Guidelines for Optimizing

Safe Implementation and Use

of Smart Infusion Pumps

www.ismp.org
TABLE OF CONTENTS

Introduction 3

Medication Errors Associated with

Smart Infusion Pump Use 6

Developing Consensus Guideline Statements 9

Summary of the ISMP Smart Infusion Pump

Survey Findings 11

Scope 13

Guidelines for Optimizing Safe Implementation

and Use of Smart Infusion Pumps 14

1. Infrastructure 14

2. Drug Library 17

3. Continuous Quality Improvement (CQI) Data 19

4. Clinical Workflow 21

5. Bi-directional Smart Infusion Pump

Interoperability with the EHR 23

Definitions 26

References 31

Summit Participants and Disclosure 34

Acknowledgments 36

About ISMP 38

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 2
INTRODUCTION

Smart Pump Technology

Almost 20 years ago, the introduction of smart infusion pumps with dose error-reduction
systems (ders) and associated drug libraries launched an era of dramatic improvements in intravenous
(IV) infusion safety.1-7 smart infusion pumps have allowed for a greater level of control, accuracy, and
precision with drug delivery, and are designed to provide users with decision support for programmed
doses and infusion rates in order to identify errors before medications or fluids are infused. Facility-
customized ders warn healthcare providers about potential prescribing, calculation, and programming
errors by generating alerts intended to prevent infusions from being programmed outside facility-
established limits. These limits can be either hard limits (which cannot be bypassed and prevent
users from starting the infusion as programmed) or soft limits (which provide a warning that an
entered parameter is outside of the anticipated range but will still allow users to start the infusion as
programmed once the alert has been acknowledged).3,8 smart pump drug libraries can be tailored to
reflect organizational practices and are typically subdivided into care areas/profiles configured for
different patient populations, specific care areas, or based on patient weight.3,9

Adoption of Smart Infusion Pumps

smart infusion pumps are now used in more than 80% of
US hospitals and are widely regarded as a standard of care to
reduce infusion-related medication errors.8,10 They are among
the most ubiquitous devices in healthcare.11 Their use includes
administration of continuous infusions, bolus dose and
loading dose infusions, intermittent infusions, patient-
controlled analgesia (PCA) and epidural infusions. smart pump
technology can also provide a great deal of data that is useful in improving safe practices, including
compliance with using the drug library, alert types and frequency, action taken in response to an alert
(e.g., reprogramming), and the frequency of overridden soft limits.4,6 The data can also help when
investigating pump-related errors and assist in identifying risky practices such as unnecessary nurse
dilution of IV medications.12 Wireless connectivity of smart pumps has been a significant technological
advance, allowing the potential for hundreds of pumps to connect to a single server within a health
system in order to facilitate the uploading of software revisions and the downloading of infusion data.1,3

Limitations of Smart Pump Technology

In their nearly two decades on the market, the widespread implementation of smart infusion pumps
has helped to: standardize infusion practices and drug concentrations, dose/ dose-rate nomenclature,
and dosing limits for IV medications and fluids; prevent potentially fatal under- and over-dosing while
documenting “good catches”; and provide a wealth of infusion data that can be used to improve
patient safety.1,13 Without diminishing their significant role in advancing infusion safety, in most
healthcare organizations, smart infusion pumps still operate in isolation, unable to interact with other
technologies available to maximize safety. For example, most smart pumps are not linked to available

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 3
barcode medication administration (BCMA) systems and are not assigned to a specific patient. They
do not directly communicate with the computerized prescriber order entry (CPOE) system or electronic
health record (EHR), so auto-programming of the pump from the prescriber’s order and auto-
documentation of the IV therapy in the EHR cannot occur. Thus, smart infusion pumps cannot
prevent wrong patient errors, incorrect ders library selections (as well as infusion line mix-ups), and
they are not designed to overcome frequent alert overrides or poor compliance with engaging the ders
library.1,3 Presently, most smart infusion pumps cannot record the reason for each override and are
unable to communicate alerts and the status of infusions in real time to another appropriate healthcare
provider who can act on the information.1 While smart pumps are capable of producing useful
information beyond basic compliance reports, many smart pump users are not collecting or analyzing
the data in meaningful ways to make improvements.4,9,10,14

Integrated Technology Systems

The wireless connectivity of smart pumps, barcode scanning, radio-frequency identification (RFID)
capabilities, and an industry-wide impetus to implement CPOE and EHRs have laid the foundation
for integration among these technologies that can elevate smart infusion pumps to a new level of
intelligence.15 National surveys show that the vast majority of hospitals have implemented or budgeted
for smart pumps, EHRs, CPOE, and BCMA.10,16 In many hospitals, these technologies coexist but
operate as “islands,” without realizing their full potential.1,2,7 The ultimate goal is to connect and monitor
these technologies to provide real-time clinical decision support, auto-programming and auto-
documentation, ongoing clinical surveillance, and an alert system that automatically flags any critical
situation that requires immediate attention and communicates the information to the most appropriate
healthcare provider, adding a new dimension to IV infusion therapy safety.1,15 Standardization of drug
names and dose/dosing units across the formulary, CPOE, automated dispensing cabinets (ADCs),
BCMA, and the EHR is critical,3 as well as the assessment and planning that occurs in order to mobilize
and prepare for sufficient resource allocation, as part of the integration success.18

smart pump-ehr interoperability enables the prescriber’s ordered infusion parameters that have
been reviewed by the pharmacist to pre-populate the smart infusion pump screen (which must be
confirmed by the user prior to starting the infusion) and automatically documents infusion data in the
EHR.1,15 Successful implementation can effectively reduce a variety of error types that still can occur
with smart pumps such as issues involving pump programming, wrong drug concentration, wrong
rate, wrong drug, and patient weight, as well as to reduce manual data entry steps.19

interoperability between smart infusion pumps and the EHR is a huge step forward for
patient safety, and at the same time, is complicated and costly requiring long-term organizational
commitment.15,19 Among the key requirements for smart infusion pump interoperability are
a robust and reliable wireless infrastructure, electronic medication orders that include necessary
infusion parameters, high BCMA compliance, and smart infusion pumps capable of bi-directional
communication with the EHR.15,19,20 While very little information is available concerning the financial
impact of smart infusion pump interoperability, a recent study demonstrated a positive relationship
concerning improved charge capture and billing compliance.20

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 4
smart infusion pump interoperability represents the next milestone in infusion safety19 and one day
will likely be the standard for how IV medications and fluids are administered. That day is not so far off,
as early adopters of smart pump interoperability have created momentum and are forging the way
through the myriad of challenges facing healthcare providers. These innovators are providing evidence
regarding the positive link between integration and key improvements in safety, nursing and pharmacy
productivity, clinical decision making, patient monitoring, alarm and alert notification, and a reduction in
variation and waste.1,17

The experiences of early adopters of smart pump interoperability can serve as a tipping point
for more widespread adoption of even more intelligent infusion systems.21 Organizations sharing
their messages about “closed-loop” success can help others optimize use of their existing systems
and prepare for the integration of technologies, paying particular attention to ensuring the adequacy
of a wireless network, enabling all available smart pump safety features, managing ders libraries
aggressively to reflect best practices, managing alerts and alarms, analyzing data on alerts and
compliance, and other key strategies.15,19

Note: bolded terms in small capital font are listed in the Definitions section of the document.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 5
MEDICATION ERRORS ASSOCIATED WITH
SMART INFUSION PUMP USE
Technology has vastly improved the safety of infusion administration over the past five decades,
from administration by gravity to automated infusion pumps that offered better control of the rate and
consistency in delivery to smart infusion pumps with ders.1,17 At the same time, infusion devices
have been involved in more adverse incidents reported to the US Food and Drug Administration (FDA)
than any other medical technology.19 smart infusion pumps with ders have exposed an alarming
and once hidden vulnerability to IV infusion errors and helped to uncover a high degree of variation in
infusion practices among and even within healthcare organizations.1,2,7 Despite their ability to detect and
warn healthcare providers about errors, often organizations have not maximized smart infusion pump
functionality to its full potential, and serious IV errors have persisted. These errors have often occurred
due to a failure to engage the ders and the ease with which healthcare providers may select the wrong
drug library entry or override serious alerts.1,3

Even when organizations optimize the use of smart infusion pump technology, safety gaps still
exist.1,12,18,22,23 Most of these gaps stem from the smart pump operating in isolation of other electronic
systems, requiring manual programming and documentation by the end user.1,19 Because current smart
infusion pump programming depends heavily on human action, and it is inevitable that humans will
make mistakes, opportunities for error still exist.

