IV Smart Pumps:
Human Factors
Considerations
KAREN K. GIULIANO, PHD, RN, FAAN
POSTDOCTORAL FELLOW
YALE SCHOOL OF NURSING
Disclosures

I am currently a postdoctoral fellow at Yale University,
studying in the area of IV infusion device safety from a
human factors perspective at the schools of nursing and
engineering

I am a former consultant/employee of Ivenix
Drug error reduction system
(DERS)

The implementation of IV
Smart pumps with drug libraries
and DERS (1997) lead to a
quantum leap in IV
medication infusion safety

There are numerous examples
in the literature that support
improved safety with the use of
DERS

However, even with the
availability of smart pumps with
DERS, serious and frequent
errors continue to occur
The fundamental question

Will the intended users of this medical
device:

be able to use it

with this user interface

and these accessories

after receiving this training

within these use environments

to achieve these results
Ron Kaye &Jay Crowley (2000). Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management.
The reality of programming

The delivery of a single dose of medication generally
involves 10 to 15 steps, each of which introduces an
opportunity for error

Although some programming automation exists, the vast
majority of smart pump programming is still completely
manual

For nurses, this often results in a clinical conundrum
because in too many cases, appropriate and timely
medication administration is literally a matter of life and
death
What does the process look
like?

The complexity of IV
medication
administration creates
a scenario that
demands close
attention to detail and
relies heavily on
human intervention to
detect and mitigate
errors
Pre-op set-up

The clinician at the point
of care, most often a
nurse, is accountable for
the final step of ensuring
that the correct IV
medication or infusion is
being delivered.
Manual programming within
DERS

There is no ability for smart pumps to detect a dosing error
that falls within the recommended infusion dosing


Even when the dosage isn’t correct for the patient to which the
medication is being administered
This is where current smart pump technology falls particularly
short

Infusion devices account for up to 35% of all medication errors
that result in significant harm
National Quality Forum. Critical paths for creating data platforms: patient safety: intravenous infusion pump devices.
http://www.qualityforum.org/Publications/2012/10/Critical_Paths_for_Creating_Data_Platforms__Patient_Safety__Intravenous_Inf
usion_Pump_Devices.aspx.; McAlearney, AS, Scheck A, Vrontos J, et al. Strategic workarounds to accommodate new
technology: the case of smart pumps in hospital care. J Patient Saf. 2007;3(2):75-81.
Adverse drug events

The majority of adverse drug events are related
to various aspects of incorrect programming
(NQF, 2012).

Incorrectly entering (or selecting from menus of) drug
names, doses/concentrations, rates, and drug
administration duration times (Keohane, Hayes, & Saniuk,
2005);

Bypassing the drug library, either accidentally or intentionally
(Rothschild, 2005)
Time & interruption

Interruption frequency observed during nurses'
medication administration tasks ranges from 0.8 to 41.8
events per hour

The severity of medication errors increases with the
frequency of interruption

Common sources of error

Overriding of dose error alerts

Using basic programming to bypass the smart pump’s drug
libraries and dose error reduction systems (DERS) completely
Biron, A. D., Loiselle, C. G., & Lavoie-Tremblay, M. (2009). Work interruptions and their contribution to
medication administration errors: An evidence review. Worldviews on Evidence-Based Nursing, 6(2), 70-86.
Westbrook, J. I., Coiera, E., Dunsmuir, W. T. M., Brown, B. M., Kelk, N., Paoloni, R., & Tran, C. (2010). The
impact of interruptions on clinical task completion. Quality & Safety in Health Care, 19(4), 284-289.
User study on programming:
nursing sample
Variable
Nursing experience (years)
Critical care experience
(years)
Number of hospital beds
Mean
17
12.3
316
Number of critical care beds
34
Length of time using any IV
Smart Pump (years)
7.8
Length of time using current
IV Smart Pump (years)
7.3
Programming tasks
1.
Change the rate on a running infusion
2.
Deliver an antibiotic as a secondary
infusion
3.
Deliver a weight-based infusion
4.
Titrate a weight-based infusion
5.
Deliver a Morphine infusion with a bolus
Differences across the 3 devices
Mean Programming Time (in seconds)
90
85.7
80
70
59.6
60
54
49.3
50
36.6
40
30
27.5
24.8
20
10
49.3
27
13.9
8.1
3.3
6.5
16.1
5.2
0
Task 1: Titrate a
running infusion
Task 2: Deliver an
antibiotic as a
secondary
Task 3: Deliver a
Task 4: Titrate a
Task 5: Deliver a
weight-based infusion weight-based infusion morphine infusion with
a bolus
Pump A
Pump B
Pump C
Use errors

Use error: defined as incorrect final programming
Percent (based on total
opportunities for error)
Pump A
Pump B
Pump C
7.5%
2.9%
1.33%
The environment of care

Improved clinical processes and changes in
workflow could help to address some of the
problems that contribute to IV medication
infusion errors
 Incorrect
 Mental
 The
clinical decisions
computation error
time it takes to program
 Interruptions
process
during the medication administration
The role of technology

Many of the fundamental issues will need to be addressed
through innovation and the development of new
technology


We need a simplified user interface
Overall, other known deficits in the technology must be
improved

Keystroke errors due to system complexity

The time it takes to program

Use errors related to the infusion device interface
Giuliano, KK & Niemi, C (2015). The urgent need for innovation in I.V. smart pumps. Nursing Management, 46(3):179. doi: 10.1097/01.NUMA.0000461066.79777.06.
Dr. Rory Jaffe
March 12, 2015
“People attempting to
do things correctly in a
broken system”
The value of human factors design
It is essential that IV infusion
pumps are able to adapt to the
clinical environment versus
requiring the environment to
adapt to the pumps