“Large-volume IV smart pumps are probably one of the most ubiquitous devices in acute care in the United States,” explains Karen K. Giuliano, PhD, MBA, RN, FAAN. “Unfortunately, the most commonly used pumps are associated with numerous known safety and usability issues that need to be addressed through device innovation.”

Most large-volume IV smart pumps, Dr. Giuliano adds, have manufacturer-specified setup requirements, which include a head-height differential during secondary medication administration. “If these requirements are not followed, medications are likely to be underdelivered,” she says. “However, with the complexity of hospital care and physical space limitations at the patient’s bedside, setup requirements are often impossible to follow.”

Not Compliant With Head-Height Differential Requirement

For a paper published in the Journal of Infusion Nursing, Dr. Giuliano and colleagues conducted an observational study to document common deviations from manufacturer setup requirements for two commonly used IV smart pumps. Compliance with manufacture-recommended setup requirements for both primary and secondary infusions and secondary medication administration delay was compared between a head-height differential system and a cassette system. A total of 301 medication administration observations were included: 102 (34%) for the linear peristaltic IV smart pump (medical-surgical: n = 51; critical care: n = 51) and 199 (66%) for the cassette pump (medical-surgical: n = 88; critical care: n = 111).  The study team observed results of three key research aims:

  • Data showed that none of the observations for the primary infusion setup were compliant with the head-height differential system setup requirements of 20 inches between the pump and the primary IV head height.
  • Overall, 16% (n = 17/102) of the secondary head-height differentials were less than the required 9.5 inches, with only minor differences between medical-surgical and critical care.
  • Of the 17 secondary infusions that did not meet the recommended head-height differential, two infusions in medical-surgical had a head-height differential of 0 inches, with the remaining heights between 7 and 9 inches.
  • For the head-height differential system roller clamp, one clamp on the secondary line was found in the closed position, resulting in an omitted secondary medication dose that was not detected.
  • For the cassette system, two clamps were found to be in the closed position on initiation of the secondary infusion. In both cases, the clinician was alerted by an alarm and no medication delay occurred (Figure).
Accurate Medication Administration May Be Compromised
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“If setup requirements are not met, the secondary medication may under-infuse, not infuse at all, infuse into the primary bag instead of the patient, or infuse simultaneously into the patient with the primary infusion at a different rate than intended,” says Dr. Giuliano.

Furthermore, most secondary infusions are antibiotics, Dr. Giuliano points out. “Incomplete dosing of antibiotics not only decreases the therapeutic benefit to the patient, but also contributes to antibiotic resistance due to the resultant subtherapeutic levels, which foster bacterial mutation,” she says. “While appropriate and timely antibiotic administration as prescribed is always important, in certain clinical situations like sepsis, where every hour delay in antibiotic administration results in an 8% increase in mortality, it can literally mean the difference between life and death.”

The study team concurs that much more research is needed to understand the variations in flow rate accuracy under actual conditions that exist in acute care. “Since flow rate accuracy is almost always decreased when setup requirements are not followed, we need research to document the flow rate impact of these real-world setups,” Dr. Giuliano says. “Innovation of the head-height differential IV smart pump systems is also urgently needed in order to make these devices easier to use, without such complex manual setup requirements, both of which are needed to decrease IV medication administration error and improve patient safety.”