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CelebrateLife
For Home TPN and Tube Feeding Patients
The
Evolution
of Nutrition
Support
May 2016 | Issue 37
Contents
4
8
11
16
An Experimental Lipid Helps
an Infant with Short Bowel
Syndrome: Cameron’s Story
Cameron Stanford was born with short bowel
syndrome, a condition requiring emergency
surgery shortly after his birth. Without functioning
intestines, he survived his first few weeks on
parenteral nutrition (PN). When he developed
PN-associated liver complications, his parents
found help through a clinical study involving an
investigational lipid product called Omegaven®.
Read about how Cameron overcame challenges
to not only survive but thrive.
New Lipids on the Horizon
Lipids are important part of any daily diet. In recent
years, new intravenous (IV) lipids for parenteral
nutrition have been introduced internationally that
contain different combinations of olive oil, fish
oil, and other fats in place of the more traditional
100% soy lipids. Read more about these new
products, coming soon to the United States.
The Parenteral Nutrition Lifeline
For people who require total parenteral nutrition
(PN), the central venous catheter is often referred
to as their “lifeline.” These catheters allow these
individuals to be nourished intravenously when
their gastrointestinal tract is not working well.
Read about how catheters for IV nutrition have
evolved over the years.
ENFit: The Future of
Enteral Connection
The enteral device industry is undergoing major
changes. ENFit is the name of the new connection
standard for tube feeding sets, syringes, and
tubes. Read more about this new standard
design that has been developed to prevent tubing
misconnections and improve patient safety.
May 2016 | Issue 37
AdvocacyCorner
A Look Back on
the “Old Days” of
Parenteral Nutrition
In this month’s Advocacy Corner, Patient Advocate
Michael Medwar talks about the evolution of
nutrition therapy over the past 40 years with the
help of two long-time Coram patients.
Dr. Stanley Dudrick
Overcame Hurdles to
Develop PN
22
Research by this pioneer of parenteral nutrition
proved doubters wrong and showed the therapy
could work.
Celebrate Life
Coram’s Magazine for Home TPN and
Tube Feeding Patients
Celebrate Life Staff
Karen Hamilton, MS, RD, LD, CNSC, Clinical Editor
Alison Davis, Senior Editor
Darlene Rollins, Graphic Designer
Contributing Writers
Mark DeLegge, MD
Karen Hamilton, MS, RD, LD, CNSC
Michael Medwar
Alison Davis
Sarah Allen, MS, RD
Celebrate Life is provided as a free service to parenteral
and enteral consumers. Opinions expressed by contributing
authors and sources are not necessarily those of the publisher.
Information contained in this magazine is for educational
purposes only and is not intended as a substitute for medical
advice. Do not use this information to diagnose or treat a health
problem or disease without consulting a qualified physician.
Please consult your physician before starting any course of
treatment or supplementation, particularly if you are currently
under medical care. Never disregard medical advice or delay
in seeking it because of something you have read in this
publication.
© 2016 Coram LLC. All rights reserved. No part of this
publication may be distributed, reprinted or photocopied without
prior written permission of copyright owner. All service marks,
trademarks and trade names presented or referred to in this
magazine are the property of their respective owners.
COR09007-0516
We welcome your comments, stories and suggestions.
Please send all correspondence to:
Coram CVS/specialty infusion services
Celebrate Life Magazine
555 17th Street, Suite 1500
Denver, CO 80202
2 | Celebrate Life | May 2016 | Issue 37
20
A Note from Our Guest Editor
“The only
constant is
change.”
“The only constant is change.” This quote is as true now as it was when the
Greek philosopher Heraclitus wrote it over 2,500 years ago. Fortunately for us,
nutrition support therapies are no exception. I have seen many changes which
have positively impacted nutrition support therapy while working as an enteral
dietitian with Coram CVS/specialty infusion services. I am excited to share with
you this issue of Celebrate Life, which focuses on the continued evolution of both
enteral and parenteral feedings.
– Heraclitus
This month’s issue begins with the uplifting story of Cameron, a one-year-old boy
from Las Vegas who beat the odds. The strength and determination of his parents,
along with support from Coram, enabled him to go from being PN dependent at birth to being an active toddler
who is now able to supplement tube feeding with an oral diet.
Next, Dr. DeLegge’s article reminds us that fats, often viewed in a negative light, are in fact necessary for health.
Prior to Arvid Wretlind’s creation of a solution-stable lipid, parenteral feeds were missing this important building
block of health. This article reviews the history of parenteral lipids, provides an overview of lipids currently
available, and identifies possible improvements for the future.
It is difficult to appreciate where we are unless we remember where we have been. The following articles reiterate
this well. We tend to think of intravenous (IV) therapy in terms of modern IV bags and lines, but contributor Karen
Hamilton reminds us the plastic and Teflon of today is far from the quills used to administer medications in the
1600’s; and she provides information on the latest in infection, migration, and occlusion preventions.
Enteral (“tube”) feeding has certainly come a long way since ancient Egyptians provided nutrition via enemas and
Capivacceus invented the first “modern” feeding using a hollow tube and bladder placed into the esophagus
in 1598. In this issue’s next article, we discover the latest innovation: ENFit connections. While change is never
easy, read how this simple change will improve safety and save lives.
In this issue’s Advocacy Corner, Nourish Patient Advocate Michael Medwar
takes a look at the “good old days” as he shares the stories of three long-time
PN users, covering over 40 years of parenteral therapy memories, from mixing
solutions at home to rolling large pumps over shag carpet. Finally, learn about the
uphill battle a pioneer of total parenteral nutrition, Dr. Stanley Dudrick, faced to
prove people can and should be fed intravenously if the GI tract cannot be used.
Those of us here at Coram know that the nutrition therapy of today is not the
nutrition therapy of tomorrow. Thank you for allowing us to partner with you to
provide you with the most up-to-date, advanced products available. Together we
can make 2016 the best year yet!
In gratitude,
Sarah A. Allen, MS, RD, LDN
Coram Nutrition Support Dietitian
3
An Experimental
Lipid Helps
an Infant with
Short Bowel
Syndrome:
Cameron’s Story
By Alison Davis, Contributing Writer
In early 2014, Rozenia and Justin Stanford were
enjoying life as a newly married couple. They had
recently returned home from a dream honeymoon in
Bora Bora. They were busy settling into their first home
in Las Vegas. And then they received thrilling news —
they were expecting their first child! It was a happy and
exciting time.
