slow down
the blood flow. Oxygen uptake and 100-200ml physiological saline is needed. As for more
serious disease, patients should have hypertonic saline, hypertonic glucose, albumin
injected.
Muscle cramps (gastrocnemius, feet, upper limb and abdominal muscle)
1. Causes: Hypotension can lead to muscle cramps. Ultrafiltration is higher and faster than
normal range, which can lead to lighter weight than dry weight. I addition, low Sodium
dialysis fluid can also lead to muscle cramps.
2. Measures to deal with muscle cramp: Doctors should infuse hypertonic saline, hypertonic
glucose. The set of filtration should proper and correct. At the same time, dialysis fluid
should adjust Sodium up to 145mmol/L.
Patients with Kidney Failure can do massage to the cramping part and then apply hot compress
with towel. Before people go to sleep, they can put something under the legs. Women should not
wear high-heeled shoes.
29
Arrhythmia
1. Causes: Serum Potassium and calcium in body can lead to Arrhythmia. The second reason is
caused by hypotension, decreasing blood volume of coronary artery circulation as well as
and myocardial ischemia and hypoxia.
2. Treatment and prevention: Doctors should monitor serum Potassium and calcium before and
after dialysis so as to adjust electrolyte disorder. If there is serious arrhythmia, dialysis
should be stopped immediately.
Patients with Kidney Failure should have a good rest and keep a good mood. Enjoying light
music for relax.
Heart Failure
1. Causes: Hypertension, water and Sodium retention and people with declining of heart
function can lead to heart failure during Dialysis.
2. People with Kidney Failure should lie on bed and if feel uncomfortable, people can sit up
and keep arms fall naturally. Intake enough heat and vitamin.
® Kindly Remind: Dialysis can cause some complications; however, dialysis is necessary
for people with kidney failure. In order to get rid of dialysis as well as the complications
caused by dialysis, people should take proper treatment. Micro-Chinese Medicine
Osmotherapy and Stem Cell Transplant can effectively recover kidney function. If
kidneys can discharge wastes by themselves, dialysis can be avoided.
30
Chapter-3
DIALYSIS MACHINE
31
DIALYSIS MACHINE
Dialysis machines ensure safe treatment
The computer-controlled dialysis machine is one of the most important products in the treatment
of chronic renal patients and, in hemodialysis, it takes over a number of key functions – it pumps
blood from the patient’s body through the blood lines to the dialyzer (artificial kidney or filter).
There, a fluid known as dialysate transports the toxins and excess water filtered from the blood
away from the body. The fluid is introduced against the flow of blood through a separate circuit
that is also controlled by the dialysis machine. In addition, the device injects drugs (such as
Heparin) that restrain coagulation. The system has a number of automatic monitoring and control
functions that ensure a safe and efficient dialysis treatment for patients.
Dialysis machines also continuously collect a variety of data during treatment including arterial
and venous pressure, the rotating speed of the blood pump and the temperature as well as the
composition of the dialysate. In addition, the machine controls the amount of fluid remo ved from
the body. A clamp prevents air bubbles from entering a patient’s body. Should one of the values
exceed or fall below established levels, the machine reacts immediately and halts or alters the
treatment accordingly until the value returns to the approved range – the patient’s safety is the
most important part of dialysis.
Dialysis patients are all too familiar with the routine of their treatments: Go to the clinic, get
weighed, have their temperature and blood pressure taken, get stuck with needles (unless the
patient has a catheter access), have tubes connected from their access to the dialyzer and then sit
in the chair until it is time to go home. While waiting, have you ever wondered how a dialysis
machine works?
As “the machine man,” I would like to take this opportunity to explain how your dialysis
machine works by answering some of the most frequently asked questions.
32
The Fact:During dialysis, your blood is cleaned using a fluid called dialysate, or “bath.” Wastes and fluid
from your blood go into the bath and are drained away. The dialysis machine controls the flow of
the blood and the bath.
The dialysis machine has two systems
 The Extracorporeal (outside the body) Circuit
 The Dialysate Delivery System
The extracorporeal circuit is the tubing, blood pump, heparin (blood thinner) pump, kidney, and
monitors for blood flow, blood pressure, and air bubbles.
The dialysate delivery system of the machine mixes the bath with purified water and checks to be
sure it is safe.
What does my dialysis machine do?
The dialysis machine mixes and monitors the dialysate. Dialysate is the fluid that helps remove
the unwanted waste products from your blood. It also helps get your electrolytes and minerals to
their proper levels in your body. The machine also monitors the flow of your blood while it is
outside of your body. You may hear an alarm go off from time to time. This is how the machine
lets us know that something needs to be checked.
What are those plastic jugs sitting in front of my machine?
The plastic jugs hold the liquids used to mix the dialysate. The machine mixes the dialysate,
which is made up of an acidified solution, bicarbonate and purified water. The acidified solution
contains electrolytes and minerals. You may hear it referred to as “acid.” The other solution is
bicarbonate or bicarb, which is like baking soda. Both are mixed inside the machine with
33
purified water. While you are dialyzing, dialysate and your blood flow through the dialyzer (but
they never touch). Fresh dialysate from the machine enters your dialyzer throughout your
treatment. Impurities are filtered out of your blood into the dialysate. Dialysate containing
unwanted waste products and excess electrolytes leave the dialyzer and are washed down the
drain.
How does my blood get in and out of my body?
Blood tubing carries your blood from your access to the dialyzer. The blood tubing is threaded
through the blood pump. You’ll see the blood pump turning in a circular motion. The pumping
action of the blood pump pushes your blood through the dialyzer and back into your body.
What’s in the syringe that’s attached to my machine?
Blood tends to clot when it moves through the blood tubing. To prevent this, the nurse will give
you a drug called “heparin.” Your doctor orders the amount of heparin you get at each treatment.
That amount of heparin is drawn up into a syringe then placed on the machine into the “heparin
pump.” The heparin pump is programmed to release the right amount of heparin into your blood
tubing during your treatment. The heparin prevents your blood from clotting.
How does the machine keep me safe?
One problem that may occur during dialysis is that air gets into the blood tubing. To prevent this
from happening, blood tubings have two air traps built into them. One trap is before the dialyzer
and the other is after it. These traps catch any air that may get into the system. If air does get past
these traps an internal machine air sensor shuts down the blood pump and an alarm will sound.
All blood flow is stopped until the air is removed.
34
Why are there so many alarms?
The machine continuously monitors the pressures created by your blood inside the blood tubing
and dialyzer. It also monitors the blood flow, temperature and proper mixture of the dialysate. If
any of these go out of range, the machine lets us know by sounding an alarm, blinking lights and
shutting down blood or dialysate flow. It also lets us know if your blood pressure is too low or
high. Oh yes, it also alarms when it’s time to go home.
Want to know more?
I realize that this may not answer all of your questions. That’s why I invite you to ask the biomedical technician (machine person) at your dialysis center any questions you have. Your biomedical technician will be happy to share any information with you. The more you know, the
more comfortable you will be with your treatments.
How much blood is outside my body?
Depending on the machine and the dialyzer, no more than two cups (one pint) of blood are
outside your body during dialysis.
What is an air detector?
Air in your bloodstream is a medical emergency. This is part of the main blood path. The air
detector is the last part of the machine that monitors the main blood path, looking through the
blood going by before it goes back into the patient. It’s just below the big venous trap that
collects debris, clots, and (hopefully) any air in the tubing. Would you like to have your machine
keep on nicely pumping along if no blood was in the tubing? Sort of a bad idea. If the detector
sees air – the machine stops.
35
The thing is, this whole machine setup really sort of is the octopus from hell, the “thing with a
thousand arms”. (Maybe we should call Roger Corman. Wes Craven?) If something is clamped
wrong, then one of the 138 and a half screw connectors may start to suck air into the system, and
that air will make its way along through the system towards the patient – the air detector sees it
and stops the machine. It does take time, but eventually you can get comfortable with the setup. I
always run along the three tubing paths before I start the thing up, making sure that things are
tight, and that clamps are open and closed as they ought to be.
It is possible to save an air-contaminated system sometimes, depending on how much got in
there – but this is a hands-on maneuver that you have to learn with a preceptor. The other
problem is that air in the filter will tend to clot it up. The air detector checks the blood in the
tubing to be sure that air does not get into your bloodstream. The air detector is set before each
treatment.
An important point: this machine does not turn on the air detector while it is in priming mode,
which is why you NEVER RUN THE MACHINE IN PRIMING MODE WHEN IT IS
CONNECTED TO A PATIENT. Everybody got that?
What is the blood leak detector?
This is part of the ultrafiltrate path. Remember that the ultrafiltrate is pulled out of the little
tubules – if they break, then red cells start showing up in the ultrafiltrate path. Not good – this
translates as “filter rupture” – time for a new circuit.
Some people will just change out the filter, which I think is a terrible idea. For one thing, the
circuit is at least moderately pressurized, right? You want Hep B pressurized blood spraying
around in you local area? Not to mention sterility issues. Just change the whole damn thing.
36
What are all the transducers for?
The transducers are telling you what the pressures are in the system. As with transducers
everywhere, the trick is to try to remember what they’re “looking at”. An art-line transducer for
example is looking at the pressure in the radial artery, through the stiff tubing that connects the
transducer to whatever vessel you’re trying to measure the pressure of. These machine
transducers are doing the same kind of thing: they’re watching something, and the trick is to try
to visualize what it is.
What does the arterial transducer tell me?
There are five transducers built into our system, and the first two are easy – they’re looking at
the blood flows in and out of the patient: one is looking at the flow coming out (the “arterial”
side), and the other looks at the flow going back in (“venous”).
Interpreting the arterial transducer number is a little trickier than usual, because it’s measuring a
negative pressure. You need to remember that transducers measure pressures that rise and fall.
Positive and negative. In this case, the pump is pulling blood out of the patient through the
“arterial” port of the Quinton – and pulling is measured as a negative number. Like a “NIF” – the
negative inspiratory force that you measure when you’re trying to see if your patient is ready to
extubate, which is also measured as a negative number. Wall suction is measured negatively. My
brain is often measured negatively – actually my son’s brain…but I promised I wouldn’t yell any
more.
Anyhow. Suppose your arterial catheter pressure is a nice “low” number – meaning only about,
say, negative 20mmHG - everything is good, and your patient decides to sit up, or curl up, flip
over, or leap out of the bed and do a pirate dance – if the catheter kinks, the machine will
continue pulling, harder and harder, but only up to a limit. The number indicators on our
machine help you here, because as the negative pressure gets “higher and higher” – meaning
“greater and greater”, except it’s negative, right? – then the numbers will change and tell you
what’s happening. And when it reaches it’s limit, the machine will stop and alarm, to the effect
37
of “Uh, excuse me, you want to come over here? I think I’m kinked!” This can also happen if
the arterial port is up against the vessel wall, something you’ll usually discover when you
aspirate the ports manually at startup – try switching.
The venous transducer?
This one’s a little easier – the venous side is going back into the patient, and it has to be pushed
back in, so the venous side transducer is looking at a positive pressure. Higher numbers mean
that the machine is having to work harder to push – if the catheter isn’t kinked, this usually
means that clot debris is building up in the venous trap, plugging up the works. If the pressure
gets too high, the system may have to be changed – again some people try changing out only part
of the circuit, but I think that’s just a rotten idea.
What about the other transducers?
Instead of looking at the catheter flows, two of these are looking at the pressures on one side or
the other of the filtration membrane. One is looking at the pressure of the blood as it’s going into
the filter. Remember, the blood on the inside of the little filter tubules is on the inside of the
membrane, and the ultrafiltrate is on the outside. Another transducer is looking at the pressure
coming from the blood leak detector, which is full of ultrafiltrate (“pee”) – which is on the other
side of the membrane.
If the pressure across the membrane – the “trans-membrane” pressure – rises, it means what?:
that the fluid is having a harder time getting across, probably because some of the openings in
the tubules are getting plugged up with clot. If the pressures get really high – time to change to
blood path and filter. Or preferably, the whole system.
A last transducer looks at the pressures involved in the replacement fluid circuit. If something is
clamped, this will honk at you.
38
Jennifer M. points out that even though the transducers can be temporarily clamped, it’s really
unsafe to leave them that way, since pressures can go off the scale on one end or the other, and
you really do need to know if the machine is becoming unhappy, and why.
What is the circuit heater for?
Those replacement fluid bags hanging there under the machine are at room temperature, and
they’re infusing into the patient at 1.6 liters an hour. Cold. Even with the heater running, your
patient may get really cold on CVVH – use the Bair Hugger.
If the intern came around and wanted to know if this patient had spiked a temp overnight, what
would you say? What if your CVVH patient had a temp of, say, 100.4? Remember, the machine
cools your patient VERY rapidly… so if they spike while they’re ON the machine… hm.
How do I prime the circuit?
At this point we do machine prime: meaning, we set up all three tubing sets on the machine, and
let the pumps prime it up with whatever solution is ordered; either NS or NS with a bit of heparin
per liter, which helps keep the filter from clotting.
There are all sorts of steps in the priming dance that you have to learn – really, after the first
hundred times, it’s lots easier.
39
Why would I prime with heparin or without it?
Lots of our patients are anticoagulated for one reason or another – sometimes they’re doing it all
by themselves as a result of being “hepatorenal”. These people really don’t need any help from
extra heparin, and they often do a good job of keeping their machine circuits free of clots. Pretty
nice of them. Not to mention the problems of HIT…
How do I make sure that the circuit is ready to run?
Once you’ve gotten the whole entire enormous thing set up, the machine primes itself. I takes
about 20 minutes, and may need some tweaking as you go. Once it’s done, you’re all set – you
can let the system just sit now, and it will be ready to go when you need it.
What is my blood flow rate?
Your blood flow rate is how fast the blood pump moves your blood through the machine. Your
doctor prescribes your blood flow rate. Ask what it is. Check to be sure your blood flow rate is
right at each treatment.
What is my dialysate concentration?
Your dialysate, or bath, is prescribed by your doctor. It must have the right chemicals, or it will
not clean your blood well enough. Sometimes the wrong ingredients can even hurt you. Learn
what the right concentrate is for you, and check it at each treatment.
40
DESIGN CONSIDERATIONS
A Dialysis Machine is an artificial kidney that treats the blood or persons with inadequate kidney
function. Dialysis Machines are processor based pieces of equipment incorporating
electromechanically controlled extracorporeal blood paths that leverage pumps and semi
permeable dialyzer membranes to filter the patient’s blood. From an operational perspective,
dialysis equipment need to meet specific safety criteria, one of which is single-fault tolerance.
This means that no single point of failure in the pumps, motors, tubes, or electronics will
endanger the patient or expose them to a hazardous condition. This means that there will be
several redundant components and circuits, as well as "watchdog" managed disengage
mechanisms in the system. These devices may include both active and passive components such
as Control devices, sensors, motors, heaters, pumps, and valve drivers. Often a "Safe Mode" of
operation would mean disabling the Arterial blood pump and clamping the venous line to prevent
unsafe blood from flowing to the patient.
Typical Electronic Circuits in the Dialysis Machine could be:
 Sensor Control Board: Contains Analog to Digital Converters, precision references, Clocks
and VCOs as well as instrumentation or operation amplifiers. Although these circuits need to
respond quickly, the devices included here are often geared more towards precision than what
is considered high speed today. Part of that is also driven by the need to verify a measurement
or alarm signal and coordinating the response across the entire system, versus just reacting to
random stimuli. The A/Ds used here would provide high reliability, good noise immunity
(note that there are motors and pumps in the system), and good precision.
 Arterial And Venous Control Card: These portions of a system may include functions like;
Arterial and Venous Pressure Sensors, Blood Pumps, Line Clamps, Level Sensors, blood
detection Sensors, and various other monitoring and control features. Since TI's C2xxx DSPs
are targeted at Motor drive and Industrial Sensor applications, they are ideally suited as the
microcontroller for these blocks. Providing not only the drive and diagnostic capabilities, but
also allowing the implementation of RPM, and motor coil current sensing, as well as reading
the pressure transducers. There can also support the redundancy required in the system at a
minimal cost impact.
 Motor/Pump Drivers: There are a number of motors, pumps, valves and heaters in a Dialysis
machine. Each may need a specific drive circuit, where as some may be able to be driven
directly for a C2xxx controller. Selecting the right D/A converter and drive amplifier is
important to the control of the motor/pump, as well as to the life expectancy of the
motor/pump. Driving any of the values or motors to hard, with signals that are to noisy can
cause them to run hot and degrade quickly, as well as impact the overall comfort of the patient
connected to the machine.
41
START UP THE MACHINE
How do I get things started up?
Machine’s all set, right? Out of priming mode, final check, turnover and pump rates all correct,
all that good stuff? At this point set the business ends of the tubing down near the catheter tips,
usually on a chux, still connected to the priming bags.
 Keep things clean.
 Mask, gloves.
 Don’t forget to aspirate 10cc from each of the catheter lumens! Sometimes – not always these lines are inserted and flushed with concentrated heparin, which your liver-failure
patient does NOT need to have injected! You also want to aspirate any little clots in the
ports.
 See if both sides of the line draw rapidly – whichever one draws the easiest is going to be
the “arterial” side, regardless of whether it’s blue or red. Be very aware of what you’re
doing with the line clamps as you do the hookup.
 Give a moment’s thought: do you want to give the patient the volume in the circuit? Yes?
Hook up both lines and go. No? Hook up the arterial side, turn on the machine, and let the
patient’s blood displace the priming fluid up into the priming bag on the venous end. Then
hook up the venous connector and go. In practice, we usually give them the volume in the
circuit – supposedly no more than a couple hundred cc’s.
42
PROBLEMS
Why would the machine “go down”?
Usually this is a kink somewhere, probably the catheter, or a clot, probably in the venous trap.
You want to keep an eye on the trap – give the machine a 200cc NS flush to get a look if you
can’t see clearly. (And remember that that bolus does go into the patient.) A growing clot may
suddenly just drop to the bottom of the trap and occlude the line. If you’re lucky, it won’t be
completely blocked, and you’ll be able to give the patient her blood back from the system – if
not, she may need a packed cell. Much more common in bicarb system situations.
Are there ways that can be prevented?
Keeping the system nicely anticoagulated is the whole key, along with keeping the catheter flows
nice and smooth. Kinky catheter flows are apparently hemolytic, and the debris forms clots in the
system, not to mention destroying lots of your patient’s red cells.
What if the machine goes down, and I can’t figure out what’s wrong?
The system in general is a fussy, unpredictable beast. Did the patient cough, briefly drive up the
arterial pressure and get the arterial transducer wet? Did just enough air get into the system
somewhere to set off the air detector, even though you might not be able to see it in the line?
Arrggh! This is one of those situations where two heads are definitely better than one (or half of
one in my case) – you’ll see the senior nurses rending their garments and calling each other for
help sometimes.
43
Where are clots likely to form in the circuit?
The arterial and venous traps are the most visible places, but actually the filter is the place where
I understand most of the clotting problems go on – all those little tubes, y’know. Sometimes you
can look at the ends of the filter and see some clots forming there – gives you a clue as to what’s
going on in the filter as a whole. What will the transmembrane pressure be doing?
What does it mean if the arterial pressure starts getting very low?
“Low”? You mean: “more lower than before”, which is to say, “a greater negative pressure”? Or
“not quite as low as it was before”, meaning “higher towards zero”, and therefore “less”? Ack!
If the arterial pressure zips downwards towards -100, the machine is pulling too hard; it’s having
to work too hard to pull blood out of the patient, and it’ll stop and alarm. The catheter may be
kinked – did you turn the patient over in bed? Did he flex his leg? Or maybe you need to switch
ports. If a clot is growing in the trap filter – you may need to plan for a tubing change.
What if the venous pressure starts getting very high?
This means the machine is pushing too hard – remember? But the transducer isn’t looking
directly at the catheter lumen that goes back into the patient – it’s actually looking at the pressure
in the venous trap. If the flow through the trap and it’s filter is smooth and quick, then the
pressure will be in a nice range. If the catheter kinks anywhere along the venous line, the
machine will have to push harder to get the blood to move – the pressure will rise.
What if blood backs up into one of the transducers?
If a patient coughs, bears down, Valsalvas, or other wise briefly hypertenses, the pressure going
into the arterial side of the system will rise as the patient’s does, and it may back up into the
44
arterial transducer. The machine will stop, but it’s an easy fix: take a 10cc syringe (use a new one
every time), take off the wet transducer, push the blood column back down, screw on a new
transducer, plug it back in, and off you go. The trick is learning to see it happen.
The venous transducer can do the same thing, but it usually means that things may be clotting up
in the venous trap. Be careful pushing the blood back down in the transducer tubing – you may
dislodge a big clot and get into serious problems – although if this is happening with any
frequency, it’s sort of your clue that a crash may be coming.
Both transducers?
Both things can be going on - you need to try and figure out what you need to fix first…
What does it mean if the TMP starts getting very high?
The filter is probably getting clotted up. This means that you may not be able to get good
amounts of ultrafiltrate out of it – time to change the setup.
What if the air detector stops the machine?
Air get into the line somewhere? The detector is pretty sensitive, so that even if there’s only
“micro” air in the line it will shut down the pump. There’s a procedure for pulling back on a
syringe attached to the venous trap, while running the pump at slow speed, but you need to get
someone to do this with you about 300 times before you’re comfortable with it. The first 290 are
the hardest…
45
What if the blood leak detector goes off?
This one looks at the ultrafiltrate – blood here means that some of the little tubules in the filter
have ruptured. Not good – time to change the blood path and filter. How high was the TMP,
anyway?
What if the heater alarm goes off?
This one can be confusing – it can alarm because there’s high pressure in the replacement line, or
if the heater itself is unhappy. Make sure that the line clamps are all open when you start things
up – if the replacement fluid clamp is closed, the heater circuit will become very unhappy.
When should I start thinking about taking the system down?
If you see big clots forming in the traps or on the ends of the filter, that would be a clue. A really
high and rising TMP would be another one.
What should I do if I think the system is going to crash?
Get your catheter flushes ready: two 10cc syringes of NS, and two of whatever catheter flush
your patient needs: either heparin or ACD solution. If it looks like an imminent crash, slow the
pump rate down, give the patient her blood back, and go ahead and take it down.
46
4008 MACHINE
Through continuous optimization of the treatment modalities Fresenius Medical Care always
aims to offer patients the best renal replacement therapy to increase their well being and quality
of life.
Our hemodialysis systems 4008S guarantee safety and efficiency of all important treatment
modalities within the scope of renal replacement therapies, such as:





Bicarbonate or acetate dialysis
Single-Needle or single-needle click-clack
Ultrafiltration and sodium profiles
Isolated ultrafiltration / Bergström treatment
Online-Hemo(dia)filtration
The hemodialysis equipment can be adapted by the modular combination of extensive options to
special therapy modalities. The automated acquisition, monitoring and control of specific patient
and machine parameters provide the operator with continuous and precise assessment of the
current treatment situation.
The 4008S machine is available with 5 functional slots for slide-in modules
47
5008 THERAPY SYSTEM
The 5008 Therapy System is the right tool available today that allows you to cope with
tomorrow’s hemodialysis realities: continually increasing patient numbers with a growing share
of medically challenging patients, combined with often limited funding and staff.
The 5008 Therapy Systems offers, for the first time, the highest treatment quality – ONLINE
Hemodiafiltration – with convincingly easy handling and thoughtful use of the dialysis-relevant
resources.
It is a highly integrated system, built for sustainable dialysis – today and tomorrow.
5008 – a touching experience!
Best Handling for all Users



Well-designed user interface
Flexible, safe and easy data management
Optimised ergonomics
48
Best Therapy for your Patients



ONLINE HDF the therapy of choice
Absolute patient safety
Long term patient surveillance
Optimal Use of Resources

Efficient and sustainable
49
Chapter-4
accessories
50
DIALYZER
The dialyzer replaces important kidney functions
In hemodialysis, the dialyzer acts as an artificial kidney and replaces vital functions of the
natural organ. Blood flows through as many as 20,000 extremely fine fibers, known as
capillaries, clustered in a plastic tube approximately 30 centimeters long. The capillaries are
made of Fresenius Polysulfone, a special plastic with exceptional filtering and
hemocompatibility characteristics. Pores in the capillaries filter metabolic toxins and excess
water from the blood and flush them out of the body with dialysis fluid. Blood cells and vital
proteins remain in the blood. Dialyzers are used only once in most industrialized countries.
Fresenius Polysulfone is well tolerated
Fresenius Polysulfone has been proven in clinical trials to be biologically extremely well
tolerated. This biocompatibility of the membrane has a decisive effect on the success of dialysis
treatment since each liter of blood passes through the fine Polysulfone capillaries ten to twelve
times during a single session. The Helixone membrane was developed and is produced by
Fresenius Medical Care and is an optimized version of Fresenius Polysulfone. It is used in FXClass and Optiflux dialyzers and further improves the filtering of blood. These artificial kidneys
are also smaller and lighter than traditional models.
51
High-flux dialyzers are more efficient
Most patients have a significantly longer survival rate when treated with high-flux rather
than low-flux dialyzers. This was the conclusion of a study conducted by nephrologists and
published in 2007. Specialists believe the longer survival rates with high-flux dialyzers are the
result of a more efficient removal of metabolic toxin molecules from the blood. The pores in the
membranes of high-flux dialyzers are two-and-a-half times larger than those in low-flux
dialyzers. High-flux dialyzers also have greater water permeability. This makes the filtering
characteristics of high-flux membranes very similar to those of the glomerular basement
membranes in the human kidney and facilitates to quickly remove large amounts of fluids and
urophanic toxins from the body. High-flux dialysis can also help maintain remaining kidney
function over a longer period of time.
Most dialyzers are produced by Fresenius Medical Care
Fresenius Medical Care sets the standards for modern dialyzers. Around the world, doctors and
care personnel trust in the Company’s products since they allow them to offer the best-possible
treatment for their patients. More than 40 percent of all artificial kidneys sold every year come
from Fresenius Medical Care’s development and production sites in St. Wendel, Germany;
Ogden, Utah; Inukai in Japan and L’Arbresle, France.
Dialyzers & Filters
With over thirty years of experience in research & development and manufacturing of dialyzers,
Fresenius Medical Care offers a broad spectrum of dialyzers to meet the specific demands of the
different
therapy modalities and the
individual needs of every patient.
Fresenius Polysulfone stands for performance and safety in hemodialysis since three decades.
The Fresenius Polysulfone dialyzers combine a high performance with an excellent
hemocompatibility.
Continuing to set the standard for novel dialysis products, Fresenius Medical Care launched a
new class of dialyzers, the FX-class. These dialyzers combine an innovative housing design with
an advanced dialysis membrane – the Helixone membrane – the manufacturing of which
employs a new process of membrane making – the Nano Controlled Spinning (NCS)
Technology.
Fresenius Medical Care dialyzers and filters are subjected to an innovative method of
sterilization – the unique INLINE steam sterilization procedure, which delivers sterile and
pyrogen-free dialyzers free from pore-filling agents and with an excellent hemocompatibility
unaffected by sterilization.
52

Fresenius Polysulfone - Polysulfone-based dialysis membrane characterized by an
excellent performance, hemocompatibility and endotoxin retention.

Helixone - Advanced polysulfone-based dialysis membrane with an improved
performance profile, an excellent hemocompatibility and a high endotoxin retention
capacity.

NCS Technology - Special technology employed in manufacturing of the Helixone
membrane creating a defined pore structure and pore distribution profile of the inner
membrane layer according to the desired application.

