By Shawn O’Connell, RN, BS, MS
IV infusion pumps are a mainstay throughout healthcare sites, including hospitals, infusion centers, and emergency medical service vehicles. As a primary source of fluid and medication delivery, these pumps play a critical role in patient care. Over the past few decades, the industry has seen a dramatic increase in the use of automated IV infusion pumps—or “smart” pumps. In fact, in a 2018 survey conducted by the Institute for Safe Medication Practices, less than 1% of U.S. hospitals reported not using any smart pumps at all (Institute for Safe Medication Practices, 2018).
Despite their ubiquity, however, smart pumps continue to exhibit design flaws that contribute to patient safety risks. Commonly reported problems with smart pumps include software bugs and errors, human factors (e.g., errors related to user interface issues), broken components, battery failure, alarm failure, and over- or under-infusion (U.S. Food & Drug Administration [FDA], 2014).
Numerous FDA recalls, in conjunction with the FDA’s Infusion Pump Improvement Initiative and other industry safety programs, have highlighted these challenges and led to a decline in the number of Class I recalls over the past several years. Nevertheless, recalls continue to occur (FDA, 2021). Since 2014, 34 recalls have been issued for devices available from the market’s top vendors. Furthermore, an B. Braun examination of infusion pump failure reports in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database indicated that the frequency of incident reports appears to be increasing. Of the 33,268 reports submitted between January 1, 2014, and June 30, 2020, approximately 81% of them occurred during the latter half of the period (B. Braun Medical Inc., 2021).
So, why the uptick in failure reports, and what can be done to change this trajectory?
Today’s IV infusion pumps are being used longer and harder than ever before, possibly exceeding the number of uses anticipated in their design and validation. It is expensive and time-consuming to build a new infusion pump from the ground up. Therefore, several new FDA-approved devices are “refreshed” designs rather than all-new pumps that incorporate the latest learnings.
While many recent pump updates have added smart software, wireless capabilities, and interoperability features, most of these enhancements come without any significant advances in hardware. Yet when pump materials and mechanisms wear out and fail to function correctly, safety risks such as medication free-flow and under-infusion may result. Indeed, the MAUDE data analysis showed that the top two infusion issues involved either a “protective measures problem” (22%) or an “infusion or flow problem” (20%) (B. Braun Medical Inc., 2021).
Steps to improve patient safety
For most hospitals and health systems, changing infusion pump manufacturers is a complicated initiative that affects multiple lines of business and financial incentives. Consequently, selecting a smart pump partner impacts patient safety, finances, and operations. Here are a few steps healthcare organizations can take to optimize their smart pump purchasing decisions, reduce smart pump medication errors, and increase patient safety:
- Define, communicate, and track patient safety goals for infusion therapy. Every organization that uses smart pumps should set clearly defined goals relative to patient safety during infusion therapy. Nursing staff should know those objectives, and organizations should leverage analytics platforms to track the appropriate metrics.
- Make root cause analysis an organizational priority. Smart wireless IV infusion pumps can continually send and receive messages from electronic health record (EHR) systems. Effective wireless smart pumps should be able to transmit messages every three to five seconds and track every time a button is pushed. Magnified across every smart pump, the result is a rich database that healthcare organizations can leverage for root cause analysis. Adequately unpacking all the data, though, requires a dedicated informatics function.
- Encourage users to report all use-related issues. In addition to safety events, healthcare organizations should ask their IV pump users to provide insights into confusing or arduous processes and workflows. Pairing user feedback with IV pump data may help uncover why patient safety goals are—or are not—being met. Every quarter, nursing staff and others should troubleshoot and correct workflow issues revealed through the analysis.
- Develop a pressure-tested drug library. Organizations must develop an in-depth drug library in collaboration with nursing and pharmacy. They must also review this library routinely and update it based on the reviews. Every quarter at a minimum, organizations should use learnings gleaned from IV infusion data to optimize and deploy an updated drug library. Furthermore, organizations must resist compromising their drug library safety to enhance EHR interoperability and workflows. For example, while EHR integration may be easier if drug formularies are built for one or two care settings, best practice is to build formularies that reflect the medication safety goals based on patient populations and acuity levels for various clinical areas.
- Look for technology safeguards prior to purchase. Safety and reliability should be the primary considerations when issuing a pump request for proposal. Healthcare organizations should assess how pump usability will relate to patient safety—such as alerts and prompts that help engineer errors out of workflows. On large-volume pumps, be sure to assess free-flow protection safeguards. Where possible, standardizing through a common user interface and workflow from a single vendor may limit opportunities for errors that compromise patient safety.
Raise the bar
Interoperability between smart pumps and EHRs is a considerable concern for healthcare organizations today—and rightly so. However, we must not lose sight of the impact smart pumps can have on patient safety. First and foremost, the infusion pump needs to be safe when used manually or with integration. When purchasing new devices, safety and reliability are just as crucial as EHR interoperability.
One way to keep patient safety front and center is to consider how manufacturers are systematically improving the quality of infusion systems. This might include incorporating multiple layers of free-flow protection, leveraging comprehensive human factor studies, or constructing pumps with components that limit wear over time (B. Braun Medical Inc., 2021).
Healthcare organizations can also set goals around what they hope to accomplish via smart pumps. What return on investment does the organization need to realize? Which safety metrics are the highest priority given the organization’s patient populations? Rather than only asking smart pump vendors about the number of sites in which they operate, organizations should ask about the measurable infusion outcomes that vendors have helped their partners achieve.
By digging deeper into smart pump data, workflows, and technology, healthcare organizations can continue to raise the bar on IV infusion safety.
Shawn O’Connell, RN, BS, MS, is director of medical affairs at B. Braun Medical Inc.
Braun Medical Inc. (2021). Ongoing challenges and the need for innovative solutions within the infusion pump market [White paper]. https://www.firstinquality.com/
Institute for Safe Medication Practices (2018, April 5). Smart pumps in practice: Survey results reveal widespread use, but optimization is challenging. https://www.ismp.org/resources/smart-pumps-practice-survey-results-reveal-widespread-use-optimization-challenging
U.S. Food & Drug Administration (2014, December 2). Infusion pumps total product life cycle: Guidance for industry and FDA staff. https://www.fda.gov/media/78369/download
U.S. Food & Drug Administration (2021, July 2). Medical device recalls. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm