1. October 7, 2013
Response to Health Quality Ontario (HQO) Health Technology Assessment Series;
Vol. 13: No. TBA, pp. 1–143, September 2013 - Multiple Intravenous Infusions Phase 2a Survey and
Study
Dear Ontario Health Technology Advisory Committee (OHTAC):
Thank you for the opportunity to submit comments related to your survey and study, Multiple Intravenous
Infusions Phase 2a.
Introduction – The Ontario survey and study correctly explains how ICU wards are complex, high stress work
environments, where nurses care for critically ill patients who are connected to numerous cables, tubes and IV
lines.
Critical care nurses are tasked with the ultimate responsibility –
keeping the critically ill alive. ICU nurses face very high workloads
caring for multiple patients with immediate life-threatening
problems. ICU patients require continuous complex monitoring and
rapid assessment. Nurses are also caring for for multiple patients.
Now take into account that ICU nurses administer the most potent
(high-risk) intravenous therapies. It is not uncommon for ICU
patients to have as many as 20+ medications infusing
simultaneously.
Speed and accuracy count in the ICU when valuable seconds are
at stake for critically ill patients who’re at high risk for life-
threatening situations. The more critical a patient is, the more life-
threatened, unstable and complex the patients’ condition is,
requiring more therapies, more interventions, more monitoring, all
using cables, wires and tubing to keep a patient hemodynamically
stable, i.e. alive.
The ICU environment is filled with numerous types of plastic tubing,
lines and cables all connecting to assorted medical devices
surrounding and connected to patients. With so many connections
simultaneously critical mistakes are made, harm is done and
sometimes patients are killed. It is every nurse’s worst nightmare to
make a critical mistake that harms a patient.
In April 2006, The Joint Commission issued a Sentinel Event Alert
entitled "Tubing Misconnections - A Persistent And Potentially
Deadly Occurrence" that offered strategies for healthcare
organizations to reduce risk and called upon manufacturers to
redesign products to prevent misconnections.
http://www.jointcommission.org/assets/1/18/SEA_36.PDF
JCAHO pointed to the large quantities of mistakes due too many
look-alike IV lines, similar plastic tubing including enteral,
nasogastric, intrathecal and other look-alike tubes. In the ICU there
are assorted tubes to administer oxygen via mask or cannula.
Additional tubes administer IV fluids through assorted infusion
pumps connected to different insertion sites on the patient.
Figure 1 Nurse trying to differentiate,
"Clear, Identical, Look-Alike Lines"
Figure 2 Note numerous medications in
use in the ICU

2. For example, there are tubes that deliver nutritional feedings via one tube either through the nose or directly to the
stomach; then there are different sets of wires and lines that monitor blood pressure and other monitoring
devices. All of these tubes and lines combined pose a significant risk of tubing misconnections especially in the
busy ICU environment where nurse shortages, work stress, fatigue, distractions, alarm overload and tangled clear
identical IV lines are commonplace.
Experts Recommendations For IV Lines, Connectors and Cables -
In 2006 ECRI published an article Preventing Misconnections of Lines and Cables
https://www.ecri.org/Documents/Patient_Safety_Center/Preventing_Misconnections_of_Lines_and_Cables.pdf
According to ECRI the single most important work practice solution for clinicians is to trace all lines back to their
origin before connecting or disconnecting any devices or infusions.
In May of 2007 The Joint Commission and World Health Organization collaborated to issue a report, “Avoiding
Catheter and Tubing Misconnections.” Tubing and catheter misconnections can lead to wrong route medication
errors and result in serious injury or death to the patient. Though many of these errors are preventable and could
be averted, multiple reports of patient injury and death from wrong route, wrong line medication errors indicate
that they occur with alarming frequency.
ECRI’s report made the suggestion that colour coding of tubing and connections should be standardized. The
European standardization body has studied the colour coding of tubing and connectors in certain applications.
http://www.who.int/patientsafety/solutions/patientsafety/PS-Solution7.pdf
ColorSafe
IV
Lines®
Specific
Comments
To
The
Survey
Draft
–
ColorSafe IV Lines® would first like to point out and discuss specific comments collected from the 64 respondents
in the Survey on referenced pages in the Draft document.
Ontario Health Technology
Phase 2a, Ontario Survey
Multiple Intravenous Infusions
IV Tubing Labeling – Labeling of Plain Lines.
Ontario Survey responses varied with regard to standardization involving IV tubing labeling practices.
Ontario Survey respondents indicated their hospital’s work practices required “some” or sometimes “all” IV tubing
to be labeled, however the specifics of which labels and where they’re applied varied from institution to institution.
The survey results suggested that emergency medication lines are not always being labeled on a consistent basis
and other plain IV lines are also too often not labeled. This presents the potential for confusion when a plain IV
line is required immediately for emergency IV pushes, fluid boluses.
The Ontario Survey makes these references to the use of “colour”:
Page 41: Respondents suggested that coloured labels be used for high-alert medications.
Page 44: The 2 units that labeled plain IV lines differently indicated that they used a different colour. These two
units were an Oncology Unit and an Emergency Department. The respondent from the Oncology Unit indicated
that the use of colour was used for chemotherapy drug lines.
Page 75: Comments related to the setup, labeling and identification of IV infusions.
Colour coded IV tubing may be helpful for high-risk medications.