Everything seemed normal through the first half of
the pregnancy. But at about 18 weeks, when Justin
and Rozenia went for their mid-way ultrasound, the
technician noticed what appeared to be a small cyst on
4 | Celebrate Life | May 2016 | Issue 37
the baby’s intestines. The doctors examined Rozenia
further and didn’t seem very concerned. So the couple
went about the typical preparations for the birth of their
baby without much worry.
Baby Cameron arrived three weeks early, but was
essentially “full term” in size at about six pounds. The
labor seemed to progress normally at first. However,
when Rozenia’s water broke, the expelled fluid was
an alarming greenish color… this was their first real
indication that what the doctors had previously
described as a “cyst” on the baby’s intestines, might
actually be something much different.
As they soon discovered, Cameron’s intestines
were essentially in two separate pieces, which were
no longer intact. No one was able to explain what
caused it or when the problem occurred. But they
were told that if Cameron were to survive, the dead
tissue had to be removed immediately. The couple
watched helplessly as their day-old infant was taken
into emergency surgery for a procedure called jejunal
artresia and cystic mass resection. After the surgery,
only about 16 cm of his small bowel remained.
Cameron was diagnosed with what was known as
short bowel syndrome (or SBS).*
If their son survived, he would most likely never be able
to eat normally and would need to survive on parenteral
The first few days and weeks
after his birth were tough.
They had been completely
blindsided by the diagnosis.
The initial reports after his
surgery were terrifying.
nutrition (PN)* for the rest of his life. The Stanfords
had never even heard of PN. But as bad as things
sounded, they did learn that Cameron still had an
intact ileocecal valve and colon. This was somewhat
good news, as it provided some hope since a small
portion of his digestive tract might actually be able
to function. They would have to wait and see. The
medical staff seemed to have few other answers
for them.
Cameron spent weeks in the neonatal intensive
care unit (NICU). The daily visits to the hospital
were agonizing for the couple, seeing their baby
crying constantly from hunger, but unable to take
any nourishment by mouth. A Broviac* catheter
was inserted in a large vein leading directly into his
heart to deliver his lifesaving PN. It was the only
nourishment he received for the first few weeks of life.
Since most of their medical team had never seen
a case like Cameron’s before, Justin felt he had
no other choice but to turn to the internet for more
answers about their son’s condition. He spent almost
every waking minute, when not working and visiting
the NICU, doing as much online research as he
possibly could. It seemed that most of the medical
staff assumed the inevitable — that Cameron would
need some sort of ostomy surgery to reroute the
normal intestinal contents out of his body through his
abdominal wall. But the couple didn’t want to accept
that as the only option. Rozenia recalls, they did a lot
of praying during those first difficult weeks.
Fortunately, one morning it seemed as if their prayers
had been answered. When they arrived at the NICU,
the night nurse reported that their son had his first
bowel movement. Great news! Since his intestines
were functioning, he was able to start receiving
formula through tube feeding in addition to the PN.
Soon after, they were finally able to take
Cameron home.
*Glossary
• Short bowel syndrome (SBS): A condition that
occurs when part of the small intestine is missing
or has been removed during surgery. Nutrients
are not properly absorbed into the body as a
result.
• Parenteral Nutrition (PN): (Also referred to as
total parenteral nutrition or “TPN”). A method of
nutrition support. Nutrients are sent to the body
through an intravenous (IV) line. The digestive
system is not used.
• Broviac: A type of central venous catheter that is
surgically placed beneath the skin and threaded
to a blood vessel near the heart.
5
Rozenia recalls an especially
difficult experience shortly after
they brought him home from
the hospital. One evening, when
Cameron was about six weeks
old, he managed to kick out his
G-tube. In a panic, they rushed
him to a nearby urgent care clinic.
The attending doctor had never
heard of short bowel syndrome,
and had to call Cameron’s
surgeons for support. The doctor
asked them to test the G-tube
reinsertion, but with much more
fluid than Cameron had ever
received at one time since birth.
Fortunately, Rozenia recalled
advice given to her from nurses
in the NICU to always trust her
instincts – they stopped the test,
which could have caused major
damage to Cameron. She was so
glad she had paid attention and
done her research.
Liver Complications
Just as they were starting to feel
comfortable with the complex
home tube feeding and PN
routines, there was an alarming
new development — At about
seven weeks, Cameron’s tests
started to show signs of liver
damage. It turns out that the
PN that was keeping him alive
had started to destroy his liver.
About one third of infants like
Cameron who survive on PN for
6 | Celebrate Life | May 2016 | Issue 37
their first weeks of life, develop
what’s called parenteral nutritionassociated liver disease (or
PNALD). It was serious, and
could cause permanent liver
damage and eventual liver
failure and death.
As Cameron’s condition
continued to worsen, Justin
learned through the internet about
a clinical study being conducted
at UCLA Medical Center on an
experimental nutritional product
called Omegaven®, which might
be able to help their son. Out of
desperation, they decided it was
worth going to California for a
consultation. They felt they had
no other options.
So with her husband Justin
driving, Rozenia sat in the back
seat with the baby hooked up
to his catheter and G-tube, and
they made the first of many
drives from Las Vegas to UCLA.
There they were introduced to the
staff involved in the Omegaven
research study. Omegaven, they
learned, was a refined omega-3
fatty-acid-based lipid emulsion
made from fish oil. It had been
proven to be effective
in stabilizing or reversing liver
injury associated with the use
of PN when no other satisfactory
alternative treatments
were available.
Although Omegaven is commonly
available in Europe, it is still
considered “investigational” in
the United States, not currently
approved by the FDA. It can
only be obtained through a
few large academic settings
like UCLA that manage fragile
pediatric PN patients like
Cameron. Fortunately, they
were accepted into the study
at UCLA. Omegaven was
provided to Cameron as part
of a “compassionate use”
protocol coordinated through a
special agreement with Coram’s
wholesale division. With the
help of Coram, they were able
to receive Omegaven, as well as
their other PN and tube feeding
supplies, delivered directly to their
home in Las Vegas.