Programming Errors
For the ders limits to function effectively, the drug library must be engaged and the correct care
area/profile, medication/fluid, and concentration must be manually selected by the user.23 The
device, unaware of the patient’s prescribed therapy, also relies on the user to properly input infusion
information into the corresponding pump fields and to ensure the infusion is administered to the correct
patient.1 Data support that errors in pump programming are a significant contributor to medication errors
involving use of infusion devices.24

dose-rate and Infusion-Rate Mix-Ups

Confusing the medication dose-rate with the infusion rate is a relatively frequent
pump programming error type that is often unreported.12,25 This type of wrong-field
programming error in which the intended infusion rate is entered in the dose-rate field
can result in the patient receiving too much or too little solution and poses significant risk
of patient harm. These mistakes can be related to differences in the names that these
infusion parameters are given and the sequence in which they are listed in the medication
administration record (MAR) versus the smart pump screen.25

Custom Concentrations/Wildcards 26
Programing a custom concentration, also known as a wildcard, entails selecting a drug
from the library but then manually entering the concentration (e.g., xx mg/xx mL).
Serious errors have occurred when practitioners have unnecessarily selected a custom
concentration option, and then entered the wrong concentration, even though a standard

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 6
 concentration option for the drug was available in the pump library. Some of the errors appear
to be mental mix-ups in which the “dose per hour” was paired with the total infusion volume
(e.g., heparin 800 units/hour from a 25,000 units/250 mL bag was inadvertently entered as
a concentration of 800 units/250 mL). Mix-ups have also occurred in which the “per mL”
concentration was paired with the total infusion volume (e.g., a 0.2 mg/mL concentration
of milrinone in a 20 mg/100 mL bag was entered as a 0.2 mg/100 mL concentration).
Sometimes, the way the concentration is expressed on the label also contributes to
concentration mistakes.

Custom concentration options that do not employ a hard-minimum concentration limit have
led to harmful errors. This is mostly due to the counterintuitive, inverse relationship between
concentration and volume. More concentrated drugs require less volume to deliver a specific
dose while less concentrated drugs require more volume. When using custom concentrations,
the concentration must be programmed into the pump so that it can calculate the volume
needed to deliver the prescribed dose. If the programmed concentration is lower than the
actual concentration in the infusion bag or syringe, the pump will deliver an overdose. If the
programmed concentration is higher than the actual concentration in the bag or syringe, the
pump will deliver an underdose.

Other examples of programming errors include those related to:

Dosing nomenclature 23
– Programming errors due to non-standard nomenclature of the dose/dosing units (e.g., weight-
based versus non-weight-based dosing) and dose-rate (e.g., mg/kg/min versus mg/kg/hr)
– Calculation errors due to unit of measure inconsistency between the drug library and the EHR
(e.g., a bolus dose ordered in milligrams, but the smart infusion pump requires mg/kg)

Multiple medication infusion concentrations12,27

– Selection errors when choosing among multiple listed concentrations in the drug library for the
same medication

Secondary Infusion Errors

In their landmark study, Cassano-Piché and colleagues determined that
multiple issues exist with secondary medication administration that could
result in patient harm.27 A particularly significant risk identified was the
potential for incorrect head height differential between the primary and
secondary infusions. secondary infusion is the administration of an IV
medication or fluid through the primary infusion line using a secondary
tubing set that is attached at the upper injection port of the primary set.28
During administration of the secondary infusion, the primary infusion
is designed to temporarily pause and then automatically resume upon
completion of the secondary infusion. Most infusion pumps currently on the market require
users to manually lower the primary medication or fluid bag/bottle below the secondary container.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 7
This is necessary to increase the secondary bag pressure differential enough to prevent the flow of
the primary infusion until the secondary infusion has completed.27,30 Insufficient head height
differential between the primary and secondary infusion containers may result in both infusions
running concomitantly at unpredictable rates or possibly the secondary not infusing at all.27 Other
serious errors reported in the literature27 as well as to the Institute for Safe Medication Practices (ISMP)
Medication Errors Reporting Program (MERP) involving manual secondary infusion include:

» secondary infusion of a high-alert medication infused too quickly even when the smart
infusion pump was programmed correctly

» Secondary medication container completely infused although the volume to be infused (VTBI) was
set at a volume less than the total container volume

» secondary infusion delayed or omitted due to the user forgetting to open the roller clamp
The manual set up of secondary infusions can be implemented safely, but this method provides
more opportunities for human error, and is highly reliant on the individual practitioner’s training
and ability to remember to follow the manufacturer’s instructions. Although successful smart pump
interoperability with the EHR has the potential to avert a large majority of infusion-related events
(e.g., wrong concentration, wrong weight, wrong rate, wrong drug, wrong units, wrong dose), it is not
capable of intercepting secondary infusion set-up errors.19

Other Error Types

Additional error types associated with smart infusion pump use include:
» Infusion line or channel mix-ups when simultaneously administering multiple infusions due to visual
and physical complexity12,27

» Administration of discontinued infusions because of a delay in stopping the infusion or not removing
the associated container from the smart infusion pump1,27

» Inconsistent rate delivery by syringe pumps used to administer infusions at low rates (less than 5 mL/
hour [especially less than 0.5 mL/hour]) 31

– See an FDA Safety Communication (http://wayback.archive-it.org/7993/20171115052211/, https:/

www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm518049.htm) for recommendations
to help reduce the potential for serious adverse events caused by the absence of flow continuity.

» Dose inaccuracy due to variability in the management of infusion container overfill32

» Bolus dosing errors due to variability in bolus dose infusion preparation and the complexity
associated with bolus dose infusion programming in the pump27

This guidance document outlines safe practice recommendations, including the use of bi-directional
interoperability of smart pump technology with the EHR, to mitigate many of the risks discussed
above.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 8
DEVELOPING CONSENSUS GUIDELINE STATEMENTS
In 2009, ISMP published its original smart pump
guidelines titled Proceedings from the ISMP Summit on
the Use of Smart Infusion Pumps: Guidelines for Safe
Implementation and Use. These safe practices were the
outcome of a two-day summit of expert stakeholders and
focused on implementation of smart pump technology,
use of the drug library, and clinical practices.

To address the numerous and varied errors associated

with smart pump use reported to ISMP MERP and
published in the literature since the publication of this resource, ISMP initiated plans in 2017 to hold
its second National Smart Infusion Pump Summit. In preparation, ISMP performed a thorough review
of the literature, analyzed smart pump -related errors reported to ISMP MERP, and conducted three
ISMP practitioner surveys.12,26,33 Error data and ISMP survey responses provided important information
regarding the successes, safety concerns, and barriers with the optimization of smart infusion pumps.
Barriers included significant limitations of pump capabilities, alarm fatigue, persistent deficiencies
related to library use and updates, availability of pumps, programming workflow, associated risks with
secondary infusions, and pump data analysis.

ISMP obtained an educational grant from Baxter, B. Braun, BD, ICU Medical, and Ivenix to support its
second summit which was held in suburban Philadelphia in May 2018. The purpose of the summit was
to develop an updated and expanded compendium of expert- and evidence-based best practices to
maximize the intended safety benefits of this important technology and better position organizations for
interoperability of smart infusion pumps with the EHR.

The summit, entitled Optimizing the Safe Implementation and Use of Smart Infusion Pumps, was
guided by the following objectives:

1. Gain consensus among key interdisciplinary stakeholders on the common risks associated with
smart infusion pump use

2. Identify corresponding error-reduction strategies to address:

– Infrastructure
– Drug Library
– Continuous Quality Improvement (CQI) Data
– Clinical Workflow

3. Develop key safe practices to promote organizational readiness for bi-directional smart infusion
pump interoperability with the EHR

As with the first summit, the importance of involving end users was recognized which led to the
identification of organizations that had successfully implemented smart infusion pump technology.
Representatives from these organizations, as well as smart infusion pump vendors, professional
and regulatory organizations (Association for the Advancement of Medical Instrumentation [AAMI],

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 9
American Organization for Nursing Leadership [AONL], Anesthesia Patient Safety Foundation [APSF],
Bainbridge Health, ECRI Institute, US Food and Drug Administration [FDA], Institute for Healthcare
Improvement/National Patient Safety Foundation [IHI/NPSF], Infusion Nurses Society [INS],
Pennsylvania Patient Safety Authority, Regenstrief National Center for Medical Device Informatics
[REMEDI], and The Joint Commission [TJC]), and ISMP staff were invited to attend the second national
summit. Representatives included pharmacists, nurses, physicians, and biomedical engineers.

A framework of recommended safe practices for smart pump use was established by ISMP staff, and
then a pre-summit survey of participants was conducted to identify early consensus on these practices,
as well as top safety challenges for discussion. Breakout sessions focused on the expected use of
smart pumps and their role in perioperative, procedural, and ambulatory settings; benefits of defaulting
directly to programming in ders; avoiding errors with the administration of secondary infusions; care
area/profile designations; CQI metrics; clinical workflows; independent double checks for selected
high-alert medication infusions; and smart pump interoperability with the EHR. Combining the
pre-summit work in addition to the summit discussions, participants reached consensus on a variety
of safe practices. These draft guidelines were subsequently posted on ISMP’s website for public
comment. Recommendations from the public were reviewed and the final guidelines for Optimizing
Safe Implementation and Use of Smart Infusion Pumps were developed, which are presented in the
statements that follow.