3. Page 77: Comments from respondents touched on structural or organizational issues that may benefit from future
work. References to specific tools or resources that may be helpful in clinical environments (e.g., rake pole tops
for IV poles to separate IV bags, pump resource nurses, colour coded lines, diagrams of IV setup).
ColorSafe IV Lines® opinion of the Ontario Survey is that many of the Survey’s 64 respondents indicated that
coloured labels “could” or “would” help them to distinguish look-alike medication bags, IV pumps, IV lines and
catheters from one another; especially for high-risk medications.
Colour
Coding
of
Medications
–
There has been support for the use of colour coding for high risk medications. There is strong empirical evidence
showing that colour has worked to improve patient safety. A study conducted in Israel about applying colour-
coding labels to medications with matching coloured labels on lines and pumps by Nurit Porat, Hadassah
University Medical Center, Ein Kerem, PO Box 12000, Jerusalem 91120, Israel; nuritp@hadassah.org.il
Use Of Colour-Coded Labels For Intravenous High-Risk Medications And Lines To Improve Patient Safety.
Conducted at Hadassah University Medical Center, Jerusalem, Israel in cooperation with The Cognitive
Technologies Laboratory, University of Chicago, Chicago, Illinois, USA. Porat's study defined the list of the
highest-risk IV drugs and lines requiring labeling. Within every pharmacological class, each drug had its individual
colour and design. It was decided that the name of each drug would be printed on three different types of labels,
one for each site on the IV drug system:
(1) IV bag or syringe
(2) IV line
(3) syringe pump: adult and pediatric
The labels for the IV bags and syringes also included a space to fill in the medication dosage and the name of the
dilution and its volume.
The purpose of this study was to determine if colour-coding drugs and IV line labeling improved patient safety and
medical staff efficiency.
Hadassah
University
Medical
Center
Study
Results:
Ninety-three percent (57/61) of the participants preferred the new Colour-Coded Labels. Specific labels for high-
risk intravenous medications successfully reduced errors and allowed nurses to identify infusions more efficiently.
The study concluded that another further study could provide support to administrative personnel for changing to
a new method to reap documented evidence of patient safety and efficiency benefits despite some moderate cost
increases. Because of the limited empirical literature regarding colour-coded labels and patient safety, additional
research in the field was recommended.
To see the Porat’s study: http://www.ctlab.org/documents/use of colour-coded labels for intravenous high-risk
medications and lines to improve patient safety.pdf
ColorSafe IV Lines® would like to highlight that Ontario Survey Respondents suggested colour-coding, coloured
labels, coloured lines during the survey. Based upon the Ontario Survey responses, combined with clinical
evidence from Porat’s Hadassah University Study in Israel, and in addition the ASA recommendations and ASTM
standards, ColorSafe IV Lines® unequivocally maintains that the use of colour-tinted IV lines requires a formal
clinical study in a lab simulation experiment in an intensive care unit to assess how the use of colour-tinted IV
lines can help nurses trace multiple IV lines. Colour-tinted lines will provide an easier and clearer linkage to which
line is delivering which medication, through which pump, and through the correct route to the patient.