A Turning Point
According to Rozenia,
“Omegaven was truly a
miracle for Cameron.” Almost
immediately, he started gaining
weight — and from then on, he
continued to gain at least one
pound every month. The liver
damage quickly began to reverse
itself and his liver function tests
started to return to nearly normal.
“It changed everything,” she said.
As the months passed, Cameron
continued to do remarkably well.
Progress Today
“Cameron keeps surpassing every obstacle,” Rozenia says.
“He is now bigger than many other kids his age. He has a
very high energy level, running everwhere, and is very happy.”
Their biggest challenges now are
with Cameron’s speech delays,
but Justin and Rozenia are not
too concerned due to the major
challenges he faced. Delays were
to be expected.
They were able to discontinue
the Omegaven after six months.
They slowly started introducing
him to formula by mouth and
eventually solid baby foods like
rice and oatmeal. And as they
progressively weaned him off
of PN, his appetite continued
to increase. Before long, they
were able to discontinue the PN
altogether. In September 2015,
he celebrated a big milestone
— his first birthday — and he is
continuing to do very well!
In other positive news,
Cameron’s Broviac catheter was
removed before the New Year,
and he stopped receiving enteral
formula through his feeding tube
shortly after. Cameron is still
growing and healthy, and the
Stanfords expect his G-tube to
be removed in a few months.
What is his long-term outlook?
They know they will always
need to be careful with his diet,
but they don’t think any other
surgeries or medical procedures
will be needed. Justin and
Rozenia are so encouraged
by his progress that they have
recently enrolled Cameron into
day care.
What advice would the Stanfords
give other families going through
similar challenges with SBS?
“Educate yourself and demand
excellence of your medical
team,” they say. “And take
responsibility, and question
your medical team and don’t
hesitate to get second opinions.
And make a point to reach out
to others,” Rozenia says. “We
belong to a Facebook support
group with SBS families from
all over the world that share
information daily, which makes
a big difference.”
“We are so relieved and
overjoyed with Cameron’s
progress today,” Rozenia says.
“We are so grateful to the
excellent doctors at UCLA, the
team at Coram, and all the others
who have been involved in
his care.”
7
New Lipids
on the
Horizon
By Mark DeLegge, MD
The Importance of Lipids
Our diet consists of protein, carbohydrates, fat,
minerals and vitamins. Fat has gotten some bad
press, but it isn’t all bad. In fact, fat is a necessary
part of the diet to provide energy and essential fatty
acids used for growth and development and cell
function. Without fat, we could not maintain healthy
skin, nerves or immune function. The word “lipid” is
another name for the fat component of our diets. If a
person is unable to absorb the fat/lipids they eat or
receive by tube feeding, they can get their essential
fats intravenously. Intravenous (IV) lipids have been
in clinical use as part of parenteral nutrition (PN) for
more than 40 years.
Lipids provide us with calories (about 9 calories for
every gram of fat received) and also help prevent
essential fatty acid deficiency (EFAD). Humans
8 | Celebrate Life | May 2016 | Issue 37
can make many fatty acids internally (these are the
building blocks of lipids). However, there are two
fatty acids we cannot make; linoleic and linolenic
acid (these are referred to as essential fatty acids).
If we don’t receive these fatty acids in our diet or
intravenously we can develop EFAD. This can result in
loss of hair, brittle nails, a rash and weakening of the
immune system.
The importance of lipids in the diet extends well
beyond being a source of calories and prevention
of EFAD. Lipids are an important component of
cell membranes and cell wall “flexibility.” They
assist in the movement of cells in the body and
communication between cells. They are also
important for ensuring that our genes do what they
were programmed to do and for the synthesis of
many body hormones. Lipids also play a role in
the response to injury or infection, which is known
as inflammation. For example,
when you get a wound infection,
the area becomes red, hot and
swollen. This is the result of
activation of your immune system,
which includes directing your
white blood cells to the site of
infection. Your immune response
is needed to fight the infection.
However, sometimes the human
immune response, such as in
critically ill patients, can overshoot
its intended response and result
in damage to the body resulting
in worsening of a patient’s
clinical course.
Today’s Soybean
Oil Products
The first commercially available
lipid in the United States was a
100% soybean oil lipid developed
by the Swedish scientist Arvid
Wretlind. He was able to get
the lipid to be stable in solution
by combining the lipid with an
egg yolk emulsifier. This same
process continues today. Prior
to the development of IV lipids,
PN formulations contained only
high concentrations of amino
acids and carbohydrates. Wretlind
has been called the “father” of
complete PN therapy.
The only lipids currently approved
for use in the United States
and commercially available are
Intralipid® (Baxter Healthcare) and
Nutrilipid® (B. Braun Medical).
These IV lipids are made from
100% soybean oil. Soybean oil
is a vegetable oil that is removed
from the seeds of soybeans. In
every 100 g of soybean oil there
are 16 g of saturated fat, 23 g
of monounsaturated fat, and
58 g of polyunsaturated fat. We
describe soy lipid as being rich in
polyunsaturated fatty acids. The
essential fatty acids, linoleic and
linolenic are polyunsaturated.
IV lipids may be mixed with
the other components of PN
(carbohydrates and protein) into
one bag; this is known as a 3-in-1
solution. It gives the bag a “milky
appearance. Once hung, the
3-in-1 solution must be infused
within 24 hours after removal
from refrigeration. Alternatively,
a person may receive their PN
solution as a 2:1 product (a bag of
carbohydrates and protein which
is clear to slightly yellow in color
when multi-vitamins are added).
The lipid is infused separately.
In this instance the lipid should
be infused within 12 hours after
removal from the refrigerator.
3-in-1
During the past 15 years,
there has been some concern
about the impact of 100% soy
lipid emulsions on a patient’s
inflammatory response, immune
response and liver function. Some
published data would suggest
that soy lipids increase the
human’s inflammatory response
to injury and reduce the body’s
immune function. This could be
concerning for patients who are
severely infected or injured.
In addition, it is believed that
soy lipid may be the cause
of injury to the liver in some
patients on PN; this is known as
parenteral nutrition associated
liver disease (PNALD). This may
be more common in very young
or premature children. For these
reasons, some clinicians limit
the amount of soy lipid a patient
receives hoping to avoid these
possible side effects. However,
limiting the fat content a patient
on PN receives over time may
impair the other important
functions lipids have in humans.
