Please note.

While multiuse (reuse) dialyzers are no longer being used within

DaVita, this CE remains available for historical interest and to provide
information for teammates preparing for certification. (December 2022)

Objectives
 List three benefits and three risks of dialyzer reprocessing.
 Discuss the necessary precautions/procedures to promote patient safety.

terilization is defined as the “process of completely destroying

An Introduction

S all microorganisms” (Taber’s, p.1831). It is a process that is

common throughout healthcare. For example, following
surgery certain instruments may be resterilized. In this case, these
instruments are first cleaned and then autoclaved (a combination of
steam, pressure, and heat). Within dialysis, chemicals are used to
resterilize patients’ dialyzers. First the dialyzer is cleaned. Then
chemicals are instilled. Like with surgical instruments, this allows
multiple use of equipment.

This self-study reviews clinical issues related to dialyzer

reprocessing. The emphasis is on the promotion of patient well-
being. Benefits of reuse plus techniques to eliminate potential risks
are discussed. The self-study begins with a brief review of the
chemicals used during reprocessing.

Authors/Contributors/Reviewers  This free Continuing Education (CE) offering is provided

 Carol Farthing, BSN, RN, CNN by DaVita’s Clinical Education & Training.
 Linda Francisco, MD  To receive a CE certificate for 1.0 contact hours, complete the
 Susan Juarez, MS, ARNP, CNN online posttest.
 Donna Swartzendruber, MSN, RN, CNN  Thank you for your interest in learning!
 Denise Turnbull, RN, CNN

©2004-2022 DaVita Inc. Page 1 of 16 CEC2005

Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
The Sterilant What chemicals are used to sterilize the dialyzer? Answer the
following three questions:

Test Your Knowledge

Question #1: The name of the reuse sterilant that contains three ingredients is…?
a. Formaldehyde
b. Glutaraldehyde
c. Renalin
Answer: The correct answer is c.

Question #2: Renalin contains three chemicals. What are these chemicals?
(select the best answer)
a. Hydrogen peroxide, peracetic acid, acetic acid
b. Peracetic acid, acetic acid, and renalitic acid
c. Nitric acid, peracetic acid, and hydrochloric acid
d. Ascorbic acid, hydrogen peroxide, and peracetic acid
Answer: The three chemicals are listed in answer “a”.

Question #3: When Renalin is discussed, which one of the following names is commonly
used?
a. Hydrogen peroxide
b. Acetic acid
c. Peracetic acid
Answer: The correct answer is “c”. Peracetic acid (PAA) is Renalin’s major active
ingredient.
Please note, “peracetic acid” and “sterilant” are the terms used through
the remainder of this self-study.

©2004-2022 DaVita Inc. Page 2 of 16 CEC2005

Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
The Benefits Dialyzer reuse provides various benefits. One involves monetary
advantages. As with specialty surgical instruments, it may not make
sense to discard expensive equipment after only one procedure. Plus,
with dialyzers, more expensive models often provide various
advantages over lower-priced models. For example, dialyzers with
larger surface areas (dialyzers that clear more wastes) are typically
priced higher than those with smaller surface areas. Reuse then helps
facilities more readily buy these larger dialyzers and improve KT/V’s
and URR’s (Burdick & Port, Stragier, 2003). Another advantage
involves our environment: “Recycling” dialyzers helps decrease
landfill wastes.
Reuse also offers other patient benefits. These are discussed in
the following question.

Test Your Knowledge

Which of the following dialysis complications can be lessened or eliminated when reprocessed
dialyzers are used? (select all that apply)
a. Dialyzer blood leaks
b. Allergic reactions to ethylene oxide (ETO)
c. Dialyzer-induced complement activation
d. All of the above
Answer: Each of these potential complications can be lessened when processed dialyzers are
used (the correct answer is d). An explanation for each complication is given on the next page.

