Tracy VonBriesen RN, BSN Sr. Manager Medical Affairs

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Nursing and Human Factors Collaboration Optimized Power Injection Indicator
Tracy VonBriesen RN, BSN
Sr. Manager Medical Affairs , Baxter Healthcare Corp
Angela Muriset
Principal Human Factors Engineer, Baxter Healthcare Corp
Abstract
During the development of new catheter extension sets, it was
necessary to provide a visual indicator on sets that can be used
during power injection. Human Factors and nursing collaborated
to evaluate four prototype indicators. Together with a review of the
literature regarding use of color coding and the risks of
misconnections, the results of the user evaluation informed the
manufacturer’s decision of which prototype indicator to implement
in the final design.
Background
The use of contrast media injections during CT-scans has
significantly increased in the United States, from approximately 18
million CT- scans performed in 1993 to greater than 70 million in
2007.1 Although CT–scans have proven to be a valuable tool to
help diagnose and manage diseases, they have inadvertently
increased risk to patients with vascular access devices.
To help prevent the mechanical failures of vascular access devices,
medical device manufacturers began to develop catheters and catheter
extension sets that could withstand the increased pressures seen
during injection of contrast media.
Currently, there is no standardized method to identify devices that
can be safely used during power injection.
Color coding is one method that manufacturers have used to identify
their devices as capable of withstanding power injection. However, this
can lead to confusion and risk for misconnections. So what can
manufacturers do instead?
The FDA issued a reminder about the potential for serious injury
related to the use of vascular access devices not designed to
withstand the high pressures exhibited during CT-scans and MRI
procedures2.
In order to develop an effective indicator for it’s newly developed
power-injectable catheter extension set, Baxter used a collaborative
approach, involving both nursing and human factors engineering.
Human factors engineering (HFE) is “the application of knowledge
about human capabilities (physical, sensory, emotional, and
intellectual) and limitations to the design and development of tools,
devices, systems, environments, and organizations…HFE involves the
use of behavioral science and engineering methodologies in support of
design and evaluation.”3 According to ANSI/AAMI HE75: 2009,
development of safe and effective medical devices relies upon the
application of human factors processes and principles.3
Reported adverse events included device ruptures of central
venous catheters, implanted ports, catheter extension sets, and
small peripheral catheters. Many of these ruptures resulted in:
• Required surgical intervention
• Loss of venous access
• Clinician exposure to blood and contrast media
Baxter’s approach to developing the power injection indicator on the
new catheter extension set was a collaborative approach. It consisted
of evaluations of prototypes with intended users and developing an
understanding for the risks associated with the product and the use
environment. The ability to apply human factors techniques, while
leveraging strong understanding of the clinical users and environment,
ultimately led to the successful indicator design.
Objectives
Table 1
The objectives of human factors engineering and nursing were to
develop an indicator that would allow the clinician to determine that
a catheter extension set can be used during CT and MRI scans
without the risk of ruptured tubing. The indicator needed to:
• Provide a message that is easily understood with little or no
training
• Remain with the device throughout the life cycle of the device
• Be able to be used hospital wide without increasing risk for
misconnection
Methods
In 2009 nursing and HFE met with CT technicians and nurses from
across the United States during a series of customer visits. The
clinicians were interviewed to evaluate their understanding of the
meaning of the indicators on four different power injectable catheter
extension set prototypes.
Following the customer visits, a literature search was completed to
evaluate if there were risks associated with any of the indicators that
were not mentioned by the clinicians that could increase the
potential for misconnections (i.e., connecting something other than
an IV system component to the devices).
Results
Prototype Evaluation
Seventeen clinicians (N=17) were interviewed individually or in
small group settings. Table 1 shows the clinicians’ responses
associated with each prototype. Overall, the clinicians preferred
prototype D: purple stripe along the tubing with 325psi/2241kPa
embossed on the clamp.
Nursing and Human Factors Collaboration Optimized Power Injection Indicator
Tracy VonBriesen RN, BSN
Sr. Manager Medical Affairs , Baxter Healthcare Corp
Angela Muriset
Principal Human Factors Engineer, Baxter Healthcare Corp
Table 1: Results of Prototype Evaluation
Prototype B:
Prototype A:
Printing of 325 psi/2241 kPa along
tubing- purple clamp
the
Favorable Response:
• Clinicians understood the significance of
the “325psi/2241kPa”
Printing of 325psi/2241kPa along the
tubing - 325psi/2241kPa embossed on
purple clamp
Prototype C:
Prototype D:
Purple stripe along the tubing- purple
clamp
Purple
stripe
along
the
tubing
325psi/2241kPa embossed on purple
clamp
Favorable Response:
Favorable Response:
• The majority of the clinicians associated
purple with power injection and the purple
was easily seen across the room
• The majority of the clinicians associated
purple with power injection and the purple
was easily seen across the room
Unfavorable Response:
• Like the text written on the clamp
• Clinicians may think there is blood or
medications left in the line
Unfavorable Response:
Favorable Response:
• Clinicians understood the significance of
the “325psi/2241kPa” writing on the clamp
and liked the printing located on the clamp
Unfavorable Response:
Unfavorable Response:
• Written text on the tubing was difficult to
see
• One clinician felt the text on the tubing and
slide clamp would require additional
education because patients would want to
know what it means
• One clinician thought the text on the clamp
was not necessary
• Would need education to what purple
means
• One clinician warns against using the
color purple alone as this may be confused
with other manufacturers who use different
colors
• One clinician felt the pressure rating
should be somewhere on the device
• Clinicians may think there is blood or
medications left in the line
• Once the clinician understands the text
on the clamp, they will rely on the color
purple to determine if the device is power
injectable
Nursing and Human Factors Collaboration Optimized Power Injection Indicator
Tracy VonBriesen RN, BSN
Sr. Manager Medical Affairs , Baxter Healthcare Corp
Angela Muriset
Principal Human Factors Engineer, Baxter Healthcare Corp
Literature Review
ISMP
In 2009, the Institute for Safe Medical Practices published
a medical safety alert stating that purple is not an official
standard for either enteral feeding equipment or PICC
lines. The alert highlighted a medication error when a
nurse infused oral KEPPRA (levetiracetam) into the
patient’s vascular system via a power injectable PICC.