4. ColorSafe
IV
Lines®
Concerns
About
the
Ontario
Study
Ontario Health Technology
Phase 2a, Ontario Study
Multiple Intravenous Infusions
The Study Draft document references colour on several pages:
Page 20: Some nurses may refer to these ports by port colour (e.g., the distal port is the brown port), but these
colours are not standardized.
Page 35: IV tubing and pump mix-ups (physical errors): Nurses can mistakenly identify the wrong IV tubing to
insert into a pump. That is, a physical error can occur in identifying the IV container or tubing due to the high level
of similarity between IV containers and tubing, clear and colourless fluids)
See Page 55: Lack of visual information regarding an infusion (e.g., contents) along its pathway, Most IV infusion
components look the same e.g. high level of similarity between IV containers and tubing since they usually
contain clear and colourless fluids) and thus there can be a lack of clear differentiation between infusions.
Page 57: Specifically, the following ideas have been suggested and are further discussed below: colour tinted IV
tubing.
“Colour Tinted Tubing”
“Colour tinted IV tubing has been suggested to help minimize infusion identification errors
and is commercially available. This type of tubing is offered on gravity and secondary IV
tubing in a variety of colours, including red, blue, green, purple and orange. Colour tinted
tubing has the potential to help clinicians distinguish infusions and visually trace infusion
pathways. In addition, colour tinted tubing avoids some known problems with using
adhesive labels, such as adherence and timely removal. However, ISMP has cautioned
that there is a lack of evidence regarding colour coding to prevent medication
identification errors. Furthermore, ISMP has identified numerous concerns and risks with
using colour that have led to harmful consequences.”
“Key concerns with colour tinted IV tubing include the following:”
“Colour memory: Humans have poor colour memory, particularly similar shades (e.g.,
violet, blue) and thus, there is a limit to how many colours (and their associated meaning)
can be remembered, limiting the scope of a colour-coding scheme.”
ColorSafe IV Lines® Comment:
“Colour should never ever be used as a primary identifier. Colour can be used as
a visual aid, adding another safety layer to help distinguish clear, identical IV
tubing and to help in careful tracing of an IV line from its medication bag through
its infusion pump all the way to the catheter insertion end.”

5. “Colour mix-ups: Colour tinted tubing can potentially be mixed up with other colours used in health care (e.g.,
yellow tinted tubing may be confused for yellow striped epidural tubing) or the tubing colour may be altered by the
infusate colour (e.g., a red drug may give blue tubing a purple tint).”
ColorSafe IV Lines® Comment:
“Colour-tinted IV Lines always include a clear section to visually inspect the
medication for turbidity / sediment. All medication labels must always be checked
and rechecked several times before administering any medication.”
ColorSafe IV Lines use a Clear Drip Chamber so
nurses can check medication for color, sediment or
turbidity. Colour-tinted tubing is matched to same colour
labels using a Pantone Color Identifier Charts.
Figure 3 IV Line Spaghetti - ICU Nurses Must Trace IV Lines.
Note White Hand-Written Labels Indicating Vasoactive Drugs
Figure 4 ColorSafe IV Lines

6. “Colour-tinted IV lines may not match with colour-coded labels, leading to confusion.
Furthermore, clinicians may select the wrong tinted tubing, both unintentionally (i.e., in error) and intentionally
(e. g., insufficient inventory of a desired colour).”
ColorSafe IV Lines® Comment:
“The hospital and departments within the hospital along with the hospital leaders,
pharmacists, risk management and the nurses that are actually using the tubing
must dictate the color assigned to a medication. Refer to the ASTM D4774 as a
representative color-scheme. Upon adopting a standard the hospital pharmacists
would prepare the medication bag and label it with the hospital accepted color
label. The hospital pharmacy sends the colored bag and same color line kit to the
department to administer to a patient; the nurse hanging the medication will spike
the bag with the color tube that matches the label. If a nurse tried to spike a
medication bag with a different colored IV line kit it would be more noticeable that
it would be wrong. Nurses hanging a new IV bags will look at the label and hang
it on the same color tubing. In every instance medication bags will ALWAYS be
labeled with the medication it contains.”
“Colour misperceptions:
Some staff may exhibit colour
blindness. Poor lighting may also
contribute to the misperception of
colour.”
ColorSafe IV Lines® Comment:
“Total color blindness is extremely
rare. In the U.S., red-green color
blindness affects 7% of the male
population and 0.4% of the female
population. All color blind nurses
rely daily on their ability to carefully
read medication labels. As it stands
today all nurses are working as if
they’re all color blind, since all
current IV lines are clear, look-alike
and are identical. When colored
lines are used color blind nurses will
still be carefully reading the labels
on the medication bag as is done
currently.”
Figure 5 ASTM D4774 and ISO 26825:2008 Color-codes for Injectable Medications

