Ambulatory Infusion Pumps

Procedure No. 490-20081015-01 ( Major )

Used For:
Infusion Pumps, Ambulatory [16-491]

Commonly Used In:

All patient care areas, homes

Scope:
Applies to ambulatory infusion pumps. If the pump is used for patient-controlled analgesia, see/use Procedure
No. 489 PCA Infusion Pumps

Risk Level: High

Type Interval Time Required

Major 12 Months 0 hours

Minor 0 NA 0 hours

Overview:
Infusion pumps are often used when accurate delivery (within 5% of flow setting) is required over long
periods of time. Ambulatory pumps are small, battery operated units, that do not rely on line power or gravity
for operation. They are commonly used to infuse antibiotics, analgesics, chemotherapeutic agents, and total
parenteral nutrition solutions. Some units can be used for patient-controlled analgesia.
There are also disposable, elastomeric devices that have a flow restrictor to deliver fluid at a fixed, low rate.
They resemble a balloon and and have a typical volume of 50 mL or 100 mL. They are frequently used to
deliver IV antibiotics and subcutaneous analgesics. Flow accuracy of these devices may vary between 5%
and 10%.

Test Apparatus, Supplies, Parts:

• Electrical safety analyzer

• Pressure meter (≥50 psi)

• Infusion pump tester - optional

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Procedure No. 490-20081015-01 ( Major ) Ambulatory Infusion Pumps

• 50 mL graduated cylinder (1 mL graduations)

• Electronic balance (200 g range, 0.1 mg resolution)

• 5 mL pipette (0.1 mL graduations)

• Stopwatch or watch that displays seconds

Special Precautions:

Procedure:
Be sure that you understand how to operate the equipment, the significance of each control and indicator, and
the alarm capabilities. Before beginning an inspection, carefully read this procedure, the operators manual,
and the inspection and preventive maintenance procedures recommended by the manufacturer (typically
included in the service manual). Use the BiomedicalBenchmark Support Assessment Form to document a
maintenance decision that reflects past experience with this type of equipment and the environment where it
is used. Then use the IPM Procedure Customization Tool to modify this procedure as needed; the program
will generate a documentation form with the corresponding changes.
Use the disposable accessory (e.g., IV tubing set, cassette) specified for the infusion pump to be inspected.
Disposable accessories should be replaced at least weekly and more frequently with heavy use. Use degassed
water or, when available, bags of outdated (i.e., clinically unusable) IV solutions.
For settings ≥1 mL/hr, flow accuracy is most conveniently determined with an infusion pump tester. If an
infusion pump tester is not available, calculate flow rate by dividing the volume collected in a 50 mL
graduated cylinder (1 mL graduations) by the delivery time measured with a stopwatch. For settings less than
1 mL/hr, calculate flow rate by dividing the mass obtained in a small beaker on an electronic balance (200 mg
range and resolution to 0.1 mg) by the measurement time. If a balance is not available, use a 5 mL pipette
(0.1 mL graduations) attached to a vertical mounting stand and divide the volume collected by the delivery
time.
Operate the infusion pump on battery power during its entire inspection to check that the battery has been
charged and can hold a charge. If a low-battery alarm occurs, verify that the alarm is properly displayed and
then continue the inspection on line power. Note how long the pump was operating on battery power and the
conditions under which the low-battery alarm occurred. Fully charge the battery before returning the pump to
use.

Qualitative tasks: Chassis/Housing.

Examine the infusion pump for overall condition. The chassis should be clean and free from IV or enteral
solution residue, especially near moving parts (e.g., thumbwheel switches, pump or controller mechanisms).
Also check for dried solution deposits on accessible air-in-line sensors, pressure sensing mechanisms, and
infusion set/cassette locking mechanisms. Check that labels and markings are legible.

Mount.

Screws and brackets that attach the infusion pump to an IV pole should be secure and functioning. If the
pump is mounted on a stand or cart, examine the condition of the mount. Also examine the pole, stand, or
cart.

AC Plug.

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Procedure No. 490-20081015-01 ( Major ) Ambulatory Infusion Pumps

Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure.
Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the
plug and inspect it.
If the device or its IV pole has electrical receptacles for accessories, inspect them by inserting an AC plug
into each and checking that it is held firmly. If accessories are plugged and unplugged often, consider a full
inspection of the receptacle.

Line Cord.

Inspect the cord for signs of damage. If damaged, either replace the entire cord or, if the damage is near one
end, cut out the defective portion.

Strain Reliefs.

Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely.

Fittings/Connectors.

Examine any electrical cable connectors for general condition. Electrical contact pins or surfaces should be
straight and clean. Check any spill-protection connector caps for signs of damage.