Evidence-based research was used, as available, to support the development of the guidance
statements; however, as with many patient medication safety-related issues, controlled clinical trials
have rarely, if ever, been done for a specific safe practice, nor would they be ethical in many cases.
As such, this guidance document relies on the synthesis of the best evidence available at the time of
publication, including clinical articles and other published literature, along with expert consensus.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 10
SUMMARY OF THE ISMP SMART INFUSION PUMP
SURVEY FINDINGS
ISMP conducted three surveys12,26,33 between 2017 and 2018 to assess use of smart infusion pumps
with ders in the United States, revealing unique perspectives of over 1,000 nurses, pharmacists,
and other healthcare professionals. Ninety-seven percent of respondents reported consistently using
smart infusion pumps in various units (e.g., adult, neonatal, and pediatric critical care; medical/
surgical; pediatric; oncology; post-anesthesia care; labor and delivery; ambulatory infusion; emergency
department). While most respondents reported widespread use of smart infusion pumps, many shared
safety concerns and barriers to optimizing their use. Over 700 comments expressed barriers related to
significant limitations in smart infusion pump capabilities, alarm fatigue, deficiencies related to library
use and updates, pump availability, programming workflow, secondary infusions, and data analysis.

Infrastructure
Three percent of respondents reported using smart infusion
pumps for other types of infusions such as continuously
nebulized medications and enteral feedings. Thirty-one percent
of respondents caring for neonatal and pediatric patients reported
using the same smart infusion pump to administer both
parenteral infusions and enteral feedings. This may be due to lack
of available FDA-cleared devices within the institution for purposes
other than parenteral and/or epidural infusions. Ninety percent
of respondents from larger hospitals with 100 beds or more reported having wireless transfer of data
to and from smart infusion pumps, mostly for drug library updates (97%), data analysis (70%), and
location tracking (33%). Dozens of respondents reported insufficient smart infusion pumps when the
census was high and issues with wireless connectivity and interoperability.

Respondents also shared limitations of the smart infusion pumps, themselves, such as not being
able to self-prime, having to power down the pump in order to change the care area/profile when
transferring patients to a different care area, malfunctions, and hard-to-read screens.

Drug Library
Designing, maintaining, and using the drug library to prevent errors are foundational tasks; however,
these were the most frequently reported challenges. Eighty-nine percent of survey respondents
reported designing the drug library based upon the patient care area/profile, while 6% differentiate
by age group (i.e., adult, pediatric, neonatal). There were also reports of difficulty in reaching consensus
among prescribers regarding which medications to include in the drug library and what the standard
concentrations and dosing methods should be. Respondents also revealed the impact of drug
shortages on maintaining the drug library.

Half of respondents who manage the drug library reported 1 to 3 library modifications and updates
during the past year; less than 5% reported no updates during the past year. Up to 45% of nurses
reported programming IV fluids without the use of the library as a basic infusion more than 50%
of the time due to barriers including IV fluids not being listed in the drug library (45%), perceived

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 11
lengthy process for programming IV fluids through the drug library (19%), and lack of a hospital policy
establishing expectations to use the drug library for IV fluids (10%).

Only 79% of frontline nurses use the drug library for IV medications more than 90% of the time. For
compliance rates lower than 90%, most nurses reported barriers such as medications or concentrations
not being listed in the drug library or needing to use basic infusion mode in an emergency.

Continuous Quality Improvement (CQI) Data

Data analysis can reveal barriers to optimizing and maximizing smart infusion pump use. In the
third survey33, 96% of respondents reported that they believe reviewing data is essential to quality
improvement; however, only about half reported that their organization provides dedicated staff (56%)
and dedicated time (48%) for reviewing data. Most organizations that analyze smart infusion pump
data focus on drug library and ders compliance, as well as alert frequency. More than a quarter (26%)
of respondents do not believe they have the skills, tools, or time for meaningful data analysis. Many
respondents also reported the available data was not linked to individual patients, practitioners,
units, or facilities. Respondents reported that data on basic infusions may be unavailable or not shared.
Seventy-four percent of respondents are unable to identify risky practices associated with smart
infusion pump usage, such as unnecessary nurse dilution of products, which results in a nonstandard
concentration. Respondents (83%) who analyze smart infusion pump data reported that most of
what is being learned is being used to update or change the drug library. Only 16% of respondents
reported that data analytics has led to educational programs, and only 13% had made updates or
changes in policies, procedures, and practices. Forty-seven percent of all respondents reported
participating in external data analytics.

Clinical Workflow
Respondents shared error types that they have encountered despite the use of smart infusion
pumps. The most common types of errors reported involved secondary infusions, including delayed
or omitted secondary infusions caused by a closed roller clamp, or secondary infusions that were
administered at the wrong rate. Even with technology, human error was still reported: programming
errors due to dose-rate confusion, decimal points, and drug selection; IV line or channel mix-ups;
tubing misconnections; wrong drug; and wrong patient.

practitioners also reported frustrations with a time-consuming and complex programming process,
including difficulties finding the correct drug when scrolling through a large list of generic names and
overly sensitive and false alarms.

Bi-directional Interoperability
Fifteen percent of respondents have implemented bi-directional interoperability between
smart infusion pumps and the EHR, facilitating smart infusion pump programming and EHR
documentation. Thirteen percent of survey respondents reported their facility was planning
implementation within the next 12 months.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 12
SCOPE
These guidelines are designed to encompass practices associated with the safe use of smart infusion
pumps for the administration of medication infusions and/or IV fluids in inpatient and/or outpatient
settings, including epidural and patient-controlled analgesia (PCA) infusions. These guidelines, however,
do not specifically address:

Treatment/Device

» Continuously nebulized medications

» Dialysis therapy and continuous renal replacement therapy (CRRT)
» Elastomeric devices
» Extracorporeal membrane oxygenation (ECMO) infusion device
» Intraventricular infusions
» Irrigation infusions
» Investigational drugs
» Magnetic resonance imaging (MRI) infusions and infusion devices for MRI
» Warmed or cold fluids (resuscitation)

Situation/Topic

» Alarm management
» Cybersecurity of smart infusion pumps
» Security of opioid infusions
» The use of smart infusion pumps during trauma resuscitation

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 13
GUIDELINES FOR OPTIMIZING SAFE IMPLEMENTATION
AND USE OF SMART INFUSION PUMPS

1. Infrastructure
1.1 Establish that the use of smart infusion pump technology (i.e., ders ) is expected practice
throughout the organization, including in ambulatory settings such as perioperative/procedural/
radiology areas, the emergency department, and infusion centers for the administration of
medication infusions including but not limited to:
– continuous infusions
– intermittent and secondary infusions
– Intravenous (IV) bolus dose and loading dose infusions
– Patient-controlled analgesia (PCA) infusions
– Epidural and nerve block infusions

1.2 Establish that the use of smart infusion pump technology (i.e., ders ) is expected practice
throughout the organization, including in ambulatory settings such as perioperative/procedural/
radiology areas, the emergency department, and infusion centers for the administration of all IV
fluid infusions (e.g., continuous and bolus dose infusions ).*

*An exception may exist where gravity infusions continue to have clinical applicability (i.e.,
to administer a fluid infusion at a rate greater than the pump allows).

1.3 Utilize smart infusion pumps that default directly to programming in ders and which make it
obvious when operating outside ders.

1.4 Establish organizational expectations for use of ders with the goal to maximize practitioner
compliance to 95% or greater for the administration of medication infusions (including epidural
and nerve block infusions).

1.5 Establish organizational expectations for use of ders with the goal to maximize practitioner
compliance to 95% or greater for the administration of IV fluid infusions.

1.6 Monitor smart infusion pump compliance rates (target goal of 95% or greater), and address
barriers leading to infusions being programmed outside ders.

Discussion: smart infusion pumps with ders allow organizations to create a tailored
library of medications with dosing guidelines by establishing standard concentrations,
dosing limits, and alerts (e.g., clinical alerts, soft limits, hard limits ). smart pumps
with enabled ders can detect dosing and programming errors that may harm patients.
Failing to employ available ders as intended and to heed important clinical alerts
are common contributors to preventable infusion errors with smart infusion pumps.
Healthcare clinicians should not view the dose-checking feature of smart pumps as an
option that can be turned on or off. Nor should the alerts that arise from the system be
bypassed without serious consideration. Bypassing ders remains a key risk point in the
use of this technology, and as such, organizations should establish a ders compliance

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 14
 rate of 95% or greater and monitor compliance to maximize intended safety benefits. Any
barriers to programming through the drug library should be identified and resolved.

In conjunction with monitoring compliance reports, managers should perform periodic

bedside assessments of ders compliance to validate that the medication or fluid being
infused matches the appropriate ders selection. For example, smart infusion pumps
that have an “IV Fluid, No Drug” library entry, could allow users to select this choice to
administer a medication infusion and still be considered compliant with using ders.

