Asked what he would have done if the syringe pump behaved that way while he was treating a patient, Jim Davis paused to collect his thoughts. “If it was a critical infusion setup?” he asked, “I would have slammed the pump on the counter, muttered an expletive to myself, grabbed a new one, and hoped my patient didn’t deteriorate in the meantime.”
Jim Davis, a patient safety analyst at ECRI Institute and a critical care nurse by training, was testing the usability of syringe pump models for ECRI’s evaluation of the technology. When putting one model through its paces, he encountered a circumstance that caused the pump to freeze up – or to appear to do so – while he was programming it. A second tester encountered the same scenario.
At issue was the position of the pump’s barrel clamp while the user was loading a syringe onto the pump and programming the infusion. If the clamp is positioned a certain way too early in the sequence, the pump activates an alarm and prevents the user from proceeding until the alarm condition is cleared. The reason for the alarm and the method for clearing it, however, are not obvious to the user. Instead, the pump appears unresponsive. In a busy ICU, with a sick patient in need of medication, and faced with no clear cue for resolving the condition and starting the infusion, a user may conclude the pump is faulty and look for alternatives.
Hands-on testing, as this example illustrates, helps identify product characteristics and behaviors that can’t be gleaned from a specifications sheet. Such findings can help an organization identify the most appropriate model for purchase, and they can bring to light measures that will be needed to facilitate safe and effective use once a product has been selected.
ECRI Institute completed its testing of two models of syringe pumps in March, publishing its findings and ratings in Health Devices. Some of the key selection factors described in the nonprofit organization’s study are outlined below.
Form and Function
Syringe pumps differ from general-purpose infusion pumps in that a syringe serves as the medication reservoir for the pump. The user installs the syringe on the pump and programs the infusion. The pump then controls the rate at which the syringe plunger advances, thereby controlling the fluid flow rate to the patient. An administration set is used to connect the syringe to a patient catheter.
Syringe pumps ensure highly accurate volume delivery and consistent flow for small volumes (≤60 mL) of fluid, often containing potent pharmacologic agents. The syringe’s contents are typically delivered at flow settings between 0.5 and 10 mL/hr.
The pump itself includes functionality for programming the infusion; it displays information about the status of the infusion, and it incorporates an alarm system to notify clinicians about conditions that warrant attention. The pump can be clamped to an IV pole for positioning at the bedside.
Pumps today commonly include a dose error reduction system (DERS), fault-condition alarms and wireless connectivity. ECRI Institute recommends all these features. As for new capabilities, manufacturers continue to develop solutions for minimizing use-related programming errors and for facilitating pump integration with electronic medical records (EMRs).
Key Findings and Differentiating Factors
Because of the applications for which they are used, syringe infusion pumps must provide highly accurate volume delivery and consistent flow. Thus, ECRI Institute examines key performance factors during its testing. Just as important to selection decisions, however, are the safety features, interoperability capabilities and maintenance issues associated with the models being considered.
Performance. To evaluate how well a pump performs its basic functions, ECRI Institute tests performance factors such as the following:
The evaluated models generally met ECRI Institute’s key performance criteria.
Safety. ECRI Institute identified safety shortcomings with both models it tested. While the issues were not significant enough to recommend against the purchase of these models, they nevertheless are matters that should be brought to the attention of users.
On one model, dose entry can be confusing, increasing the risk of the pump being misprogrammed. On the other, the pump lacks a continuous persistent indication of imminent battery depletion. Without such an indicator, the clinician may be unaware of the battery status and fail to plug in the unit before it shuts down, causing the infusion to cease. This is particularly problematic with life-sustaining medications. Additionally, both models can be operated in a basic mode – that is, without the safety limits of the DERS – with no clear indication that the pump is functioning without drug library limits.
Interoperability. “This is the new frontier,” remarks Juuso Leinonen, a senior project engineer in ECRI Institute’s Health Devices Group. “Syringe pump technology hasn’t changed much over the years. The one area where we’re seeing advancements, though, is in the level of integration being achieved.”
Infusion pump interoperability, or integration, refers to technologies that enable the creation of an electronic connection between an infusion pump channel and an EMR system. This connection allows the pump channel, the patient and a medication order to be associated with each other. Benefits include:
When done well, integration can prevent infusion-related medication errors, simplify workflow and improve documentation. But the process of integrating pumps is complex and difficult. ECRI Institute prefers models with proven integration capabilities, as evidenced by facilities that have completed the process. The evaluated models differed in this regard.
Maintenance. With the number of pumps that a facility might include in its inventory and the frequency with which they are used, maintenance issues – such as cumbersome cleaning requirements or problems associated with component breakage – are not a trivial concern. This is another area where ECRI Institute identified differences between evaluated models.
– This article is adapted from ECRI Institute’s “Evaluation Background: Syringe Infusion Pumps” (Health Devices 2019 Mar 20). The complete article – including model-specific test results and product ratings, along with additional guidance for purchasing and using syringe pumps – is available to members of ECRI Institute’s SELECTplus, Health Devices System and associated programs. To learn more about membership, visit www.ecri.org/solutions/evaluation-and-comparison, or contact ECRI Institute by telephone at 610-825-6000, ext. 5891, or by email at firstname.lastname@example.org.
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