Each time a dialyzer is processed, a pressure test is completed to

Figure 1 verify no tears are present in the dialyzer membrane. If a dialyzer
Definition fails this test, it is discarded. Blood leaks during the dialysis
Complement treatment are therefore quite rare.
 A part of our immune
system that is activated Allergic responses to ethylene oxide (ETO) and dialyzer membranes
when blood comes in are also less likely with processed dialyzers.
contact with foreign
substances.
 ETO is a gas used by some manufacturers to sterilize their
 Blood contact with
certain dialyzer newly-made dialyzers. Usual policy is to preprocess all
membranes may cause reuse dialyzers (to fill with peracetic acid prior to its first use).
“complement activa- With preprocessing, the ETO is removed before any patient
tion”. If this occurs, contact can occur (Stagier, 2003).
neutrophils migrate to
the lungs, causing a  The possibility of complement activation* (see figure 1) also
temporary neutropenia is lessened when reprocessed dialyzers are used. During the
(low serum neutrophil first patient use of a dialyzer, a protein film soon coats the
level). inside of the hollow fiber membranes. This film then helps
Bregman et al., 2001,
Dahlin, J, 1992 distance the patient’s blood from the “foreign” dialyzer
membrane. Reprocessing with peracetic acid does not remove
the film. Therefore, when this same dialyzer is used for later
treatments, any potential for complement activation is
lessened or eliminated. In this instance, reuse allows the
©2004-2022 DaVita Inc. Page 3 of 16 CEC2005
Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
 dialyzer to become more “biocompatible” (Burdick & Port,
2002; Kaufman & Levin, 2001).
* Please note, complement activation is primarily associated
with dialyzer membranes that are now seldom used within our
facilities.

To summarize, when reprocessed dialyzers are used, the number of

blood leaks is lessened, the possibility of complement activation is
decreased, and the risk of a reaction to ETO is eliminated.

Potential Yes, there are various benefits to reusing dialyzers. But is reuse
Clinical Issues safe for patients? Can clinical outcomes be achieved?
The answer to these questions is yes.
.

The remainder of this self-study discusses four clinical topic

related to reuse. Each topic reviews techniques to promote safe,
effective dialysis care.

Clinical Issue #1: The Accidental Infusion of Peracetic Acid

Figure 2
Test Your Knowledge (mock scenario)
Possible Symptoms of a You insert Charlie’s fistula needles and initiate his treatment. While you are
Peracetic Acid Infusion completing his treatment record, he suddenly complains “this doesn’t feel
 Symptoms may resemble right…I’ve never felt like this before… I can’t breathe…my lips feel
an allergic response tingly…something’s wrong!” You know Charlie’s dialyzer is reprocessed.
including… Your immediate response is to… (select the best answer)
1) Vasodilatation & a. Give 200ml of normal saline. It looks like his blood pressure
movement of fluid may be taking a dive.
into the tissues. This
b. Start oxygen via an O2 nasal cannula.
leads to hypovolemia
(hypotension, N&V, c. Stop the blood pump.
dizziness, chest pain) d. Call for help.
2) A histamine response Answer: Anytime a patient with a reprocessed dialyzer becomes ill just after
(sensation of warmth, a treatment has started, be suspicious of a peracetic acid infusion. The blood
itching) pump should be immediately stopped. Then the situation can be evaluated.
3) Paresthesia (numbness Calling for help is also important, but waiting to stop the blood pump until
and tingling of lips) after help arrives increases the potential risk to the patient. The same applies
4) Feeling of doom for starting oxygen – stop the blood pump first, then treat the symptoms.
 Direct irritation may Lastly, if a peracetic acid infusion is feared and the patient is hypotensive,
cause burning at access
saline should not be given via the blood pump. To avoid further infusion of
site.
 High levels may cause peracetic acid, give saline directly into the access needle. Your immediate
hemolysis (“clear blood” response should be answer c.
--
post dialyzer, hypotension,
chest pain, drop in Hct,
rise in serum potassium).
(Merck; Taber’s; Medivators)

©2004-2022 DaVita Inc. Page 4 of 16 CEC2005

Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
Identifying the cause of the symptoms
Back to the above scenario. The symptoms occurred about three
minutes into the patient’s dialysis treatment. At that point, can you
“prove” what just caused the symptoms? Can you either prove or
disprove that it was the result of the sterilant? Consider the following
questions.

 At this point, can you draw a sample from the patient’s venous
bloodline and test this sample with a residual test strip?
Per Medivators (the company that makes Renalin), if a
sample contains blood, the test strip cannot accurately
tell if sterilant is present. Why? As soon as the
peracetic acid solution comes in contact with blood, its
chemicals rapidly decompose into oxygen and acetic
acid. Even if the sterilant caused the symptoms, the test
strip may show a negative reading (W. Carlson,
personal communication, January 21, 2004).