1.7 Identify particular medications to be administered only as uninterrupted/ primary infusions and
specifically configure these in the drug library.

1.8 Use an automated secondary iv infusion management system that is not dependent on
head height differential and can assure secondary flow. In the absence of this technology, at
a minimum, implement safe practice 1.7.

1.9 Purchase/lease only smart infusion pumps capable of wireless drug library updates, data
transmission, and bi-directional communication with the EHR.

1.10 Require comprehensive, reliable wireless connectivity throughout the organization where smart
infusion pumps will be in use to:

– Update drug libraries

– Obtain smart infusion pump reports and data
– Support bi-directional communication with the EHR

1.11 Utilize tracking technology to locate and manage smart infusion pumps within the organization.

1.12 Define the committee(s) or department(s) with oversight of smart infusion pump system
software, drug library revision requests, process decisions, protocol development, and pump
acquisition and maintenance.

1.13 Allocate resources for ongoing maintenance of smart infusion pump -related electronic
databases/systems to ensure standardization of infusion parameters and timely system updates
to address drug shortages, new drugs added to the formulary, and development of new drug
protocols.

1.14 Conduct a risk assessment prior to acquiring new smart infusion pumps. Involve frontline
users of these devices during the evaluation stage to uncover potential failure modes and
usability issues.

1.15 Develop policies and procedures to address the use of smart infusion pumps that accompany
patients upon transfer between clinical units as well as external healthcare facilities.

1.16 Develop policies and procedures, as necessary, for the short-term rental or borrowing of smart
infusion pumps from outside facilities or vendors to supplement capacity. Before distribution for
use, ensure that the rental/borrowed pumps:
– Are inspected by the organization’s biomedical engineering department (or contracted service)
– Have cached data deleted

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 15
 – Are programmed with the organization’s current drug library
– Are connected to the appropriate wireless configuration

Discussion: smart infusion pump software can capture extensive details about how
smart infusion pumps are being used and the alerts that have been generated. As
such, when receiving rental or borrowed pumps from outside facilities or vendors, it is
very important to ensure there is a process for removing any cached data and uploading
the organization’s current drug library prior to distribution to patient care areas/
profiles. If the cached data is not removed, then the pump quality improvement (QI)
data will include data from the current rental/borrowing site and from previous facilities
that temporarily used these pumps making data difficult to interpret. This could lead to a
facility changing clinical practices or drug libraries based on usage patterns that are not
reflective of their organization. It is also important to have a process to delete pump QI
data when returning rental/borrowed pumps as it may include protected health information
(PHI) if practitioners enter medical record numbers or other patient identification when
programming the smart infusion pumps.

1.17 Develop policies and associated processes to address the cleaning (e.g., frequency, product[s],
and methods recommended by the manufacturer), storage, distribution, and maintenance of
smart infusion pumps.

1.18 Implement policies and procedures for ensuring that smart infusion pumps suspected of
malfunction are removed from use. Before being released for patient care, the affected smart
infusion pumps should be calibrated and tested by biomedical engineering (or contracted service).

1.19 Implement standardized training and competency assessments for the use of smart infusion
pumps (including large-volume, PCA, epidural, and syringe infusion devices) across the
healthcare organization and validate user competence, including traveling/agency staff, at the
time of hire/orientation and on an ongoing basis.

1.20 Report adverse events, close calls, and hazardous conditions associated with the use of smart
infusion pumps (including large-volume, PCA, epidural, and syringe infusion devices) within the
healthcare organization and to external safety organizations such as ISMP for shared learning.

1.21 Provide practitioners who use smart infusion pumps (including large-volume, PCA, epidural,
and syringe infusion devices) with ongoing information about associated risks and errors that
have occurred in the organization and/or have been reported by external organizations, as well as
the strategies required to minimize these risks and errors.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 16
2. Drug Library
2.1 Establish an interdisciplinary team (which may include, but is not limited to, a pharmacist, nurse,
clinical/biomedical engineer, data analyst, medication safety representative, information systems
personnel, and prescriber) to develop and test the drug library, as well as to update the library at
least quarterly.34 Consider maintaining a log of such changes in a centralized location.

2.2 Implement a standardized process for communicating drug library content changes to end users.

2.3 Standardize smart infusion pump libraries across affiliated facilities within a health system
unless services are not available (e.g., neonatal intensive care unit).

Discussion: Drug library standardization is also essential for successful implementation

of smart infusion pump interoperability with the EHR. See section on Bi-directional
smart infusion pump interoperability with the EHR for more information.

2.4 Implement a systematic process for reviewing drug library content that includes recent literature,
evolving practice changes, facility-specific requests, formulary changes, and CQI data.

2.5 Develop and operationalize a formal change control process for the drug library to ensure
requested changes are evaluated, tested, and uploaded in a coordinated and timely manner.
Ensure that drug library updates are in alignment with the EHR.

2.6 Prior to go-live and for subsequent drug library modifications:

– Require an independent double check of every drug entry (e.g., drug name, dosing units,
concentration, dose limits, and associated clinical alerts ) to verify accurate data entry.
– Review configuration and infusion running displays on the pump screen for each drug entry.

Discussion: Building the drug library requires significant manual input of information. As
such, organizations should take steps to prevent transcription errors during crucial points
of the drug library build and subsequent modifications. An independent double check
should be performed for the entry or modification of each drug-specific element such as the
standardized drug name (see statement 2.8) and applicable tall man lettering, dosing
units, concentration, dose limits, and associated clinical alerts. After such additions or
modifications are made, a review of how this information appears on the smart infusion
pump display screens (after a medication has been selected and while the medication or
fluid is infusing) should be performed. This is an important step to identify any potential
errors that may be attributed to the way information is displayed; the end user should be
able to interpret and utilize the drug information and clinical alerts as intended. Frontline
users should participate in the review of smart infusion pump displays as they will bring a
unique perspective when determining the most effective way to present this information.

2.7 Establish care areas/profiles that are tailored to specific patient populations, acuity, and/or
patient weight.

Discussion: care areas/profiles can be customized within the drug library to meet the
drug therapy needs of different patient populations within an organization, as well as to
provide significant safety benefits through the provision of IV medication concentrations and
associated soft and hard limits that are specific to that care area/profile.35 These

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 17
 care areas /profiles can be organized in the drug library based on patient acuity, location,
and/or weight such as adult, pediatric, and neonatal intensive care units; medical/surgical
units; emergency departments; and ambulatory infusion centers.

2.8 Standardize the nomenclature of the drug name (including the application of tall man
lettering ), dose/dosing units (e.g., weight-based versus non-weight-based dosing; mcg/
kg versus mg/kg), and dose-rate (e.g., mg/kg/min versus mg/kg/hr) in the drug library to the
fullest degree possible. Ensure that this nomenclature is consistent with the EHR, pharmacy
infusion labels, and pharmacy IV workflow systems.

2.9 Limit the use of volumetric flow rate programing to fluids and medications for which it is not
feasible to program in dose/dosing units, such as products prescribed as mL/kg/hr or mL/hr
(e.g., IV immune globulin [IVIG], combination products such as a fentaNYL and bupivacaine
epidural infusion).

2.10 Standardize and limit the number of drug concentrations for continuous and intermittent
infusions in the drug library and ensure they are consistent within the EHR and pharmacy IV
workflow systems.

2.11 Use commercially prepared, premixed IV solutions, whenever they are available from the
manufacturer and are clinically appropriate, as the basis for standardizing concentrations within
the drug library.

2.12 Develop standard definitions for terms used in IV medication administration (e.g., bolus dose
and loading dose infusions, continuous infusion, iv piggyback, intermittent infusion,
iv push, “keep vein open [KVO],” and secondary infusion ).

2.13 Actively utilize ders (upper and lower, soft and hard limits ) for the following:
– Medication doses – bolus dose and loading dose
– Medication concentrations infusions (e.g., dose, duration, rate,

– Infusion rates bolus interval)

– intermittent infusion time duration – Patient weight

Specifically target the implementation of upper and lower hard limits for medication doses,
concentrations, infusion rates, and bolus dose and loading dose infusions.

2.14 Restrict/limit the ability to manually program continuous medication infusion concentrations
(i.e., using wildcard/custom concentrations). See section on Medication Errors Associated with
smart infusion pump Use for more information.

2.15 Standardize the management of infusion container overfill, programming the volume to
be infused (VTBI), and priming and flushing parameters (for intermittent infusions ) for
preparation, drug library build, and smart infusion pump programming. Provide the total
volume (e.g., bag volume + manufacturer’s overfill + drug additive volume) on the product
label for pharmacy dispensed single dose intermittent infusions.

2.16 Develop and incorporate clinical alerts into the drug library that provide practitioners with
information that should be acknowledged during programming of the infusion (e.g., “infusion
requires central line”).

