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Medical Devices

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"Smart" Infusion Pumps are Selectively Intelligent

By Kathleen Cummings, BSN, RN, and Ryan McGowan, BS

(Article reprinted from Nursing2011, March issue, p.59.)

LARGE-VOLUME, SYRINGE, and patient-controlled analgesia infusion pumps are commonly used in healthcare settings to deliver medications, fluids, and nutrients to patients at precisely controlled rates. In recent years, "smart" infusion pumps have become increasingly sophisticated and include such features as close error reduction software, commonly referred to as drug libraries. This technology allows infusion pumps to perform functions that assist healthcare providers with programming and calculating dose and delivery rates. When used properly, these features help prevent I.V. medication errors and reduce patient harm.1

However, these smart pumps can't prevent all programming and administration errors. Clinicians must use professional judgment and adhere to established standards of care and standard operating procedures for safe medication administration when using this or any other technology.
(See Pumping up safety.)

"Pumping up safety"

While smart pump technology helps reduce medication errors and prevent patient injury, it's not intended to replace clinical practices, institutional policies, and vigilant patient monitoring. When using this technology, clinicians must continue to practice the "five rights" of medication administration: the right patient, the right drug, the right dose, the right route, and the right time.4 Clinicians should also have another nurse perform an independent double check with high-risk infusions.

Get to know your "libraries"

Drug libraries let clinicians select medications and fluids from pre-loaded lists, which can be tailored to each healthcare facility and patient care area. For example, a drug library profile used in an ICU would include vasoactive medications; one in a medical-surgical unit probably wouldn't.

Some facilities also integrate smart infusion devices with electronic medical records, computerized order entry systems, and medication barcode scanning systems. Integrating these systems with smart pumps provides additional safety checks that may make administering I.V. medications safer.2

Healthcare facilities may choose to implement limitations, commonly called hard and soft limits, on preselected drugs. If a clinician programs a smart pump outside predetermined dose or rate parameters for a drug with hard limits, the pump generates an alert and won't let the clinician proceed with the selection. Hard limits are typically set for high-risk drugs such as heparin. With soft limits, the clinician can override the alert and proceed with the infusion. 2,3

What can go wrong?

Despite advances in infusion pump technology, the FDA continues to receive reports related to programming and administration errors, even when clinicians use drug libraries. The following cases were reported to the FDA through its Medical Device Reporting program:

Case 1 - Incorrect dose programmed

A nurse discovered that the infusion pump was delivering heparin (25,000 units/500 mL) at a rate of 0.5mL/hour* instead of the intended 26 mL/hour. The pump had been inadvertently programmed to infuse a heparin dose of 26 units/hour instead of the prescribed dose of 1300 units/hour (26 mL/hour). This programming error led to the administration of a non-therapeutic anticoagulation dose. The patient required lower extremity amputation, but the report didn't indicate whether the heparin dosing error caused or contributed to this outcome. The user facility has updated the drug library with new minimum hard and soft dose limits for heparin and implemented additional education for the nursing staff to prevent recurrence of this programming error.

*The original reporter may have rounded this value down from 0.52 mL/hour to 0.5 mL/hour.

Case 2 - Overriding soft limits

A nurse intended to program an infusion of parenteral nutrition (PN) using the pump's drug library feature for 45.7 mL/hour, but accidentally selected a rate of 457 mL/hour. Although the pump generated a soft-limit alert, the infusion was started and continued for 2 hours until the hourly infusion rate error was noticed. The patient developed acute hyperglycemia and was transferred to the ICU. The facility has modified the drug library configuration to include a PN profile with a hard limit that the user can't bypass.

Case 3 - Overriding soft limits

A patient with chronic kidney disease was experiencing a hypertensive emergency. The healthcare provider ordered a nitroglycerin drip at 5 mcg/minute. A nurse who was experienced with the infusion pump was prompted to select either "mcg/minute" or "mcg/kg/minute." Standard practice was to use mcg/minute, but both options were available in the drug library. The pump screen was below eye level, making it hard to read, and the nurse inadvertently chose "mcg/kg/minute." After confirming the pump settings, a soft limit alert appeared. The nurse bypassed this warning and the nitroglycerin infused at 500 mcg/minute, a 100-fold increase in the intended delivery rate that wasn't detected until the I.V. bag was empty.

Drug libraries and hard and soft limits are configured to accommodate typical clinical settings at institutions. Smart pump technology can't determine whether clinicians are infusing nonstandard concentrations appropriately or overriding a soft alert based on unique patient needs.

What precautions can you take?

The following recommendations, which were created using the FDA's infusion pump website, may help prevent errors:

  • Before starting an infusion or changing an infusion setting, confirm that the infusion pump is programmed correctly.
  • When infusing a high-risk medications, have a second clinician perform an independent double check of infusion pump settings according to your facility's policy.
  • If the infusion pumps at your facility contain a drug library feature, use it according to facility policy.
  • When a patient is receiving multiple infusions, consider labeling the infusion pump channels and corresponding tubing with the name of the medication or fluid to avoid programming the wrong channel or infusion pump.
  • Don't rely solely on the pump to identify problems. Monitor the patient and infusion according to nursing best practices and your facility's policies and procedures.
  • Pay attention to displayed alerts and cautions, and investigate them appropriately.
  • When multidisciplinary teams are tasked with implementing and revising smart pump technologies and drug libraries, these teams should include members of each discipline that interfaces with the device.
  • Continuously reevaluate drug library settings and modify them to align with the standard of care and facility policies and procedures. This should include implementing and altering soft and hard limits (when clinically relevant) as well as standardizing concentrations, dosing configurations, and names of high-risk medications throughout your institution.
  • Make sure you're properly educated to manage all infusion pumps used on your unit.
  • Facility policies and procedures should be readily available, and clinicians should be promptly notified of changes or updates.

For more information about infusion pumps, including additional risk reduction strategies, see http://www.fda.gov/infusionpumps.4

REFERENCES

  1. Wilson K, Sullivan M. Preventing medication errors with smart infusion technology. Am J Health Syst Pharm. 2004;61(2):177-183.
  2. Proceedings From the ISMP Summit on the Use of Smart Infusion Pumps: Guidelines for Safe Implementation and Use. Philadelphia, PA: Institute for Safe Medication Practices; 2009. http://www.ismp.org/tools/guidelines/smartpumps/printerVersion.pdf.disclaimer icon
  3. Keohane CA, Hayes J, Saniuk C, Rothschild JM, Bates, DW. Intravenous medication safety and smart infusion systems: Lessons learned and future opportunities. J Infus Nurs. 2005;28(5):321-328.
  4. FDA. Medical Devices: Infusion Pumps. 2010. http://www.fda.gov/infusionpumps.

Although you need to support your facility's adverse event-reporting policy, you may voluntarily report a medical device that doesn't perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax 1-800-FDA-1078) or online at http://www.fda.gov/Safety/MedWatch/HowToReport. Diane Dwyer, BSN, RN, who coordinates Device Safety, is a nurse consultant at the Center for Devices and Radiological Health at the FDA in Silver Spring, MD.

Kathleen Cummings is a nurse consultant and Ryan McGowan is a biomedical engineer at the Center for Devices and Radiological Health, Office of Surveillance and Biometrics, in Silver Spring, MD.