 What about the dialysate? Can you use a residual test strip to
test the patient’s dialysate?
This too could give us inaccurate information. Two
examples are listed below:
 A dialysate reading may not accurately reflect the
conditions within the blood-side of the dialyzer
(W. Carlson, personal communication, February 5,
2004).
 Between treatments, the reuse technician cleans the
dialyzer’s plastic exterior with peracetic acid. If any of
this solution remains on the outside of the dialysate
ports, it may “contaminate” your sample as it flows out
of the dialyzer through this port. In this case, even if no
sterilant was present within the dialyzer, the reading
could be positive (W. Carlson, personal communication,
February 5, 2004).

 What about the symptoms? Can a patient’s symptoms “prove”

that a patient either did or did not receive peracetic acid? Are
there other complications that have similar symptoms that
should be considered? Consider the following two questions:

©2004-2022 DaVita Inc. Page 5 of 16 CEC2005

Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
 Test Your Knowledge
Question #1: Of the following dialysis-related complications, which one(s) may cause symptoms
similar to what Charlie was experiencing? (circle all that apply)
a. Complement activation
b. Reaction to ETO
c. Air infusion / air embolism
d. Pyrogenic reaction
Answer:
 First, consider the issue of “timing”. Like with Charlie’s symptoms, answer a, b, & c could
occur close to the onset of a dialysis treatment. Symptoms of a pyrogenic reaction,
however, are unlikely to begin until about one hour into the treatment (Keen, Lancaster &
Binkley, 2001).
 Second, consider the symptoms.
 Complement activation, ETO reactions, and a peracetic acid infusion can all produce
an allergic-like response. Symptoms can therefore be similar and difficult to
differentiate (for symptoms of an allergic-like response, see figure 2 on the previous
page).
 An air embolism also may have similar symptoms (such as chest pain and hypotension).
 Symptoms of a pyrogenic reaction, however, are quite different; they include chilling
and a fever.
The correct answers to the above question are a, b, c.

Test Your Knowledge

Question #2: You realize that each of the following complications may cause at least some of the
symptoms Charlie was experiencing. From what you know about Charlie, can any be “ruled out”?
Of the following, which could not have caused Charlie’s symptoms? (select all that apply)
a. An ETO reaction
b. Complement activation
c. An air infusion / air embolism
d. An infusion of peracetic acid solution
Answer: Think back to the reuse benefits mentioned on page 2. Two benefits are the removal of
ETO and the decreased risk of complement activation. Since Charlie is dialyzing on a reprocessed
dialyzer, it is quite unlikely that either answer a or b could be the cause of his symptoms. If Charlie’s
access was a catheter, there is the potential of an accidental infusion of air when the bloodlines were
attached to the catheter ports. But, according to earlier information, Charlie has an AV fistula, and
an accidental air infusion is less likely.
From the information available, the most likely cause for Charlie’s symptoms continues to be an
accidental infusion of peracetic acid (answer d).

©2004-2022 DaVita Inc. Page 6 of 16 CEC2005

Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
 Key point. As with all complications, symptoms can vary from
If an infusion of patient to patient. This can make it difficult to quickly identify the
peracetic acid is
exact cause of the problem. Per procedure, if a peracetic acid infusion
suspected…
1. Stop the blood pump is suspected, the blood pump should be immediately stopped, and the
(immediately!). patient’s blood should not be returned. In addition, symptoms should
2. Do not return the be treated. For example, oxygen should be started for chest pain and
blood to the patient. emergency medical assistance should be called when appropriate.
3. Treat symptoms.
4. Notify the physician. What could cause an accidental infusion of sterilant?
5. Refer to procedure. To prevent the accidental infusion of peracetic acid, following policy
and procedure is key. Most importantly, a residual test must be
completed just prior to the initiation of the patient’s treatment. This
verification is to be completed by two clinical teammates and that the
results must be 1 ppm or less.

But is it possible for the patient to receive peracetic acid even after a
residual test indicated a negative reading? The answer, in certain
situations, may be yes. Consider the following examples. Again,
following DaVita policy is key to preventing these occurrences.
I. Peracetic acid within the saline bag.
During recirculation, certain situations may cause the
peracetic acid solution to inadvertently be pushed into the
saline bag. If this occurred, it is possible for the blood tubing
to be clear of the sterilant (to see a negative
residual test). Yet the patient could receive sterilant if this
contaminated saline was infused.