Also, in order to make up for the
loss of calories in the PN solution
with the reduction in soy lipid,
glucose concentrations are often
increased which can result in
hyperglycemia (elevated
blood sugars).
solution must be infused
within 24 hours after
removal from refrigeration
9
The Newest Lipids
Over the last 15 years, new lipids have been
introduced internationally to reduce the amount of
soy lipid content in the lipid emulsion. This includes
combinations of olive oil, fish oil and medium
chain triglycerides (MCT) (a different type of fat). In
clinical practice, these “new generation lipids” have
replaced the more traditional 100% soy lipids in many
countries. All of these lipids contain some percentage
of soy lipid. For instance, a product known as
Clinoleic (Baxter Healthcare) contains 80% olive oil
and 20% soy lipid. Another product SMOF (Fresenius
Kabi) contains 25% olive oil, 30% MCT, 15% fish oil
and 30% soy lipid. Over the next few years we should
see these newer combination lipid products approved
and commercially available in the United States.
Lipids are a critical component of our daily diet.
Their use intravenously over the past five decades
has shown the current commercial products to be
very beneficial. However, there is some concern
from clinicians about the impact of 100% soy lipid
formulations on a patient’s inflammatory response,
immune response and liver function. Further research
should help to determine if these concerns are valid.
Meanwhile, combination lipids should arrive in
the United States for use within the next one to
two years.
10 | Celebrate Life | May 2016 | Issue 37
Clinoleic (Baxter Healthcare)
+ 20%
80%
soy lipid
olive oil
SMOF (Fresenius Kabi)
25%
30%
olive oil
+
MCT
+
15% 30%
fish oil
soy lipid
Over the next few years we should
see these newer combination
lipid products approved and
commercially available in the
United States.
The
Parenteral
Nutrition
Lifeline
By Karen Hamilton, MS, RD, LDN, CNSC –
Senior Advisor, Nutrition Programs & Services
The central venous catheter of a person
who requires parenteral nutrition is often
referred to as their “lifeline”– it is the route
that allows them to be nourished when their
gastrointestinal tract is not working well.
continued...
11
Today, parenteral nutrition
(PN) is a life-sustaining
therapy that supports
individuals for as long as they
require it — weeks, month,
years or even a lifetime. This
was not always the case, as
both central venous catheters
and IV nutrition are 20th
century innovations and have
experienced significant and
profound improvements since
their beginning.
12 | Celebrate Life | May 2016 | Issue 37
This article takes a look back at how
access devices evolved to support the safe
use of IV therapy and a look forward to how
access devices and supplies have evolved
today to produce better patient outcomes.
A look back at IV Therapy
The history of intravenous (IV) therapy dates back
to the Middle Ages, but it was not until the 1600’s
when the first experiments with IV injections were
noted. Physicians would use quills and bladders of
animals as instruments to deliver medications. In the
1830’s, the cholera epidemic struck and IV saline
infusion was used to keep patients hydrated.1-2 It
was not until the 20th century, however, that two
world wars cemented a role for IV therapy as routine
medical practice. In 1965, IV nutrients were given to
puppies, which then grew and thrived, leading to
the development of the parenteral nutrition we
know today.
Historical View of
Access Devices
The limiting factor to successful IV treatment,
historically, has been the access device itself. Since
World War II, continuous innovations have been
developed to create lighter, safer and more durable
IV access devices that can be used for a range of
medications and nutrition therapies. With the advent
of plastic manufacturing and the development of
Teflon, each new material represented an advance
over its predecessors and addressed a specific
clinical challenge. As a result, patients benefit from
enhanced clinical performance, decreased irritation to
vein walls and catheters that help to prevent bacterial
colonization and infection.3-5
Around the same time period that Dr. Stanley Dudrick
was experimenting with IV nutrition solutions in
beagle pups, plastic syringes and disposable needles
were introduced into the American and European
markets, supporting more widespread use of longterm, central venous access. This, in turn, allowed
patients in hospitals, extended care facilities and
home care to have better access to safer long-term
IV therapy. Additionally, the role of nurses in access
device care and placement expanded, resulting in the
use of these devices for a wider population.
Today’s Catheters
For individuals who require PN support, a central
venous access device (CVAD) is essential to deliver
the large volume of nutrients without damaging the
blood vessel. Catheters can be implanted surgically
for long-term use (years) or inserted peripherally
for shorter-term use (weeks to many months). A
peripherally inserted central catheter (or PICC) is
inserted into the arm and threaded through the
blood vessel into an ideal position. The mutual goal
of these catheters is to deliver the nutrition directly
into the bloodstream, while avoiding the potential
complications often associated with catheters such
as infection, migration (catheter creeping out of the
vein) and occlusion (narrowing or closing off of the
inside or lumen of the catheter). Today’s catheters,
catheter supplies and novel catheter locks continue
to evolve to support achievement of these goals.
Infection Prevention
Catheter-related blood stream infection (CRBSI) is
associated with any vascular access device and is a
serious potential health complication. This risk can be
minimized by using strict aseptic techniques during
insertion, maintenance and access of the CVAD.6
Today, there are several available catheter care
products that can also aid in infection prevention.
These include products for skin and CVAD cleaning
and catheter protection.
Skin and Catheter Cleaning
For regular skin and CVAD cleaning, research has
shown that a 2% chlorhexidine-based alcohol
solution is more effective at decontaminating the
access site than povidone-iodine.7 Once the device
has been placed, ongoing cleaning using single-use
2% chlorhexidine-based alcohol pads on the skin
prior to port access or around tunneled catheters and
PICC insertion sites is suggested to reduce bacterial
contamination of the skin and reduce possible
catheter infection. Scrubbing the hub of the CVAD
with an alcohol pad is also essential to decontaminate
the CVAD before access, thus minimizing the
possibility that bacteria on the hub may be flushed
into the catheter and bloodstream. Another
innovation used to prevent infection is a disinfectantimpregnated end cap that will kill bacteria that may be
located at the end of the catheter within five minutes
of application and will keep the surface disinfected for
up to seven days if the cap is not removed.
