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Providers assume infusion pumps deliver medications as intended at an accurate and consistent flow rate. This is particularly important for high-alert medications, which pose significant risk when improperly delivered. Pumps undergo extensive pre-market testing, and vendor manuals provide detailed documentation of the results. However, pump performance in the real world often differs significantly from lab results, with a potentially significant impact on patient safety. Therefore, a fundamentally new paradigm in pump engineering is required to ensure high quality patient care and safety.
An adaptive pumping system that automatically compensates for external factors impacting fluid flow will help administer infusions as the clinician intended. Currently, new technologies enabling this are under development, as recognition of flow problems and their potential patient harm grows. Actual pump performance in real-world conditions typically is less understood, despite the dramatic effect changing conditions can have on pump output and patient response.
LVP flow accuracy is how closely the average pump flow rate correlates with the programmed rate. Typically manufacturer values are based on an average over a minute interval. Flow continuity measures the variance from that average during the minute window. In LVP technical documentation, both accuracy and continuity are communicated using trumpet curves, as defined in the international standard for infusion devices: IEC IEC, Flow rate during the first two hours of infusion is plotted in a startup graph.
The first hour is considered warm-up time. Multiple calculations are performed during the second hour. The initial computation measures the overall flow accuracy and provides statistical analysis of flow variability during a range of time intervals.
From those measurements, expected maximum and minimum variations are calculated. As the time interval for the averages increases, small fluctuations in flow rate are eventually smoothed and the variability decreases. These results are expressed in the trumpet curve. Startup and trumpet curves showing computed pump performance data are illustrated in Figure 1. Manufacturers typically report startup graphs and trumpet curves in their user manuals to provide approximate information for a specific LVP.
However, trumpet curve testing in a controlled lab fails to account for many conditions potentially impacting pump performance in clinical settings. Thus, Pump B delivers the target 90 mL over the hour without any accuracy error, but has poor flow continuity. The performance of both pumps is illustrated in Figure 2. Flow Characteristics in the Clinical Environment In a real-world environment, various environmental factors may dramatically affect flow rates.
While there are variations in the exact mechanics, this general operation is common across most leading vendors. Peristaltic fluid movement is fundamentally discontinuous, as various pump elements that propel and occlude fluid movement come into contact with the tubing.
With slower infusion rates when pumping stroke duration increases, flow variations become more visible in curve analysis. Most LVPs can deliver fluids at rates as low as 0. Most systems incorporate a stepper motor to drive the peristaltic mechanism.
Stepper motors move in discrete portions along the IV tubing leading to a finite but constant volume. At extremely low pumping stroke rates the time between drive motor actuations increases to seconds or even minutes. Similarly, to the Pump B scenario above, the result of this variance is short-duration flow rate spikes, followed by periods of little or no flow.
A sample startup graph and trumpet curve for a typical large volume peristaltic pump operating at a target flow rate of 0. The flow variation in the startup graph is indicative of a pumping stroke that repeats approximately every 20 minutes. The stroke initiates with a flow rate that is substantially higher than the target.
The flow gradually decreases through the stroke and ends at a rate substantially below the target. This position determines the fluid weight and pump pressure exerted at the tubing inlet. Along with tubing stiffness, this drives tubing fluid uptake during the fill portion of the pumping cycle.
Likewise, outlet pressure variation causes changes to the volume of the flexible tubing. The IEC standard cites outlet pressure ranges of mmHg to mmHg due to variation in the orientation of the pump to the patient and the backpressure of small-bore catheters.
Tubing material properties can also dramatically affect accuracy. For example, published data show tubing made of silicone remain effectively consistent over time. However, base tubing materials such as PVC are less resilient and eventually lose their ability to fully rebound. This reduces the volume contained in the tubing and decreases the average flow.
The Potential Impact to Patient Safety Approximately nine out of 10 hospitalized patients receive intravenous infusions Baranowski, LVPs are used to deliver most intravenous fluids, especially high-alert medications.