The color purple may have played a role in the nurse
incorrectly identifying the route of administration :4
ISMP warns against the use of color coding in medical
devices due to:5
• Poor memory recall for color
• Potential confusion with other medical devices with
similar color
• Potential to misperceive color due to dark hospital rooms
or colored medications may change the appearance of the
medical device
• Potential to instill a false sense of security without tracing
lines.
Figure 1
Infusion Nurses Society
2011 Standards of Practice
Standard 17:
Verification of Products and
Medications, INS warns against the use of color
coding as well:
“Practice Criteria A: The nurse should not use
color coding, color differentiation, or color
matching for product or medication identification.
Color coding can lead users to rely on the color
coding
rather than ensuring a clear
understanding of which tubing and catheters are
connected.” 6
The Joint Commission
In 2006, The Joint Commission published a
Sentinel Event Alert related to misconnections
of medical devices in the clinical setting.7 The
medical devices included central venous
catheters, feeding tubes, peritoneal dialysis
catheters, blood pressure insufflator tubes and
tracheostomy cuffs. Risk factors associated
with the misconnections include patients
moving from one clinical area to another and
healthcare worker fatigue. 7
Although the use of color coding is intended to
aid the clinician to identify different tubes and
catheters, The Joint Commission warns against
using color coding:
“This can lead users to rely on the color coding
rather than assuring a clear understanding of
which tubes and catheters are connected
correctly to which body inlets. In addition, the
training and educating of all staff (including
temporary agency and travel staff) about the
institution’s color-coding system requires
continuing attention. Finally, color-coding
schemes often vary across institutions in the
same community, creating increased risk when
agency and travel staff are used” .7
Nursing and Human Factors Collaboration Optimized Power Injection Indicator
Tracy VonBriesen RN, BSN
Sr. Manager Medical Affairs , Baxter Healthcare Corp
Angela Muriset
Principal Human Factors Engineer, Baxter Healthcare Corp
Conclusions
References
Input from the clinicians during the prototype evaluation demonstrated that
most clinicians associated the color purple with power injector
compatibility. Clinicians all understood that the terminology “325psi / 2241
kPa” identified the extension sets as power injectable compatible. While
clinicians had preferences among the four prototypes and offered
suggested improvements, all four prototypes were acceptable in terms of
meeting the intended users’ needs surrounding identification as power
injectable compatible.
1. Sarma, Asha, et al. "Radiation and Chest CT Scan Examinations Radiation
Knowing that all four prototypes would be acceptable to the intended user,
nursing and HFE turned to the literature review to guide the selection of
the final concept. The development team determined that even though the
clinicians associated the color purple with power injectable compatibility, it
should be eliminated from the device so that the indicator used for
CT/MRI procedures would not inadvertently lead to misconnections in
other areas of the hospital. The team selected prototype B with “325psi /
2241 kPa” written along the tubing, and chose to enhance the font for
improved legibility while maintaining visualization of the fluid path. The
clamp is embossed with “325 psi/2241 kPa” and the color of the clamp
was changed from purple to white, thus removing the risk for
misconnections associated with color.
3. ANSI/AAMI HE75: 2009. "Human factors engineering-Design of medical
A collaborative human factors approach entails more than just developing
the product that a user states he, or she prefers. In this instance, data
was collected from 17 intended users in a way that allowed the
development team to understand their needs and the constraints of their
workflow and environment. Once this understanding was cultivated, the
solution could be developed in a way that would meet user needs and
also minimize risks that had been identified analytically through the
literature review. The balance of methods and collaborative participation
of nursing, human factors engineering and end users led to the successful
development of the final product.
7. “Sentinel Event Alert: Tubing Misconnections—a Persistent and
and Chest CT Scan Examinations What Do We Know?." CHEST Journal
142.3 (2012): 750-760.
2. "Reminders from FDA Regarding Ruptured Vascular Access Devices from
Power Injection." Www.FDA.gov. U.S. Food and Drug Administration, 21
Mar. 2013. Web. 17 Mar. 2014.
devices.”
4. Alert, ISMP Medication Safety. “Acute Care" Purple is not an official
standard for either enteral feeding equipment or PICC lines 14.11 (2009):
2.
5. Alert, ISMP Medication Safety. “Acute Care" Will color-tinted IV tubing
help? July 30, 2009.
6. Infusion Nurses Society (INS): Infusion nursing standards of practice, J
Infus Nurs 34 (suppl 1S):S1-S110, 2011
Potentially Deadly Occurrence." Www.jointcomission.org. The Joint
Commission, 3 Apr. 2006. Web. 17 Mar. 2014.
Baxter is a registered trademark of Baxter International Inc. Any other
trademarks, product brands or images referenced herein are the property
of their respective owners.
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