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Cpsi uohi baxter paper submit- the prevention of infusion medication errorsx
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 1
RUNNING HEAD: WHAT DOES YOUR INFUSION PUMP DATA TELL YOU?
What does your IV Smart Pump Infusion Data tell you
about IV Clinical Practice and Patient Safety?
Tim Hoh, BScPhm, John Llaguno, RN, NMD, PhD, Nadia Mamer, BSc., MBA, Mauricio Rodriguez BASc., MBA., PMP.,
Department of Clinical Informatics, Baxter Healthcare, Canada
Bonnie Bowes, RN., BN., CCNC, Heather Sherrard RN., Timothy J. Zakutney, MHSc., PEng.
University of Ottawa Heart Institute, Canada.
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 2
SMART pumps can provide retrospective data which, when interpreted in collaboration with clinician
users, can provide valuable insight into IV medication practices, compliance with Dose Error Reduction
Software (DERS), resource utilization of infusion pumps, and intercepted medication errors and can assist
in the promotion of a culture of patient safety. An evaluation of the value the Colleague Infusion Pump
with GUARDIAN DERS brings to clinical practice at the University of Ottawa Heart Institute (UOHI) was
undertaken through the quantitative analysis of infusion pump data. Interpretation of these reports in
collaboration with nurses assisted in identifying various issues impacting best practice. Targeted
approaches to practice changes, protocol redesign and further education were identified.
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 3
Adverse events (AEs) result in 9,000 – 24,000 preventable deaths in Canada each year (1). Although
surgical procedures were found to be the most common type of AE in the Canadian Adverse Events Study,
the second most common AEs were associated with drug- or fluid-related events. Adverse drug events
(ADE) specifically focus on the delivery of medication to patients and represent a significant vulnerability
for patients in hospitalized settings. In addition, ADEs place a financial burden on the healthcare system
through an increased length of stay and the implementation of treatment plans to mitigate the injury (2,3).
In 2004, Health Canada issued a Notice to Hospitals warning of the risks associated with intravenous
infusion pumps. Between 1987 and 2003 Health Canada received reports of 425 separate incidents
involving infusion pumps. Of these 425 incidents, 23 resulted in deaths, 135 resulted in injury and 127
could have potentially led to injury or death. Of the 23 deaths, 20 were suspected to be the result of pump
technology or user error. All 135 injuries were attributed to pump technology or user error (4). As a result
of these findings, Health Canada recommended a number of safety steps to be implemented in healthcare to
protect against infusion device medication errors including the recommendation that hospitals use infusion
devices with safety features such as software that provide safeguards against dosing and infusion related
errors 5. These devices are commonly known as “SMART Pumps” (5). Upper and lower dosing limits are
developed in conjunction with hospital clinical and pharmaceutical protocols and programmed into the
pump (5). Should a clinician program an infusion medication dose outside of those limits considered safe,
the pump will alert the clinician to this potential error. The clinician may then choose to accept their choice
(since occasionally in clinical practice scenarios the dosing limits must be overridden) or they may
recognize a programming error and cancel the dose before the infusion has commenced.
The Canadian Adverse Events Study suggested that as many as 37% of adverse events (AE) in healthcare
are preventable (1). Other studies have shown preventable AE rates as high as 51% (6). Although most
patients who experienced and AE recovered, many experienced an increased length of stay in hospital or
temporary disability and a number of them died as a result of their injury (1). Costs have been estimated at
approximately $8,000.00 per ADE in the US (3, 6-8) and this estimate does not include the additional costs
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 4
associated with litigation, malpractice insurance premiums and injury related costs such as lost income or
It is reasonable to suggest that acuity levels in Canada are rising as the population ages. It is also
reasonable to suggest that complex infusion therapy usage will also rise creating a greater potential for
infusion errors (10). Nursing workforce shortages place additional burdens on clinicians who must do more
with less, increasing the potential for human error (11 - 13). Increasingly, those responsible for the delivery
of healthcare services understand that individual clinicians are rarely singularly responsible for an adverse
event rather, recognizing that the clinical environment is complex and many factors can contribute to errors
16. Within the context of a “just” environment, health care providers have been shown to be a reliable
source of information about the nature and conditions giving rise to medication errors (13, 15).