INLINE steam sterilization - Special sterilization process, in which both, the blood- and
the dialysate sides of the dialyzers and filters are continuously flushed with steam,
enabling safe and comfortable treatments.
53
DIALYSATE
So - when you dialyze someone, you put their blood (hypertonic – very full of stuff that needs
removing) on one side of a membrane – and put some hypotonic solution on the other side (that’s
the dialysate), and off the little critters go a-running over the membrane border there, from where
they get washed away and sent back into the Great Pond, or wherever. And the number of BUN
and creatinine molecules in the blood decreases, along with a bunch of even smaller ones like the
electrolytes, which is why we spend so much time worrying about giving them back.
However – you haven’t removed any fluid yet…
Dialysate is one of the two fluids used in dialysis. The other fluid being blood. The term
dialysate is borrowed from physical chemistry and refers to fluids and solutes which have
crossed a membrane.
The main function of the dialysate, is to remove waste material from the blood and to keep useful
material from leaving the blood. Electrolytes and water are some materials included in the
dialysate so that their level in the blood can be controlled.
As previously mentioned, the make up of dialysate or the dialysis 'bath', is: sodium chloride,
sodium bicarbonate or sodium acetate, calcium chloride, potassium chloride, and magnesium
chloride. This is the general composition of dialysate, but other compounds such as glucose may
also be included. Glucose is sometimes included.
Dialysate consists of purified water and various substances dissolved in it. With the exception of
glucose, the substances dissolved in the dialysate are all electrolytes. Their concentration
(besides potassium and the buffer substance) closely resembles the concentration of the
electrolytes occurring naturally in the blood. Dialysate regulates the electrolyte and acid-base
balance of the dialysis patient and removes waste products.
Fresenius Medical Care's product range of concentrates and solutions:





Acid concentrates
Bicarbonate concentrates
Hemofiltration solutions
Rinsing solutions
Concentrates for the GENIUS system
54
The goal of dialysis for patients with chronic renal failure is to restore the composition of the
body’s fluid environment toward normal. This is accomplished principally by formulating a
dialysate whose constituent concentrations are set to approximate normal values in the body.
Over time, by diffusional transfer along favorable concentration gradients, the concentrations of
solutes that were initially increased or decreased tend to be corrected. When an abnormal
electrolyte concentration poses immediate danger, the dialysate concentration of that electrolyte
can be set at a nonphysiologic level to achieve a more rapid correction. On a more chronic basis
the composition of the dialysate can be individually adjusted in order to meet the specific needs
of each patient.
55
DIALYSATE COMPOSITION FOR HEMODIALYSIS
In the early days of hemodialysis, the dialysate sodium concentration was deliberately set low to
avoid problems of chronic volume overload such as hypertension and heart failure. As volume
removal became more rapid because of shorter dialysis times, symptomatic hypotension emerged
as a common and often disabling problem during dialysis. It soon became apparent that changes
in the serum sodium concentration—and more specifically changes in serum osmolality— were
contributing to the development of this hemodynamic instability.
A decline in plasma osmolality during regular hemodialysis favors a fluid shift from the
extracellular space to the intracellular space, thus exacerbating the volume-depleting effects of
dialysis. With the advent of high-clearance dialyzers and more efficient dialysis techniques, this
decline in plasma osmolality becomes more apparent, as solute is removed more rapidly. Use of
dialysate of low sodium concentration would tend further to enhance the intracellular shift of
fluid, as plasma tends to become even more hyposmolar consequent to the movement of sodium
from plasma to dialysate. The use of a higher sodium concentration dialysate (>140 mEq/L) has
been among the most efficacious and best tolerated therapies for episodic hypotension. The high
sodium concentration prevents a marked decline in the plasma osmolality during dialysis, thus
protecting the extracellular volume by minimizing osmotic fluid loss into the cells.
In the early 1960s acetate became the standard dialysate buffer for correcting uremic acidosis
and offsetting the diffusive losses of bicarbonate during hemodialysis. Over the next several
years reports began to accumulate that linked routine use of acetate with cardiovascular
instability and hypotension during dialysis. As a result, dialysate containing bicarbonate began to
re-emerge as the principal dialysate buffer, especially as advances in biotechnology made
bicarbonate dialysate less expensive and less cumbersome to use. For the most part, the
bicarbonate concentration used consistently in most dialysis centers is 35 mmol/L. Emphasis is
now being placed on individually adjusting the dialysate bicarbonate concentration so as to
maintain the predialysis tCO2 concentration above 23 mmol/L.
Increasing evidence suggests that correction of chronic acidosis is of clinical benefit in terms of
bone metabolism and nutrition. Dialysis assumes a major role in the maintenance of a normal
serum potassium concentration in patients with end-stage renal disease. Excess potassium is
removed by using a dialysate with a lower potassium concentration, so that a gradient is achieved
that favors movement of potassium. In general, one can expect only up to 70 to 90 mEq of
potassium to be removed during a typical dialysis session. As a result, one should not
overestimate the effectiveness of dialysis in the treatment of severe hyperkalemia. The total
amount removed varies considerably and is affected by changes in acid-base status, in tonicity, in
glucose and insulin concentration, and in catecholamine activity.
56
The concentration of calcium in the dialysate has implications for metabolic bone disease and
hemodynamic stability. Like the other constituents of the dialysate, the calcium concentration
should be tailored to the individual patient. Some data suggest that lowering the dialysate
calcium concentration would exacerbate exacerbate hemodynamic instability during the dialysis
procedure. In this regard, the intradialysis drop in blood pressure noted in patients dialyzed
against a low-calcium bath, while statistically significant, is minor in degree. Nevertheless, for
patients who are prone to intradialysis hypotension avoiding low calcium dialysate concentration
may be of benefit. On the other hand, the use of a lower calcium concentration in the dialysate
allows the use of increased doses of calcium-containing phosphate binders and lessens
dependence on binders containing aluminum. In addition, use of 1,25-dihydroxyvitamin D can
be liberalized to reduce circulating levels of parathyroid hormone and, thus, the risk of inducing
hypercalcemia. With dialysate calcium concentrations below 1.5 mmol/L, however, patients need
close monitoring to ensure that negative calcium balance does not develop and that parathyroid
hormone levels remain in an acceptable range.
57
DIALYSATE COMPOSITION FOR PERITONEAL DIALYSIS
To meet the ultrafiltration requirements of patients on peritoneal dialysis, the peritoneal dialysate
is deliberately rendered hyperosmolar relative to plasma, to create an osmotic gradient that
favors net movement of water into the peritoneal cavity. In commercially available peritoneal
dialysates, glucose serves as the osmotic agent that enhances ultrafiltration. Available
concentrations range from 1.5% to 4.25% dextrose. Over time, the osmolality of the dialysate
declines as a result of water moving into the peritoneal cavity and of absorption of dialysate
glucose. The absorption of glucose contributes substantially to the calorie intake of patients on
continuous peritoneal dialysis. Over time, this carbohydrate load is thought to contribute to
progressive obesity, hypertriglyceridemia, and decreased nutrition as a result of loss of appetite
and decreased protein intake. In addition, the high glucose concentrations and high osmolality of
currently available solutions may have inhibitory effects on the function of leukocytes, peritoneal
macrophages, and mesothelial cells. In an attempt to develop a more physiologic solution,
various new osmotic agents are now under investigation. Some of these may prove useful as
alternatives to the standard glucose solutions.
Those that contain amino acids have received the most attention. The sodium concentration in
the ultrafiltrate during peritoneal dialysis is usually less than that of extracellular fluid, so there is
a tendency toward water loss and development of hypernatremia. Commercially available
peritoneal dialysates have a sodium concentration of 132 mEq/L to compensate for this tendency
toward dehydration. The effect is more pronounced with increasing frequency of exchanges and
with increasing dialysate glucose concentrations. Use of the more hypertonic solutions and
frequent cycling can result in significant dehydration and hypernatremia. As a result of
stimulated thirst, water intake and weight may increase, resulting in a vicious cycle.
Potassium is cleared by peritoneal dialysis at a rate similar to that of urea. With chronic
ambulatory peritoneal dialysis and 10 L of drainage per day, approximately 35 to 46 mEq of
potassium is removed per day. Daily potassium intake is usually greater than this, yet significant
hyperkalemia is uncommon in these patients. Presumably potassium balance is maintained by
increased colonic secretion of potassium and by some residual renal excretion. Given these
considerations, potassium is not routinely added to the dialysate.
The buffer present in most commercially available peritoneal dialysate solutions is lactate. In
patients with normal hepatic function, lactate is rapidly converted to bicarbonate, so that each
mM of lactate absorbed generates one mM of bicarbonate. Even with the most aggressive
peritoneal dialysis there is no appreciable accumulation of circulating lactate. The rapid
metabolism of lactate to bicarbonate maintains the high dialysate-plasma lactate gradient
necessary for continued absorption. The pH of commercially available peritoneal dialysis
58
solutions is purposely made acidic by adding hydrochloric acid to prevent dextrose from
caramelizing during the sterilization procedure. Once instilled, the pH of the solution rises to
values greater than 7.0. There is some evidence that the acidic pH of the dialysate, in addition to
the high osmolality, may impair the host’s peritoneal defenses. To avoid negative calcium
balance—and possibly to suppress circulating parathyroid hormone—commercially available
peritoneal dialysis solutions evolved to have a calcium concentration of 3.5 mEq/L (1.75
mmol/L). This concentration is equal to or slightly greater than the ionized concentration in the
serum of most patients. As a result, there is net calcium absorption in most patients treated with a
conventional chronic ambulatory peritoneal dialysis regimen. As the use of calcium-containing
phosphate binders has increased, hypercalcemia has become a common problem when utilizing
the 3.5 mEq/L calcium dialysate. This complication has been particularly common in patients
treated with peritoneal dialysis, since they have a much greater incidence of adynamic bone
disease than do hemodialysis patients. In fact, the continual positive calcium balance associated
with the 3.5-mEq/L solution has been suggested to be a contributing factor in the development of
this lesion. The low bone turnover state typical of this disorder impairs accrual of administered
calcium, contributing to the development of hypercalcemia. As a result, there has been increased
interest in using a strategy similar to that employed in hemodialysis, namely, lowering the
calcium content of the dialysate. This strategy can allow increased use of calcium-containing
phosphate binders and more liberal use of 1,25-dihydroxyvitamin D to effect decreases in the
circulating level of parathyroid hormone.
In this way, development of hypercalcemia can be minimized.
59
DIALYSIS FLUID FILTERS
The quality and the purity of the dialysis fluid are of major concern in renal replacement
therapies, as large volumes of dialysis fluid come into contact with the patient’s bloodstream
during each treatment.
In treatments, such as ONLINE Hemodiafiltration, in which large fluid volumes are exchanged,
the quality and purity of the substitution fluid are of even greater importance.
Bacterial endotoxins and other microbial contaminations present in dialysis fluid may elicit
undesirable acute reactions and influence long-term patient outcomes. In order to avoid
endotoxin-related complications in dialysis, the usage of ultra pure dialysis fluid is strongly
recommended.
The routine production of ultra pure dialysis fluid and substitution fluid relies on the
implementation of ultrafilters – such as DIASAFEplus – within the fluid pathway of the dialysis
machine.

DIASAFEplus – Dialysis fluid filter with Fresenius Polysulfone based membrane fibres.
Endotoxins and other microbial products are retained through size-exclusion principles
and adsorption during cross-flow filtration.

Ultra pure dialysis fluid – Dialysis fluid having a high degree of purity with endotoxins
below 0.03 IU/mL.

The routine application of ultra pure dialysis fluid helps to reduce dialysis-related
inflammation. Moreover, it improves the control of anaemia, making it an important
cornerstone of Cardioprotective Hemodialysis.
60
DISINFECTANTS
Citrosteril
Citrosteril is used for chemo-thermal disinfection (a combination of chemical and heat
disinfection) of haemodialysis machines with recirculation.
Advantages of Citrosteril:




Excellent removal of calcium / magnesium deposits
Odorless
Biodegradable
Active ingredients composed of natural substances
Composition:
Citric acid 1-hydrate, lactic acid, malic acid, adjuvants. To be used according machine
instructions at elevated temperatures only.
Diasteril
Diasteril is used for chemo-thermal disinfection (a combination of chemical and heat
disinfection) of haemodialysis machines with recirculation.
Advantages of Diasteril:




Decalcifying
Odorless
Biodegradable
Economical and environmentally friendly procedure
Composition:
Hydroxy acetic acid, water. To be used according machine instructions at elevated temperatures
only.
61
Puristeril plus
Puristeril plus combines the outstanding advantages of peracetic acid with substantially increased
convenience in transportation and handling.
Advantages of Puristeril plus:




High potent disinfectant
Suitable for all Fresenius Medical Care haemodialysis machines
Biodegradable (decomposes into acetic acid, oxygen and water)
Odor similar to that of weak acetic acid
Composition:
Peracetic acid, hydrogen peroxide, acetic acid, adjuvants, water.
Puristeril 340
Puristeril 340 is an aldehyde-free cleaning and disinfecting agent based on peracetic acid.
Advantages of Puristeril 340:



High potent disinfectant
Suitable for all Fresenius Medical Care haemodialysis machines including GENIUS
Therapy System
Biodegradable (decomposes into acetic acid, oxygen and water)
Composition:
Peracetic acid, hydrogen peroxide, acetic acid, adjuvants, water.
Sporotal 100
Sporotal 100 is a fast acting cleansing agent for removal of biofilms in haemodialysis machines
and in water distribution systems. Acts also as disinfectant.
62
Advantages of Sporotal 100:




Reducing biofilms
Strong cleaner
Fast acting
Contains also chlorine
Composition:
Sodium hypochlorite (releases chlorine); potassium hydroxide, corrosion inhibitors.
ClearSurf
ClearSurf is ideally suited for efficient disinfection and cleansing of surfaces of dialysis
machines and medical devices.
Advantages of ClearSurf:




Excellent antimicrobial activities
Fast acting
Odorless
Free from aldehydes or phenols
Active ingredient:
Benzalkoniumchloride.
Antimicrobial effects:
Bactericidal, fungicidal, inactivation of enveloped viruses (Vaccinia virus and BVDV as
surrogate viruses for e.g. HBV/HCV/HIV), inactivation of feline calci virus FCV (surrogate
virus for Norwalk-like virus).
Note:
Always proceed according to the manufacturer’s instruction.
63
FISTULA NEEDLES
Fresenius Medical Care ensures a high quality and reliability of all products and services.
Therefore, our components are subject to permanent control in order to guarantee a consistent
high quality standard.
Fistula Needles are a crucial link between the patient and the dialysis machine. For this reason,
all needles have to meet the requirements of highest quality, safety and comfort – both from the
user’s as well as from the patient’s perspective.
Advantages of Fresenius Medical Care's fistula needles:





Reliable geometry of the cutting-edge
Colour coded
Optimized flow-geometry
Biocompatibility
Consistent high product quality
64
TUBING SYSTEMS
Fresenius Medical Care has been producing bloodline systems since thirty years. The result of
these many years’ experience is sophisticated technical expertise to achieve consistently high
product quality.
At Fresenius Medical Care, we carefully and continually check the interfaces between our
different products. There are numerous interfaces between bloodlines and dialysis machines all
of which play a prominent and safety relevant role.
Fresenius Medical Care bloodlines make a difference for doctors, nurses and patients:




Safe and easy to use components
Excellent medical grade raw materials from renowned suppliers
Certified quality system in development and production according to ISO 9001 and ISO
13485
Constant highest quality guaranteed by state of the art design and numerous controls
Fresenius Medical Care's range of bloodlines and tubing systems:
Standard bloodlines for 4008 Fresenius Medical Care machine:




NaturalLine – Steam-sterilized bloodlines
AdvancedLine - Gamma-ray-sterilized bloodlines
Pediatric bloodlines
Accessories
Bloodlines for 5008 Therapy System:

Newly developed e-beam sterilization
E-beam sterilization does not require any radioactive materials in the production, but works with
accelerated electrons created in a cathode-ray tube. Due to the short time of exposure to the
radiation (few seconds), e-beam sterilization has for example a minor effect on the polymer
stability of the irradiated material in comparison to gamma-irradiation.
65
WATER TECHNOLOGY
Fresenius Medical Care provides a comprehensive range of reverse osmosis water treatment
systems designed to meet the needs of today’s dialysis market requiring user-friendly operation,
microbiological purity, technical safety and economical operation. Our water treatment products
are a key part of the Fresenius Medical Care product range.
For further product information please click on the respective link:










AquaUNO
AquaWTU
Aquasafe 08
AquaHWCS
Aquasafe DUO
AquaB
AquaB DUO
Central Concentrate Treatment Products Overview
CDS08
Granumix
AquaUNO
The mobile single patient reverse osmosis AquaUNO is designed to operate with a range
hemodialysis machines such as the dialysis systems 4008 and 5008. It is especially well suited
for home dialysis patients as well as in Intensive Care Units. A range of options is available for
the use of the AquaUNO including the AquaPorter trolley for easy transportation.
The AquaUNO meets today’s requirements for user-friendly operation, microbiological purity,
technical safety and economical operation.
Advantages of AquaUNO:






Easy to use display panel
Quiet operation
Re-circulating permeate supply line
Self test of safety components in start up
Automatic rinsing, cleaning and disinfection cycles
Recovery of excess permeate and concentrate
66
AquaWTU
The AquaWTU (Water Treatment Unit) is a complete reverse osmosis water treatment system
including pre-treatment, reverse osmosis and distribution. The standard pre-treatment comprises
10 µm particle filter, volume controlled duty / standby softener, ultraviolet lamp and 5 µm
carbon impregnated filter. An optional additional pre-treatment filter can be mounted on the rear
of the unit if required.
The unit is available in two sizes 125 l/h and 250 l/h. Its versatile design means it can operate as
a direct feed unit supplying dialysis machines through a circulating ring main or with permeate
storage tank mode for operation with equipment such as the Fresenius Medical Care Genius.
Advantages of AquaWTU:






Compact, portable, water treatment system
Easy to use display panel
Semi-automatic volume controlled chemical disinfection for accurate and safe operation
Programmable automatic start/stop controls with ‘auto rinse’ functions
Microprocessor controlled
Online water saving device
Aquasafe 08
The Fresenius Medial Care Aquasafe 08 of reverse osmosis range is the heart of the Fresenius
Medical Care water treatment product portfolio. The range includes 8 models for central
installations requiring up to 2000 l/h permeate.
Advantages of Aquasafe 08:








Easy to use display panel
Semi-automatic conductivity controlled chemical disinfection for accurate and safe
operation
Programmable automatic start/stop controls with ‘auto rinse’ functions
Integrated aseptic sample points in the permeate flow and return lines
Optional Fresenius Polysulfone ultra filter
Controlled microprocessor
Optional AquaDAS (Data Acquisition System) for remote data transfer and diagnostic
use
Online water saving device
67
AquaHWCS
The AquaHWCS provides a fully integrated hot water rinsing system enabling the complete
system to be hot rinsed - from the reverse osmosis membranes all the way through to the dialysis
machines. The unit is based on the proven Aquasafe 08 with a separate heater unit. Two hot
water rinse options allows the operator to select whether to hot rinse the permeate distribution
loop, reverse osmosis membranes or both.
Advantages of AquaHWCS:






Includes all features and benefits associated with the Aquasafe 08 relating to
microbiological purity, technical safety and economical operation
Choice of hot water rinsing and / or semi-automatic conductivity controlled chemical
disinfection
Fully integrated hot water option of the reverse osmosis membranes, distribution loop
and machines
Programmable automatic hot water rinsing operating
Emergency bypass of hot water facility
Online water saving device
Aquasafe DUO
In some cases the need for single pass even with hot water rinsing is considered not enough.
Fresenius Medical Care has therefore brought together two proven systems to provide a package
of Aquasafe 08 and AquaHWCS. The result is the Aquasafe DUO HWCS. This product
combines all the benefits provided by both the Aquasafe 08 and the AquaHWCS.
Advantages of Aquasafe DUO HWCS:






Includes all features and benefits associated with the Aquasafe 08 and the AquaHWCS
relating to microbiological purity, technical safety and economical operation
Choice of hot water rinsing and / or semi-automatic conductivity controlled chemical
disinfection
Fully integrated hot water option of the second stage reverse osmosis membranes,
distribution loop and machines
Programmable automatic hot water rinsing operating
Emergency bypass of the hot water facility and both the first or second reverse osmosis
stage
Online water saving device
68
AquaB
The AquaB range of central reverse osmosis units were developed from our experience gained
from the Aquasafe 08 and AquaWTU product lines. This competitively priced unit provides
many of the features found on more expensive units. The product line has 8 units operating from
250 – 2000 l/h and is suitable for both direct feed and for use with a permeate water storage tank.
Advantages of AquaB:






Easy to use display panel
Semi-automatic volume controlled chemical disinfection for accurate and safe operation
Programmable automatic start/stop controls with ‘auto rinse’ functions
Controlled microprocessor
Integrated aseptic sample points in the permeate flow lines Online water saving device
Online water saving device
AquaB DUO
The AquaB DUO is a double pass reverse osmosis unit that demonstrates the modular design of
the AquaB product family. Additional security is provided by the emergency bypass option,
which allows either the first or second stage reverse osmosis module to be isolated and bypassed,
whilst maintaining an reverse osmosis permeate supply to service. The AquaB DUO product line
range provides from 500 – 1500l/h.
Advantages of AquaB DUO:






Easy to use display panel
Semi-automatic volume controlled chemical disinfection for accurate and safe operation
Programmable automatic start/stop controls with ‘auto rinse’ functions
Microprocessor controlled
Integrated aseptic sample points in the permeate flow lines
Online water saving device
69
Central Concentrate Treatment Products Overview
CDS08
The CDS 08 is at the center of a modern and economical central concentrate delivery system.
The microprocessor-controlled unit provides economic and accurate delivery of the concentrate
via a circulating distribution loop. The circulation of the dialysis concentrate(s) starts at the bulk
concentrate storage tank(s). When linked to a media supply center, the dialysis machine can draw
off the required volume of dialysis concentrate. Surplus dialysis concentrate is returned into the
cycle of the central concentrate supply avoiding wastage.
Advantages of CDS 08:




Ultrafiltration filters provided added protection against the entry of particles, bacteria,
endotoxin and air into the existing distribution loop
Circulating distribution loop for added quality control
Automatic warning and change over of bulk concentrate containers
Minimizes wastage, spillages, concentrate handling, disposal of empty containers
Granumix
The Granumix is a custom designed unit for the dissolution of dry concentrate products
(Fresenius Medical Care Granudial) using reverse osmosis permeates water. The unit provides a
quick, easy and economical method for the in house preparation of high quality liquid
concentrate.
Advantages of Granumix:




Economical
Easy to use
Low maintenance
Can be used as part of a central concentrate distribution system
With all our units a range of options are available to add security and reliability e.g. remote
control / nurse alarms, leakage detectors, online water hardness monitors etc. We also have our
own project engineering and installation teams so we can discuss, design, deliver, install and
service your water treatment or concentrate delivery system.
70
SUPPORTING EQUIPMENT
Fresenius Medical Care provides in cooperation with LIKAMED a complete scope of dialysis
equipment.
LIKAMED has experience and competence in the design and manufacture of dialysis chairs,
beds and trays for more than twenty years. For the top-quality LIKAMED received certification
marks like "TÜV" (German Technical Control Board).
Dialysis Chairs - product scope:




SMART X - The Basic
TOP X / SK - The Classic / Compact
NOVO X 220/330 - Dialysis Chair Deluxe
NOVO XS 3/4 - The complete variability
Dialysis Bed Chair - product scope:

NOVO X 550
Dialysis Trays - product scope:


ST standard
DT comfort
Sleep Safe Porter - product scope:

Sleep Safe Porter
AquaUNO Porter - product scope:

AquaUno Porter
71
Ionometer
The Ionometer is a full automatic and small-sized electrolyte analyzer for determining sodium,
potassium, calcium, pH-value, hematocrit and conductivity in whole blood, plasma, serum and
dialysis fluid.
Special features of the new Ionometer:






Integrated program for quality control
Integrated thermal printer
Menue with dialog function in five languages
Printable error history buffer
Two measurement modes for rapid routine control and high-precision measurement
Solution sparing standby-mode
Available types of ionometer3:




ionometer3 EF: sodium (Na), potassium (K), calcium (Ca)
ionometer3 EH-F: sodium (Na), potassium (K), calcium (Ca), pH
ionometer3 EF-HK: sodium (Na), potassium (K), calcium (Ca), hematocrit (Hkt),
hemoglobin * (Hb), conductivity (Cd)
ionometer3 EH-HK: sodium (Na), potassium (K), pH, hematocrit (Hkt), hemoglobin*
(Hb), conductivity (Cd)
*hemoglobin value is a calculated parameter
72
Chapter-5
statistics
73
COST COMPARISON OF DIALYSIS
The total health related expenditure can be broken up into five categories:
1. Dialysis
2. Erythropoietin
3. Medication, Lab Tests and Doctors consultation
There could be other expenses too if some condition develops that needs to be treated. However,
during normal months, these will be the main expenses.
(Note that these are only indicative and approximate costs based on enquiries with different
sources. Your vendors / centers might charge different amounts based on various factors.)
1. Dialysis
Peritoneal Dialysis:
This involves the cost of the PD bags of fluid. The fluid is available in different concentrations.
The rate of the fluid does not depend on the concentration. The rate depends only on the volume.
Most people on CAPD use the 2 liter bags while those on CCPD use 5 liter bags.
There are different companies offering PD treatment in India like Baxter, Gambro etc.
Baxter costs:
CAPD:
Cost of one 2 liter bag: Rs. 170
Total cost of bags assuming 4 exchanges per day, 7 days a week: Rs. 21,000
74
CCPD:
Cost of one 5 liter bag: Rs. 416
Total cost of bags assuming 2 bags used per night, 7 nights a week: Rs. 25,000
Cost of renting Home Choice machine: Rs. 10,000 per month.
Initial deposit for Home Choice machine: Rs. 1,50,000
In Center (Hospital) Hemodialysis:
Cost of dialysis with new kit: Rs. 2,000 to 3,000
Cost of dialysis with reuse: Rs. 1,250 to Rs. 2,300
Assuming one does thrice a week session and uses a new kit every 2 weeks:
Total minimum cost: Rs. 17,000
Home hemodialysis
Initial cost:
Hemodialysis machine: Rs. 6,00,000 (approximate, depends on the brand)
Reverse Osmosis Water Treatment Plant: Rs. 1,00,000 (approximate, depends on the brand)
Electrical wiring, plumbing and miscellaneous: Rs. 1,00,000
Recurring monthly cost: Depends on the number of sessions and the duration of each session.
For six nights a week, 7 hours each night, assuming that a new dialyzer and tubing is used every
week, approximate cost: Rs. 18,000.
75
2. Erythropoietin:
Erythropoietin (EPO) is a hormone that is produced by the kidneys that helps to regulate the
Hemoglobin which affects our energy levels among other things. Many people on dialysis have
low Hemoglobin and need to take some dose of EPO. The cost of EPO varies from company to
company and depends on the strength (number of units). Here I give approximate values just to
get an idea.
Please note that cost varies from city to city too.
2,000 units - Rs. 300 to Rs 750
4,000 units - Rs. 865 to Rs. 2000
10,000 units - Rs. 1800 to Rs. 3000
As you can see there is a wide range in the costs. The actual cost depends on the manufacturer
and the city.
3. Medication, Lab Tests and Doctor's Consultation:
These vary greatly from month to month depending on the circumstances.
For budgeting purposes, I would allocate Rs. 1000 for medication, Rs. 1500 for lab tests and Rs.
500 for doctors consultation.
76
CHANGING PATTERNS OF DIET IN PATIENTS WITH KIDNEY
DISEASE
Traditionally diet plays an important role in any disease. The first doubt the patient has is what to
eat when he has any medical problem. To understand the concept of diet in patients with kidney
disease, we should know briefly the functions of the kidneys.

Basically the kidneys excrete the products of metabolism. The food we eat is broken
down into simpler components and after absorption energy is produced in the body. The
most important component of the food i.e. protein is broken down into amino acids
which then release ammonia as an end product. Ammonia is converted to urea in the
liver. Urea is removed by the kidneys. Similarly the proteins especially animal proteins
produce acids which are excreted by the kidneys. Hence when kidneys are diseased the
blood urea levels go up and acid accumulation takes place in the body.

