OR Manager July 2022 - 22

OR Business
BY TARSILLA MOURA
Contrast media shortage reveals cracks in supply chain
ay 2022 saw a critical shortage
of the iodinated contrast
medium (ICM) iohexol that extended
well into June because of a COVID-19-related
shutdown of a GE Healthcare
plant in Shanghai, China, that
interrupted the manufacture of ICM.
According to the American College of
Radiology, contrast media were added
to the US Food and Drug Administration
(FDA) drug shortage list on May 9.
Contrast medium is used to confirm
accurate needle placement and injectate
delivery, and to exclude the flow
of medication into off-target tissue in
interventional pain procedures. Iohexol
has been unavailable or in limited supply
due to the shutdown, which led the
American Society of Regional Anesthesia
and Pain Medicine (ASRA Pain Medicine)
on May 23 to develop and publish
recommendations clinicians should
take during the shortage.
OR Manager discussed the implications
surrounding the shortage, as well
as the rapid response from a multidisciplinary
team, with anesthesiologist
and pain medicine physician David Dickerson,
MD, chair of the American Society
of Anesthesiologists' Committee on
Pain Medicine.
Background information
" The shutdown led to a significant supply
chain error where people were trying
to order their usual amount of stock
for their patients and were seeing that
their orders weren't being fulfilled, "
says Dickerson. " There are two different
types of contrast media: one, called
gadolinium, is for MRI [magnetic resonance
imaging] scans. Then there's iodinated
contrast media, or ICM, which
is used for CT [computed tomography]
scans. " CT scans are one of the most
common diagnostic imaging tests done
in the country, making ICM a critical
supply.
According to Dickerson, while ICM
is mostly used for CT scan purposes-
about 50 to 200 milliliters of the media
22
OR Manager | July 2022
M
per usage-it is also an
important component in
pain procedures, which
often end up being in
areas that have lots of
blood vessels. Specialties
including interventional
cardiology, interventional
vascular surmedication
shortages, " says Dickerson.
The groups collaborated to create a
summary document that:
1) notified clinicians about the shortage
David
Dickerson,
MD
gery,
and interventional radiology, use
ICM for various interventional therapies.
" We effectively want to make sure
the medicine is going to go around the
nerve area or into the epidural space
to the nerves in order to reduce the
inflammation in that area, " says Dickerson.
" When these procedures are done
with contrast, you see when you're in
a blood vessel and need to reposition
your needle. "
The amount needed for such usage
is a fraction of what is needed for a
CT scan, about 1 to 3 milliliters. However,
that can lead to wasteful practice,
says Dickerson. " When you're doing 20
to 30 procedures in the course of the
day, and you're using single-use vials,
you might be using 1 milliliter out of a
10 milliliter vial 20 times. That means
you're wasting 90% of the vial each
time. "
Then the shutdown happened, and
immediate guidance for alternative
usage was needed.
" For instance, we don't use gadolinium
contrast in pain procedures, "
Dickerson explains. " People who don't
recognize why that's the case might
say, 'Well, just use the other contrast.'
And that's dangerous. There's some
injury associated with gadolinium; it can
damage brain cells and cause significant
injury for patients. "
Multidisciplinary response
" When we saw the shortage was coming,
multiple pain medicine societies,
including spinal intervention societies,
came together in multidisciplinary working
groups to share information to do
with policy and procedure related to
2) listed ways for clinicians to save
existing supply of ICM for critical
use
3) guided clinicians to employ strategies
and techniques to get therapy
for patients or targeted delivery
of steroid or other medications to
the area of interest while avoiding
the need for contrast.
The shortage forced the delay of
many non-emergency exams. The goal
of quickly releasing guidance was to
help clinicians leverage all the ways
available to treat pain issues with procedures
that do not require contrast,
when possible, and create an awareness
of how to keep patients safe.
" Step one is to allocate and create
prioritization for patients and procedures
that really need to be done
during the shortage period, " Dickerson
explains. " Then step two is making sure
that we understand how not to harm
patients. We highlighted that we have
multiple approaches to targets, when
you should still use contrast and when
you can make do without contrast if you
know you will avoid a significant vascular
area. " For instance, the released
guidance says that transforaminal
epidurals in certain areas of the body
should still be performed with ICM, and
that gadolinium contrast agents should
not be used for spinal procedures.
Mitigating future shortages
The Shanghai factory is open and has
resumed production, says Dickerson.
" The challenge is not just learning to
adapt to a shortage like this, but really,
how do we prevent it from happening
again? "
" To have a nondiversified supply
chain puts so much at risk diagnostically
because of that CT scan need, "
he adds. " We need a process improvewww.ormanager.com
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OR Manager July 2022

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