Prepare an Executive Summary identifying the best Infusion pump to purchase for your hospital based on the device incident history. The executive summary should be no more than 5 pages. The Executive summary should provide:Background of what infusion pumps are used for in the hospital, why they are critical devices and who uses them and how they work. Utilize the Included ECRI summarySummary of the two pumps on the market – Baxter Spectrum and Carefusion (BD) AlarisCommon problems with each device – this is the largest content section of the reportPlease utilize the– FDA – Medical device User Experience – MAUDE database to search reportable incidents from 2018 to 2020 related to Infusion pumps (product class – Pump, Infusion)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm?smc=1For each device – Please summarize the common issues reported by reviewing at least 20 incidents/reports for each pump type and summarizing the major issues.In addition – Please visit each medical devices – home page and identify if there are any active RECALLS related to the issues reported. If there are recalls, identify the actions required and the risks associated with continued use of the device. Based on the incidents you reviewed, the ECRI summary document (provided), and the Manufacturers website and active recalls – please provide a summary of which device you would recommend and why.Manufacturer
WHERE MARKETED
FDA CLEARANCE
CE MARK (MDD)
CONFIGURATION
Number of channels
Max units per pole
DISPLAY
Data displayed
PUMP CAPABILITIES
Flow range, mL/hr
Increments, mL
Baxter Healthcare
Corp Medication
Delivery
SIGMA Spectrum
Version 8
Canada, Puerto
Rico, USA
Yes
No
BD
ICU Medical Inc
Alaris Pump Module Plum 360
Worldwide
Worldwide
Yes
Yes
Yes
Yes
1
≤4
8
Depends on IV pole
1 line (2 concurrent
delivery, direct
connection of
secondary to
cassette)
Depends on hospital
Care area, drug
name, dose rate, rate
(mL/hr), time
remaining, audio
level indicator,
volume remaining,
indicator for primary
or secondary,
alarms, network
status, battery level
Infusion status, drug Program dependent
name, dose,
concentration,
primary or
secondary, infusion
rate, VTBI, patient
weight (if used),
volume infused,
profile name, dataset
name, channel
indicator, patient ID,
dynamic pressure
display, alarm
information
0.5-999
0.1-999
0.1 to 999
0.1 (0.5-99.9 mL/hr), 0.1 (0.1-99.9 mL/hr), 0.1 (0.1-99.9 mL/hr),
1 (>99.9 mL/hr)
1 (10-999 mL/hr)
1 (100-999 mL/hr)
KVO rate, mL/hr
Defined in drug
library, 1 default
Accuracy, %
5
VTBI, mL
0.1-9,999
Automatic piggybacking
Bolus mode
Syringe delivery
MRI conditional
Fluid resistant
Front-panel lockout
IV SET
Yes
Yes
No
No
IPX0
Keypad lock
0.1-20 (0.1 mL
increments)
1, or the last delivery
rate on the
associated line
(whichever is less)
5.5 @ ≤1 mL/hr, 5 @ 5 (1-999 mL/hr), 10
>1-999.9 mL/hr
(0.1-0.9 mL/hr)
0.1-9.99 (0.001
0.1-9,999
increments), 10999.9 (0.1
increments), 1,0009,999 (1 increments)
Yes
Yes
Yes
No
IPX1
Yes
Yes
Yes
Yes
No
IPX2
Yes
Free-flow protection
Air-trapping capability, volume
Needleless IV connection
ALARMS & INDICATORS
Occlusion upstream
Occlusion downstream
Detection mechanism
Set-based
NA
Yes
Yes
Yes
Yes
Yes
Ultrasonic, pressure Selectable
transducer, relative
pressure
Yes
Yes
Selectable
Pressure, psi
Real-time display
Air in line
System malfunction
Set loaded improperly
Door open
Infusion complete
Low battery
Depleted battery
Clinical advisory messages
AUDIBLE ALARM
Volume control
Momentary silence
DOSE ERROR REDUCTION SYSTEM
(smart technology)
Defaults to DERS on startup
6 ±4, 13 ±6, 19 ±9
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
0.5-10.2
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
1-15
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
2 min
Includes titration
error prevention
Yes
Level 1-5
Yes
Yes
Yes
Guardrails Suite MX ICU Medical MedNet
Library size
5,000
No. of care areas
No. of drug entities per care
Wireless connectivity
Autodocumentation
Autoprogramming
Log-analysis software
DATA PORT
32
≤5,000
Yes
Yes
No
Via wireless
IrDA
EVENT LOG
Printout
Number of events
Events stored
Yes
Via computer
≥4,500
Parameter settings,
alarms, power
source, time stamp,
IV set events, pump
events, drug errors,
others
POWER SOURCE
Line power, VAC (Hz)
Battery
Yes
No
Yes
No default mode,
clinician to choose
10,000 drugs and
fluids
30
1,500
Yes
Yes
Yes
Yes
RS232 (RJ45),
wireless
Yes
Yes
≥10,000
All, including
Guardrails alerts with
subsequent
programming
100-240 (50/60)
100-240 (50/60)
Lithium ion, standard Ni-MH
and wireless
Yes
2 mL
Yes
Yes
2,500 (medications