Escalating healthcare costs in Canada result in hospital administrators having to make difficult decisions
about resource allocation and infrastructure upgrading. Efficient use of current technology allows limited
funds to be redirected towards more pressing shortfalls. SMART pumps have been shown to intercept
potentially costly medication errors, thereby demonstrating their usefulness (2). One such device, Baxter’s
Colleague CXE with GUARDIAN Dose Error Reduction Software (DERS), was implemented throughout
the University of Ottawa Heart Institute (UOHI), in Ottawa, Ontario, Canada. The University of Ottawa
Heart Institute (UOHI) is Canada’s largest and foremost cardiovascular health centre dedicated to
understanding, treating and preventing heart disease. The UOHI has three clinical floors (116 beds)
offering specialized cardiac care, including cardiac life support, a 90,000-square foot Research Centre, a
Prevention and Rehabilitation Centre, a Diagnostic Centre, and the Cardiac Reference Centre. The Institute
serves more than 1.5 million residents from Eastern and Northern Ontario, and Western Quebec, and has
the largest artificial heart program in Canada (17).
This paper provides an overview of the efficacy of Baxter’s Colleague CXE with GUARDIAN DERS in
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 5
In August, 2007, data from 199 Baxter Colleague CXE infusion pumps at the UOHI was downloaded,
representing 73.4 hours, or approximately 3 days, of infusion pump activity. Several quantitative reports
were generated from this data including:
1. Unit specific medication error intercepts
2. Medication error intercepts and associated time of day
3. Unit specific data of infusion starts using dose error reduction software
4. Management of high risk infusion medications
These reports were presented to UOHI Nurse Educators, Unit Managers and Biomedical Engineering
Services Department members for qualitative feedback. Individual interviews were conducted and
recorded. Additionally, 3 focus groups with end users were conducted in December 2007 and audio-
recorded. A total of 52 users participated in the focus groups. The reports were presented without
interpretation, and users were asked to interpret the findings and comment on their relevancy to clinical
practice and error prevention. Field notes were taken. Audio tapes were transcribed and coded to generate
themes. Correlation between themes generated by focus groups, individual interviews and group
The download of data from the 199 infusion pumps translates to approximately 3 days of typical pump
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 6
The COLLEAGUE GUARDIAN DERS feature allows clinicians to administer intravenous infusions
within the institution’s pre-defined safety limits. These safety limits are determined in collaboration with
Pharmacy, Medicine and Nursing and programmed into the GUARDIAN drug library. If the clinician
programs a drug infusion outside of the defined limits, an alert message provides the user with two options
a) Accept the dose that was entered (OVERRIDE
b) Cancel the dose that was entered and re-enter the correct dose (NEAR MISS
During the three-day time frame, 14 medication errors were intercepted through use of GUARDIAN.
Figure 1 demonstrates the drug type and dosage of medication errors that were intercepted.
Heparin 25000 units/250 mL
Nitroglycerin 50 mg/250 mL CCU
Nitroglycerin 50 mg/250 mL CSU
Norepinephrine 8 mg/250 mL
Vasopressin 100 units/100 mL
Figure 1: Drug Type and Dosage of Intercepted Errors This data was further stratified by time of day. Figure 2 demonstrates the chronogram illustrating specific
time of day when errors were intercepted.
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 7
Figure 2: Chronogram of Intercepted Errors Interpreting this data in conjunction with clinician users allowed for the examination of clinical practice
and other routine duties. For example, nurses commented that 09:00H was the time when they were
typically occupied with reporting activities and on rounds with Physicians, transcribing medications, etc.
11:30H was the time when the first group of nurses generally take their lunch break (and the remaining
nurses are particularly short staffed, busy and hungry!) and 19:00H was evening change of shift time for
“These are all “rushing times”….you know 9:00, we’re putting out our pills, orders are being done, 11:30 …well, here we are, we’re all rushing to go to first break….and 7:30 in the evening is change of shift and that can be really hectic with people coming and going.”
Clinicians were particularly surprised at the strong clustering of intercepted errors at these times. Although
they could quickly account for the intercepted errors in terms of what activities were taking place in the
clinical environment, they remained concerned that these times were resulting in such striking patient
“We’re surprised at what we’re seeing….people are tired…stuff happens, but the feature is working as it’s intended to… you can trust it…you don’t need to check the higher and lower limits….”