Anti-microbial foam discs are another catheter supply
that can aid in creating an environment that manages
13
both moisture and bacteria at the
same time. The foam dressing
is applied around the exit site
of the catheter and it absorbs
wound exudates (drainage), while
a powerful antiseptic targets
and kills bacteria on contact.
This novel supply provides an
additional safeguard against
potential infection.
Dressings
CVADs need a dressing that
creates a barrier to reduce the
risk of infection. A tunneled CVAD
or port needs a dressing around
the entrance to the skin tunnel
until the wound has healed. This
should take around 10 to14 days
depending on the individual
patient. Once the skin has healed,
the only dressings subsequently
required are to secure the access
needle in place when the port
is being used. PICCs need to
have a dressing over them as
they are placed directly through
the skin overlying the puncture
site where the catheter accesses
the vein. Modern dressings
used today are transparent so
the patient or caregiver can
regularly observe the site for
redness or oozing, indicators of
potential infection. The dressing
must also seal well around the
catheter insertion site to keep
the area dry. A moisture barrier
dressing is also recommended
14 | Celebrate Life | May 2016 | Issue 37
to protect the PICC dressing
and site while bathing. Specific
dressings that are non-DEHP and
are impermeable to waterborne
bacteria are available.
Migration
Prevention
PICCs are the only long-term
CVADs that require ongoing
securement to reduce the
likelihood of the catheter moving
out of position. Historically, this
has involved suturing (stitching
into place); however, these
sutures can become loose over
time and can act as a potential
area for infection to develop.8
The use of self-adhesive
anchoring devices that have been
developed in recent years has
reduced the likelihood of PICC
loss due to catheter migration by
up to 71%, and has also reduced
insertion site infections.9
Occlusion
Catheter occlusion* is not an
uncommon complication and
its occurrence varies by patient
population and length of time
an individual has a catheter. A
CVAD occlusion can be partial,
such that blood cannot be
drawn from the catheter but it
is still possible for the infusion
to go through the catheter. Or
it can be a complete occlusion,
such that neither a blood draw
nor the infusion is possible.
A CVAD occlusion can occur
due to mechanical obstruction
(catheter pinch-off or kinking),
precipitation* of medications or
PN, or thrombotic* causes.
Today, patients are fortunate
to have a variety of novel
approaches to managing an
occluded catheter. The goal,
ideally, is to resolve the occlusion
so that the catheter does not
need to be removed. Even
better than resolution, though,
is prevention. Mechanical
occlusions can be either external
or internal. External occlusions
stem from a kink or clamp in
the portion of the catheter that’s
outside the patient. It is important
to check whether any clamps are
closed and look for sutures or
securement devices that could
be pinching the catheter too
tightly. The catheter should then
be checked for kinks. Finally, the
IV tubing and pump should be
examined for obstructions and
malfunctions.
Internal occlusions occur inside
the patient and are harder to
assess. A rare type of internal
mechanical obstruction is known
as “pinch-off syndrome”. It is
important for patients to be
aware of the symptoms and
signs associated with this rare complication, so that
immediate medical attention can be sought. The most
common clinical signs noted in patients with pinch-off
syndrome is pain, with or without swelling, at the
catheter insertion site. The next most common sign
is a dysfunctional catheter, in other words, problems
with blood aspiration or flushing.
Careful screening of at-risk patients’ medications
and nutritional formulas may also prevent occlusion.
However, when occlusion does occur because of
medication or PN, there are a variety of treatments
that can be used. Occlusion caused by low pH
medications or calcium phosphate crystals can
be treated with a “catheter lock” or instillation and
withdrawal of 0.1% hydrochloric acid (HCl). If high pH
medications cause occlusion, these can be effectively
treated with sodium bicarbonate or sodium hydroxide
also instilled and withdrawn from the catheter.
When occlusion is caused by lipid residue from PN,
successful clearing of the catheter can occur with
use of a 70% ethanol lock solution. When thrombus
leads to catheter occlusion, it is most likely due to
a buildup of a fibrin sheath around the catheter tip.
In less frequent cases, thrombus can occur due to
underlying disease. In either case, thrombolytic or
“clot busting” agents can be used to restore the
catheter to functional status. Thrombolytic agents are
an area of catheter care that continues to evolve with
improved agents being brought to market to improve
patient outcomes.
References
1.Feldmann H. History of injections. Pictures
from the history of otorhinolaryngology
highlighted by exhibits of the German
History of Medicine Museum in Ingolstadt.
Laryngorhinootologie. 2000;79(4):239-246.
2.Lewins R. Injection of saline solutions in
extraordinary quantities into the veins in cases
of malignant cholera. Lancet. 1832;2:243-244.
3.Millam D. The history of intravenous therapy.
J Intraven Nurs. 1996;19(1):5-14.
4.Barsoum N, Kleeman C. Now and then the
history of parenteral fluid administration. Am J
Nephrol. 2002;22(2-3):284-289.
Today’s catheters, related supplies and treatments
have thankfully significantly evolved from the days of
quills and bladders and have allowed patients who
require long-term IV support to manage their health
and therapies in the comfort of their own home, safely
and effectively. For patients who receive daily PN
infusions, having a choice about the type of lifeline
that fits their personal needs and lifestyle is essential.
When CVAD replacement is necessary, it is important
to have a proactive and open discussion with your
healthcare team to determine the best catheter
type. Further, periodically talking to your homecare
clinicians about standardized catheter care protocols
and novel supplies available to help keep your lifeline
safe, infection free and working well will give you the
peace of mind to know you are receiving the best and
most current care.
*Glossary
• Precipitation – low pH or high pH medications
or certain unstable parenteral solutions can
develop solid particles due to a reaction of the
elements within these liquids.
• Thrombotic – formation of a blood clot
inside a vessel
• Occlusion – narrowing or closing off of
a catheter.
5.Ingram P, Lavery I. Peripheral intravenous
therapy: key risks and implications for
practice. Nurs Stand. 2005;19(46):55-64.
6.Mermel LA, Allon M, Bouza E, Cravem DE,
Flynn P, et al. Clinical practice guidelines
for the diagnosis and management of
intravascular catheter-related infection: 2009.
Updated by the Infectious Diseases Society of
America. Clin Infect Dis. 2009;49(1 July):1-45.