used in multiple
clinical care areas
and count as a single
entry)
40
400
Yes
Yes
Yes
Yes
Yes
Yes
Yes
~1 year
Settings, alarms,
alerts, system errors,
hard and soft limits
120 (50/60), 50 VA
Internal sealed leadacid rechargeable 6
V
Life, hr @ flow (mL/hr)
8 @ 125 (at highest
backlight setting,
new battery)
Recharge time, hr
12
4 @ 95%
$3,200
1 year
2015
Not specified
$3,000
1 year
2001
October to
September
H x W x D, cm (in)
WEIGHT, kg (lb)
PURCHASE INFORMATION
List price
Warranty
Year first sold
Fiscal year
6 @ 25 (1 channel)
>6 @ 125
≤8 hours operating at
125 mL/hr on one
line
14.7 x 10.6 x 6.4 (5.8 22.6 x 8.4 x 14 (8.9 x 20 x 20 x 15 (8 x 8 x
x 4.2 x 2.5)
3.3 x 5.5) pump
6)
module; 22.4 x 17.5
x 22.9 (8.8 x 6.9 x 9)
PC unit
0.95 (2.1)
1.2 (2.6) pump
4.5 (10) with battery
module; 3.3 (7.2) PC
unit
$5,500
1 year
2015
January to
December
OTHER SPECIFICATIONS
Drug library/DERS
prevents potential
programming errors
before infusion
begins; titration error
prevention system
catches potential
programming errors
within the soft limits;
27 continuous dose
modes (+1 for cyclic)
plus 18 amount/time
dose modes; uses
standard IV sets
(Baxter); humanfactors engineered,
field upgradable.
Includes Guardrails
Suite MX Software;
Alaris EtCO2
Module, Alaris PCA
Module, Alaris
Syringe Module,
Alaris Auto-ID
Module (bar-code
reader) and Alaris
Systems Manager.
UMDNS CODE(S)
LAST UPDATED
Supplier Footnotes
Model Footnotes
27889, 28057
February 2020
17634, 28057
December 2017
Data Footnotes
Model 8100.
Formerly marketed
as Medley
Medication System.
Customizable,
hospital-specific drug
library; Hospira
MedNet software
provides hospitaldefined best practice
guidance and safety
rule sets supporting
a hospital’s drug
delivery and
standardization of
practices; enables
delivery of
concurrent
secondary infusion
without changing
head height of
primary container;
enables automated
backpriming to
remove accumulated
air without
disconnecting patient
line; data transfer
between MedNet
server and pump
facilitated by a/b/g/n
wireless functionality;
the infuser has an
intelligent alarm
system that handles
more than one alarm
at a time; different
indicators for high,
medium, and low
priority alarms; ICU
Medical MedNet 6.21
forwards alarm
messages to third
17634, 28057
December 2017
Health Product Comparison System (HPCS)
© 2020 ECRI Institute
Device Overviews & Specifications ‐ Comparative Data
Infusion Pumps, Large-Volume
Published 7/1/2018
EXECUTIVE SUMMARY
Comparison Chart
Infusion Pumps, Large-Volume
This Product Comparison covers large-volume infusion pumps (LVPs), some of which have two or more channels.
Pumps in this report are calibrated in flow settings of milliliters per hour (mL/hr) ranging from 0.1 to 3,600
mL/hr; most have a drug-/dose-calculation feature that permits programming of the flow setting directly from
physician dose orders.
LVPs are used to accurately deliver liquids through intravenous (IV) or epidural routes for therapeutic and/or
diagnostic purposes. They are used in hospitals, in alternative care settings (e.g., homes, long-term care facilities,
physicians’ offices, outpatient infusion centers), and, occasionally, in emergency medical service vehicles.
In general, infusion pumps are used when the solution to be administered must be delivered with greater
accuracy than can be provided through a manually adjusted gravity administration set. Because they allow more
accurate fluid delivery, infusion pumps have proven to be useful in applications such as continuous epidural
anesthesia, administration of IV cardiovascular drugs, chemotherapy, and autotransfusion, as well as in pediatric
applications and for home IV therapy. Blood infusions can also be performed with most pumps, although some
pumps require a special administration set for this application.
LVPs can supply higher pressures than those provided by manually clamped gravity infusion sets or infusion
controllers—for example, to deliver viscous fluids through micropore bacteria filters or to deliver arterial infusions.
The following device terms and product codes as listed in ECRI Institute’s Universal Medical Device
Nomenclature System™ (UMDNS™) are covered:
Infusion Pumps, Multitherapy, Large Volume [28-057]
Infusion Pumps, Multitherapy, Large Volume, MRI Safe/Conditional [28-063]
Infusion Pumps, Multitherapy, Large Volume, Multichannel [17-634]
Infusion Pumps, Multitherapy, Large Volume, Single-Channel [27-889]
These devices are also called: general-purpose infusion pumps, microinfusion pumps, multichannel pumps,
volumetric infusion pumps.
