Methodology for Ensuring Accuracy and Validity of Infusion Pump Alarm Data

Clinical alarm reduction is a priority goal among national organizations, professional societies, healthcare facilities, and industry. The Joint Commission’s National Patient Safety Goal on clinical alarm safety requires healthcare facilities to identify the most important medical device alarms to manage, then make improvements to ensure that these alarms are heard and addressed. The collection of data is among the first steps in assessing and identifying which alarms to manage. Data are essential to healthcare facilities’ ability to identify which medical devices to target and which alarms are most problematic. Because these data will serve as the basis for measuring and reporting clinical alarm outcomes, they should be meaningful and accurate and the methodology for extracting them should be reliable and valid. To date, most research on medical device alarms has focused on physiological monitoring, with little to no published benchmarks on infusion pump alarms. Using infusion pump data from U.S. hospitals, we sought to establish a baseline regarding alarm incidence and duration. These hospitals were using a validated proprietary data management software application that collected infusion data in real time and collated the data into various clinical reports. Although the software application collected infusion alarm data, the version in use at the time of this study did not compile collected alarm data into a preassembled, standardized report. Therefore, we were tasked with collating the validated software alarm data from various hospitals and assembling it in a meaningful way for clinical analysis. Collating data across multiple hospitals and running queries on that data entails intricate management of complex data; therefore, we were compelled to apply sound research methodology to ensure accuracy and validity. Finding no comparable process or validation protocol for collating and/or assembling infusion pump data in the literature, we created and tested a validation methodology using one pump platform. Establishing a validated process for ensuring the reliability of assembled data is an important first step that needs to precede the development of infusion alarm data metrics and reported benchmarks. The goals of this article are to share insights on the complexities of collating and assembling infusion pump alarm data across multiple hospital datasets and to describe a research-based process to maximize the accuracy and validity of the data. For healthcare facilities that are not using a validated software program that collects and assembles alarm data, these same principles and/ or methods can be applied to best ensure the quality of the data.