The second important function of the kidney is to maintain the internal environment of
the body (i.e.) the acid-base and electrolyte of water and it is the responsibility of the
kidneys to correctly remove the exact quantity so that we are neither dehydrated nor
swollen up. Similarly we take lot of salt in our diet (which is sodium chloride) to
improve the taste of food and it becomes the duty of the kidneys to remove this extra salt
so that we do not get high blood pressure. Various minerals including potassium are
found in natural food which again are excreted by the kidneys.
Protein intake
Historically the first diet that was recommended for patients with kidney failure was rice potato
diet which was based on the concept that proteins should be avoided to the maximum and the
patients should get energy from carbohydrates. This would then result in less production of urea.
Similarly barley was promoted as an important food since it is purely a carbohydrate.
Subsequently the 20gm protein including vegetable and animal proteins. The biggest drawback
of all the above diet was that the urea levels came down but patients became under nourished and
the quality of life suffered. Hence the present concept where protein restrictions mainly holds for
the western diet to about 40-50 gms per day. The vegetarian diet does not contain large protein to
be restricted. So average Indian vegetarian diet is more or less tailor made with regards to the
protein intake in patients with kidney failure. It is also important to differentiate whether patients
suffer from acute or chronic kidney failure. In acute kidney failure where there is temporary
cessation of kidney function, nutrition is very important for the recovery of the patient. Hence
protein restriction is not advocated. Whereas in chronic renal failure where the kidneys are
irreversibly damaged protein reduction to 40 gms per day especially animal protein is advocated
early in the disease to prevent progression. When the disease is advanced, protein restriction is
not recommended since patients will become under nourished.
77
Salt intake
Coming to the salt intake, salt is sodium chloride and not urea as confused by lay people. All
patients with kidney disease do not require salt restriction. Only those who have swollen legs
require salt restriction. Salt substitute are dangerous since they contain potassium.
Water intake
There is a misconception that large quantities of water will improve kidney function. On the
contrary, in patients with kidney failure, water accumulates in the body resulting in
hyponatremia. Hence water or fluid restriction is important which will vary from patient to
patient.
Potassium intake
Almost all patients with kidney failure require potassium restriction in the diet. High potassium
is found in fruit juices, coconut water, dried fruits, red meat, etc.
Stone disease
Coming to patients with kidney stone, again there is change in the concept of diet. Originally
since majority of the stones are calcium oxalate stones, low calcium and oxalate diet were
recommended. However it has been shown that restriction of calcium on the contrary leads to
loss of calcium in bones and continuation of stone formation and hence low calcium diet is not
advised. Similarly tomatoes have become notoriously responsible for stone formation which is
not correct. What has been found out is that the high protein in the diet leads to uric acid
formation and highly acidic urine. This inturn precipitates stone formation. Also high salt in the
diet drags the calcium along with sodium in the urine resulting in stone formation. Hence the
present recommendation is low protein and low salt diet for patients with kidney stones.
Similarly an acidic urine results in burning especially when there is urinary tract infection. The
diet with large quantities of vegetables makes the urine alkaline and relieves the symptoms.
78
FOOD COMPOSITION CHARTS
Here is a list of common Indian foods along with their Potassium and Sodium contents. All
values are mg/100 grams of edible portion of the food item. It also has the content of other
minerals.
(Source: National Institute of Nutrition, Hyderabad's publication "Nutritive Value of Indian
Foods")
79
80
81
82
83
84
Chapter-6
Infection control
85
INFECTION CONTROL IN THE DIALYSIS SETTING
Dialysis is used as a life sustaining treatment for patients with renal failure. Patients undergoing
dialysis are already at risk of certain types of infections resulting from underlying diseases or
conditions such as:





Diabetes
Hypertension
Cardiovascular disease
Immunosuppressive therapy
Other critical diseases
Furthermore, dialysis increases the patient’s risk of infection because direct access into normally
sterile areas, including the circulatory system or peritoneal cavity, is required. Infection can be
caused by contamination occurring at various steps in the dialysis procedure or because of
intrinsic contamination of any of the components of the dialysis system.
The most common types of dialysis-associated infections:




Bacteremias
Peritonitis
Pyrogenic reactions
Infections with blood-borne pathogens
86
REDUCING DIALYSIS-ASSOCIATED INFECTION RISK
Infections and adverse reactions may be the result of inadequate infection control measures. Risk
of infection or of adverse reactions in the dialysis unit can be reduced by strictly adhering to
aseptic technique and to procedures for disinfection, by maintenance of equipment, and by
carefully monitoring all procedures in which bacterial or chemical contamination can occur.
Contact transmission is the most important route by which pathogens are transmitted in health
care settings including dialysis units. Transmission can occur when microorganisms from a
patient are transferred to the hands of healthcare personnel who do not use infection control
precautions and who then touch another patient. Less often the environment around the patient,
bedside tables, countertops, etc., become contaminated and serve as a reservoir of pathogens that
can be picked up on hands of health care personnel and transferred subsequently to a patient. For
example, if health care personnel hands are contaminated with blood-borne virus-infected blood
from one patient, they can transfer the virus to another patient’s skin or blood line access port
when the skin or port is accessed with a needle.
Hemodialysis (HD)
Hemodialysis removes toxins, electrolytes, and fluid by circulating the patients’ blood through a
hemodialyzer (artificial kidney). Patients are usually scheduled to receive hemodialysis for two
to six hours three times per week. The basic components of hemodialysis include circulatory
access, water treatment system, water distribution system, dialysate (components), dialysis
machines, blood tubing and the hemodialyzer.
Circulatory Access
Access to the patients’ circulatory system is gained through the establishment of several different
types of devices including external arteriovenous shunts, internal arteriovenous fistula, graft
arteriovenous fistula, and temporary vascular access devices (e.g., dual lumen catheter in
subclavian, jugular vein).
87
Standard Precautions
Hand Hygiene and Protective Barriers:Indications of Routine Hand Washing in Dialysis Unit





Before and after dealing with dialysis machines
Before and after performing non-invasive techniques
After removal of gloves
If hands are visibly dirty
After leaving a particular patient dialysis station and before dealing with another patient’s
stations
Indications for Aseptic Hand Washing
 Before performing any invasive procedure such as inserting circulatory access, CV lines and
peritoneal catheters.
 Before and after connecting the patient to the dialysis machine through the AV fistulae
 Alcohol based hand rub can substitute hand washing in emergency cases or if water source
is lacking, provided that hands are visibly clean.
Gloves:
 Use non-sterile disposable gloves when performing non-invasive procedures, cleaning or
disinfecting instruments or environment including the dialysis machine.
 Use sterile gloves when performing invasive procedures or connecting the patient to the
dialysis machine
 Water-proof aprons or gowns should be worn if the nurse is located within the patient
station producing any service.
 Personnel should always have protective equipment (fluid resistant gown, mask, and
eyewear) readily available to prevent their exposure to blood in the event that there is
rupture of hemodialyzer membrane and/or a disconnection or rupture of tubing. These
events can happen if there is increased pressure in the blood compartment of the
hemodializer caused by an obstruction between the blood outlet of the hemodialyzer and
the patient.
88
Aseptic Technique
Healthcare personnel can reduce the risk of infection by practicing the following
procedures: Hands should be washed or waterless alcohol-based hand rub should be applied before and
after each patient contact.
 Any item taken to a patient's dialysis station could become contaminated with blood and
other body fluids and therefore could serve as a vehicle of transmission to other patients
either directly or by contamination of the hands of personnel. Therefore, items taken to a
patient's dialysis station, including those placed on top of dialysis machines, should either be
disposed of, dedicated for use only on a single patient, or cleaned and disinfected before
being returned to a common clean area or being used for other patients.
 HCP should prepare a sterile set of materials for each patient for insertion of central venous
catheters.
 Heparin should be prepared just prior to use for each patient. Vials should not be shared
between patients.
 Aseptic technique of the skin over the fistula site (creation of a sterile field, use of sterile
barriers and gloves) is effective in preventing infection.
 Before fistula cannulation, the patient should clean the arm with soap, if possible. Then any
antiseptic solution (e.g. alcohol, betadine) should be applied in an outward circular motion
to the selected needle insertion site and allowed to dry. If betadine (povidone-iodine) is
used, permit it to dry for > 2 minutes prior to catheter insertion.
 Meticulous attention to aseptic technique should be used and the insertion site should not be
palpated once the site has been prepared.
 A sterile gauze should be saturated with an antiseptic solution and applied to the ports of the
central venous catheter for 5 minutes before opening the catheter when initiating
hemodialysis and before disconnecting the blood lines at the termination of hemodialysis.
 Clean, non-sterile exam gloves and clean technique should be used during dressing changes.
 When shunts or central venous catheters are used for vascular access, a new sterile dressing
should be applied after each dialysis treatment. Adhesive tape should not be applied directly
to the catheter.
 Patients should be instructed in the proper way to care for the site.
89
Equipment-Dialysis Machines:Blood Pump
A blood pump consists of two or more rollers and is usually necessary to pump the patient’s
blood through tubing and the hemodialyzer at stable and accurate blood flow rates.
Fluid Pathways
There are three types of hemodialysis machines: Recirculating Machines:- Recirculating machines recirculate dialysate repeatedly through
the hemodialyzer during dialysis.
 Recirculating Single Pass Machines:- Recirculating single pass machines recirculate
dialysate repeatedly through the hemodialyzer during dialysis; however, dialysate in the
recirculating reservoir is partially displaced by a constant flow of fresh dialysate.6
 Single Pass Machines:- Single pass machines provide a constant flow of dialysate, which
passes through the dialysate compartment and is discarded.
90
RECOMMENDATIONS
Single-pass delivery machines are preferred. Recirculating systems permit nutrient-rich waste
products from the patient to be used as nutrients for microorganisms and therefore may result in
increased levels of bacteria during the dialysis treatment. In contrast, contamination of single
pass machines is usually related to the quality of treated water or other dialysate components
going into the machine and the adequacy of cleaning and disinfection procedures.
In a Single Pass Machine
 Pipes and tubing of incoming water (batch system) or dialysate (proportioning system) as
well as the internal dialysate and dialysate pathways must be disinfected at the end of the
day
 In a single-pass machine the internal fluid pathways that supply dialysis fluid to the dialyzer
are not subject to contamination with blood.
 If a blood leak occurs in a single-pass machine, it is not necessary to disinfect the internal
fluid pathways because even if the fluid pathways that exhaust the dialysate became
contaminated with blood, it would be unlikely that this blood contamination could reach the
patient.
 External surfaces of the machine should be cleaned and disinfected between patients using
low level disinfectant (according to manufacturers’ instructions).
In a Recirculating or Recirculating Single Pass Dialysis Machine
 All fluid pathways should be disinfected immediately prior to first use and after each patient
use.
 If a blood leak occurs, then the disinfection procedures used to control bacterial infection in
the machines are considered sufficient to reduce blood contamination below infectious
levels.
 Waste from the dialysis machine must not be allowed to back flow into the machine. This is
often accomplished by allowing an air gap between the drain hose and the drain.
Blood Tubing
 To avoid bacteremia from contaminated blood tubing (e.g. gram-negative bacilli infecting
the blood from ultrafiltration waste) the following control measures should be followed:
 Do not attach the venous tubing directly to the waste container during hemodialyzer
priming.
 Always follow gloving and hand washing guidelines after contact with ultrafiltration waste.
91
 Decontaminate ultrafiltration waste containers daily.
 Cleaning of dialysis machines.
 For single-pass machines perform rinsing and disinfection procedures at the beginning or
end of the day.
 For batch recirculating machines, drain, rinse, and disinfect after each use. Follow the same
methods for cleaning and disinfection if a blood leak has occurred, regardless of the type of
dialysis machine used.
 Venous pressure transducer protectors should be used to cover pressure monitors and should
be changed between patients and should not be reused.
92
ENVIRONMENTAL ISSUES
 Establish written protocols for cleaning and disinfecting surfaces and equipment in the
dialysis unit, including careful mechanical cleaning before any disinfection process.
 If the manufacturer has provided instructions on sterilization or disinfection of the item,
these instructions should be followed.
 After each patient treatment, clean and perform low level disinfection of the environmental
surfaces at the dialysis station, including the dialysis bed or chair, countertops, and external
surfaces of the dialysis machine.
 Ideally, all linens should be changed between patients.
 Between uses of medical equipment (e.g., scissors, hemostats, clamps, stethoscopes, blood
pressure cuffs), clean and apply a hospital disinfectant (i.e., low-level disinfection). If the
item is visibly contaminated with blood, use an intermediate-level disinfection.
 For a blood spill, Clean up blood spills immediately. Besides preventing the spread of
infection, prompt removal also prevents accidents. When cleaning up spills, always wear
gloves, such as disposable or heavy duty gloves. If the spill is small, wipe it with a
disposable cloth and then disinfect the surface area of the spill with another disposable cloth
that has been saturated with a disinfectant (200-500 PPM chlorine solution). If the spill is
large, place a disposable paper or cloth towel ove the spill to soak up the fluid. Still wearing
gloves, pick up the towel, dispose into a container and then soak the area with non-diluted
chlorine). Leave it for considerable time then dry the surface. Do not simply place a cloth
over the spill for cleaning up later; someone could easily slip and fall on it and be injured.
 Housekeeping staff members in the dialysis facility should promptly remove soil and
potentially infectious waste and should maintain an environment that enhances patient care.
Monitoring Water Used for Dialysis
 There should be a designated staff member who is responsible for the initial and routine
monitoring of water and dialysate. This staff member should be knowledgeable of all
aspects of the water treatment and distribution systems and have the authority to investigate
and act on problems related to the quality of water used for hemodialysis.
 Water used to prepare dialysate and dilute germicides and reprocess hemodializers should
meet Ministry of Health standards as defined in Ministerial Decree #63 for the year 1996.
Microbiologic and chemical monitoring should be performed at least monthly in accordance
with this decree.
93
Microbiologic Monitoring
 The microbiologic monitoring of treated water should be performed at least monthly and
more frequently if problems are identified.
 Water used to prepare dialysate should be collected at the point where it enters the
proportioner or the dialysis machine.
 Water used to clean hemodialyzers during reprocessing or to dilute germicides should also
be sampled.
 Dialysate samples should be collected during or at the end of dialysis or beyond the point
where the dialysate leaves the hemodialyzer.
 Microbiologic testing of samples:1. Total viable counts should be obtained using either spread plates or the membrane filter
technique. A calibrated loop should not be used because the small amount of water
sampled makes this test insensitive.
2. The sample should be inoculated onto tryptic soy agar within 30 minutes of collection or
the sample should be refrigerated at 5 degrees Celsius and processed within 24 hours.
3. Culture plates should be incubated at 35 to 37 C for 48 hours before colonies are counted.
4. Identification of organisms may be necessary to link high counts to cases of bacteremia.