© 2020 ECRI Institute
Health Product Comparison System (HPCS)
Comparison Chart
Infusion Pumps, Large-Volume
Scope of this Product Comparison
This Product Comparison covers large-volume infusion pumps (LVPs), some of which have two or more channels.
Pumps in this report are calibrated in flow settings of milliliters per hour (mL/hr) ranging from 0.1 to 3,600 mL/hr;
most have a drug-/dose-calculation feature that permits programming of the flow setting directly from physician
dose orders.
These devices are also called: general-purpose infusion pumps, microinfusion pumps, multichannel pumps,
volumetric infusion pumps.
Purpose
LVPs are used to accurately deliver liquids through intravenous (IV) or epidural routes for therapeutic and/or
diagnostic purposes. They are used in hospitals, in alternative care settings (e.g., homes, long-term care facilities,
physicians’ offices, outpatient infusion centers), and, occasionally, in emergency medical service vehicles.
In general, infusion pumps are used when the solution to be administered must be delivered with greater accuracy
than can be provided through a manually adjusted gravity administration set. Because they allow more accurate
fluid delivery, infusion pumps have proven to be useful in applications such as continuous epidural anesthesia,
administration of IV cardiovascular drugs, chemotherapy, and autotransfusion, as well as in pediatric applications
and for home IV therapy. Blood infusions can also be performed with most pumps, although some pumps require a
special administration set for this application.
LVPs can supply higher pressures than those provided by manually clamped gravity infusion sets or infusion
controllers—for example, to deliver viscous fluids through micropore bacteria filters or to deliver arterial infusions.
Principles of Operation
LVPs use one of two basic types of pumping mechanisms to move fluid from the solution container through the IV
set to the patient: peristaltic or cassette.
The most common peristaltic mechanism is the linear peristaltic device, which uses fingerlike disks to occlude the
IV tubing successively in a rippling, wavelike motion. The tubing is held against a stationary backing plate and
alternately compressed and released by the moving fingers, forcing the fluid to flow. Similar to the linear peristaltic
device, the rotary peristaltic pump uses a short length of silicone rubber tubing held taut around rollers mounted on
a rotor. As the rotor is turned at precise speeds by a motor drive, the rollers occlude the tubing and force the fluid
from the solution container into the patient at the preselected rate. The cycling rate of either a linear or rotary
peristaltic mechanism is determined by a stepper motor, which delivers a specific volume with each pulse; varying
the infusion rate changes the frequency of the pulses.
The second type of pumping mechanism uses a cassette normally fitted with either a syringelike or pistonlike device
and tubing running from two sides. In syringe cassettes, a motor-driven plunger moves into and out of a cylinder.
The inward motion pumps the fluid out of the cassette toward the patient, while the outward motion draws fresh
fluid from the solution container to refill the cassette. In some cassettes, a valve directs the flow along the desired
© 2020 ECRI Institute
Health Product Comparison System (HPCS)
path at the appropriate times in the plunger cycle.
In piston-actuated diaphragm cassettes, a diaphragm is mounted near a moving piston that displaces a fraction of
a milliliter of fluid toward the patient with each inward stroke and allows the diaphragm to refill with each outward
stroke. A valve assembly directs the flow along the desired path at the appropriate time in the plunger cycle. This
pumping mechanism delivers the infusate in discrete volume increments, normally in a pulsating flow. The flow is
automatically controlled by varying the piston stroke length and rate. Some pumps use a pair of pistons to infuse
the solution through a dual-chamber cassette.
Most infusion pumps allow the user to select the dose or volume to be infused (VTBI). If this limit is reached before
the fluid source is depleted, most pumps will alarm and continue infusing fluid at a very low rate to prevent the
infusion catheter from clogging. This low flow is referred to as the “keep vein open,” or “KVO,” rate.
Many pumps can deliver secondary (piggyback) infusions, controlling two different solutions sequentially per
pumping channel. A variety of mechanisms control primary and secondary infusions; most pumps require a special
administration set with a check valve that prevents secondary infusate from flowing up to the primary bag. Pumps
capable of piggyback delivery can be programmed to revert to a primary flow setting after the secondary infusion
dose is delivered. Many models require users to hang the primary bag lower than the secondary bag; gravity forces
the secondary bag to flow until it is empty, at which time the primary bag begins to flow again.
Pumps may have more than one infusion channel. Multichannel devices can simultaneously infuse from and
monitor two or more IV lines and can be substituted for several single-channel infusion pumps that might be used
on one patient. One model is modular, permitting up to four pump modules to be attached to a common
programming module.
Most infusion pumps sold in the USA, and some marketed globally, now have a dose error reduction system (DERS)
or onboard protocol library. Also called “smart pumps,” these devices aid in prevention and warn users of
programming errors that could result in under- or overdelivery, and some systems include starting dose
parameters. These systems allow infusion pumps to warn users if the rate programmed is above the set limit for
that medication, calculation errors, or misprogramming that would result in significant under- or overdelivery of a
drug, electrolyte, or other fluid. DERS are an important part of a facility’s defenses against medication errors and
are available on large-volume (also known as general-purpose), syringe, patient-controlled analgesic (PCA), and
ambulatory pumps. To implement such a system, a facility must establish standardized concentrations and
minimum/maximum dose limits for pain medications used in each clinical location (including limits for continuous,
bolus, and total dose parameters); all pumps are then programmed with these parameters in a drug or protocol
library.
