Performance Evaluation of a Novel Digital Flow-Imaging IV Infusion Device

Goal: Assess performance and potential use of a novel, servo-controlled, gravity-driven infusion device with FDA regulatory clearance obtained 3/1/2024(K242693). Introduction: "SAFEflow^TM " (SF) using real time flow measurement and feedback control, has been cleared by USFDA. We hypothesized that due to its architecture using video imaging there will be both benefits, and functional contrasts with the behavior of legacy infusion pumps (LIPs). Methods: We conducted type-tests of critical metrics using AAMI and IEC standards together with computational simulations. Results were compared with claimed and measured performance of two widely-used LIPs. Results/Discussion: Across its rated flow range of 1-600 ml h^-1, SF's measured flow performance was superior (95/95% confidence/reliability -4.3% to +4.5% mean flow rate accuracy) to claims of two LIP designs, Occlusion detection was more consistent and rapid across flow rates and requiring less user interaction. Conclusion: SF's infusion performance was superior with reduced weight, size, and low parts count compared to LIPs. Regulatory evaluation standards may require updating for this class of infusion device.