7. “Lack of colour standardization: There is no established and universal medication colour scheme in health care.
Colours used between clinical units, hospitals, or vendors are often different and can have very different meaning.
As such, colour coding is generally considered error prone. Thus, coloured IV tubing may lead users to rely on
colour to identify an infusion rather than tracing infusions to confirm infusion contents (on IV container label) and
connections.”
ColorSafe IV Lines® Comment:
“The STUDY indicates that there are no universal color schemes. However
there are existing standards that color-code injectable drugs ASTM D4774 and
ISO 26825:2008. There has been considerable work in standardizing colour
coding of high-risk medications. In October 2004 the American Society of
Anesthesiologists (ASA) adopted a formal “Statement on the Labeling of
Pharmaceuticals for Use in Anesthesiology”, supporting the use of five
cumulative methods of enhancing the impact of labeling on patient safety,
consistent with standards established by the American Society for Testing and
Materials International (ASTM). The ASA stated, “Colour-coding can help with
drug classification but prominently printing the drug’s name, concentration and
volume or total contents is the most important method of ensuring that users will
accurately identify the specific medications.1
”
”… IV tubing may lead users to rely on colour to identify an infusion rather than tracing infusions to confirm
infusion contents (on IV container label) and connections. Given these, and other issues, the Joint Commission
cautions that colour coding of IV tubing may have unintended consequences and the Infusion Nursing Society
and the Royal College of Nursing recommend that nurses should not use colour coding, colour for differentiation,
or colour matching for product or medication identification. As such, colour tinted IV tubing was excluded from
further investigation in this research."
ColorSafe IV Lines® Comment:
“Colour tinted IV tubing should not have excluded from the Study solely on the fact that it
is not standardized. There are very few medical devices in hospitals that are
standardized. Infusion pumps are not always standardized even within the same
hospital and certainly not between hospitals. Countless infusion pumps have been
recalled for being inaccurate and not standardized, yet hospitals continue to use them.
Should hospitals stop using infusion pumps and start counting infusion drops just
because they are not standardized? Color tinted IV tubing is a visual aid to help nurses
distinguish clear identical lines from one another from each other will help improve
safety. Many mistakes are made BECAUSE things look too much alike, especially
during an emergency.”
1
To see the ASA Letter: http://www.fda.gov/ohrms/dockets/dockets/05n0036/05N-0036_emc-000009-01.pdf
The ASTM colour-coding system for syringes containing medications used during an anesthetic identifies the class of drug
(induction agents, muscle relaxants, vasopressors, etc.). Many anesthesiologists believe that colour-coding on anesthesia
syringes and ampoules may lower the number of errors occurring in operating rooms. The American Society of
Anesthesiologists along with other agencies, are combining strategies to reduce errors with high-risk medications.
To see ASTM D4774: http://www.astm.org/Standards/D4774.htm

8. ColorSafe IV Lines® would point out that JCAHO, WHO, ECRI ISMP, NIH have all pushed to make different
medication ampules and vials in distinctly different sizes, colors, fonts, letter heights and have also recommend
that their placement within a setting be separated to help prevent medication errors. We believe that more errors
are made when everything looks similar and identical. To date there has never been a clinical study, but
thousands of nurses’ support using colour-tinted IV lines, and agree that colour tinted IV lines will likely reduce
medication errors. We believe that it would be inaccurate to pass judgment without further testing.
ISMP has supported different types of uses for colour –
Please reference this statement by Michael R. Cohen, RPh, MS, DSc, and President of the Institute for Safe
Medication Practices about color-coding.
"It is important to point out the difference between color coding, color differentiation, and user-applied versus
commercially-applied color cues. Color-coding as a systematic application of color to identify specific products.
Color differentiation entails use of color to make certain features stand out or to help with identifying items, but the
color itself has no specific meaning (it's not a code for something) and is not necessarily applied in the same
consistent way as it is with color coding. Color differentiation is another story. Depending on how it is applied
commercially, it can be an aid to reducing errors and I've recommended it many times for commercial use."
http://www.ihi.org/IHI/Topics/PatientSafety/MedicationSystems/ImprovementStoriesColorCodingBestPract
icesforLabelingofIntravenousLinesforPatientswithMultipleSimultaneous+nfusions.htm
ColorSafe IV Lines stance is currently there is insufficient information and no available clinical evidence to
suggest that colour-tinted IV lines are not an effective tool to help prevent IV line errors. We further assert that use
of colour-tinted IV lines with corresponding coloured labels for the medication bag, pump and distal end will
improve patient safety.
Figure 6 Numerous IV Lines Twisted and Tangled Figure 8 ColorSafe IV Lines exhibiting at Infusion Nurse Society