To give an infusion, a nurse selects the appropriate clinical location/application (e.g., “ICU” or “orthopedic post-op”)
and then the correct drug entity (name, volume of the reservoir, and concentration or total drug amount in diluent).
The clinician then enters any required patient-specific parameters like starting dose parameters and weight, and
the pump will display a warning if programmed parameters would result in a rate that is outside the predetermined
limits for the selected drug. For “soft limits,” the nurse can either change the programmed dose or override the
warning and start the pump as programmed. For “hard limits,” the nurse must change the settings so that the dose
is within the acceptable limits. Many infusion pumps with a protocol library have both soft- and hard-limit
capabilities, which gives the facility the ability to set up the drug library so that any given drug entity may have only
soft limits, only hard limits, or soft limits nested within hard limits. The drug name and concentration are also
displayed during infusion.
Some pumps that lack full DERS features offer a programmable or downloadable drug library that allows a
clinician to program a pump by selecting a dosing protocol from a computer via a wired or wireless connection.
© 2020 ECRI Institute
Health Product Comparison System (HPCS)
When a clinician chooses a protocol, the pump is populated with the drug name, concentration, starting dose, timebased dosing limit, and lockout interval, thus eliminating the possibility of entry errors in initial programming.
Pumps have a series of alarms that warn the operator of conditions in the infusion system that could be harmful to
the patient. These include air in line, upstream or downstream occlusion, empty fluid container, set disengagement,
and flow error. Alarm conditions are detected by pressure and/or ultrasonic transducers and optical sensors. A few
pumps can interface with the facility’s nurse call system to send alarm conditions to the central nursing station.
Most pumps also have a memory that can retain the programmed settings and the total volume infused in case of
temporary power interruption. Most pumps with memory can log data, such as pump settings, alarm occurrences,
system errors, user key presses, and the time and date of each event. In addition, a data port, such as an RS232 or
Ethernet port, allows hospitals to retain electronic or hard copies of infusion data. Some pumps have optional
wireless capabilities for transferring data (such as more detailed logs or drug libraries) to and from a centralized
server over a hospital’s wireless network.
Many infusion pumps are wireless, which enables wireless drug library updates, infusion pump log analysis, and
pump integration. Infusion pump integration is the connecting of pump servers with other information systems to
ensure that pump programming matches provider orders. There are two ways to integrate, namely
autoprogramming and autodocumentation. Autoprogramming increases the safety of infusions by engaging the
pump’s drug library as well as preventing manual data entry errors. Autodocumentation automatically populates
the patient’s records with accurate infusion administration information, thus reducing the documentation burden on
caregivers and expediting workflow.
Reported Problems
Infusion devices are the subject of many adverse incident reports to the Food and Drug Administration (FDA) and
the consequences of infusion errors can be severe. Patients can be highly sensitive to the amount of medication or
fluid they receive from infusion pumps, and some medications are life-threatening if administered in the wrong
amounts or to the wrong patient. In April 2010, FDA issued a white paper about improving infusion pump safety
and announced that it would be looking into the devices in order to aid in the development of safer and more
effective infusion technologies and practices. FDA noted that many of the reported infusion pump problems were
unrelated to manufacturer or brand, or even technology; the most common problems included software defects
and user interface issues (e.g., confusing or unclear instructions). Medication errors due to infusion pump
mechanism malfunctions occur less frequently, usually when a pump has been damaged or in rare instances of
problems with pump administration sets.
Medication errors that occur with infusion pumps often result from (1) an operator failing to correctly program the
infusion order into the pump or (2) a physician issuing an incorrect or inappropriate order. Such errors can be
reduced by establishing clear protocols for ordering infusions and programming pumps (e.g., double-checking
medication orders) and by using pumps with dose-calculation capabilities; these steps will simplify or even
eliminate the somewhat error-prone process of performing manual dose calculations. However, even when these
measures are observed, administration errors can still occur (e.g., if a decimal point is omitted or if an incorrect
dosing unit is programmed).
Gravity flow, or free-flow (a situation in which fluid flows into the patient without being controlled by the infusion
pump) used to be a significant risk of infusion therapy, but over-infusion due to gravity flow is rarely reported now
that ECRI Institute and the Joint Commission consider infusion pumps without set-based free-flow protection to be
unacceptable for purchase or rental. However, gravity flow can still occur if the operator manually opens the set’s
© 2020 ECRI Institute
Health Product Comparison System (HPCS)
anti-free-flow clamp or valve.