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 18
3. Continuous Quality Improvement (CQI) Data
3.1 Provide dedicated time and resources for regular review and analysis of smart infusion pump
data, at least on a quarterly basis.

3.2 Use internal and external information about adverse events, close calls, and hazardous
conditions associated with the use of smart infusion pumps for CQI.

3.3 Establish organizational baseline and target values for the following CQI metrics and regularly
monitor these to assess drug library compliance and identify barriers to use:
– Facility compliance rate with ders
– Compliance rate with ders by care area/profile
– Compliance rate with ders by medication and fluid
– Total number of alerts by alert type (e.g., soft or hard limit, upper or lower limit)
– Total number of alerts by infusion parameter (e.g., dose, dose-rate, concentration,
duration, rate)
– Total number of alerts by medication and fluid
– Percent of overridden alerts (number of overridden alerts/total number of actions taken in
response to an alert)
– Number and percent of canceled/abandoned infusions
– Percent of alerts resulting in reprogramming (e.g., good catches)
– Percent of pumps with the current version of the drug library (i.e., saturation)
– Frequency and duration of operational alarms, identifying top alarms by type and care area/
profile that may require organizational intervention

3.4 To further improve infusion safety with the use of smart infusion pump technology, consider
the use of the following more advanced CQI metrics:
– Rate of alerts (total alerts/total number of ders infusions)
– Rate of alerts by medication and fluid
– Rate of overridden alerts by medication and fluid
– Medications that have a low frequency of use, but high rate of alerts
– Percent of medication and fluid infusions available in the drug library (total number of
medication and fluid infusions available in the library/total number of orderable medication
and fluid infusions in the EHR)
– Percent of medications programmed outside of preset concentrations (i.e., using wildcard/
custom concentrations) to identify unapproved concentrations and risky practices such as
bedside dilution and practitioner preparation of solutions
– Alerts due to concentration settings that are programmed below the minimum
concentration limits
– Percent of infusions administered via gravity (See discussion on next page)
– Rate of alerted infusions subsequently programmed as basic infusions (See discussion on
next page)

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 19
 Discussion: These metrics are more difficult to obtain and represent stretch goals for
organizations seeking to further understand and improve smart infusion pump use.

Percent of infusions administered via gravity

This metric can be useful for an organization to monitor since gravity infusions
are not currently captured by smart infusion pump software. To obtain an
estimate of the infusions being administered by gravity: 36
1. Calculate the number of medication and fluid infusions expected to be
administered via smart infusion pumps from the organization’s EHR data
(“total administered infusions”). The accuracy of this information is the most
critical component of the calculation. Errors in determining this number can
result in widely variable estimations of the infusions being administered by
gravity.
2. Add together the number of ders infusions and basic infusions in the smart
pump analytics software to calculate “total pump infusions.”
3. Subtract “total pump infusions” from “total administered infusions.”
4. The difference provides a close approximation of the number of gravity
infusions.

Rate of alerted infusions subsequently programmed as basic infusions

There is tremendous value to this metric as it can be very useful in driving
compliance with ders. While it is possible to link a ders infusion for which the
user received an alert and then reprogrammed the infusion outside the drug library
with the subsequent basic infusion entry, this type of report is challenging to build. An
organization will not likely be able to create this report on their own and will typically
need advanced data support from a third-party expert.

3.5 Address any trends identified through data analysis. Use this information as appropriate to:
– Improve compliance with the use of ders
– Update the drug library
– Align the drug library with the EHR
– Address nuisance alerts
– Update/change related policy or procedure
– Modify clinical workflow
– Identify opportunities for additional education

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 20
4. Clinical Workflow
4.1 Before starting an infusion, ensure the administration set is installed in the pump according
to the manufacturer’s instructions, as inappropriate administration set installation can impact
medication flow (e.g., free-flow ).

4.2 When starting selected facility-defined high-alert medication infusions and at additional
facility-defined steps (e.g., change of shift/handoffs, change in the rate/dose of infusion, change
in bag/bottle/syringe) require that a double check be performed and documented to verify the
following before starting the infusion:
1. Patient
2. Patient weight used for weight-based medications
3. Drug/solution
4. Drug concentration
5. dose-rate of continuous infusions, dose and rate of intermittent infusions
6. Channel selection
7. Line attachment

For items 1-6, use available technology (preferred method) to perform and document the
double check or use a second practitioner to perform and document an independent
double check. For item 7, use a second practitioner to perform and document an
independent double check.

Exception: Frequent rate changes when titrating medications (e.g., vasopressors) to effect.

Discussion: Manual independent double checks of certain high-alert medications

have been widely promoted in healthcare to help detect potentially harmful errors before
they reach patients.37,38 ISMP believes that the selective and proper use of manual
independent double checks can play an important role in medication safety. Numerous
studies have demonstrated the ability of independent double checks to detect up to
95% of errors.39-43 Based on this understanding, an error rate of 10% (1 in 10) can be
reduced to 0.5% (1 in 200) by introducing an independent double check process.44
Automated double checks using technology, such as BCMA and auto-programming of
infusion parameters from the EHR system to the smart infusion pump, likely yield even
better results in intercepting errors.

An independent double check requires two people to separately check the targeted

components of the work process, without knowing the results of their colleague.44 For
example, when starting a continuous infusion of a selected facility-defined high-alert
medication, the first practitioner programming the smart infusion pump would verify
the patient, patient weight (for weight-based infusions), medication, concentration, and
dose-rate against the MAR and then validate the channel selection and line attachment.
A second practitioner would subsequently verify the same components using the MAR
and then check the channel selection and line attachment before the infusion is started.
If an organization has implemented smart infusion pump interoperability with the
EHR, the first practitioner would scan the patient, the high-alert medication infusion,
and smart infusion pump channel to pre-populate the smart infusion pump screen

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 21
 with the pharmacist-verified infusion parameters. The first practitioner would verify the
patient, patient weight (for weight-based infusions), medication, concentration, dose-rate,
and channel selection before starting the infusion. Also, a second practitioner would still
be needed to perform an independent double check of the line attachment since current
technology cannot provide an automated double check of this component.

4.3 When transferring patients to a different clinical unit, ensure the drug library care area/
profile is appropriate for the receiving unit.

4.4 When infusions are started, reconnected, or changed (i.e., new bag/bottle/syringe), trace the
tubing by hand from the solution container, to the pump, and then to the patient for verification
of the proper pump/channel and route of administration.

4.5 Differentiate infusion pumps used to administer medications and fluids via different routes of
administration (e.g., IV, enteral, epidural) to reduce the risk of wrong route errors.
– Utilize only devices that have been cleared by the FDA for the delivery of enteral nutrition
solutions.
– To differentiate from IV infusions, use separate FDA-cleared pumps that are designated for
epidural infusions.
– Only use multi-channel infusion pumps for a single patient for the simultaneous delivery
of therapies by the same route (e.g., IV and epidural infusions are not infused on the same
individual pump).
– Utilize International Organization for Standardization (ISO) route-specific connectors (e.g.,
neuraxial [when available], enteral).

4.6 If administering an IV bolus dose or loading dose infusion from a continuous medication
infusion, only use a smart infusion pump that allows programming of the bolus dose
infusion (or loading dose infusion ) and continuous infusion with separate hard limits
for each and then automatically switches to the continuous infusion rate once the bolus
dose or loading dose infusion has been delivered.

4.7 Immediately discard all continuous IV medications and epidural infusions (e.g., continuous
infusions of magnesium, neuromuscular blocking agents, and opioids) after discontinuation
(i.e., do not leave hanging on an IV pole or at the bedside).

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 22
5. Bi-directional Smart Infusion Pump Interoperability with the EHR
5.1 Implement bi-directional (i.e., auto-programming and auto-documentation ) smart
infusion pump interoperability with the EHR.

5.2 Establish a multidisciplinary project team to guide the planning and implementation of smart
infusion pump interoperability with the EHR that includes all key stakeholders such as:

– Nursing – Biomedical engineering

– Pharmacy – Risk management
– Medical staff – EHR/BCMA vendor
– Senior leadership – smart infusion pump vendor
– Finance – Medication safety practitioner
– Information technology services – Clinical educator

Ensure representation includes subject-matter experts, administrative decision-makers, and

frontline practitioners, representing each patient care area where the technology will be
utilized. Identify a member of senior leadership as a champion of the project.

5.3 Clearly define the scope of the project including necessary financial and labor resources as well
as the patient care areas that are to be included and excluded.

5.4 Establish organizational expectations for the use of auto-programming with the goal to
maximize practitioner compliance to 95% or greater for the administration of medication
infusions contained within the drug library.

5.5 Establish organizational expectations for the use of auto-programming with the goal
to maximize practitioner compliance to 95% or greater for the administration of IV fluid
infusions contained within the drug library.

5.6 Prior to implementation, perform a detailed assessment of the wireless infrastructure, to

ensure robust and reliable wireless coverage in all patient care areas where infusion pumps are
used. Upgrade the wireless network if gaps in coverage are identified.