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 8
The GUARDIAN DERS captured 67 Overrides in the three-day time frame. The most commonly
overridden drugs are illustrated in Figure 3.
Figure 3: Most Commonly Overridden Drugs This information can be used to determine appropriateness of pre-set hospital protocols in light of current
practice, or alternatively, can be used to examine current practice in light of safe medication management
“We are always overriding ni-pride…it gets annoying for the patient…the limits don’t seem to be working for us.”
Interesting to note in this particular example that despite the perception that “We are always overriding ni-
pride…” in fact, nitroprusside was not a commonly overridden drug in these 3 days. The quantitative data
may also assist in supporting or refuting commonly held perceptions. Regardless, the collaboration
between nursing, pharmacy, medicine and industry suppliers to develop drug libraries that support best
clinical practice can only serve to improve patient safety.
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 9
In the three-day time frame, the majority of infusion starts were in “rate-volume” (that is, not started within
Figure 4: Infusion Start Methods The data downloaded provided unit specific information regarding clinical practice and usage of the
GUARDIAN safety system. This information, interpreted in conjunction with clinical practice common to
specific units, allowed for evaluation of the appropriate level of GUARDIAN usage per unit and assisted in
the identification of gaps in education. Clinical Nurse Educators commented that the quantitative data
provided by Baxter’s Clinical Informatics program had given them the evidence they needed to target
education for practice change within specific units. Figure 5 depicts the breakdown of infusion start
methods per unit. Hospital protocol dictates that high-risk medications should always be started within
GUARDIAN. Quantitative data combined with clinical observation suggested that this was not always the
case. Nurses confirmed this in the focus groups.
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 10
“I’ve known some people that once they’ve hit the rate sometimes they say “Forget It”…get out of it and just use rate volume because they don’t have time to fuss. It’s not OK….it’s asking for a mistake. Especially for heparin!”
Figure 5: Infusion Method Starts by Unit
Other = pumps that were located at a neighbouring hospital
The data provided by the Clinical Informatics download also provided insight into the management of infusion pump batteries. Figure 6 depicts the breakdown of discharged batteries by unit. Discharged batteries are less capable of maintaining their charge for the full capacity of the battery, thereby posing the risk of unanticipated cessation of infusion therapy to the patient. Fully charged batteries can be counted on to maintain infusion therapy during those times when the pump must run on battery, such as during some diagnostic tests or transport. Nursing users identified that simply plugging the pump in whenever possible can assist in maintaining the health (and safety) of infusion pump batteries. Highlighting areas with poor battery management practices allows for targeted education as well as additional review of biomedical maintenance programs. In some cases, there are insufficient and/or inaccessible plugs and this, too can be addressed with the specific data provided. “Sometimes you worry that you’ll injure your back trying to get at those plugs….and then we don’t want our patients opening up their sternotomy reaching under their bed for a plug!”
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 11
Figure 6: Breakdown of Discharged Batteries by Unit Finally, the reports provided information about infusion device utilization. When determining the number of infusion devices required by an institution, administrators must find the balance between providing sufficient devices for periods of high usage and ensuring that scarce healthcare dollars are not spent on unnecessary equipment. Figure 7 depicts UOHI’s infusion pump utilization. Of note, one of the days on which data was collected was a statutory holiday with lower patient volumes. Staff expressed satisfaction that sufficient pumps were available during higher usage times, thereby enhancing the provision of safer patient care. This information further provides clinicians and administrators with the opportunity to review their mix of both single and triple channel pumps, in light of their patient profile and demands for infusion therapy.
Figure 7: UOHI’s Infusion Pump Utilization The infrastructure required to support this technology is readily available in hospitals in Canada. A number of SMART pumps require wireless connectivity. However, older physical structures, remote areas and/or shrinking budgets often result in wireless connectivity not being an option and/or a priority in terms of spending. As a result the case could be made for utilizing SMART pumps that do not require wireless
What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 12
connectivity in these instances. Timothy Zakutney, UOHI’s Manager of Biomedical Engineering,
suggested, “Wireless connectivity to infusion pumps may be a great benefit to facilitate updating pharmacy profiles in
infusion pumps but should not be treat3ed as a prerequisite to implementing SMART pumps. The value of
this type of protective software in terms of reducing patient risk and improving patient care outweigh the
added value of wireless connectivity.”