Infiltration (also called extravasation) is the extravascular accumulation of a solution being infused. This can result
in tissue irritation, compartment syndrome, or tissue necrosis; in addition, the patient is denied the necessary fluids
or medications. A number of infiltration incidents have been reported to ECRI Institute implicating all types of
infusion pumps. However, infusion pumps typically play only an ancillary role in such incidents, and the belief that
pumps themselves produce infiltration is inaccurate. Rather, the usual causes of infiltration are dislodgment or
improper insertion of either a catheter or, in the case of a subcutaneous injection port, a needle. Thus, to avoid
problems, staff members should monitor IV sites of patients who are receiving infusions through pumps at least
hourly to ensure that catheter or needle dislodgment and subsequent infiltration do not occur.
ECRI Institute has received reports about infusion pump cleaning-related problems including difficulty with
complying with manufacturer’s cleaning instructions and inappropriate cleaning methods that can result in
equipment damage and affect the device’s functionality. Repeated use of incompatible cleaning agents can
damage equipment surfaces and degrade plastics, resulting in equipment malfunction including improper battery
or inter-unit interface connections. These connection failures can result in frequent alarms, infusion interruptions,
and potentially patient harm.
An inconsistency in the time format between the infusion pump and the EMR can lead to confusion and incorrect
time entry on the infusion pump. If the time is entered incorrectly, infusion therapy rate may be affected resulting in
overinfusion or underinfusion of medication, which can lead to patient harm. ECRI Institute recommends verifying
time entry format or using pump integration to avoid the need for manual data entry on the pump to help avoid this
hazard.
Infusion errors can be deadly, but simple safety practices can greatly decrease the likelihood of harm. These steps
include noticing signs of physical damage to the infusion pump components, ensuring appropriate use of the roller
clamp on the IV tubing, and checking the drip chamber beneath the medication reservoir for unexpected flow.
These practices are commonplace and critical for patient safety.
Purchase Considerations
ECRI Institute Recommendations
Included in the accompanying comparison chart are ECRI Institute’s recommendations for minimum performance
requirements for LVPs. In general, LVPs should be able to provide a flow of 0.1 to at least 999 mL/hr and maintain
an accurate flow rate to within 5% of flow settings.
ECRI Institute believes that pumps with a DERS will significantly reduce calculation, transcription, and
misprogramming errors. ECRI Institute does not recommend using an infusion pump without a DERS for general
patient care. The library should cover at least 10 care areas with at least 100 drug entities per care area. Some
units may be able to be extensively configured with each drug entity and care area. Units that default to the DERS
ensure that the user is forced to opt out from the safety software if attempting to infuse without safety limits. The
system must also be able to connect wirelessly to the Internet.
ECRI Institute considers set-based free-flow protection a required feature on all newly purchased infusion pumps.
Facilities that currently own pumps that do not use anti-free-flow infusion sets should make their replacement a
very high priority. ECRI Institute has rated all pumps without set-based free-flow protection Unacceptable. The Joint
Commission had included free-flow protection in its National Patient Safety Goals since July 2002. Although the
patient safety goal pertaining to free-flow protection was retired for 2006, hospitals will still be expected to comply
with the retired goal under the Joint Commission’s Environment of Care standard EC 6.20 (see Health Devices 2004
© 2020 ECRI Institute
Health Product Comparison System (HPCS)
Dec).
LVPs should alarm and stop infusing when air-in-line volume reaches a level of 100 µL. The alarm should also not
activate in response to air volumes of less than 50 µL. This recommendation is based on the practical
consideration that volumes below 50 µL would trigger nuisance alarms for outgassed microbubbles, which are
common and nonthreatening. LVPs detect upstream occlusions. In addition, pumps should have alarms and
indicators for downstream occlusions, infusion complete, set loaded improperly, door open, circuit malfunction, and
low/depleted battery. LVPs should also have a log of alarms, volume infused, dose limit warnings, and key presses.
The log should be able to store information from a full week.
The pump should be designed to revert to a KVO rate between 1 and 5 mL/hr (but not greater than the
programmed flow rate) once the programmed volume is delivered. Pumps should have an automated secondary
(piggyback) infusion that switches from a programmed secondary flow rate to the primary flow rate once it has
delivered the secondary volume.
ECRI Institute recommends that LVPs have integral batteries that can run for at least 5 hours at a flow rate of 25
mL/hr, are commonplace, and are easily replaced. Batteries should fully recharge in less than 8 hours and should
be capable of charging independently of the main power switch. In the case of a line-power failure, pumps should
automatically switch over to battery power. All LVPs should be fluid-proof and should automatically alarm and shut
down if fluid penetrates the electronic circuitry. LVPs should also be able to connect to the hospital’s wireless
network and communicate to a central pump server.
As with many devices, purchasing infusion pumps is much more complicated than it used to be. Infusion system
purchases involve buying a complete drug delivery platform, including pumps, software, and communication
interfaces. In addition, if a facility plans to utilize wireless networking capabilities on its infusion pumps, they must
ensure that the hospital network is equipped to provide reliable wireless communication everywhere a pump will
be. Finally, to experience the safety benefits of DERS, a large commitment to drug standardization and drug library
development is required.