Potential causes include situations that create a positive

pressure in the bloodlines (this increase in pressure may
cause the sterilant to be pushed upward into the saline
bag). Two possibilities are listed below.
A. A TMP problem. Within the dialyzer, if the dialysate
pressure is greater than the blood-compartment
pressure, fluid will move from the dialysate into the
blood compartment and then into the bloodlines. When
the bloodlines are in the closed-loop recirculation
position, this increase in fluid volume would increase
the pressure within the entire loop, and peracetic acid
could be pushed into the open saline bag.
B. Lowering a drip-chamber level. When the bloodlines
are positioned in a closed loop and air is pushed into a
drip-chamber to lower its level, the pressure in the
bloodline loop would increase. Again peracetic acid
could enter the saline bag.

To prevent an accidental infusion of contaminated saline,

remember the following:
 If, during recirculation, you believe sterilant may have
entered the saline bag, change the saline bag at that
time.
©2004-2022 DaVita Inc. Page 7 of 16 CEC2005
Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
  After obtaining a negative test for residual, attach a
new saline bag. “Fresh” saline (without any possible
peracetic acid contamination) must be used to flush the
bloodlines and dialyzer prior to initiating the treatment.

II. The backflow of peracetic acid into lines

attached to the blood tubing
A second possible cause of an accidental infusion of
peracetic acid involves the auxiliary lines attached to
the blood tubing. If peracetic acid were to back up into
the heparin line or the medication ports, it is again
possible that the solution within the bloodlines may
test negative for sterilant yet the patient may be at risk.
To prevent this possibility, as a part of your set up
procedure, clamp these attached lines close to the
bloodline.

III. “Rebound”
Definition Just like a sponge absorbs water, a dialyzer’s potting
Potting material: material and hollow fiber membrane may absorb
 A urethane material peracetic acid between treatments. This absorbed
used to stabilize the sterilant is slowly released (rebounds) during the
hollow fibers within
15-minute recirculation time. This is known as
the dialyzer.
“rebound”.

Some rebound may continue after this recirculation period.

Can this later rebound cause symptoms? As long as
diffusion and ultrafiltration continue to occur across the
dialyzer membrane, the level within the bloodlines will
remain minimal – will remain at a safe, acceptable level (1
ppm or less).

©2004-2022 DaVita Inc. Page 8 of 16 CEC2005

Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
Clinical Issues & Dialyzer Reuse

Test Your Knowledge

Which of the following examples would stop diffusion across the dialyzer membrane and
possibly cause the buildup of peracetic acid? (select all that apply)
a. A stopped blood pump
b. An empty bicarb jug
c. A conductivity alarm
d. Raising the level of the arterial drip chamber

Answer: If either the blood pump or the dialysate flow is stopped, diffusion across the dialyzer
membrane will also stop. Yet the rebound from the potting material or the dialyzer membrane
may continue; the sterilant concentration in the blood compartment would then increase. If this
concentrated solution accidentally reaches the patient, it may cause symptoms.
The correct answers are a, b, and c (both b & c will cause the machine to go into bypass/stop the
dialysate flow).

A summary of steps to prevent symptoms due to peracetic acid

rebound include the following (ReNews, 1998):
 Do not stop the flow to either the blood or the dialysate
compartment. This continual flow will allow for the
continual removal/diffusion of peracetic acid. If after the
initial residual test this flow is stopped, repeat the residual
test prior to initiating the treatment.
 Following recirculation, do not stop the ultrafiltration.
Maintain at a minimal rate.
 If following the initial residual test the start of the dialysis
treatment is delayed, repeat the test prior to starting the
treatment. This test would then identify if a rebound problem
had arisen since the first test.
 Immediately before starting the treatment, attach a new bag of
saline and flush the bloodlines and dialyzer. Use of this new bag
will prevent any possibility that peracetic acid may be present in
the bag.
 If after the start of the dialysis treatment the blood pump must
be stopped (for example, to restick after an infiltrated needle),
recirculating the blood in the bloodlines will allow diffusion to
continue and prevent problems from rebound that may occur
during that time.