Total viable bacterial counts in water used to prepare dialysate or to reprocess
hemodialyzers should not exceed 50 colony forming units (cfu) per milliliter.
Total viable count for dialysate should not exceed 2000 cfu/ml. If the count is greater than
2000 cfu/ml, dialysate equipment should be disinfected and culture repeated.
94
WATER TREATMENT
Municipal or potable water used to prepare dialysate or reprocess hemodialyzers must be treated
to remove chemical, bacterial, or endotoxin contaminants that could be harmful to patients.
When chlorine is removed from the water, as occurs during the treatment of water for
hemodialysis, there is little to impede bacterial growth. Therefore, care must be taken at each
step in the water treatment process to minimize the risk of introducing bacteria into the system or
of allowing treated water to remain stagnant.
 No system should be considered 100% effective at removing bacteria and/or endotoxin.
This means that there is always a need to monitor product water for bacterial and
endotoxin contamination.
Most hemodialysis water treatment systems consist of the following components:
 Carbon Filters: Carbon filters remove chlorine, chloramines, and organic material from the
potable water. Carbon filters are prone to bacterial contamination.
Consider placing at least two carbon filters in series to increase their effectiveness and to
provide redundancy in the system.
Because of the risk of cross-contamination and inadequate disinfection, carbon filters should
be replaced, not regenerated, when exhausted.
 Particulate Filters: Particulate filters are used to remove sediment from water. Bacterial
growth can occur on the filter and lead to subsequent bacteremia and/or pyrogenic reactions.
 These filters should be replaced and disinfected according to the manufacturer’s
Recommendations.
 Reverse Osmosis (RO): RO uses osmotic and hydrostatic pressure over a semi-permeable
membrane to remove ions and organic compounds. In theory RO is capable of removing
90% to 99% of electrolytes and all bacteria, viruses and endotoxins.
95
 Cleaning and restoration of semipermeable membranes should be done according to the
manufacturer’s recommendations.
 Deionizers: Deionizers contain resin beds, which remove cations and anions by binding
them to the resin and releasing hydrogen and hydroxyl ions. Deionizers do not remove
bacteria and endotoxin and resin beds may contribute to significant bacterial growth.
 Deinonizers should be suspected of producing water that may contain high numbers of
bacteria and/or endotoxin, even if proceeded by RO.
 Filters, Ultrafilters, and Ultraviolet Germicidal Irradiation (UVGI): Some dialysis
centers use filters, ultrafilters, and/or UVGI to further reduce microbial and/or endotoxin
contamination. UVGI may be ineffective in killing some bacteria and does not remove
endotoxin. Only ultrafiltration is capable of removing bacteria and endotoxin.
Water Distribution and Storage
 Water distribution systems should be constructed of plastic pipes because metal pipes could
contaminate the treated water with chemicals such as copper, lead, or zinc.
 The minimal number of elbows and T joints should be used and outlets should be at the
highest point of the system to allow adequate contact of all parts of the system with
germicide.
 When possible, storage tanks should not be used because they increase the amount of water
and surface area available for bacterial contamination. If a storage tank is used, it should be:
1.
2.
3.
4.
The smallest tank possible.
Designed to have a constant flow with no stagnant areas.
Airtight using an airtight lid.
Able to be cleaned, disinfected, and rinsed.
 All piping (including water lines to the dialysis machines) and storage tanks must be
disinfected at intervals adequate to prevent bacterial growth in excess of 200 cfu/ml. The
interval will depend on the quality of water entering the system and on the system’s design.
96
Waste Management
 All disposable items should be placed in bags thick enough to prevent leakage. Wastes
generated by the hemodialysis facility might be contaminated with blood and should be
considered infectious and handled accordingly.
 Solid medical wastes should be disposed of properly.
 Sharps should be disposed separately in a safety sharp disposal box immediately after use.
Safety box should be available for each patient station.
Peritoneal Dialysis (PD)
 Peritoneal dialysis removes toxins, electrolytes, and fluid by diffusion through the peritoneal
membrane. Peritoneal dialysis requires placement of a catheter into the abdomen for access
and repeated infusion and drainage of dialysate.
Basic components for peritoneal dialysis include:
 Abdominal access with a peritoneal catheter that can be placed either surgically or
medically.
 Dialysate: a solution that is commercially available in glass bottles, polyvinyl bags, and
plastic bottles. In Egypt plastic bottles are available in high and low concentrations.
 A schedule and system for dialysate infusion and removal.
 There are three types of infections related to site of insertion for peritoneal dialysis: exit
site infection, subcutaneous tunnel infections, and peritonitis. Sources of pathogens
include the patient’s skin or nares, the dialysate, migration from the gastrointestinal tract,
and vaginal leaks. Catheter related infections are due primarily to catheter placement and
maintenance.
Aseptic Technique
Strict use of aseptic technique in the care of the operative wound and catheter exit site should be
observed. Exit site care should be performed daily and when exit site becomes wet or soiled.
Soap and water may be as effective as povidone-iodine for exit site care. Powders, lotions,
ointments, and other skin irritating compounds should not be used. Patients and personnel should
recognize early manifestations of infectious complications.
97
Equipment
 Intermittent peritoneal dialysis (IPD) is performed several times a week (usually overnight),
lasts to up to 48 hours.
 Continuous ambulatory peritoneal dialysis (CAPD) involves exchanges every 4 to 6 hours
during the day.
Prevention of Infection
 Sterile technique and sterile field should be maintained during insertion of peritoneal
catheter.
 Aseptic techniques should always be used during exchange procedures.
 The use of a mask during connect and disconnect procedures may reduce risk of infection
with nasally carried S. aureus.
 The catheter exit site should be kept clean and dry.
 The catheter should be immobilized in a way that minimizes the chances of accidental
pulling or trauma to the surrounding skin.
 Patients should be educated on proper catheter exit site care.
 Use of a disconnect system should be considered for each patient as they have been
demonstrated to decrease the incidence of peritonitis.
Dialysis Personnel
 Training and education for all personnel at risk for occupational exposure should be
provided on a regular basis (e.g. annually) and for all new employees before beginning work
in the dialysis unit.
 Hepatitis B vaccine should be provided to all dialysis personnel.
 Personnel should use of protective barriers in order to protect themselves and in order to
prevent soiling of clothing when performing procedures during which spurting or spattering
of blood might occur (e.g., during initiation and termination of dialysis, cleaning of
dialyzers, and centrifugation of blood).
 Protective clothing or gear should be changed if it becomes soiled with blood, body fluids,
secretions, or excretions.
 Staff members should not eat, drink, or smoke in the dialysis treatment area or in the
laboratory.
 No work restrictions for staff infected with HVC, HBV or HIV/Aids, however they should
strictly follow dialysis specific precautions.
98
Environmental Factors and Design Issues for the Dialysis Facility
Key Principles of Design





Adequate provision of storage of clean and sterile supplies.
At least one separate room for dialysis of patients who are HbsAg positive.
Separate area of adequate size for all the water treatment equipment and filters.
Separate room for disinfection of portable dialysis equipment.
Separate area for disposable of soiled supplies and large volumes of body fluids.
Patient Care Issues
Devices used in dialysis units create an access site, which requires patient education to help
minimize the risk of infection-related morbidity and mortality. Patient education steps that
should be taken include:
 Patients should be instructed to keep the access site clean and dry at all times. The
importance of personal hygiene and its possible relation to access site infections should be
emphasized.
 Patients should be instructed in the proper way to care for the access site and to recognize
and report any signs and symptoms of infection immediately. These signs include fever,
chills, pain, and redness or drainage around the access site.
 Patients can be served meals or can eat food brought from home at their dialysis station. The
glasses, dishes, and other utensils should be cleaned in the usual manner. No special care of
these items is needed.
 HBsAg +ve patients should use be isolated in special rooms and use specific machines.
 Staff should be dedicated to these patients.
99
PREVENTION OF TRANSMISSION OF BLOOD-BORNE PATHOGENS
General Recommendations:
 Staff members must follow Standard Precautions when exposure to blood or other
potentially infectious materials (including peritoneal fluid) is likely.
 Dialysis clinics and centers should perform a hazard assessment to determine what personal
protective equipment is necessary. Protective clothing might include fluid resistant gowns,
gloves, masks, and/or protective eyewear.
 Times when exposure is likely to occur include initiation of dialysis, termination of dialysis,
and during cleaning and disinfection procedures.
 Personal protective equipment should be available to dialysis personnel and visitors in the
appropriate sizes. Use of protective equipment should be monitored and enforced.
 Prompt thorough cleaning and disinfection of surfaces and equipment that are contaminated
with blood or other potentially infectious materials should be done with chlorine solution or
with other disinfectants.
 Disposable items contaminated with blood, peritoneal fluid, or other potentially infectious
materials should be disposed of according to the waste management guidelines found in Part
I “Waste Management II: Safe Sharps Disposal.”
 All soiled linen should be considered potentially infectious and handled according to
procedures outlined in Part I: “Environmental Cleaning”.
 When multiple dose medication vials are used, prepare individual patient doses in a clean
(centralized) area away from dialysis stations and deliver separately to each patient. Do not
carry multiple dose vials from dialysis station to station.
 Personnel who experience an exposure incident should follow the procedures outlined in
their facility’s infection control plan.
Prevention and Management of Hepatitis B Virus Infection
Preventing HBV Transmission among Chronic Hemodialysis Patients requires: Infection control precaution recommended for all hemodialysis patients.
 Regular testing for HbsAg every 3 months and prompt review of results.
 Isolation of HBsAg-positive patients with a dedicated room, machine, other equipment,
supplies, and staff members.
 Vaccination of all patients pending availability of resources.
100
When a HBsAg-Positive Sero-conversion occurs: Review all patients’ routine laboratory test results to identify additional cases.
 Investigate potential sources for infection to determine if transmission might have occurred
within the dialysis unit. Include a review of the newly infected patient’s recent medical
history (e.g. blood transfusion, hospitalization), of high-risk behaviors (e.g. injecting drug
use, sexual activity), and of unit practices and procedures.
 Repeat HBsAg testing.
 Three months later repeat HBsAg testing and test for HBsAb to determine clinical outcome
and need for counseling, medical evaluation, and vaccination of contacts.
 Patients who become HBsAg negative are no longer infectious and can be moved from
isolation.
Isolation of HBV-Infected Patients: In order to isolate HBsAg-positive patients, designate a separate room for their treatment.
 Dedicate machines, equipment, instruments, supplies, and medications that will not be used
by HBV susceptible patients.
 Staff members who are caring for HBsAg-positive patients should not care for susceptible
patients at the same time. This includes the period when dialysis is terminated on one patient
and initiated on another.
 In facilities in which a separate room is not possible, HBsAg positive patients should be
separated from HBV-susceptible patients in an area removed from mainstream activity and
should undergo dialysis on dedicated machines.
 If a machine that has been used on an HBsAg-positive patient is needed for an HBVsusceptible patient, internal pathways of the machine can be disinfected using conventional
protocols and external surfaces can be cleaned using water and detergent and germicide.
 Dialyzers should not be reused on HBsAg-positive patients. Because HBV is efficiently
transmitted through occupational exposure to blood, reprocessing dialyzers from HBsAgpositive patients might place HBV susceptible staff members at increased risk for infection.
 Chronically infected patients (i.e., those who are HBsAg positive, total anti-HBc positive,
and IgM anti-HBc negative) are infectious to others and are at risk for chronic liver disease.
They should be counseled regarding preventing transmission to others and their household
and sexual partners should receive hepatitis B vaccine. They should be evaluated (by
consultation or referral, if appropriate) for the presence or development of chronic liver
disease according to current medical practice guidelines. Persons with chronic liver disease
should be vaccinated against hepatitis A, if susceptible.
 Chronically infected patients do not require any routine follow-up testing for purposes of
infection control. However, annual testing for HBsAg is reasonable to detect the small
percentage of HBV-infected patients who might lose their HBsAg.
101
Vaccination
 Ideally, Hepatitis B vaccine should be administered for all susceptible hemodialysis patients
and staff. Vaccination is recommended for all pre-end-stage renal disease patients before
they become dialysis dependent. The hepatitis B vaccine should administered through the
intramuscular route and only in the deltoid muscle for both adults and children.
 Because antibody response is poorer in hemodialysis patients than in healthy controls, larger
vaccine doses or an increased number of doses are required. In addition, vaccine induced
protection is less complete in dialysis patients and necessitates administration of booster
doses if antibody levels decline below 10 miu by enzyme immunoassay.
 If an adult patient begins the vaccine series with a standard dose before beginning
hemodialysis treatment and then moves to hemodialysis treatment before completing the
series, complete the series using the higher dose recommended for hemodialysis patients.
Post-vaccination Testing and Revaccination of Non-responders
 Test all vaccinated patients for antibody to surface antigen (anti-HBs) one to two months
after the last primary vaccine dose to determine if the response to the vaccine is adequate
(an adequate response is defined as > 10 mIU/ml).
 Patients and staff who do not respond to the primary vaccine series should be revaccinated
with three additional doses and retested for response.
 No additional doses of vaccine are warranted for those who do not respond to the second
series.
 Evaluate personnel who do not respond to revaccination to determine if they are HBsAg
positive. Persons who are HBsAg positive should be counseled accordingly (e.g. the need
for medical evaluation, vaccination of sexual and household contacts).
 Primary non-responders who are HBsAg negative should be considered susceptible to HBV
infection and counseled regarding precautions to prevent HBV infection and the need to
obtain post exposure prophylaxis with hepatitis B immune globulin for any know or
probable percutaneous or mucosal exposure to HBsAg-positive blood.
Prevention and Management of Hepatitis C Virus Infection
HCV transmission within the dialysis environment can be prevented by strict adherence to
infection control precautions recommended for all hemodialysis patients. Although isolation of
HCV-infected patients is not recommended, routine testing for ALT and anti-HCV is important
for monitoring transmission within centers and for ensuring that appropriate precautions are
being properly and consistently used.
102
HCV-negative Patients: Testing for anti-HCV every 3 months should be sufficient to monitor the occurrence of new
HCV infections.
 Monthly ALT testing will facilitate timely detection of new infections and will provide a
pattern from which to determine when exposure or infection might have occurred.
 If unexplained ALT elevations are observed in patients who are anti-HCV negative, repeat
anti-HCV testing is warranted.
 If unexplained ALT elevations persist in patients who repeatedly test anti-HCV negative,
testing for HCV RNA should be considered.
Anti-HCV Sero-conversions
When a Sero-conversion occurs: Review all other patients' routine laboratory test results to identify additional cases.
 Perform additional testing as indicated later in this section.
 Investigate potential sources for infection to determine if transmission might have occurred
within the dialysis unit. Include a review of the newly infected patient’s recent medical
history (e.g., blood transfusion, hospitalization), of the patient’s high-risk behaviors (e.g.,
injecting-drug use, sexual activity), and of unit practices and procedures.
 If ongoing HCV transmission among patients is identified, implement control measures
based on results of investigation of potential sources for transmission and monitor their
effectiveness.
HCV-positive Patients
 Patients who are anti-HCV positive (or HCV RNA positive) do not have to be isolated from
other patients or dialyzed separately on dedicated machines. Unlike HBV, HCV is not
transmitted efficiently through occupational exposures.
 HCV-positive persons should be evaluated (by consultation or referral, if appropriate) for
the presence or development of chronic liver disease according to current medical practice
guidelines.
 They also should receive information concerning how they can prevent further harm to their
liver and prevent transmitting HCV to others. Persons with chronic liver disease should be
vaccinated against hepatitis A, and B if susceptible.
103
Prevention and Management of Hepatitis-D Infection Transmission
Because of the low prevalence of HDV infection, routine testing of hemodialysis patients is not
necessary or recommended. However, if a patient is known to be infected with HDV or if
evidence exists of transmission of HDV in a dialysis center, screening for delta antibody is
warranted. Because HDV depends on an HBV-infected host for replication, prevention of HBV
infection will prevent HDV infection in a person susceptible to HBV. Patients who are known to
be infected with HDV should be isolated from all other dialysis patients, especially those who
are HBsAg-positive.
Prevention and Management of HIV Infection
 Routine testing of hemodialysis patients for HIV infection every 3 months for infection
control purposes is recommended. If infected, they can receive proper medical care and
counseling regarding preventing transmission of the virus.
 Infection control precautions recommended for all hemodialysis patients are sufficient to
prevent HIV transmission between patients. HIV-infected patients do not have to be isolated
from other patients or dialyzed separately on dedicated machines.
Prevention and Management of Bacterial Infection
Follow published guidelines for judicious use of antimicrobials, particularly vancomycin, to
reduce selection for antimicrobial-resistant pathogens.
Infection control precautions recommended for all hemodialysis patients are adequate to prevent
transmission for most patients infected or colonized with pathogenic bacteria, including
antimicrobial resistant strains. However, additional infection control precautions should be
considered for treatment of patients who might be at increased risk for transmitting pathogenic
bacteria. Such patients include those with either:
 An infected skin wound with drainage that is not contained by dressings (the drainage does
not have to be culture positive for VRE, MRSA, or any specific pathogen).
 Fecal incontinence or diarrhea uncontrolled with personal hygiene measures.
For these patients, consider using the following additional precautions: Staff members treating the patient should wear a separate gown over their usual clothing and
should remove the gown when finished caring for the patient.
 Dialyze the patient at a station with as few adjacent stations as possible. (e.g., at the end or
corner of the unit).
104
Chapter-7
Myths & facts
105
MYTHS & FACTS ABOUT DIALYSIS
People with end stage renal disease (ESRD) may require dialysis, treatments that replace kidney
function by removing wastes and excess fluid from the body. While the life-saving nature of
dialysis is undisputed, several myths may contribute to common misconceptions about the
burden of being on dialysis. Here are five of those myths and the truths behind them.
Myth 1: Dialysis isn’t for someone who fears needles.
FALSE! Fear of needles and the pain associated with needle sticks is common for patients. To
ease your fear, medications are available to numb the skin prior to inserting the needle. You can
apply a numbing cream over your vascular access (the area that allows your blood to travel to
and from the dialysis machine to remove toxins from the body) about one hour before your
treatment. Lidocaine, a local anesthetic, may be an option used by your center.
If your access is an arteriovenous (AV) fistula, needles are inserted in the exact same site every
treatment, which creates a tunnel similar to a pierced ear. This site is called a buttonhole and
once established, needle insertion becomes less painful.
Another way for patients to ease their fear of needles is self-cannulation. Your dialysis care team
can teach you how to self-cannulate, which is inserting needles into your own access. Gaining
control over the procedure may also make you more comfortable with it. Finally, peritoneal
dialysis (PD) is a form of home dialysis that does not use needles. This treatment is explained in
more detail below.
Myth 2: Dialysis isn’t affordable
FALSE! In 1972, the United States Congress passed legislation to extend Medicare coverage to
Americans of any age with ESRD. The Centers for Medicare and Medicaid Services (CMS)
established coverage to anyone who:



Has worked long enough to earn a minimum number of credits toward retirement under
Social Security, the Railroad Retirement Board or as a government employee,
Is already getting or is eligible for Social Security or Railroad Retirement benefits, or
Is the spouse or dependent child of a person who meets either of the requirements listed
above.
The social worker at the dialysis center can explain and help you obtain Medicare coverage,
assist you with getting secondary insurance or other financial assistance and answer additional
questions.
106
Myth 3: Dialysis can be done only at a center
FALSE! In-center hemodialysis is just one of several dialysis treatment options and it too offers
a variety of choices, such as in-center self care and in-center nocturnal dialysis. However, an
increasing number of patients are choosing to dialyze at home. Listed below are home treatment
options and descriptions of how each might suit the different needs and lifestyle of a patient.


Peritoneal dialysis (PD): PD is the most common type of home dialysis. It works by using
the peritoneal membrane to filter the waste and fluid from your bloodstream. The
peritoneal membrane is a thin membrane that lines the abdomen. No needles are involved
as the dialysis solution is instilled into the abdomen through a permanent catheter. PD
can be done in two ways:
 Continuous Ambulatory Peritoneal Dialysis (CAPD) involves patients manually
performing fluid exchanges into the abdomen, usually four times per day.
 Continuous Cycling Peritoneal Dialysis (CCPD) involves a machine called a
cycler to perform the exchanges. The patient connects to the cycler in the evening,
and fluid is exchanged in and out of the abdomen during sleep. Some patients will
also perform an exchange during the day. The cycler is small enough to be taken
along on trips and tends to be an excellent therapy for active people who like to
travel.
Home hemodialysis (HHD): Home hemodialysis uses a hemodialysis machine to clean
the blood the same way as it’s done in a center but from the comfort of a patient’s home.
HHD can be done in two ways, both of which require assistance from a care partner:
 Traditional home hemodialysis is performed three times per week for three to four
hours per day. When short daily HHD became available, the majority of HHD
patients switched to that option instead of traditional treatment.
 Short daily home hemodialysis treatments are usually done six times per week
with shorter treatment times, ranging from two to three hours. Because treatments
are done more frequently, patients report improved well-being and improved
energy levels. In addition, the dialysis machine used is small enough to be taken
along when traveling.
DaVita’s Treatment Evaluator can help determine which treatment option may best match your
lifestyle. Take the results to your doctor to discuss further when choosing your dialysis
treatment.
Myth 4: People on dialysis can no longer travel
FALSE! You can still soak up the sun, camp, visit family or travel for work with some advance
planning and dialogue between you, your doctor, nurse and social worker. Patients on
hemodialysis can arrange treatments at a center at their planned vacation destination. Patients on
PD can have supplies directly delivered to wherever they are going. Follow the guidelines of this
travel checklist to make traveling on dialysis an easier process. You can also call DaVita Guest
Services to help with dialysis plans while traveling at 1-800-244-0680.
107
Myth 5: There are too many things to learn about dialysis
FALSE! While there are many things to learn, whatever your treatment choice, there is an entire
kidney healthcare team, including nephrologists, nurses, dietitians, social workers, care
technicians and others, to support you throughout the dialysis process. Here are some ways they
help:








Educating patients about ESRD and dialysis treatment options
Helping patients cope emotionally
Mapping out a treatment plan for specific needs
Prescribing a kidney diet and helping choose kidney-friendly foods
Helping patients apply for insurance and financial assistance
Connecting patients with support groups
Scheduling dialysis treatments if patients decide to travel
Providing in-depth training programs with close supervision and plenty of opportunities
to practice for patients and their care partners who choose dialyzing at home
In addition, DaVita.com has a wealth of education articles that cover CKD, ESRD, dialysis, diet
and nutrition, diabetes and more.
Some More…!!!
 Kidney disease is Hereditary - Very few kidney diseases are hereditary like polycystic.
 Single or double kidney failure - All medical diseases affect both the kidneys. The word
kidney
failure refers to both the kidneys not functioning. If a single kidney is not functioning the
blood
urea will not go up.
 Dialysis once started has to be permanent - This depends on whether the patient has acute or
chronic kidney failure. Acute failure might require only temporary dialysis.
 It is not safe to donate a kidney - If the general health of the donor is normal without
diabetes
or blood pressure; it is safe to donate a kidney. Donors have led a normal life including
marriage and childbirth, etc.
 Water should be consumed in large quantities by patients with kidney disease - Often
restriction in water consumption is required since maintenance of water balance in the body
is
one of the functions of the kidneys.
 Beer drinking is good for the kidneys- Beer, because of its large content of water produces
increases urine output and does not improve kidney functioning.
 Salt substitutes can be used in kidney patients- Salt substitutes being potassium chlorides are
more dangerous in patients with kidney failure as potassium excretion is already affected.
108
How can I have a safe and comfortable dialysis treatment?
Problem
How can I prevent it?
I’m worried about how
safe dialysis is?
 Check the machine at times
during your treatment and learn
how to read your blood flow
rate, bath temperature, blood
pressure etc.
 Ask the team what each
machine alarm means.
 Dress in layers. Bring a hat and
gloves if you need to (but staff
must always be able to see your
access).
 Ask if you can have a blanket
during dialysis.
 Use an exercise bike during
your treatment.
 See if the temperature of the
bath can be safely turned up a
bit.
 Don’t gain too much fluid.
 Learn what low blood pressure
feels like: you may feel faint,
too warm, anxious, have spots
in your vision, be sweaty, or
have cold, clammy skin.
 Tell staff if you feel your blood
pressure dropping.
 Don’t gain too much fluid.
 Stretch your legs and feet in the
dialysis chair.
 Massage the area.
 Ask for a warm towel or heating
pad for the cramping muscle.
I feel cold when I’m on
dialysis.
My blood pressure drops
during dialysis
I get muscle
during dialysis.
cramps
What should I ask?
 Which part is blood pump?
 How can I read the bath
temperature?
 Where is the air detector?
 Where the machine does
shows my blood pressure?
 Can this room be made
warmer?
 What can I bring with me to
treatment?
 Does this centre have an
exercise bike I can use during
treatment? How can I get my
doctor’s okay to got it?
 I’m feeling funny-what is my
blood pressure right now?
 How much fluid is being
removed? How much was
prescribed to be removed?
 Should my dry weight be
adjusted?
 Are my electrolyte levels
okay?
 Can I have something to help
my cramps?
Summary
The best way to deal with ESRD and dialysis is to know the facts. You’ve uncovered the truth
behind five common myths that can alleviate stress, help you choose the better treatment option
and improve your quality of life.
109
Chapter-8
Indian economy & dialysis
110
INDIA FACES ACUTE SHORTAGE OF DIALYSIS UNITS
India gets 1.5 lakh (150,000) patients with kidney failures every year and a majority of them die
within five years due to the acute shortage of dialysis units in the country, an expert said. There
are only 1,470 hemodialysis units in the whole country, whereas 40,000 of them are immediately
required, said D.S.Rana, secretary, Indian Society of Hemodialysis.
Less than 10 percent of the total patients requiring dialysis are able to avail the facility, while
only half of them are able to afford it on long term basis, due to cost, time and logistical factors,
he said, delivering the welcome address at the fourth congress of the Society here, according to a
press release.
Currently, about eight lakh patients with terminal renal disease in India require dialysis and
transplantations. But only 4,000 patients are getting kidney transplantations and an equal number
are on maintenance hemodialysis.
Unfortunately, not a single dialysis unit is made in India and they have to be imported from
Sweden and Germany, Rana said. About 90 percent of these facilities are in the private sector for
which patients, whether rich or poor, have to pay.
Hemodialysis treatment is very expensive. A patient normally receives dialysis at least thrice a
week, and monthly expenses amount to Rs.30,000. The medicines are also equally costly and a
majority of the patients are not able to afford this treatment.
Adding to the problem, health insurance policies do not cover the cost of dialysis owing to the
high cost, he said. Rana also noted the acute shortage of the trained medical professionals in
India. At present, there are only 1,000 nephrologists while 20,000 are required. There is also
acute shortage of dialysis technologists and nurses.
The situation is expected to get worse, he said. The International Diabetes Foundation has
reported approximately 54 million diabetic patients in India in 2010, and the number is likely to
touch 70 million by the year 2025.
�Every third patient suffering from diabetes mellitus develops chronic kidney disease.
Majority of these patients will die of coronary artery disease or a stroke and only a minority
reaches the stages of end stage renal failure. Rana urged the NGOs and the corporate sector to set
up standalone dialysis facilities in small towns, affiliated with reputed hospitals in metros, to
serve the needs of poor patients.
111
BIG MARKET FOR DIALYSIS IN INDIA
As growing incomes give India’s millions access to First World staples such as cars and cell
phones, the population is also experiencing an unpleasant byproduct of Westernized lifestyles: an
epidemic of diabetes and the kidney disease it causes. While the number of Indian diabetics is
predicted to hit 101 million by 2030, the cost of dialysis makes it a luxury for most patients.
“There’s a huge demand for dialysis centers, but only those who can afford it get it,” says Georgi
Abraham, a professor at India’s Pondicherry Institute of Medical Sciences and founder of the
nonprofit Tamilnadu Kidney Research Foundation that provides subsidized dialysis to the poor.
“Often I find that patients just disappear. They get one or two sessions when they have some
money and then stop. Within a week or two of stopping dialysis, they may just collapse and die.”
Fresenius Medical Care, the world’s No. 1 provider of kidney dialysis equipment and supplies,
says sales of blood-filtering products in India have risen more than 30 percent annually since
2006. Apollo Hospitals Enterprise (APHS:IN) and Fortis Healthcare India (FORH:IN), the
nation’s biggest private hospital operators, are opening dialysis centers nationwide. And the
Indian market for kidney care may grow to $152 million next year from $97 million in 2007,
forecasts researcher Global Markets Direct. Equipment makers and dialysis providers are betting
that more Indians will seek treatment as incomes rise or the government picks up more of the
cost. “Every major health-care provider wants a share of this market,” says Jayant Singh of
consultant Frost & Sullivan’s India unit.
New Delhi-based Fortis plans to open 50 dialysis clinics over the next two years, says Varun
Sethi, chief executive officer of its Renkare dialysis unit. The first opened in New Delhi last
month. The service costs about 30,000 rupees ($570) a month for 12 visits, Sethi says. Such costs
are prohibitive in a nation where most people get by on less than $2 a day. More than 90 percent
of the 230,000 people who develop chronic kidney failure each year in India die within months
because of lack of treatment, according to a 2009 study by the All India Institute of Medical
Sciences and the Health Ministry.
Entry-level dialysis machines made by Gambro sell for $8,000 to $12,000 each, says Stuart Paul,
the Swedish company’s president for the Americas and the Asia-Pacific region. A year of
dialysis and drugs for chronic kidney disease patients in India can go from 60,000 rupees at a
government-subsidized provider to more than 700,000 rupees for home-based treatment that
some affluent Indians are buying, says Pondicherry Institute’s Abraham. That’s a fraction of the
$30,000-plus annual cost in the U.S., but a fortune to most Indians.
The bottom line: About 52,000 patients in India are on kidney dialysis. It’s only 4 percent to 33
percent of the cost in the U.S., but too rich for most Indians.
112
ECONOMICS OF DIALYSIS IN INDIA
Chronic kidney disease is a worldwide public health problem, a social calamity and an economic
catastrophe. In the year 2000, in the United States (US) alone, about 30 million people were
diagnosed with chronic kidney disease (CKD). It is estimated that by 2010, six million
worldwide would need renal replacement therapy (RRT) costing 28 billion dollar.
Burden of CKD in India
The exact burden of CKD in India still remains undefined with only limited data from the three
population-based studies addressing this issue.
It is hoped that the CKD registry, recently established by the Indian Society of Nephrology, may
provide useful epidemiological data in the future. In the prevention study done in Chennai, the
prevalence at the community level is 8600 per million populations (pmp) in the study group and
13900 pmp in the control group. The second study based in Delhi revealed a prevalence of CKD
(serum creatinine more than 1.8 mg %) at 7852 pmp. The third study from Bhopal revealed an
incidence of 151 pmp suffering from end stage renal disease (ESRD). Do we have the resources
and skill to handle this ever increasing population of ESRD in India?
Economic Scenario in India
As per the December 2007 index declared by Rajya Sabha, the per capita income in India is Rs
20734 per annum. The total population is 113 crore of which 26% live below the poverty line
(BPL) where the daily earning is Rs 10, in comparison, the international standard BPL is US $1
per day i.e. Rs 45 per day. By this parameter, in India, 70% of the population would be BPL. The
government spends barely US $8 per capita on health with priorities more on infectious disease,
sanitation, nutrition etc.
Facilities for RRT in India
In the absence of any available data, Mumbai Kidney Foundation (MKF) conducted a data
collection exercise with the help of industry, sources, personal discussion with nephrologists and
telephonic confirmation of dialysis centers.
113
India has close to 950 nephrologists (not all ISN members) all over the country. There are 700
dialysis centers with a total of 4000 dialysis machines, predominantly in the private sector and
mainly concentrated in cities, especially metros. There are around 20,000 patients undergoing
dialysis at these centers. There are around 170 government recognized transplant centers in
India, performing around 3500 transplants annually. The patients on CAPD number less than
5000. Clearly, the choices and facilities for RRT are predominantly focused on maintenance
hemodialysis and are woefully inadequate.
Cost of RRT in India
The MKF data also gave insights into the costing of ESRD management.
The cost of each hemodialysis (HD) session in India varies from Rs 150 in government hospitals
to Rs 2000 in some corporate hospitals. The monthly cost of HD in most private hospitals
average Rs 12000 and the yearly cost of dialysis is Rs 1, 40000, equivalent of $3000, which is in
sharp contrast to an annual cost of $60,000 in the US and UK. So we are the cheapest in the
world and yet more than 90% of Indians cannot afford it.
The cost of an AV fistula construction is Rs 6000 to Rs 20000 from a government hospital to
varying grades of private hospitals. The average cost of erythropoietin per month is Rs 4000 (bio
similar) to Rs 10000 (the pioneer brand).
The average cost of kidney transplant varies from Rs 50000 in a government set-up to Rs 300000
in an average private hospital. Also the yearly maintenance cost post transplant for drugs
amounts to Rs 12 0000 per year or Rs 10000 per month.
Actual Cost Break-up of Dialysis in a Private set up
MKF conducted a survey of actual costing of dialysis in few private hospitals in different cities
of India and asked for their running cost of maintenance of hemodialysis in centers that have a
chronic dialysis program and we came up with interesting findings.
a. The cost differed from a nephrologist owned facility versus a corporate hospital.
b. The administration greatly exaggerated the cost.
c. Even in large corporate hospitals the recurrent cost dialysis worked out to be between Rs
700-900.
114
The average cost to the patient across the country works out to be Rs 1100, which truly is,
beyond the reach of more than 90% of India. To increase the reach of dialysis, bring it out of the
corporate hospital set up and make it cheaper in the smaller free standing units or nephrologistsowned units.
Concept of Nephrologist Owned Unit
Is it cost effective? The answer is yes! If you do not mind the travails of running a center. One
could either own the set up or take it on lease and pay rent. It could be a day care centre attached
to your consulting room, or a full fledged small hospital with indoor facilities.
By my own experience, the cost of a single dialysis session to the nephrologist comes to less than
600 if we make bulk purchases. Laboratory facilities or outsourcing can fetch additional income.
Sale of EPO after obtaining a pharmacy license is easy and lucrative and can easily subsidize the
cost of dialysis.
Our Experience in Mumbai
If you go through the table, you will realize that Mumbai has the distinction of offering the
cheapest dialysis in India at an average cost of Rs 700 per session largely because of the
presence of two distinct models which have been in existence since many years.
Concept of Free Standing Unit
Also called community dialysis centre or satellite dialysis units, they essentially offer only
dialysis facility with no admission facility. Thus, they can offer dialysis at a reasonable price by
cutting down the overheads. It comprises of a full fledged dialysis centre with 10-20 dialysis
machines, isolated machines for Hepatitis B and C, RO plant and a resuscitation trolley with
monitor and defibrillator. It also has trained nurses, technicians and doctors trained in
resuscitation of a serious patient. The patient is screened at the entry point and taken only if he is
stable for OPD dialysis. Semi-acute problems are solved by telephonic consultation between the
RMO and nephrologist. During an occasional acute emergency, the RMO or the paramedics
resuscitate and if need be transfer to a hospital.
115
The nephrologist reviews the patient at least once in a week, if not daily. Such a concept of free
standing unit already exists in the USA and Singapore. Based on this model, presently, Mumbai
has 17 such free standing units out of a total of 112 dialysis centers in the city.
Concept of Charitable Dialysis Unit
The second model, which brought down the cost of dialysis further down in Mumbai, was the
involvement of philanthropists and setting up of non-governmental organization (NGO) backed
charitable dialysis units, either in an established hospital or as free standing units.
The involvement of the NGO can be in the following manner.
a. The entire space and machinery belongs to the trust and they provide dialysis on a no profit
no loss basis.
b. The NGO is interested only in donating machines and RO plant to an already existing
private dialysis centre and in lieu of the donation gets a fixed number of free dialysis to help
poor patients.
c. The philanthropist is interested in donating dialysis machine and wants the unit to be named
after him or gets into the advisory board of the dialysis unit.
d. The NGO enters into a public-private partnership with the government which provides space
for the unit in a government hospital and the NGO runs the charitable dialysis unit.
Other areas in which NGOs or philanthropists work in dialysis field are:
a. Bulk purchase of medicines especially injection Erythropoietin and providing them at an
extremely subsidized price to dialysis patients.
b. Bulk purchase of dialyzers, tubings and other disposable items used for dialysis and selling
them to patients at subsidized rates.
c. Offering pick up and drop services to dialysis patients.
d. Offering free monthly rations to poor CKD patients.
e. Holding blood donation camps for providing blood to dialysis patients.
As a result of promoting these two concepts, Mumbai has 112 dialysis centers, of which 17 are
free standing units. Of the 600 dialysis machines which Mumbai has, 150 are in charitable units.
In Mumbai, there are about 5000 dialysis patients of which 1250 are taking dialysis at less than
Rs 350 per dialysis and the average price of dialysis is Rs 700 - 750 per session, which is the
cheapest in the country (National average cost is Rs 1100). Further more, some patients pay less
than Rs 100 per dialysis.
116
Suggestions for Increasing the Outreach of Dialysis all over India
In summary what can be done to make dialysis more affordable?
The Mumbai model can be used as an example to improve the availability as well as affordability
of dialysis therapy all over the country. This can be done in the following manner:
a. Build middle level cost effective nephrologist-owned dialysis units costing Rs 800 per
session as dialysis cost.
b. Encourage free standing units or satellite dialysis units.
c. Involve philanthropists to adopt patients and donate machines. There is no dearth of such
people wanting to help for a good cause.
d. Encourage the govt. to lend space for private public partnership in a govt. hospital with
NGO participation.
e. Lobby with the govt. to subsidize or make dialysis equipment and disposables tax free. If
multiplexes can enjoy tax free holidays, dialysis units also deserve some help from the
government. Also, let the electricity used by such units be charged at non-commercial rates.
f. Buy cheap labor by training intelligent, smart, non-graduates to become dialysis technicians,
thereby bringing down the labor cost. ISN can start such courses.
g. ISN should back its nephrologists for every medico legal case arising out of there subsidized
dialysis units. This can be done by laying minimum standard of care criteria which the units
need to adhere to.
Thus one can be cynical and say there are two options - let patients succumb to their illness as
Indians cannot afford RRT or adopt the Mumbai model of providing RRT at highly subsidized
rates.
117
Chapter-9
FRESENIUS MEDICAL CARE
118
FRESENIUS MEDICAL CARE
Our Vision:
Creating a future worth living. For people. Worldwide. Every Day.
More than three decades of experience in dialysis, innovative research, the global leader in
dialysis services and products – that is Fresenius Medical Care.
Patients with kidney disease can now look ahead with much more confidence thanks to our
innovative technologies and treatment concepts. We give them a future, one that offers them the
best-possible quality of life.
We use the increasing demand for modern dialysis methods to our advantage and work
consistently to enhance the Company’s growth. Together with our employees, we focus on
pursuing strategies that will enable us to uphold our technological leadership. As a vertically
integrated company, we offer products and services for the entire dialysis value chain.
The highest medical standards are our benchmark. This is our commitment to our patients, our
partners in the healthcare system and our investors, who trust in the reliable performance and the
future of Fresenius Medical Care.
In Europe, South America and Asia Pacific this service from Fresenius Medical Care is
called NephroCare.
Fresenius Medical Care is the committed partner in renal care - dedicated to providing
complete renal replacement therapy at the point of care.
Our dialysis centres in Europe, Middle East, Africa, Latin America and Asia Pacific provide
dialysis services in more than 35 countries with NephroCare as our service brand.
NephroCare is an explicit commitment to excellence in renal patient care focusing efforts on
three core elements:
Our dialysis centres
The first centre opened 1994 in Hungary. Today, Fresenius Medical Care is treating more than
85,000 patients in over 1.000 dialysis centres, providing more than 5,900,000 treatments/ half-
119
year in more than 35 countries. This enormous growth is the result of massive and sustained
investment in state-of-the-art centres and technologies. The uniform enforcement of strict safety
and quality guidelines takes on an ever increasing importance as we increase in size and
capacity. Safety standards and quality guidelines have to be implemented and continuously
monitored at all centres in accordance with Fresenius Medical Care's high quality standards.
Our employees
NephroCare has over 23,600 staff committed to delivering the highest possible quality of care.
We are aware of our responsibility to empower our staff through a modern cooperative working
environment, including our employees in organisational and work related decision, making and
enabling a continuous professional and social development.
Our patients
All that we do within NephroCare is focused upon providing our patients with a better quality of
life. Fresenius Medical Care works to provide the appropriate renal care for each patient, using
advanced technologies to enable the best therapies, while taking the time to listen to patients and
understand their needs. Only then, we can ensure high-quality care and empower patients to take
over responsibility.
NephroCare’s commitment to excellence and the resulting comprehensive business model drives
us to work closely with the healthcare authorities to ensure affordable renal care. Now and in the
future, for the maximum possible number of patients.
Fresenius Medical Care is continuously developing innovative concepts for a sustainable future
while focusing on proven quality.
Fresenius Medical Care: forerunner in biocompatible dialysis solution
With balance and bicaVera, Fresenius Medical Care offers two pH-neutral dialysis solutions that
contain only minor amounts of glucose byproducts, protecting the peritoneum. As a recently
published study shows, peritoneal dialysis patients live significantly longer when the
biocompatible balance dialysis solution is used rather than a traditional dialysis solution in renal
therapy.
120
Chapter-10
References
121
REFERENCES

Madras Institute Of Nephrology, Chennai, India

"Atlas of Diseases of the Kidney, Volume 5, Principles of Dialysis: Diffusion,
Convection, and Dialysis Machines"

Ahmad S, Misra M, Hoenich N, Daugirdas J. “Hemodialysis Apparatus. In: Handbook of
Dialysis”. 4th ed. New York

Khanna U. “The Economics of Dialysis in India”. Indian J Nephrol 2009; 19:1-4

Nephrology Now Meta-Journal and Online Journal Club—Nephrology literature updates
service, as well as a place to discuss important articles with colleagues around the world.

National Kidney Foundation—A major voluntary nonprofit health organization, is
dedicated to preventing kidney and urinary tract diseases, improving the health and wellbeing of individuals and families affected by kidney disease and increasing the
availability of all organs for transplantation

US Renal data system. USRDS 2000 Annual Data Report: Atlas of End Stage Renal
disease in the united states. National institutes of health, national institute of diabetes and
digestive and kidney Diseases: Bethesda, MD, 2000.