5.7 Perform a risk assessment of current workflows, identify variable practice patterns, and create
standard work for the administration of medication and fluid infusions, including:
– primary infusions – Use of “carrier” infusions or
– secondary infusions “medication lines”
– gravity infusions – Intermittent line flushes
– Titrated infusions – Priming
– bolus dose and loading dose – Emergency situations
infusions – Small volume, low flow syringe
infusions

5.8 Maximize the use of BCMA by analyzing data related to scanning compliance of medications/
fluids and patients.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 23
 5.9 Align medication names, concentrations, dosing units, and dosing limits in medication-related
policies/procedures/protocols and throughout organizational electronic databases/systems.

5.10 Ensure that all dosing configurations (e.g., total dose, weight-based dose, body surface area
[BSA]-based dose) for each medication infusion are built to flow from the EHR to the smart
infusion pumps correctly.

5.11 Perform testing of all infusion orders in a test environment or with a test patient prior to go-
live as well as, at a minimum, comprehensive testing of all infusion order types with any
EHR software update. In addition, perform testing of modifications to the drug library prior to
activating the update.

Discussion: Some organizations have found that this testing is most successful when
frontline nurses are engaged as the primary testers.

5.12 Ensure smart infusion pump drug library parameters match protocols and order sentences for
titratable medications. The titratable order sentence should include the following:
– Starting dose/ dose-rate
– Minimum and maximum dose
– Increments by which to adjust the dose and specific time interval for assessment/adjustment
– Measurable clinical parameters to determine dosage adjustment

5.13 Evaluate and modify EHR and pump tolerance settings (e.g., system rounding logic ) as
clinically appropriate to avoid nuisance alerts between the EHR and smart infusion pump.

5.14 Ensure all smart infusion pumps /channels are correctly identified with a unique barcode label
that is permanent, accessible, readable, and cleanable.

Discussion: To support smart infusion pump interoperability, smart infusion

pumps /channels (including rental or borrowed pumps) need to have a scannable barcode
that matches a record in the EHR. Correct installation of the barcode label on each smart
infusion pump and pump channel is a vitally important step.18 Mix-ups between smart
pumps /channels while setting up or programming an infusion have been reported.45,46 A
2017 ISMP newsletter highlighted an error in which a single pump channel barcode was
associated with more than one pump leading to the electronic documentation of insulin at
two different rates of infusion (3 mL per hour and 60 mL per hour). In the absence of a built-
in pump/channel barcode, perform an independent double check to verify the pump serial
number and EHR record when affixing barcodes to smart infusion pumps / channels.46

5.15 Develop workflows for the transfer of patients between areas with interoperability and
without interoperability.

5.16 Define procedures for smart infusion pump dissociation between use on separate patients to
avoid incorrect data association.

5.17 Develop downtime procedures to guide workflow (e.g., the use of manual smart infusion
pump programming [without interoperability], monitoring the replacement of continuous
infusions ) in situations when the system has gone down.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 24
 5.18 Develop a smart infusion pump interoperability response plan for any unscheduled
wireless network downtime and newly discovered gaps in wireless coverage.

5.19 Establish a standard approach for initial and ongoing staff training and competency assessment
for use of interoperability workflow. Ensure the education provided to staff simulates the
new workflow as closely as possible and emphasizes the intended safety benefits.

5.20 Monitor and share data available from both the EHR and smart infusion pumps with key
organizational stakeholders to ensure improvements in interoperability performance.
Consider the following CQI metrics to assess smart infusion pump interoperability:
– Compliance with interoperability (e.g., by care area/profile, medication/fluid, user) (See
discussion below)
– Total number of alerts by medication/fluid, care area/profile
– auto-documentation mismatch with EHR order (See discussion below)
– Percent of failed auto-programming attempts
– Rate of auto-programmed infusions (total number of auto-programmed infusions/total
number of administered infusions)

Discussion:

Compliance with interoperability

How this metric is calculated likely differs depending on an organization’s
specific EHR and pump vendors. For compliance with interoperability at the
organizational level, aim to determine the number of in-scope infusions where auto-
programming was initiated and completed divided by the number of all in-scope
infusions.

auto-documentation mismatch with EHR order

This metric can be useful to understand the degree to which users are manually
changing infusion parameters that have been sent to the pump. It is calculated by
determining the percent of infusions which have successfully auto-populated on the
pump screen, but one or more parameters (e.g., VTBI, rate, dose) were modified before
the infusions were started and thus the information sent back to the EHR from the pump
does not match the original order.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 25
DEFINITIONS

Term Definition

auto-documentation Sending infusion information (such as intake data, dose-rate of

(also known as continuous infusions, dose changes, rate changes, and IV start and
auto-charting or infusion stop times) automatically to the EHR system for manual practitioner
documentation) confirmation to enable accurate recording of this information in the
patient’s record after the infusion has started. (Adapted from: ECRI
Institute, 2018) 47

automated secondary A smart infusion pump capable of automatic infusion delivery of two
iv infusion different medications or fluids (e.g., plain IV fluid and an intermittent IV
management antibiotic) through the same tubing. This mode ensures that the entire
system intermittent infusion volume is infused, without the need to adjust the
head height of the primary and secondary infusion containers. This
mode also detects if the secondary line is clamped.

auto-programming Automatic programming of infusion parameters from the EHR system to

the smart infusion pump (which are then verified, and the infusion is
started manually by a practitioner ) after use of the BCMA system to
associate the patient, medication/fluid container (e.g., bag, bottle, syringe),
and pump channel. (Adapted from: ECRI Institute, 2018) 47

bolus dose infusion A discrete dose of medication or fluid given in a set volume at the desired
infusion rate or for a specified time duration prior to (see loading dose
infusion ) or during a continuous infusion.

care area/profile Method of grouping medication and fluid infusions that may have different
soft and hard limits, patient weight parameters, as well as different
pump alarm thresholds (e.g., air-in-line alarm threshold), and are typically
associated with a specific nursing unit, location, or patient population.
Examples include critical care, medical/surgical, pediatrics. (Adapted from:
Hoh & Krueger, in collaboration with ISMP, 2017) 34

clinical alerts Information about a specific medication or IV fluid that is displayed on

the smart infusion pump screen when the medication/fluid is selected
from the library and which typically requires clinician acknowledgement to
proceed. This information is configured by the facility.

continuous infusion A medication or fluid that is prescribed with a dose-rate (e.g., 10 mg/kg/
min) or infusion rate (e.g., mL/hour). The infusion continues until therapy is
no longer required or when the solution container is depleted. Dose or rate
programming changes may occur during the infusion. (Adapted from: Hoh
& Krueger, in collaboration with ISMP, 2017) 34

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 26
Term Definition

dose error-reduction Refers to the integral computer software in smart infusion pumps
systems (ders) intended to aid in prevention of infusion programming-related errors and
warn users of potential over- or under-delivery of a medication or fluid by
checking programmed doses/rates against facility-configurable preset
limits specific to a medication/fluid, and to a clinical application (e.g.,
epidural administration) and/or location (e.g., neonatal intensive care unit,
medical/surgical unit).

dose-rate Amount of medication (in non-volumetric units) in a continuous infusion

administered per unit of time (e.g., 10 mg/kg/min)

flush /flushing A term used to describe the administration of a compatible IV fluid through
an IV line so that the existing contents of the line are administered into
the patient’s bloodstream. This is a method to ensure residual IV fluid or
medication in the dead volume has been administered to the patient or
cleared from the IV line. Methods of delivery can be manual (e.g., iv push )
or by infusion pump. (Adapted from: Pinkney, S. et al., 2014) 45

The Infusion Nurses Society (INS) defines flush /flushing as the act
of the vascular access device into the bloodstream: used to assess and
maintain patency and prevent precipitation due to solution/medication
incompatibility.4

free-flow This is a condition where uncontrolled flow of medication or fluid occurs

through an infusion set.

gravity infusion Medication or fluid administered without an infusion device or ders that
relies on the force of gravity to infuse and that is manually controlled (e.g.,
with a roller clamp).

hard limit A medication or fluid-specific forcing function that ensures that an infusion
(within drug library) cannot be given outside facility-established medication or fluid-specific
parameters (e.g., concentration, dose-rate of continuous infusions,
dose of intermittent infusions, duration of intermittent infusions ).
These upper (maximum) and lower (minimum) limits are set in the drug
library and cannot be overridden.

head height With most infusion pumps, the primary medication or fluid bag/bottle
differential needs to be lowered using a hanger provided with the secondary
administration set to create a distance between the bottom of the
secondary infusion container and the top of the fluid level in the
primary container. (Adapted from: ECRI Institute, 2016) 28 See secondary
infusion for related graphic.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 27
Term Definition

high-alert Drugs that bear a heightened risk of causing significant patient harm
medications when used in error. Although mistakes may or may not be more common
with these drugs, the consequences of an error are clearly more
devastating to patients. See ISMP’s List of High-Alert Medications in
Acute Care Settings at: https://www.ismp.org/recommendations/high-
alert-medications-acute-list.