Buying a pump involves establishing a long-term relationship with the pump’s supplier for initial implementation,
product upgrades, and ongoing support. The barrier to switching suppliers once a facility has already implemented
a smart pump model is also much higher than with traditional pumps: if a facility is going to switch, it will probably
have to make changes to the drug library, which can be time-consuming. The facility will also need to consider that
the differences in operation between the devices means that users will need to be retrained, and the differences in
the log-analysis and library-editor tools may mean that it is possible to lose some of the expertise administrators
have developed from working with the previous system.
Other Considerations
Before choosing a new infusion pump, healthcare facilities should first consider their needs. Determine the number
of pumping channels needed, and find out whether it is advantageous to purchase single-channel pumps,
multichannel pumps, or both. Facilities should attempt to standardize on one supplier’s LVP or family of pumps
(that use the same administration set and control panel) for use throughout the hospital. Standardization will
greatly simplify protocol library implementation and maintenance, user training, and supplier involvement. If
standardization on a single model is impractical, the next most desirable option is to standardize on a single
supplier’s product line.
Apart from the basic concerns for pump safety and performance, pumps must include data logs that store all user
interactions and pumps settings. A date- and time-stamped event log (typically activated in service mode) is
extremely valuable in determining the cause of a pump-associated adverse incident. Pumps with a DERS should
© 2020 ECRI Institute
Health Product Comparison System (HPCS)
have a separate log that records dose limit events and clinician responses (e.g., override soft limit, reprogram
pump).
Because DERSs vary greatly in their features and functionality, evaluating these systems is a critical part of the
pump selection process. Some features to look for include larger drug libraries, wireless connectivity, log-analysis
software, and interfaces between a pump server and third-party information systems. Wireless connectivity can
allow pushing new drug libraries or dosing information to the pump as well as pulling event logs from the pump.
Log analysis software is useful for tracking near misses, monitoring the use of the drug library, and for refining the
library to match the clinical needs of the practice. In addition, interfaces between the pump and EMRs or pharmacy
dispensing systems are desirable.
Establishing drug libraries and limits requires planning and clinician compliance. Some facilities wish to include a
clinical trial in their selection process; generally, smart-pump vendors work with facilities to identify a few
representative clinical locations in which to deploy trial pumps and then develop a small drug library for those
locations. Such a library is typically limited to five or six drugs per location, with the drugs being those that pose the
greatest risk or that are delivered most frequently (or some combination of both). Other vendors prefer to forgo the
trial process, opting instead for clinical simulations to allow clinicians to assess the interface and functionality of
their pump model. Drug library editing and log analysis are two of the most important elements of successful smart
pump-implementation, so any pump selection process should also include an assessment of the vendors’ software
applications for these functions. Hospitals should also consider the vendor’s ability to assist with drug library
creation, training, and overall smart pump implementation. Pump vendors often play a valuable role in the
implementation of such a system because they are generally more experienced than the hospital and can assist
with specific library development questions. Therefore, vendors who are established within several hospitals,
and/or offer a comprehensive support program should be considered.
Medical device integration (MDI) is of growing interest to hospitals in the United States, and interest in connecting
pump servers to other information systems is growing in two applications: (1) automatically programming infusion
pumps or checking manual programming against electronic provider orders, and (2) automatically documenting
infusion status and administration in a patient’s electronic medical record. Hospitals that wish to connect their
infusion pump servers to other information systems should carefully document their expectations of such an
implementation, and should carefully consider whether each pump and information system supplier can support
these expectations. For further information, refer to ECRI Institute’s Health Devices citations in the bibliography of
this report.
Cost Containment
Because infusion pumps entail ongoing maintenance and operating costs, the initial acquisition cost does not
accurately reflect the total cost of ownership. A life-cycle cost (LCC) analysis that takes into account the cost of
software licenses, maintenance, and upgrades; disposables (e.g., primary and secondary infusion sets, needleless
accessories); device maintenance; and personnel training should be prepared. Many suppliers offer various
programs for rental, lease, or purchase of infusion pumps, including volume discounts.
An acquisition decision should be based on issues such as LCC, local service support, discount rates and non-pricerelated benefits offered by the supplier, and standardization with existing equipment in the department or hospital
(i.e., purchasing all infusion pumps from one supplier). Prices quoted from the suppliers (not list prices) will be
needed to make a useful cost comparison. Hospitals interested in purchasing infusion pumps with a DERS should
also be aware of additional fees for software licensing, software maintenance, and implementation consulting. The
software licensing fee is a one-time fee paid at the time of purchase that covers the right to use the supplier’s DERS
© 2020 ECRI Institute
Health Product Comparison System (HPCS)
software. The software maintenance fee is an annual fee that covers software updates, patches and virus
protection, and other technical support. The implementation consulting fee is a one-time fee paid at the time of
purchase, covering services such as staff and clinician training and developing a customized drug library. ECRI
Institute recommends taking advantage of supplier licensing, maintenance, and consulting plans; therefore,
hospitals should consider these fees when requesting quotes for pumps with a DERS. Fees for developing and
maintaining interfaces to other information systems (if MDI is desired) should also be considered in a cost
comparison.