Medication delivery errors add to the challenges of delivering healthcare in Canada. Since as many as 51%
of AE in healthcare are considered potentially preventable (1), it is incumbent upon healthcare providers and
administrators to investigate methods of reducing these avoidable errors. One approach involves
collaboration with industry providers to implement technology that can contribute to a safer Canadian
healthcare environment. SMART pumps are an easily implemented infusion system proven to intercept
medication errors before they can cause harm to the patient. In the 3 day time frame evaluated at UOHI, 14
medication errors were intercepted. If the average cost per ADE is estimated to be $8,000.00 (6), one can
easily see how a SMART pump system might quickly provide return on investment.
Initial evaluation by clinicians using the system indicates that clinicians recognize the value this system
brings to the clinical setting. Since the reports generated do not specify which individual clinician is
responsible for which intercepted error, clinicians felt that the Clinical Informatics reports could effectively
contribute to the promotion of a safer culture through targeting units or areas that require further education
rather than blaming individual clinicians. Discussions regarding potential practice and/or protocol changes
that can improve safety in infusion therapy further support a just culture through the inclusion of
practitioners in the development of strategies, a “grass-roots” approach to the reduction of adverse drug
Initial evaluation of Baxter’s Colleague CXE Infusion Device with GUARDIAN DERS indicates that
clinicians and administrators alike find value in the investment in terms of providing safer patient care and
promoting a culture of safety. Future directions include a follow up download of data from infusion pumps
to validate the efficacy of practice and protocol changes that have been implemented in response to the
feedback provided by the Baxter Clinical Informatics team with the goal of improving GUARDIAN
utilization in the practice setting.
Accreditation Canada (AC) has outlined Required Organizational Procedures (ROPs) for managing
medications. SMART pumps addresses ROP 21.0, “The organization has a coordinated risk management
program to reduce medication related errors and sentinel events”, 21.2, “The organization’s error
prevention strategies target the system, not the individual (emphasizing shared accountability)”, and 21.3,
“The organization uses a drug use evaluation (DUE) process for medications with heightened error
Baker, GR., Norton, PG, et al, the Canadian Adverse Events Study: the incidence of adverse
events among hospitalized patients in Canada. The Canadian Medical Assoc.Journal, 2004: 170(11); 1678 – 86.
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Classen, DC., Pestonik, SL., et al. Adverse drug events in hospitalized patients: excess length of
stay, extra costs and attributable mortality. Journal of American Medical Assoc., 1997: 277(4); 301 – 311.
Rodriguez- Monguio, R, et al. Assessing the economic impact of adverse drug effects.
Pharmacoeconomics, 2003: 21 (9); 623 - 650
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Wilson, K and Sullivan, M. Preventing medication errors with smart infusion technology.
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patients. Results of the Harvard Medical Practice Study I. New England Journal of Medicine, 1991: 324 (6); 370 - 7
Malashock, CM, Gould Shull, SS., et al. Effect of smart infusion pumps on the prevention of
potential medication errors resulting from the programming of infusion devices.Hospital Pharmacy, 2004: 39; 460 -9
Bates, DW., Spell, N., et al. The costs of adverse drug events in hospitalized patients. Journal of
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referral hospital. Joint Commission Journal of Quality Improvement 2000: 26 (10); 563-75
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or in hospitals. Health Reports,2008: 19
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Balas, MC, Scott, LD, et al. Frequency and type of errors and near errors reported by critical care
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What does your IV Smart Pump Infusion Data tell you about IV Clinical Practice and Patient Safety? 14
Glossary of Terms: A SMART pump is an infusion device, which includes both hardware and Dose Error Reduction software (DERS). Dose Error Reduction Software (DERS) is software integrated into the pump which allows clinicians to incorporate their best practice guidelines into infusion therapy through dosing limits. Adverse Event (AE) is an unintended injury or complication that results in disability at the time of discharge, death or prolonged hospital stay and that is caused by health care management rather than by the patient’s underlying disease process. (Canadian Adverse Events Study)
Adverse Drug Event (ADE) is any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient or consumer. Such events may be related to professional practice, health care products, procedures and systems including: prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use. (Institute for Safe Medication Practices)
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