Medications with very short half-lives need continuous administration for therapeutic efficacy and outcomes. These medications often are administered to acutely ill patients to address blood pressure or arrhythmias, provide sedation, or in some cases for therapeutic paralysis. Clinicians should be aware of the clinical impact of the LVP used for delivery.
Discontinuous Flow Norepinephrine is a mainstay therapy for hypotensive patients in septic shock. Norepinephrine has a half-life of approximately three minutes and a short duration of action of approximately two minutes.
This means discontinuous delivery may then require a bolus if appropriate , dose increase, or adjunct therapy. An LVP that continuously and consistently delivers the appropriate dosing, versus small bursts, may lead to beneficial patient outcomes. Recommendations for oxytocin include administration at the lowest possible dose to achieve a positive effect using an LVP with accurate flow rate American College of Obstetricians and Gynecologists, Unrestricted pump flow poses another risk.
Inaccurate flow of medications requiring precise delivery also can compromise patient care. Infusion delivered sooner than intended or infusing the dead space volume following a programmed delivery can result in adverse events.
These are not isolated examples and emphasize the need to investigate accurate medication delivery. Raising Awareness LVP manuals generally provide sufficient information to convey expected pump accuracy and flow continuity under many clinical scenarios. Trumpet curves are accurate. Users must become cognizant of deviations in LVP performance in the real world and compensate for them in patient care.
The FDA and the infusion pump industry are aware of this disconnect. AAMI is currently working towards revised infusion device test standards aimed at more clearly conveying actual pump performance under various conditions and the potential impact on the patient.
This focus on more accurate and descriptive disclosure, however, misses a broader point. The Need for Adaptive Infusion Pump Technology Enhanced pump performance across a full range of conditions requires a new paradigm in pump engineering. It calls for an adaptive technology that seamlessly interacts with the main elements of the traditional gravity-driven peristaltic pump — pressure head height and resistance roller clamp — to achieve continuous flow.
Rather than propelling fluid with a fixed-displacement mechanism, it should directly apply pressure to push the fluid and provide a restriction in the flow path to regulate delivery.
The result is greater accuracy and continuous fluid flow through the system. Representative adaptive pumping system startup and trumpet curves illustrate the significance of the improvement. The startup curve below shows smooth, continuous flow, without the major cyclical deviations characteristic of fixed-displacement pumps, Figure 4. Beyond Flow Continuity: Measure and Respond While a pressure-based system will improve flow continuity, it also must address average pump output under changing external conditions.
Backpressure in the tubing remains an important factor affecting flow rate. To compensate for this, adaptive pump technology must include a means to measure the actual fluid output from the system. Existing peristaltic LVPs rely on pre-determined position or speed measurements of the various pumping elements. If, for example, a motor is turning at the proper speed, the system assumes that flow output is as desired. However, in reality, external conditions also influence the fluid path.
For example, the motor might be moving correctly, but an increase in downward head pressure from the medication container may alter the fluid volume in the tubing. Currently, the impact of this is not measured and compensated for by infusion system software.
By contrast, a pneumatically-driven, adaptive pumping technology enables direct measurement of volumetric changes right at the point where fluid exits the pump and enters the patient.
This direct flow measurement allows adjustment of the LVP through its control software to maintain target flow rates as external conditions change. Now, while an increase in backpressure might decrease flow, the system recognizes this and makes adjustments to bring the rate back to the target.
The combination of a smooth profile and an adaptive measurement and control system ensures that the pump is delivering what the clinician intended, regardless of system dynamics and external factors. New test and disclosure standards focusing on accuracy and flow continuity are underway. But, more importantly, a new paradigm for fluid delivery is necessary. It must enable LVPs to adapt to external conditions while delivering fluids continuously and accurately. References American College of Obstetricians and Gynecologists.
Obstet Gynecol, , 7. Presidential address: take ownership. J Intraven Nurs, 18, —4. Blincyto R [package insert]. Thousand Oaks, CA: Amgen. IEC , October IEC What Is an Infusion Pump? Reflections on the Current State of Infusion Therapy. Biomed Instrum Technol. Be the Expert!
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Infusion Pump Performance: Flow Accuracy and Continuity Often Don’t Add Up