9.
ICU
Nurses
Support
Use
Of
Colour-­‐tinted
lines
–
ColorSafe IV Lines® were developed by IV nurses with more than 50 years of combined
experience administering infusion therapies. ColorSafe IV Lines® has collected opinions of
thousands of nurses who were shown colour-tinted IV Lines at ICU nursing trade events. There
is tremendous support for colour-tinted IV Lines to help them perform their work more easily,
they commented that the colour served as a visual aid to help them manage their patients IV
lines.
Hospital ICU’s are becoming increasingly complex. Considering the shortage of nurses, the possibility of adverse
events in the delivery of intravenous administration of drugs has been continually problematic. The high demands
placed on nurses exceed their capacity to function without making errors. Errors in administering intravenous
medications are most of the time human errors. The more pressured the hospital environment the higher the risk
of medication error and harm to patients is highly increased.
ICU nurses who are working in the ICU departments are the experts. Please ask IV nurses; they’re the end-users
of IV lines and should be involved in helping to choose clear vs. colored to help identify and avoid potential patient
safety issues. As you’re well aware ICU cares for patients with life-threatening health conditions such as multi-
organ failure often surrounded by a nest of lines and wires attached to complicated invasive infusion and
monitoring devices. There is frequent administration of potent cardiac and vasoactive medications and it’s a very
stressful environment. ICU nurses are overloaded with too many patients due to ICU nurse shortages and budget
cutbacks. They’re spending too much time untangling IV line spaghetti.
Figure 7 - ICU Patient IV Medications Figure 8 - Complexity of Look-Alike IV lines
cables and tubing
With So Many IV Lines, Tubes, Cables Its No Wonder Nurses Struggle To Tell Them Apart –
It is a widely accepted fact that the risk of tubing misconnections increases as the number of parenteral, epidural,
and enteral lines attached to the patient increases.

10. Colour-tinted IV lines help nurses to distinguish the lines more easily and trace the coloured IV tubing from the
patient to the source bag with a similarly coloured label. The different colours are used only as a tool and the
colour and not intended as a primary identifier.
Colour-tinted lines help nurses to do their job more safely, more easily, with less stress and faster which surely
improves the overall quality of patient care.
Despite the current lack of standardization for color-coding as a safety strategy, when colour-tinted IV lines are
used as part of a multi-factorial system color-tinted lines will aid in preventing errors. Colour-tinted IV lines will be
effective but only when it’s combined as one of several strategies used to prevent IV line errors.
In summary the Ontario STUDY disqualified colour-tinted IV lines as a preventative measure without any testing
and without proof of their efficacy or lack of.
ColorSafe IV Lines® strenuously disagrees with the statement in the Study…“Institute for Safe Medication
Practices, Joint Commission and others have cautioned that colour coding of IV tubing may have unintended
consequences and the Infusion Nursing Society and the Royal College of Nursing recommend that nurses should
not use colour coding, color for differentiation, or color matching for product or medication identification. As such,
colour-tinted IV tubing was excluded from further investigation in this research.” This is stating opinion as fact.
THERE HAS NEVER BEEN ANY CLINICAL TESTS EVIDENCING BENEFITS OR RISKS USING COLOUR-
TINTED IV LINES – FURTHER INVESTIGATION IS REQUIRED AND A FORMAL STUDY MUST BE DONE.
It is unfair of the Study to condemn use of colour-tinted IV lines. As of this date there is no existing empirical
research examining the benefits or risks with use of colour-tinted IV lines; their potential to reduce adverse drug
events; helping nurses to trace lines more quickly with greater accuracy and improving patients’ total quality of
care. The Ontario STUDY Draft excluded Colour-tinted IV lines as, “potentially harmful and leading to unintended
consequences.” Where is the evidence showing that colour-tinted IV lines are harmful? Survey ICU nurses on the
frontlines caring for patients with 20+ lines infusing simultaneously.
ColorSafe IV Lines® suggests a high fidelity lab simulation experiment in an intensive care setting where ICU
nurses perform IV-related tasks with and without colour-tinted IV lines that have colour-matching labels for the
Medication bag, IV pump and line ends. Colour-tinted IV lines must be verified as a method to reduce the risks of
IV line mix-ups. The colour-tinted lines should prove helpful distinguishing different lines, cables and tubing when
delivering multiple IV infusions, further the coloured IV lines should improve ICU nurses speed and accuracy in
tracing and reconciling patients numerous infusion lines.
Colour-tinted IV lines must be properly investigated as a method to help prevent injuries and deaths from clear,
identical, look-alike IV lines. A lab simulation study must be conducted to analyze in detail the effect of using
colour-tinted IV lines on the accuracy of medication selection and efficiency in administration of multiple high-alert
medications.
We believe that use of colour-tinted IV lines will greatly improve Ontario’s health care system to provide superior
level of care by reducing IV Line mix-ups and helping nurses to perform their jobs more easily. Please consider
the possibility that coloured IV lines must be properly tested to determine if they’re a help or a hindrance.
Respectfully,
Evan Lipstein
Evan W. Lipstein
Marketing Manager
ColorSafe IV Lines®