©2004-2022 DaVita Inc. Page 9 of 16 CEC2005

Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
Clinical Issue #2: Reuse and Infections
Yes, the accidental infusion of peracetic acid can be avoided when
“When reprocessing
policies and procedures are followed. But what about infections?
is performed in accor- Can we be sure patients will not become infected by a reprocessed
dance with accepted dialyzer? As stated throughout this self-study, the peracetic acid
standards and practices solution is a sterilant. It kills all microorganisms including bacteria,
(AAMI, 1995), the
viruses, fungi, and bacterial spores (W. Carlson, personal
risks of the procedure
are negligible”. communication, January 29, 2003). When used properly, it will
(Kaufman, A. sterilize the dialyzer. Again, following written policies and
& Levin, N, procedures is key.
2001, p. 173)
This section reviews three components – timing issues,
concentration issues, and visual issues. It begins with a series of
questions on timing.
I. Correct Timing + Correct Concentration + Visual Inspection  Sterilization of
Dialyzer

Test Your Knowledge

Question 1: To be effective as a sterilant, the correct concentration of peracetic acid solution must be
present in the dialyzer for minimum of at least ___ hours but not more than ___ days.
Answer: The peracetic acid solution is not like a magic brew that can, “poof”, instantly turn all
microorganisms into stone. Peracetic acid needs time to act, to kill the various microorganisms that
may be present. A minimum of 11 hours contact time is needed. Equally important is that peracetic
acid eventually loses its potency. Additionally, dialyzer should not be used if more than 14 days have
passed since the dialyzer was processed.

Question 2: Since patients normally dialyze three times a week, meeting the above time requirements
is usually easy, so easy that verification of timing may be forgotten. List two examples where meeting
either the minimum or maximum time requirements may become an issue with a dialysis patient?
1. _____________________________________________________________________
2. ______________________________________________________________________
Answer: Here are two common examples. You may know of others.
(1) The physician orders an extra run for early the following morning, and the dialyzer is not
processed until late the night before.
(2) A patient is on vacation or in the hospital, and the last reprocessing was more than two weeks ago.

Question 3: You are setting up machines. On a specific patient’s dialyzer, how can you quickly verify
the time interval is adequate? (select the best answer)
a. Check the “presence test”. If the strip turns blue-gray or blue-black, the dialyzer is OK to use.
b. Check to see if the patient was recently hospitalized or on vacation. If yes, ask the reuse tech if
the dialyzer is OK to be used.
c. Check the dialyzer label for the last reprocessing date and time. Then do some math.
Answer: Just because the peracetic acid is present at an appropriate strength does not mean it has had
time to “sterilize” the dialyzer (answer a is not the correct answer). Yes, the reuse tech (answer b)
could give you the needed information, but they too would need to check the label to verify the correct
timing. Answer c makes the most sense.

©2004-2022 DaVita Inc. Page 10 of 16 CEC2005

Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
 Test Your Knowledge

Question 4: Take a look at the dates and times on the (Information from sample Renatron Label)
sample reprocessing label. Which of the following
Last reprocessed: 11:08:14 PM 1/9/2014
statements is true? (select all that apply)

a. The earliest this dialyzer can be used is 8:09 AM on January 10; the latest is on January 16.
b. The earliest this dialyzer can be used is 9:09 AM on January 10; the latest is on January 19.
c. The earliest this dialyzer can be used is 10:09 AM on January 10; the latest is on January 23.
d. The earliest this dialyzer can be used is 11:09 AM on January 10; the latest is on January 24.

Answer: According to the information printed on the sample Renatron label, the dialyzer completed the
reprocessing cycle at 8 minutes after 11 PM on January 9.
 If the minimum dwell time for peracetic acid (11 hours) is added to the time on the sticker, the earliest
this dialyzer could be used would be at 8 minutes and 14 seconds after 10 AM the next morning.
 If the maximum dwell time for peracetic acid (14 days) is added to the processing date on the sticker,
the latest this dialyzer could be used would be on January 23.
The correct answer is c.

II. Correct Timing + Correct Concentration + Visual Inspection  Sterilization of Dialyzer

Equally important as verifying the date and time component is

verifying that the concentration of peracetic acid is sufficient to kill
organisms. The “presence”/Perassay 500 test is used for this
verification.