independent A procedure in which two individuals, preferably two licensed

double check practitioners, separately check each component of the work process.
An example would be one person calculating a medication dose for a
specific patient and a second individual independently performing the same
calculation (not just verifying the calculation) and matching the results.

intermittent A medication or fluid infusion that is delivered over a specified time at

infusion prescribed intervals. (Adapted from: Hoh & Krueger, in collaboration with
ISMP, 2017) 34

interoperability See smart infusion pump interoperability

iv piggyback See secondary infusion

iv push Direct manual administration of a medication using a syringe, usually under

pressure, connected to an IV access device; this may include a manually
administered IV bolus dose in an emergency.

loading dose The initial dose of a medication given by infusion that is intended to rapidly
infusion achieve a therapeutic level prior to initiating the continuous infusion or
scheduled maintenance dose infusion.

overfill The excess volume in a container of an injectable product, exceeding the

content indicated in the labeling. The excess volume is intended to be
sufficient to permit withdrawal and administration of the labeled volumes.
(Adapted from: FDA, 2015) 49

practitioner A licensed healthcare professional who is authorized within the institution

to prescribe, dispense, or administer medications, such as a physician,
physician assistant, nurse anesthetist, nurse practitioner, nurse,
pharmacist, or respiratory therapist.

primary infusion Infusions (e.g., continuous or intermittent medications, IV fluids) that are
delivered through the primary administration set.34

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 28
Term Definition

secondary infusion The infusion of a second IV medication or fluid through a patient’s

primary infusion line using a secondary set at the upper injection port of
the primary administration set. (Adapted from: ECRI Institute, 2016) 28

Secondary infusion
Hook

Primary infusion
Roller
clamp
Clamp Upper injection port
Back check
valve Dead volume

© Queen’s Printer for Ontario, 2015

smart infusion pump/ An infusion pump with integral computer software (see ders ) that is, at a
smart pump minimum, capable of: 1) maintaining a drug library of standard medication
concentrations, which when enabled, is used to support dose calculations
and alert the user to incorrect orders, calculation errors, or programming
errors, that would result in significant over- and under-delivery of a
medication or fluid; and 2) capturing administrative infusion data in a
systematic, objective manner to support improvement in safe medication
administration. If the programmed dose is outside the preset limits, the
pump alerts clinicians and can either require confirmation before beginning
delivery ( soft limit) or not allow delivery at all ( hard limit).

smart infusion pump Refers to technologies that enable the creation of an electronic connection
interoperability between an infusion pump channel and an EHR system. This connection
(also referred to as allows the pump channel, the patient, and the medication order to be
smart infusion pump associated with one another. (Adapted from: ECRI Institute, 2018) 47
integration)

soft limit A medication or fluid-specific limit that can be overridden by a

(within drug library) practitioner. These upper (maximum) and lower (minimum) limits advise
the user that the specified infusion is about to be infused outside facility-
established parameters (e.g., common dosage range).

system rounding logic An algorithm or a method used to standardize rounding parameters to

avoid unnecessary nuisance alerts during smart infusion pump auto-
programming.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 29
Term Definition

tall man lettering Refers to a method of differentiating the appearance of similar drug names
known to be confused with one another by using bolded, uppercase
letters to draw attention to a small group of unique letter characters that
are different in each of the drug names. A list of look-alike drug names
with recommended tall man letters can be found at: https://www.ismp.
org/recommendations/tall-man-letters-list.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 30
REFERENCES
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19. ECRI Institute. Infusion pump integration. Health Devices. 2013;42(7):210–21.
20. Suess TM, Beard JW, Ripchinski M, Eberts M, Patrick K, Tharappel LJP. Smart pump–electronic
health record (EHR) interoperability with autodocumentation is associated with increased submission
of infusiontherapy billing claims at a community hospital. Pharmacoecon Open. 2019. https://doi.
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© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 31
21. Pregulam SJ, Rinda JE. Building a plug and play future for healthcare. Medical Device and Diagnostic
Industry. 2010. http://www.mddionline.com/article/building-plug-and-play-future-healthcare.
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22. Prusch AE, Suess TM, Paoletti RD, Olin ST, Watts SD. Integrating technology to improve medication
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26. Institute for Safe Medication Practices (ISMP). Smart pump custom concentrations without hard “low
concentration” alerts can lead to patient harm. ISMP Medication Safety Alert! 2018;23(11):1-4.
27. Cassano-Piché A, Fan M, Sabovitch S, et al. Multiple intravenous infusions phase 1b: practice and
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Safety & Quality Healthcare. January/February 2007. https://www.psqh.com/analysis/smart-pumps-
advanced-capabilities-and-continuous-quality-improvement/. Accessed August 13, 2019.
36. Robert B. McDaniel, PharmD, BCPS, email communication, January 3, 2019.
37. Institute for Safe Medication Practices (ISMP). The virtues of independent double checks—they really
are worth your time! ISMP Medication Safety Alert! 2003;8(5):1.
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Committee on Hospital Care. Prevention of medication errors in the pediatric inpatient setting.
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40. Grasha AF, Reilley S, Schell KL, Tranum D, Filburn J. Process and delayed verification errors in
community pharmacy: implications for improving accuracy and patient safety. Technical Report
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administration errors during anaesthesia. Anaesthesia. 2004;59(5):493–504.
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judiciously and properly. ISMP Medication Safety Alert! 2019;24(11):1-6.
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documentation of different flow rates. ISMP Medication Safety Alert! 2017;22(24):1-2.
47. ECRI Institute. What is infusion pump integration, and which models offer it? Health Devices. January
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© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 33
SUMMIT PARTICIPANTS AND DISCLOSURE
The Institute for Safe Medication Practices (ISMP) gratefully acknowledges the expert contributions
made by the summit participants, without whom the development of this consensus document would
not be possible. Of note, ISMP would like to acknowledge the assistance of E. Robert (Bob) Feroli,
Jr., PharmD, FASHP who facilitated the summit. All participants were volunteers and received no
compensation other than travel and meeting expense reimbursement.

Mary Alexander, MA, RN, CRNI, CAE, FAAN Karen Giuliano, PhD, RN, MBA, FAAN
Infusion Nurses Society Northeastern University
Ivyruth Andreica, PharmD, BSN, FISMP Matthew Grissinger, RPh, FISMP, FASCP
Ivenix Inc. ISMP
John Beard, MD, MBA Amy Hollar, PharmD, BCPS
ICU Medical Inc. Catawba Valley Medical Center
Michelle Bell, BSN, RN, FISMP, CPPS Marla Husch, MS, RPh, LBBSS, PMP
Patient Safety Authority Health-Quest
Deborah Bonnes, RN, MS Cary Ikemoto, RPh
UCHealth Baxter Healthcare Corp.
Julie Boytim, DNP, CRNA Viktoriya Ingram, PharmD, FISMP
Performance Anesthesia Services ISMP
Vivek Brahmbhatt, PharmD, FISMP Jamie Irizarry, RN, BSN, MS, CCRN-K
ISMP Children’s Hospital of Philadelphia
Kayla Cierniak, PharmD, MS, BCPS, FISMP Dennis Killian, PharmD, PhD
ISMP Peninsula Regional Medical Center
Michael Cohen, RPh, MS, ScD (hon), DPS Marie Kozel, MBA, BSN, RNC-BC, PMP
(hon), FASHP Nebraska Methodist Health System
ISMP
Leroy Kromis III, PharmD, BCPS
Gwen Erdmann, BScN, MN, RN Lehigh Valley Health Network
Alberta Health Services
Rebecca Lamis, PharmD, FISMP
Paul Filiatrault, BScPharm, RPEBC ISMP
ISMP Canada
Juuso Leinonen, BEng
N. Jeffery Fleming, PharmD ECRI Institute
Children’s Hospitals & Clinics of Minnesota
Ronald S. Litman, DO, ML
BarbraKaryne N. Nchinda Fobi, PharmD, MPH, ISMP/APSF
CPPS, FISMP
Janet Lowe, RN, MBA
ISMP
ICU Medical Inc.
Donald Gerhart, Jr., RPh
Rebecca Mahuren, BSN, RN
WellSpan Health
Parkview Health
Marianne Gill, RN, MSHA
Michelle Mandrack, MSN, RN
BD
ISMP
Nicole Gitney, MS, RN
Ashley Martin, BS
BayCare Health System
Baxter Healthcare Corp.