Stage of Development
Pumping mechanism technology has remained stable; however, notable developments include smaller and lighter
pumps, and infusion pump integration.
Some pumps with DERSs offer wireless connectivity between pumps and a server, allowing the transfer of event
and alarm logs from the pumps to the server in near-real-time and the transfer of new drug libraries from the server
to pumps. This capability enhances the use of DERSs by allowing for regular review of alarm and event logs for
library revision (an important maintenance activity) and updates to drug libraries without the need for locating
pumps and physically connecting them to a computer.
Standardizing infusion devices that have DERS capabilities can be a struggle for facilities. Replacing pumps with
DERS-capable systems may not be possible for facilities that are under contract with an original equipment
manufacturer (OEM). Standardization is also difficult in areas where pumps are purchased for specific criteria and
applications. A lack of proper training on these devices, coupled with frequent staff turnover can often negate the
benefits provided by the DERS-capable pumps.
Some pumps with server-based architecture may be interfaced with other hospital information systems (e.g.,
pharmacy information systems, electronic medication administration records) to populate these systems with realtime or near-real-time administration information; order-checking and auto-documentation capabilities are possible.
This would require a method of accurately associating infusion pumps with patients (e.g., bar-code readers), a
network connection between the pumps and the server to populate the server with updated log information from
the pumps, and customized software to pull administration information from these logs and send it to other hospital
systems. Pump integration is being driven both by safety concerns and by the desire to electronically document
infusion activities, the latter of which will allow hospitals to meet meaningful use goals required by the Health
Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Infusion pump integration to
computer-provided order entry systems, electronic medical records (EMRs), and even patient monitors can
dramatically reduce medication administration errors. It is rapidly expanding and is available from most vendors.
BIBLIOGRAPHY
Breland BD. Continuous quality improvement using intelligent infusion pump data analysis. Am J Health Syst
Pharm 2010 Sep 1;67(17):1,446-55.
Burdeu G, Crawford R, van de Vreede M, et al. Taking aim at infusion confusion. J Nurs Care Qual 2006 AprJun;21(2):151-9.
Cummings K, McGowan R. “Smart” infusion pumps are selectively intelligent. Nursing 2011 Mar;41(3):58-9.
ECRI Institute. A road map for medical device interoperability: seven key steps to help your facility establish and
maintain interoperability [guidance article]. Health Devices 2013 Feb;42(2):62-6.
BD—Alaris Pump Modules: ECRI Institute members continue to report inter-unit interface connector problems
© 2020 ECRI Institute
Health Product Comparison System (HPCS)
[ECRI Exclusive Hazard Report]. Health Devices 2017 Nov 1.
Checklist: dose error reduction systems. Health Devices 2007 Oct;36(10):332-6.
Choosing an air-in-line alarm threshold: why we recommend 100 μL. Health Devices 2016 Feb 3.
Dose error reduction systems: features and functions. Health Devices 2015 Feb 25.
Ease of use: a critical component of infusion pumps. Health Devices 2015 Feb 25.
ECRI Institute’s infusion pump criteria [guidance article]. Health Devices 2008 Feb;37(2):52-8.
Epidural infusion pumps: safe selection and use. Health Devices 2017 May 31.
Evaluation background: large-volume infusion pumps. Health Devices 2017 Jan 11.
Executive brief: top 10 health technology hazards for 2017. Health Devices 2016 Nov.
General-purpose infusion pumps [inspection and preventive maintenance procedure].
BiomedicalBenchmark. Procedure no. 416-20081015-01.
Infiltration during infusion therapy: why it occurs and how to prevent it. Health Devices 2016 Feb 3.
Infusion errors can be deadly if simple safety steps are overlooked. Health Devices 2016 Nov 4.
Infusion pump dose error reduction systems [guidance article]. Health Devices 2004 Dec;33(12):427-9.
Infusion pump inspection frequencies: how often is enough? Health Devices 2016 Feb 3.
Infusion pump integration: why is it needed, and what are the challenges? [guidance article]. Health Devices
2013 Jul;42(7):210-21.
Infusion pumps. Healthc Risk Control 2011 Jul;3, Medical Technology 15:1-9.
Infusion pumps/electronic medical records—time format inconsistency may lead to over—or underdelivery of
medication [ECRI Exclusive Hazard Report]. Health Devices Alerts 2017 Nov 30.
Infusion pumps—failure to follow manufacturers’ recommended cleaning instructions may cause premature
device failures. [ECRI Exclusive Hazard Report]. Health Devices Alerts 2016 Jun 16.
Infusion pumps to consider for use with hyperbaric chambers. Health Devices 2016 Feb 17.
Infusion pumps: understanding key terms and concepts. Health Devices 2016 Feb 3.
Infusion technology purchasing: it’s not just about pumps. Health Devices 2015 Feb 25.
Large-volume infusion pumps: features and functions. Health Devices 2015 Feb 25.
MR-conditional pumps: the smarter choice for infusions in the MR environment. Health Devices 2015 Jul 29.
Tips and tools for a smart pump clinical assessment. Health Devices 2017 Jan 6.