Controls/Switches .

Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a
control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping.
Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the
inspection, be sure to check that each control and switch performs its proper function.

Battery.

Inspect the physical condition of batteries and battery connectors, if readily accessible. Operate the pump on
battery power during its entire inspection to check that the battery has been charged and can hold a charge. If
a low-battery alarm occurs, check to ensure that it is properly displayed and then continue the inspection
using line power. Note how long the infusion device has been operating and the conditions under which the
low-battery alarm occurred. Fully charge the battery before returning the pump to use. When it is necessary
to replace a battery, label it with the date.

Indicators/Displays.

During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, visual
displays, and display backlighting, if so equipped. Be sure that all segments of a digital function. (Many
infusion devices automatically check indicator and display function when turned on or during a manually
activated self-test.)

Self-Test.

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Procedure No. 490-20081015-01 ( Major ) Ambulatory Infusion Pumps

For units with a self-test mode, activate it and determine if the expected response is produced.

Time/Date Settings.

Verify that the time and date settings on the unit are correct.

Network/Wireless Interfaces.

Review measures taken to ensure protection against the potential risks and vulnerabilities to the
confidentiality, integrity, and availability of electronic information stored or transmitted by the device or
system and verify that preventive measures are still active. For example, are passwords being applied
correctly, have operating system and virus protection patches and upgrades been installed, is the device still
operating on a VPN (virtual private network) and are wireless security measures still in place. Verify that
data backup processes are activated and that data can be retrieved from backups.

Alarms.

Many infusion device alarm capabilities can be checked qualitatively. The following procedures include tests
for the most common alarm conditions. Check the instruction manual to see how the alarm should work.
When an alarm occurs, check to see that both audible and visual alarms are activated and that flow stops or is
reduced to a keep-vein-open rate (e.g., ≤5 mL/hr). Confirm appropriate alarm volume, as well as the
operation of any volume control.

Audible Signals.

Operate the device (e.g., press rate switches) to activate any audible signals. Confirm appropriate volume, as
well as the operation of the volume control, if so equipped.

Open Door/Misloaded Infusion Set.

Check this alarm during setup and operation.

Free-flow Prevention Mechanism(s).

Turn the power off with the infusion set primed and loaded in the device. With all tubing clamps open, a full
fluid container, and the tubing hanging to the floor, verify that no fluid flows out of the distal connector.
If the device incorporates a mechanism that automatically closes the set or requires the set to be manually
closed before it is removed from the device, verify the operation of this mechanism.

Occlusion.

If the device delivers from an external fluid container, verify upstream occlusion detection by activating
infusion with the tubing clamped just below the container. Verify operation of downstream occlusion
detection by activating infusion with the infusion set's distal connector capped.

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Procedure No. 490-20081015-01 ( Major ) Ambulatory Infusion Pumps

Labeling.

Check that all necessary placards, labels, and instruction cards are present and legible.

Quantitative tasks: Grounding Resistance.

Measure the resistance between the grounding pin of the power cord (if so equipped) and exposed (unpainted
and not anodized) metal on the chassis. Grounding resistance should not exceed 0.5 Ω. If the unit is double
insulated, grounding resistance need not be measured.

Flow Accuracy.

Determine the flow accuracy at two typical flow settings ≥1 mL/hr (e.g., 10 and 100 mL/hr).
Use an infusion pump tester or collect the output in a graduated cylinder. Use a stopwatch or a watch that
displays seconds to time the delivery into the graduated cylinder until at least 10 mL is collected. Record the
time interval and volume collected, and calculate the delivery rate in mL/hr.
To calculate flow error, use the following formula:

Most ambulatory pumps are specified to deliver within 5% of the flow setting. (Note: Negative and positive
flow error represents underdelivery and overdelivery, respectively.)

Maximum Pressure.

Reference the pump's maximum pressure determined during acceptance testing. Connect the distal end of the
primed administration set to a pressure meter or use an infusion pump tester (if equipped to perform this
task). Start infusion at a commonly used flow setting (e.g., 10 or 100 mL/hr) and record the maximum
pressure. Restart the pump after an occlusion alarm to ensure that maximum infusion pressure has been
attained.

Air-in-Line Detection.

If the pump has an air detecor, inject 100 µL air into an injection port of the IV tubing with a U-100 insulin
syringe between the fluid container and the air-in-line detector. 100 µL can be approximated by 10 units from
a U-100 insulin syringe. Sensitivity to air volumes of less than 50 µL is likely to result in nuisance alarms.
Most pump will trigger an alarm for 50 to 100 µL air.

Preventive Maintenance: Replace.

Replace the primary battery and/or the clock/memory battery/cell, if necessary, and label it with the date.

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