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 34
Christina Michalek, BScPharm, RPh, FASHP Chip Stubsten, PharmD
ISMP B Braun Medical
Patricia Mook MSN, RN, NEA-BC, CAHIMS Tina Suess, MHA, BSN, RN-BC, CPHIMS,
AONL, Appointed Board Member CPPS
Penn Medicine Lancaster General Health
Susan Niemeier, MHA, BSN, RN
Ivenix Inc. Cathy Sullivan, MSN, RN, FNP, CCRN
Shawn O’Connell, MS, RN Pamela Swarny, PharmD, JD
B Braun Medical Cleveland Clinic Union Hospital
Sean O’Neill, PharmD Jason Trahan, PharmD, DPLA, CPPS
Bainbridge Health Baylor Scott & White Health
Susan Paparella, MSN, RN Kristin Tuiskula, PharmD
ISMP Massachusetts General Hospital
Dean Parry, RPh Samuel Ubanyionwu, PharmD, BCPS
Geisinger Health System - Care Support Services Mayo Clinic
Deborah Pasko, PharmD, MHA Allen Vaida, PharmD, FASHP
ASHP ISMP
Edward Pollak, MD David Valentine, PharmD, FISMP
The Joint Commission ISMP
Susan Proulx, PharmD Timothy Vanderveen, PharmD, MS
Med-ERRS AAMI Foundation
Christine Ruhl, BSN, MBA, CCRN-K Lolita White, PharmD
Western Maryland Health System U.S. FDA, Division of Medication Error Prevention
and Analysis
Margaret Schmidt, PharmD, MBA
Allina Health Nicole Wilson, MSN, RN, CPHIMS
BD
Ann Shastay, MSN, RN, AOCN
ISMP Richard Zink, MBA
Regenstrief Center for Healthcare Engineering,
Judy Smetzer, BSN, RN
Purdue University
ISMP
Erin Sparnon, MEng
ECRI Institute

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 35
ACKNOWLEDGMENTS
ISMP acknowledges the dedicated ISMP staff and fellows who provided outstanding research and
writing support for this project:
Ghadeer Banasser, PharmD, CPHQ, FISMP Susan Paparella, MSN, RN
Samantha Burton, PharmD, FISMP Farzana Samad, PharmD, FISMP
Michael Cohen, RPh, MS, ScD (hon), DPS Ann Shastay, MSN, RN, AOCN
(hon), FASHP
Judy Smetzer, BSN, RN
BarbraKaryne N. Nchinda Fobi, PharmD, MPH,
Allen Vaida, PharmD, FASHP
CPPS, FISMP
David Valentine, PharmD, FISMP
Rebecca Lamis, PharmD, FISMP
Michelle Mandrack, MSN, RN
Christina Michalek, BScPharm, RPh, FASHP

ISMP would also like to thank the practitioners, vendors, and professional organizations who provided
edits and comments throughout this project.
Mary Alexander, MA, RN, CRNI, CAE, FAAN Chelsea Christopher, PharmD, MHIIM
Infusion Nurses Society LifePoint Health
Ivyruth Andreica, PharmD, BSN, FISMP Brad Cook, PharmD, BCPS
Ivenix Inc. Providence Medical Center
Bryan Bailey, PharmD, MHA, BCPS, FISMP, Regina Cregin, MS, PharmD, BCPS
LTC, MS White Plains Hospital
U.S. Army Medical Command
Rabih Dabliz, PharmD, FISMP
Silvana Balliu, PharmD, RPh Cleveland Clinic Abu Dhabi
Cleveland Clinic
Joel Daniel, MS, PharmD
John Beard, MD, MBA CoxHealth
ICU Medical Inc.
Shawn Dowling
Kelly Besco, PharmD, CPPS, FISMP Royal Alexandra Hospital
OhioHealth Alberta Health Services
Kelly Biastre, PharmD, FFSHP, CPh Deedee Dun, MSN, RN-BC, CCRN, CNS
Baptist Health Jacksonville Samaritan Hospital
Alison Bloomquist, PharmD Jessica Ellis, PharmD
Smiths Medical St. Mary Medical Center
Deborah Bonnes, RN, MS Paul Filiatrault, BScPharm, RPEBC
UCHealth ISMP Canada
Kelly Burch, PharmD Jennifer Foy, RN, BA
Mercy Children’s Hospital Alberta Health Services
Gregory Burger, PharmD, CPPS, FASHP, Melissa Gabriel, PharmD
NREMT Truman Medical Centers
Stormont Vail Health
Kathy Ghomeshi, PharmD, MBA, BCPS, CPPS
Robert Butterfield UCSF Medical Center
RDB Medical Instrument Consulting

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 36
Marianne Gill, RN, MSHA Patricia Mook MSN, RN, NEA-BC, CAHIMS
BD AONL, Appointed Board Member
Nicole Gitney, MS, RN Kelly Nutter, BSN, RN
BayCare Health System OhioHealth
Karen Giuliano, PhD, RN, MBA, FAAN Don O’Brien
Northeastern University Epic
Emily Grant Sean O’Neill, PharmD
UCHealth Bainbridge Health
Corey Herod, BSP Ketan Patell, PharmD
Regina General Hospital Los Angeles County Dept. of Health Services
Saskatchewan Health Authority
Kristin Repp, PharmD, BCPS
Elizabeth Hess, PharmD, MS, FISMP Saint Luke’s North Hospital
University of Kentucky HealthCare
Andrea Robertson, PharmD
Tim Hoh Smiths Medical
Baxter Healthcare Corp.
Gretchen Roeger, PharmD, BCPS
Nema Hosseini OhioHealth
Epic
Margaret Schmidt, PharmD, MBA
Trey Jenkins, PharmD, BCPS Allina Health
WellStar Health System
Karen Smollen, PharmD
Ciara Kirke, MSc, BSc, MPSI Indiana University Health
Ireland’s Health Service Executive
Christine Steffensen, PharmD, MA, BCPPS
Christina Lawrenz, RPh, BCPS Duke Children’s Hospital & Health Center
Lawrence Memorial Hospital
Chip Stubsten, PharmD
Juuso Leinonen, BEng B Braun Medical
ECRI Institute
Tina Suess, MHA, BSN, RN-BC, CPHIMS,
Rhonda Liberto, PharmD, BSPharm, CPPS CPPS
Ochsner Health System Penn Medicine Lancaster General Health
Janet Lowe, RN, MBA Danielle Taylor, RN
ICU Medical Inc. Concord Hospital
Rebecca Mahuren, BSN, RN Valerie Tork
Parkview Health UCHealth
Ashley Martin, BS Timothy Vanderveen, PharmD, MS
Baxter Healthcare Corp. AAMI Foundation
Robert (Ben) McDaniel, PharmD, BCPS Rachel Vitoux, MBA, MSN, RN, CPHIMS
MD Anderson Cancer Center B Braun Medical
Nancy McKee, BSN, RN Elizabeth Wade, PharmD, BCPS, FASHP
The University of Tennessee Medical Center Concord Hospital
Steven Meisel, PharmD, CPPS Robert Warhurst, PharmD
Fairview Health Services Indiana University Health
Dana Miller, PharmD Stacy Lee Wells, PharmD
Sentara Healthcare The University of Tennessee Medical Center

© 2020 Institute for Safe Medication Practices | Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps 37
ABOUT ISMP
The Institute for Safe Medication Practices (ISMP) is the only 501c (3) nonprofit organization devoted
entirely to preventing medication errors. During its more than 25-year history, ISMP has helped make a
difference in the lives of millions of patients and the healthcare professionals who care for them.

ISMP is known and respected as the gold standard for medication safety information. It also has served
as a vital force for progress. ISMP’s advocacy work alone has resulted in numerous necessary changes
in clinical practice, public policy, and drug labeling and packaging.

Among its many initiatives, ISMP runs the only national voluntary practitioner medication error reporting
program, publishes newsletters with real-time error information read and trusted throughout the global
healthcare community, and offers a wide range of unique educational programs, tools, and guidelines.

In 2020, ISMP formally affiliated with ECRI Institute to create one of the largest healthcare quality and
safety entities in the world. The affiliation will allow both organizations to work more closely together for
the benefit of providers, patient advocates, governments, and most importantly, patients.

As an independent watchdog organization, ISMP receives no advertising revenue and depends entirely
on charitable donations, educational grants, newsletter subscriptions, and volunteer efforts to pursue
its life-saving work. For more information or to donate to protect patients worldwide from harmful
medication errors, visit ISMP online at www.ismp.org.

The summit and production of this guidance document was funded through the generous
support of Baxter, B. Braun, BD, ICU Medical, and Ivenix.

Institute for Safe Medication Practices

An ECRI Institute Affiliate
200 Lakeside Drive, Suite 200, Horsham, PA 19044
Phone: (215) 947-7797 Fax: (215) 914-1492
www.ismp.org

© 2020 ISMP Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps is a federally registered trademark in
the name of the Institute for Safe Medication Practices (ISMP). This publication is owned and copyrighted by ISMP and is being made
available to your organization for internal assessment of medication practices. ISMP hereby grants your organization permission to copy
this publication to accommodate your internal assessment process. If you are not an employee or agent of the organization utilizing this
assessment you have no right to copy or use this publication in abrogation of the rights of ISMP.