What is infusion pump integration, and which models offer it? Health Devices 2018 Jan 17.
Gebhart F. Are smart pumps being used intelligently? Drug Topic Suppl [online]. 2007 Aug 20 [cited 2017 Nov
15]. Available from Internet: http://www.drugtopics.com/hospitalhealth-system-pharmacy.
Healthcare Technology Safety Institute. Best practice recommendations for infusion pump-information network
integration. 2012 [cited 2017 Nov 15]. Available from Internet:
https://www.pharmamedtechbi.com/~/media/Supporting%20Documents/The%20Gray%20Sheet/38/33/Infusi
on_Pump_White_Paper_Aug4.pdf
Iacovides I, Blandford A, Cox A. Infusion standardization and dose error reduction software. Br J Nurs 2014 Jul;23
© 2020 ECRI Institute
Health Product Comparison System (HPCS)
Suppl 14:S16-24.
Ibarra-Perez R, Puertolas-Balint F, Lozano-Cruz E, et al. Intravenous administration errors intercepted by smart
infusion technology in an adult intensive care unit. J Patient Saf 2017 Apr 1 [Epub ahead of print].
Infusing Patients Safely. Priority issues from the AAMI/FDA infusion device summit. 2010 [cited 2017 Nov 15].
Available from Internet:
http://s3.amazonaws.com/rdcmsaami/files/production/public/FileDownloads/Summits/AAMI_FDA_Summit_R
eport.pdf
Koutnik E. Infusion pumps are reducing medication errors Pharm Times [online]. 2004 Nov 1 [cited 2017 Nov
15]. Available from Internet: http://www.pharmacytimes.com.
O’Brien G, Edwards S, Littlefield K, et al. Securing wireless infusion pumps in healthcare delivery organization
NIST SP 1800-8 Practice Guide, DRAFT [online]. 2016 July [cited 2017 Dec 5]. Available from the Internet:
https://nccoe.nist.gov/publication/1800-8/.
Phelps PK. Smart infusion pumps: implementation, management, and drug libraries. 2nd ed. Bethesda:
American Society of Health-System Pharmacists; 2011.
Sparnon E. Select smarter pumps that work for you. Mater Manag Health Care 2009 Jul;18(7):30-2.
Trbovich P, Easty A. Smart pump implementation: a guide for healthcare institutions. 2012 [cited 2017 Nov 15].
Available from Internet: http://www.aami.org/htsi/SI_Series/Smart_Pump_Implementation.pdf.
Weinger MB, Kline A. Reflections on the current state of infusion therapy [online]. Biomed Instrum Technol 2016
Jul-Aug;50(4):253-62.
Wetterneck TB, Skibinski KA, Roberts TL, et al. Using failure mode and effects analysis to plan implementation of
smart i.v. pump technology. Am J Health Syst Pharm 2006 Aug;63(16):1,528-38.
RESOURCE LIST
Comparison Chart
Infusion Pumps, Large-Volume
Request for Proposal Template
Infusion Pumps, Large-Volume
RELATED RESOURCES
Infusion Pumps, Ambulatory
Infusion-Pumps,-Enteral-Feeding
Infusion Pumps, Insulin
Infusion Pumps, Patient-Controlled Analgesic
Infusion Pumps, Syringe
TOPICS AND METADATA
Topics
Infusion Therapy
;
Pain Management
;
Technology Selection
© 2020 ECRI Institute
Health Product Comparison System (HPCS)
Caresetting
Ambulatory Surgery Center
;
Emergency Department
;
Home Care
;
Hospice
;
Hospital Inpatient
;
Hospital Outpatient
;
Skilled-nursing Facility
;
Trauma Center
Roles
Allied Health Personnel
;
Materials Manager/Procurement Manager
;
Nurse
Information Type
Comparative Data
UMDNS
Infusion Pumps, Multitherapy, Large Volume [28-057]
Infusion Pumps, Multitherapy, Large Volume, MRI Safe/Conditional [28-063]
Infusion Pumps, Multitherapy, Large Volume, Multichannel [17-634]
Infusion Pumps, Multitherapy, Large Volume, Single-Channel [27-889]
© 2020 ECRI Institute
Purchase answer to see full
attachment
Why Choose Us
- 100% non-plagiarized Papers
- 24/7 /365 Service Available
- Affordable Prices
- Any Paper, Urgency, and Subject
- Will complete your papers in 6 hours
- On-time Delivery
- Money-back and Privacy guarantees
- Unlimited Amendments upon request
- Satisfaction guarantee
How it Works
- Click on the “Place Order” tab at the top menu or “Order Now” icon at the bottom and a new page will appear with an order form to be filled.
- Fill in your paper’s requirements in the "PAPER DETAILS" section.
- Fill in your paper’s academic level, deadline, and the required number of pages from the drop-down menus.
- Click “CREATE ACCOUNT & SIGN IN” to enter your registration details and get an account with us for record-keeping and then, click on “PROCEED TO CHECKOUT” at the bottom of the page.
- From there, the payment sections will show, follow the guided payment process and your order will be available for our writing team to work on it.