Test Your Knowledge

Question 1: According to the Perassay 500 procedure…
 If the entire reaction pad is blue-grey or blue-black within __ seconds and does not fade, the
peracetic acid concentration is at or greater than ____ ppm (parts per million).
 If the test strip pad has no color development, if there are scattered spots of blue-gray or blue-
black or brown, or immediately fades, the concentration
of peracetic acid is ____ (high/low) and the dialyzer _________ (should/should not) be used.
Answers:
The test strip should be read within 10 seconds. The concentration should be at or above 500 ppm
(note “500” is in the test strip’s name).
The entire test strip pad should turn blue-grey or blue-black and not fade. If not, the peracetic acid
concentration is
low and the dialyzer should not be used.

©2004-2022 DaVita Inc. Page 11 of 16 CEC2005

Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
 Test Your Knowledge
Question 2: During set up of the dialyzer, you accidentally use a residual test strip to test for
“presence”. Which of the following statements is true?
a. No need to worry. Both test strips will tell if peracetic acid is present.
b. Worry! Even the darkest reading on the residual test strip only indicates a concentration of
100 ppm or greater is present. Only the presence test can verify that the “presence” of
Peracetic Acid is sufficient to sterilize the dialyzer, to prevent bacterial growth, to protect the
patient.
Answer: The correct answer is b.

III. Correct Timing + Correct Concentration + Visual Inspection  Sterilization of Dialyzer

Verifying both timing and concentration is necessary, but the

dialyzer must also be adequately filled with the peracetic acid
solution in order to achieve sterilization. If, for example, a cap came
off allowing some of the sterilant to leak from the dialyzer, the
dialyzer cannot be considered sterile. Before setup, always inspect
the dialyzer.
 Verify all caps are on (both blood-port caps and both
dialysate-port caps).
 Verify the dialyzer is adequately filled with sterilant. Each
header must be at least 2/3’s filled with sterilant while holding
the dialyzer horizontally with the dialysate ports facing up. Any
bubble in the header is to be no larger than 1/3 the total cross
sectional area of the header.

IV. Correct Timing + Correct Concentration + Visual Inspection  Sterilization of Dialyzer

To summarize, the sterility of the dialyzer may be compromised if

problems are found in any of the above areas. It is the responsibility
of the patient-care teammates to check for possible problem areas,
and, if identified, return the dialyzer to reuse.

Additional procedures
The above section reviewed procedures completed by the patient-
care teammates to verify sterilization of reprocessed dialyzers.
Additional procedures are completed both by our reuse teammates
and our biomedical teammates. Two areas that require continuous
attention are listed here.
1) Cleaning the headers of the dialyzers. If the headers or the
O-rings within the header caps are not cleaned and disinfected
properly, a septicemia (from live bacteria) or a pyrogenic
reaction (from endotoxins) may occur. This is also known as
“header syndrome.”

2) Water quality. If the water used to reprocess a dialyzer

contains elevated bacteria or endotoxin levels, multiple
patients may develop similar symptoms (fever, chills...).
 When due to live microorganisms, blood or dialysis cultures
©2004-2022 DaVita Inc. Page 12 of 16 CEC2005
Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
 may be positive (septicemia may be present).
 When due to endotoxins, LALs completed on dialysate or
water samples may be elevated.

Again, to protect our patients, multiple policies and procedures

have been developed. For more information, read the DaVita
self-studies titles:
 “Fever in the Dialysis Unit”.
 “Endotoxins and Pyrogenic Reactions.” This article is
written by Eileen Peacock, Research Assistant - Special
Projects.

Clinical Issue #3: Reuse and Dialyzer Clotting

Do patients using reuse dialyzers have more trouble with clotted
hollow fibers than patients who do not reuse? Most causes for
dialyzer clotting are the same for patients using either dry-pack or
reprocessed dialyzers. For example, insufficient heparin dosing or
heparin pump malfunctions can cause dialyzer clotting problems on
all patients. However, one cause of clotting that may be more
troublesome when peracetic acid is used in reprocessing is the
formation of tiny air bubbles.

 How do air bubbles cause fibers to clot?

Bubbles can plug the hollow fibers, preventing blood flow
through these fibers.

 How can we decrease the amount of bubbles that may form

during set up?
During setup, prime the dialyzer first with saline, then
with the dialysate. Why? Consider the following question.

Test Your Knowledge

Which of the following statements is true? (select the best answer)
a. If dialysate enters the reprocessed dialyzer before the blood compartment is primed with
saline, the tiny hollow fibers may collapse, trapping air within the fibers.
b. If dialysate enters the reprocessed dialyzer before the blood compartment is primed with
saline, the combination of the bicarb and the sterilant within the hollow fibers may cause the
formation of bubbles.