7.Gabriel J. Infusion therapy part two: prevention
and management of complications. Nurs
Stand. 2008; 22: 32, 41-48.
8.Gabriel J. Venous access devices 1: long-term
central venous access device selection. Nurs
Times. 2013;109: 39: 12-15.
9.Moureau N, Lannucci A. Catheter securement:
trends in performance and complications
associated with the use of either traditional
methods or an adhesive anchor device. JVAD.
2003;8:1, 29-33.
15
ENFit:
The Future of Enteral
Connection
By: Sarah A. Allen, MS, RD, LDN
16 | Celebrate Life | May 2016 | Issue 37
Enteral misconnections
can be very serious
— a matter of life or
death for tube feeding
consumers.1
Misconnections can occur in two ways:
• When an enteral feeding is connected into a
non-enteral access device
• When a non-enteral therapy is connected into an
enteral access device
A “near miss” event occurs when the misconnection
is observed and corrected before administration is
started. Enteral misconnections and near misses may
occur with non-enteral medical interventions such as
intravenous (IV) lines, dialysis catheters,
and ventilators.
The U.S. Food and Drug Administration (FDA)
reports that it is difficult to assess exactly how many
misconnections and near misses occur as these
events are under-reported. However, those events
that have been reported show how common these
misconnections may be. For example, the state of
Pennsylvania alone had 36 tubing misconnection
events reported between January 2008 and
September 2009.2 The FDA has identified 116
published case studies of misconnections between
enteral feedings and IV lines. Since 1971, 21 known
deaths have occurred due to enteral misconnections.
Even one enteral misconnection is one too many.
In the past, hospitals and manufacturers of enteral
supplies voluntarily took steps to reduce the
possibility of misconnections. Some hospitals
introduced policies such as requiring clinicians
to trace tubing back to the point of origin prior to
connections, routing lines in standardized directions
(i.e., IV lines facing the head and enteral lines facing
the feet), and identifying and correcting the worker
fatigue known to contribute to misconnections. Some
manufacturers made their products a specific color to
identify them as enteral products, and created special
adapters that would only permit enteral supplies to fit
easily with enteral lines. However, these steps were
not standardized throughout the industry or between
medical facilities, and misconnections continued
to occur.
In 2011, the FDA accepted the International
Organization for Standardization’s (ISO) series
80369 general requirements for standardization
of small-bore connectors.1 ISO’s series 80369
(Small-bore Connectors for Liquids and Gases in
Healthcare Applications) recommends changes in
enteral and a variety of other medical applications
so that the new connection design of each will make
them incompatible with another.3 The worldwide
standardization facilitates enteral tubes, feeding sets
and syringes to connect while making non enteral
applications incompatible. This allows for portability
of care from hospital to hospital, city to city, state to
state, and country to country. The goal is to finally
bring misconnections to zero.
Most current enteral connections have an openended feeding tube with which a catheter tip syringe
or a bag with a tapered “Christmas tree” end is
used to administer feedings. However, this is not
an industry-wide standard. Additionally, different
manufacturers of catheters and extension sets, may
Picture of the older open-ended feeding tube
(left) and a “Chistmas tree” adapter (right) — the
non-ENFit” design
17
not fit with each other, so a consumer would have to
use all of one type or manufacturer supplies, even if
another manufacturer’s supplies may work better for
their needs.
The Global Enteral Device Supplier Association
(GEDSA) was founded in 2013 to address issues
and explain the ENFit changes.4 A website, www.
stayconnected.org, was created to keep clinicians
and patients updated on the ENFit transition phases,
which are continuing in 2016.5
The timing of the syringe and feeding tube rollout
(Phase 2) is planned, but not yet confirmed, for some
time in second quarter of 2016. Changes to the
low-dose syringes (<2 ml syringes) are being made to
resolve a dosing accuracy challenge identified with
the current ENFit design. This has contributed to the
delay in the implementation schedule.
Picture of Phase 1 ENFit Bag Connection (right) and
ENFit Adapter (left)
Picture of ENFit Feeding Tube (left) and ENFit Supply
Connection (right)
Phase 1 was implemented during the second quarter
of 2015. Feeding bags have been made with the
new ENFit connection, but with transition adapters
that fit into current feeding tubes. The Infinity pump,
manufactured by Moog, temporarily changed back
to the original red “Christmas tree” connection while
they fix their transition set adapter, which has had
some issues with cracking and leaking.
18 | Celebrate Life | May 2016 | Issue 37
Over the next few years, until all old feeding tubes are
replaced with new ENFit-compatible feeding tubes,
ENFit supplies and old supplies/feeding tubes may
continue to be used with adapters. Eventually all
enteral feeding bags, syringes, feeding tubes, and
related enteral supplies will be transitioned to the
ENFit connection.
While there is no current federal law requiring
compliance with ENFit changes, California passed
HB 1867 which “…will prohibit general acute
care, acute psychiatric, and special hospitals from
using an epidural, intravenous or enteral feeding
connector that fits into a connection port other than
the type for which it was intended.”6 Other states
are expected to pass similar laws. Manufacturers of
enteral supplies have followed the ENFit connection
recommendations of the ISO and FDA. They have
generally been following the GEDSA timeline both
in anticipation of legal requirements and in order to
keep enteral consumers safe from
misconnections.
Despite advancements in safety,
concerns remain among some
enteral consumers around the
ability to vent G-tube contents,
or to successfully and efficiently
feed blenderized foods. Also,
there are concerns about
providing accurate medication
administration in low-dose
syringes for infants and pediatric
patients. To address these
concerns, GEDSA and several
consumer organizations have
been working together on
several solutions.
To address the pediatric dosing
concerns, syringe manufacturer
engineers developed
manufacturing revisions to the
low-dose syringes that will solve
the dosing accuracy obstacle.
These revisions are pending FDA
approval, but are expected to be
adopted by the manufacturing
community.
For patients who tube feed
blenderized foods, successful
feeding through the ENFit
connectors may be variable
depending on ingredients used
and blender quality. GEDSA is
looking to healthcare providers to
recommend blenderized recipes
that will ensure more consistent
success in infusion, while
providing optimal nutrition intake.
