Abstract
BACKGROUND: To demonstrate the safety and performance of the Arrow EZ-IO Intraosseous Vascular Access System, particularly in the pediatric patient population, a retrospective observational study was conducted in 2021 and 2022. METHODS: Following study design, IRB approval, and investigator selection, data were collected for all patients needing intraosseous access-adult and pediatric. The primary endpoint was the success rate for achieving intraosseous access; the secondary endpoint was the rate of adverse events. Following initial data collection, additional data were collected and a sub-set analysis was conducted to demonstrate the same in pediatric patients only, which is the focus of this report. RESULTS: Data for 106 pediatric cases were collected. The success rate for achieving intraosseous access and infusion was 96.2%. There were three adverse events in two patients (1.9%); none serious or previously unreported. The mean duration of device use was 60 h (SD = 46). For 46 patients, the device was used for up to 48 h, and for another 45 patients, the device was used for a longer duration. CONCLUSIONS: This report is the first characterization of the safety and performance of the Arrow EZ-IO Intraosseous Vascular Access System when used in the pediatric population for longer dwell times (>24 h), with no serious complications reported. Performance and safety objectives were met. The results of this real-world evidence study are in alignment with findings from the clinical literature concluding that, for pediatric patients, the Arrow EZ-IO Intraosseous Vascular Access System is safe and effective for providing vascular access in urgent, emergent, and medically necessary situations, in which intravenous access is difficult or impossible to obtain. In addition, this study supports the use of intraosseous access for dwell times greater than 24 h.