Answer: “Bicarb bath” (a base) + Peracetic Acid Solution  Formation of gas (bubbles)
Diffusion causes the bicarbonate in the dialysate (in the bicarb bath) to move across the dialyzer
membrane into the blood compartment of the dialyzer. If this movement happens before the peracetic
acid solution is rinsed from the blood compartment, a chemical reaction between the peracetic acid
solution and the bicarb may cause bubbles to form within the hollow fibers. Fortunately, this is easy
to prevent. Simply do not attach the dialysate lines until the blood compartment of the dialyzer is
rinsed with saline (ReNews, 1998). The correct answer is b.

 Lastly, how can we decrease the amount of bubbles that may

form after a dialyzer is processed?
©2004-2022 DaVita Inc. Page 13 of 16 CEC2005
Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
 Another way to decrease the amount of bubbles that form
within the hollow fibers is to adequately clear the dialyzer of
blood during takeoff.

If blood products remain in the dialyzer when it is reprocessed, this

too will cause bubbles to form.

Peracetic Acid Solution + Protein (from the blood)  Formation of gas (bubbles)

To summarize, completing these two tasks (priming first with saline

and rinsing blood back appropriately) will decrease the risk of future
dialyzer clotting due to air bubble formation within the fibers.

Clinical Issue #4: Reuse and Adequacy

Another issue to consider involves adequacy of dialysis. Can

dialyzer reuse affect adequacy? Will a patient’s KT/V and URR
readings drop as the number of uses for one’s dialyzer increases?
This is an area that has been extensively researched. Let’s begin with
a review of the “total cell volume” (TCV), the amount of blood a
dialyzer can hold.

Test Your Knowledge

Question 1: The average TCV for most new dialyzers is approximately… (select the best answer)
a. 100 ml
b. 200 ml
c. 300 ml
d. 400 ml
Answer: The best answer is 100 ml.

Question 2: A dialyzer is “failed” if the Renatron

(reprocessing machine) determines the dialyzer’s current TCV is…
(select the best answer) Importance of
Preprocessing
a. < 95% of its original TCV (the volume before its first use)  To obtain the
b. < 90% of its original TCV original dialyzer
c. < 85% of its original TCV volume, all
d. < 80% of its original TCV dialyzers must
Answer: The correct answer is D. If, for example, the original volume of the be preprocessed
prior to their first
blood compartment of the dialyzer was 100 ml, the dialyzer would fail if this use.
value dropped below 80 ml.

Verifying all dialyzers TCV is at least 80% of its original volume

verifies that adequacy of dialysis can be reached with a reprocessed
dialyzer. Research has shown that a drop of 20% in TCV causes the
urea clearance to only drop 5-11%. Quoting Kaplan, “given this
relatively modest loss of urea clearance, a TCV of more than 80%
was accepted as a standard for reused dialyzers…. it ensures that urea
clearance will remain reasonably close to that of a new, unused
dialyzer” (Kaplan). The AAKP and K/DOQI agree with this
statement (AAKP, 2004; K/DOQI, 2000).
©2004-2022 DaVita Inc. Page 14 of 16 CEC2005
Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
References
 Andrysiak, P. (1997). Dialyzer reuse. In J. Curtis Dialysis Technology. (pp.. 92-94). NANT.
 Bregman, H., Daurgirdus, J., Ing, T. (2001)l Complications during hemodialysis. In J. Daugirdas &
T. Ing, Handbook of dialysis (3rd ed), (pp. 148-168). Philadelphia, Lippincott, Williams & Wilkins.
 Burdick, R, & Port, F. (2002) What do I need to know about reuse of hemodialyzers? Available at
http://www.aakp.org/Reuse.htm, accessed 1/21/2004.
 Dahlan, J., & Beckett-Tharp, D. (1992). Dialyzer reprocessing. In Core curriculum for the dialysis
technician (2nd Ed.), Module 6. AMGEN.
 Kaplan, A. (2000). Dialyzer reuse: what we know and what we don’t know. Seminars in Dialysis,
Vol. 13, No.5, 271-274.
 Kaufman, A., & Levin, N. (2001). Dialyzer reuse. In J. Daurgirdas & T. Ing, Handbook of dialysis
(3rd ed), (pp. 169-182). Philadelphia, Lippincott, Williams & Wilkins.
 Keen, M., Lancaster, L., & Binkley, L. (2001) Hemodialysis in ANNA Core Curriculum for Nephrology
Nursing (4th ed) (pp. 294). Jannetti, Pitman.
 NKF K/DOQI (2000). Guidelines for hemodialysis adequacy: Hemodialysis reprocessing and reuse
(guidelines 10-13). NKF. New York.
 Peacock, E. (2003). Endotoxins and Pyrogenic Reactions: Part I. DaVita Medicare Survey Hot Tips.
Vol. 4, No. 4, 1-2.
 Peacock, E. (2003). Endotoxins and Pyrogenic Reactions: Part II. DaVita Medicare Survey Hot Tips.
Vol. 4, No. 5, 1-2.
 Shusterman, N., & Feldman, H. (1993). Methods and complications of dialyzer reuse. In A. Nissensen &
R. Fine (Eds), Dialysis therapy (pp. 133-138). Hanley & Beflus, Inc., Philadelphia.
 Stagier, A. (2003) Dialyzer Reuse: the debate continues. Nephrology News & Issues, Nov., Vol 17,
No. 12.
 Top reprocessing questions you weren’t afraid to ask. (1998). ReNews/Minntech. Vol. 5, No. 2.