For patients who use their
G-tubes for venting, the new
ENfit design presents some
challenges. More feedback to
the manufacturers is needed
from consumers, clinicians and
caregivers. The biggest concern
revolves around patients who eat
food in addition to their G-tube
feedings and require venting or
draining of gastric contents. It
was acknowledged at the Oley
Foundation Global ENFit Summit
in Atlanta, GA in December 2015
that this is currently a challenge
that may not be made easier
with the ENFit design standard
implementation.
The next several months and years will be an adjustment
period for manufacturers, suppliers, and consumers alike as
ENFit changes occur. However, the end result of reduced
misconnections and saved lives will make the transition to
ENFit worth any short-term challenges.
References
1. U.S. Food and Drug
Administration. “Information
for Manufacturers of SmallBore Connectors and Medical
Devices with Connectors.”
FDA website, accessed
July 28, 2015: http://www.
fda.gov/MedicalDevices/
Safety/AlertsandNotices/
TubingandLuerMisconnections/
ucm313322.htm
2. Pennsylvania Patient
Safety Advisory. “Tubing
Misconnections: Making
the Connection to Patient
Safety.” PA Patient Safety
Authority website, accessed
July 21, 2015: http://
patientsafetyauthority.
org/ADVISORIES/
AdvisoryLibrary/2010/Jun7(2)/
Pages/41.aspx
3. International Organization
for Standardization (ISO).
“Small-Bore Connectors
for Liquids and Gases in
Healthcare Applications.” ISO
website, accessed July 28,
2015: https://www.iso.org/obp/
ui/#iso:std:iso:80369:-20:ed1:v1:en
4. Global Enteral Device Supplier
Association (GEDSA).
“Welcome to GEDSA.” Global
Enteral Device Supplier
Association website, accessed
July 28, 2015: http://www.
gedsa.org/about.html
5. GEDSA. “Reducing the Risk
of Medical Device Tubing
Misconnections.” Stay
Connected 2015 website,
accessed July 21, 2015: http://
www.stayconnected.org/
gedsa-news
6. Dewhurst Evi. “Enteral
Connections: Safety
Initiatives.” Medela Neonatal
Perspectives blog, accessed
March 17, 2015: http://
blog.neonatalperspectives.
com/2015/05/14/enteralconnections-safety-initiatives
19
AdvocacyCorner
Don and Jerry were both diagnosed with Crohn’s
disease* in the 1960s and started PN at home
because they ran out of options. They had both been
through surgeries to remove large sections of bowel
that had been ravaged by the disease. At that time,
there were few drugs available to treat Crohn’s.
“The only thing I could picture was a big IV pole, big
pump, and being tied to it,” Jerry said. “I didn’t want
to do it. But back then I didn’t have a choice.” Both
Don and Jerry remember when infusion companies
didn’t exist. They mixed their own formula and picked
up supplies from hospitals.
Don’s Story
By Michael Medwar, Nourish Patient Advocate
Look Back on
the “Old Days” of
Parenteral Nutrition
By Michael Medwar, Nutrition Patient Advocate
While we’re looking forward in this
issue of Celebrate Life, it’s also a
good time to look back at early days
of parenteral nutrition (PN) and how
nutrition therapy has evolved. We tend
to remember “the good old days.”
But the old days of nutrition therapy
weren’t necessarily good... and they
were certainly more complicated.
Just ask Coram patients Don Young
and Jerry Fickle.
20 | Celebrate Life | May 2016 | Issue 37
Don Young, a resident of upstate New York, is one of
the pioneers of home nutrition therapy. He hooked up
his IV for the first time on March 18, 1975. In those
early days, he picked up supplies every two weeks
from the hospital. He mixed his own formula because
he felt that the infection rate was lower than when it
was mixed in the home versus in the hospital.
Don recently told me that he still believes that
nutrition therapy made its biggest leap forward
around 1980. This is when the first home infusion
companies opened for business. Home companies
took care of mixing PN and delivering it along with
supplies to his home. “The introduction of home care
companies made a positive difference because they
take care of an area where most people don’t have
any expertise,” Don said. “And they helped handle the
“dirty work” such as securing third-party
insurance coverage.”
When Don marked his 40th anniversary on PN in
March 2015, I interviewed him on our Consumer
Connect Call about his experiences. (Hear the audio
of Don’s interview at www.wenourish.com.)
On the call, he compared the prospect of going on
PN to a scene in the classic film, Butch Cassidy and
the Sundance Kid. Outlaws played by Paul Newman
and Robert Redford are arguing over whether they
should escape by jumping off a cliff into a river.
The Sundance Kid admits he doesn’t want to jump
because he can’t swim. Cassidy laughs and says,
“Are you crazy? The fall will probably kill you.”
Don said he remembers when
lipids were introduced, not long
after he began home therapy. He
asked his nutrition team about the
milky-looking substance… what
was it? He was told it was fats
— soybean oil and egg whites.
Because it was not yet approved
for sale in the United States, it
came from Sweden. Back then,
lipids had to be infused separately
from PN. It wasn’t until years later
that “3-in-1” IV bags came along.
And dressings? Don covered his
catheter site with gauze and tape.
“We did things very differently
back then,” he said. “We changed
the dressing every day.”
Jerry’s Story
Jerry Fickle’s anniversary date
is June 28, 1981 — he is getting
ready to mark 35 years on PN.
The Indiana resident said that
for the first four years he mixed
all of his PN at home. One of
the people who trained him at
the hospital was Jon Wolf, a
pharmacist back then, who
today works as a branch manager
for Coram in the Fort Wayne,
Indiana area.
“Jon would get everything ready
for me, and I would back the car
up and he would load up boxes of
supplies,” Jerry said.
Technology was rapidly improving
in the late 1980s, and in those
pre-internet days, the best place
to learn about the advancements
was through the Oley Foundation,
an education and support group
for people on nutrition therapy.
Jerry attended his first Oley
conference in Saratoga Springs,
in the late 1980s. Jerry said he
only knew two or three people
from his area who were fellow
PN consumers, so it was valuable
to attend conferences to gain
perspective from others on
therapy. “The first couple years,
it was amazing stuff you heard
at Oley about what was going
on,” Jerry said. “You look at
technology, and everything today
and it’s just amazing. You’d hear
other families talk about their
problems and think, ‘I’m not as
bad off as thought I was.’”
Both Jerry and Don said a big
factor in advancing quality of
life for PN patients was the Oley
Foundation. Don was an early
president of Oley.
Don said recently that there is still
room for improvement in PN. He
is still waiting for the development
of a “simple pump that’s userfriendly for the home patients.”
As Don recalls, “I’ve said many
times, the best pump I had was
the IMED 960.” This was a
heavy pump, about the size
of a car battery, which I also
remember well.
Michael’s Own Story
I had my first stint on home PN
in 1984, due to Crohn’s disease,
when I was age 14. I was mostly
on therapy until 2001. But unlike
Don and Jerry, I never had to mix
my formula at home or pick up
supplies at a hospital.
I do remember the IMED pump,
however. The IMED, used in
the 1980s, featured dials to set
the hourly infusion rate. For a
while, I actually had two of them,
because back then lipids needed
to be infused separately. What
was it like for someone my size
rolling two heavy IMEDs on a pole
on shag carpets? Let’s just say, “I
was going nowhere fast.”
But by the time I went to college
at the University of Rhode Island
in 1988, pumps were getting
smaller and 3-in-1 bags were
becoming common. And I was
grateful for that, because some
wise guy in the dorm kept pulling
the fire alarm in the middle of the
night, so I would need to roll the
IV pole out of the dorm with the
rest of the crowd. At least some
of them learned about PN while
we shivered in the cold.
I first saw a portable pump —
called a Provider One — in the
late 80s at an Oley conference. It
wasn’t too much bigger than my
Walkman that played cassettes.
It was exciting to see this new
technology. By my sophomore
year I had a portable pump with
a backpack.
The innovations throughout the
last 40 years, and those that
continue today, have made a
huge difference in the quality of
life for PN patients. I’m grateful
for the people who made those
advances possible and early
consumers like Don and Jerry
who paved the way.
*Glossary
• Crohn’s disease – A chronic
inflammatory disease that
affects the intestines.
21
Dr. Stanley Dudrick Overcame
Hurdles to Develop PN
By Michael Medwar, Nutrition Patient Advocate
I was lucky to be in
attendance during
Clinical Nutrition
Week (CNW) 2016 in
Austin, Texas, where
I received a history
lesson from Dr.
Stanley Dudrick, the
first president of the
American Society
for Parenteral and
Enteral Nutrition
(ASPEN), which
hosts CNW. He spoke during a session with other
former presidents of the group.
Dr. Dudrick’s research led to the development of
parenteral nutrition (PN) in 1968. But it was a difficult
road. Colleagues told him he was wasting his
time trying to develop a way to feed sick patients
intravenously. People would say, “Why are you
doing this? You’re throwing away your career.”
In the 1960s, Dr. Dudrick was chief resident in
general surgery at the Hospital of the University
of Pennsylvania (HUP). He first saw the need for
IV feeding when some of his patients survived
successful surgery but then succumbed because
they were unable to eat. “We couldn’t convince the
institutions that they were full of starving patients,” he
said. “But the dietitians and nurses really knew what
was going on.” They knew they had to do a better
job feeding patients, but they were in an “uncharted
jungle.” “We systematically had to invent virtually
everything,” Dr. Dudrick said.
He and colleague Dr. Ezra Steiger, a surgical intern at
HUP, were “tough and desperate,” Dr. Dudrick recalls.
Dr. Steiger is also a former ASPEN president and
a Coram HPEN Scientific Advisory Board member.
He helped Dr. Dudrick manage PN patients at the
Philadelphia VA and then at HUP. “The VA was
tough for us because of long hours and managing
PN patients while doing surgical residency,” Dr.
Steiger said. “For consecutive days we slept at the
VA. I developed leg edema up to my knees because
of long hours standing in the OR. The situation Dr.
22 | Celebrate Life | May 2016 | Issue 37
Dudrick called ‘tough and desperate’ was related to
caring for the first infant on PN without the availability
of fat emulsions (lipids), and also to the rigorous
schedule, continuing research and publications,
and being an active surgeon,” Dr. Steiger said.
Despite long hours, they stayed focused on their
goal, which early on, Dr. Dudrick said, was “to
provide optimal nutrition under all conditions at all
times.” That meant feeding patients no matter the
complications. But obstacles were always ahead,
starting with the problem of how to feed patients
through central venous access (a large blood vessel).
Dr. Dudrick’s mentor, surgical nutritionist Dr. Jonathan
Rhoads, and many others expressed concerns that
IV nutrition therapy would never be accepted if it had
to be given through a large vein. In addition to solving
how to do that, they also had to make additives for
solutions. “The idea you had to purify a solution
was from outer space,” Dr. Dudrick said. He meant
this literally, because the technology they used for
purifying a complex solution was adapted from the
NASA space program.
Dr. Dudrick showed that beagle puppies could thrive
on IV nutrition through a large vein. He experimented
on “200 to 300” of them, and noted that nearly all
were adopted when the experiments were over.
With all of his responsibilities, Dr. Dudrick eventually
realized that he needed help from dietitians, nurses,
and pharmacists to care for nutrition therapy patients.
“I remember saying to Dr. Rhoads, ‘I need a team’.”
That concept of a Nutrition Support Team thrives
today at Coram and around the country.
Dr. Dudrick says that nutrition support is
a work in progress, and that the work is
nowhere near finished. And neither is he.
“I’m 80 years old, and I’m still passionate,”
he says. Dr. Dudrick will receive a Lifetime
Achievement Award next year at CNW17
in Orlando.
Consumer Connect Nutrition Webinars
Join us for our next Consumer Connect nutrition presentation! This presentation
will be a live webinar and conference call. Coram’s Consumer Connect Nutrition
Series is a great way to learn about topics that affect nutrition consumers from
the comfort of your home or office.
Visit Our Website for Dates and Times
WeNourish.com/events
23
CelebrateLife
For Home TPN and Tube Feeding Patients
Consumer Contacts
Celebrate Life Magazine
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To submit stories, comments, and
suggestions for Celebrate Life, email
[email protected]
To reach a dedicated Consumer Advocate,
please call Michael Medwar at 508.254.3638
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slides from past programs, visit
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