©2004-2022 DaVita Inc. Page 15 of 16 CEC2005

Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022
Post Test Questions (to be completed in StarLearning)

1. True/False A patient can experience an ETO reaction (continued)

when using a reprocessed dialyzer. C. Check the reprocessing label & verify the time
interval since the dialyzer was last processed is
2. True/False Possible symptoms of an accidental infusion between 11 hours and 14 days.
of peracetic acid include a feeling of doom, D. Check the reprocessing label & verify the current
chest pain, a drop in blood pressure, and total cell volume (TCV) of the dialyzer.
tingling of the lips.
7. Which of the following statements is true? (select the
3. If a patient has symptoms of an accidental peracetic acid best answer)
infusion, your first response should be to… A. The presence test should be 100 ppm or less &
A. Stop the blood pump the residual test should be 10 ppm or more.
B. Give 200 ml saline B. The presence test should be 100 ppm or more &
C. Call 911 the residual test should be 10 ppm or less.
D. Repeat the residual test C. The presence test should be 500 ppm or less &
the residual test should be 1 ppm or more.
4. Which of the following may cause the peracetic acid D. The presence test should be 500 ppm or greater
solution to enter the saline bag during recirculation? & the residual test should be 1 ppm or less.
(select the best answer)
A. A TMP alarm 8. When inspecting a reprocessed dialyzer prior to setup,
B. An empty saline bag the header of the dialyzer should be at least….
C. A blood pump speed of 300 ml/minute A. Two-thirds filled with sterilant
D. A UF rate of 300 ml/hour. B. One-third filled with sterilant
C. One-half filled with sterilant
5. Peracetic acid rebound can best be described as the D. Three-fourths filled with sterilant
movement of the sterilant from the…
A. Blood compartment to the dialysate. 9. True/False To help prevent bubbles from forming
B. Blood lines into the Heparin line & syringe. inside the hollow fibers, prime the dialysate
C. Blood lines into the saline bag. side of the dialyzer prior to priming the
D. Potting material or dialyzer membrane to the blood side with saline.
blood compartment.
10. If water used for reprocessing contains elevated levels
6. During set up, to determine if the sterilant dwell time is of bacteria or endotoxins, you will most likely see…
within the range allowed by policy, you would… A. Multiple patients with hypotension & chest pain
A. Complete the presence/Perassay test & verify the B. Multiple patients with fever & chills
test reading is positive. C. Multiple access infections
B. Complete the residual test & verify the test D. Multiple clotted dialyzers
reading is negative. (continued in next column)

DaVita has been granted Continuing Education Provider status – CEP12243 - by the California
Board of Nursing (CA BON). This educational activity is approved by all states and specialty
organizations that recognize the CA BON accreditation process.

Please print your CE Certificate and retain it for four years as required by the CA BON!

©2004-2022 DaVita Inc. Page 16 of 16 CEC2005

Orig. Mar 2004
Review: Dec 2022
Revision Feb 2006, Feb 2008, Jan 2014, Feb 2015, Feb 2017, Dec 2019, Dec 2022