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Performance Evaluation of a Novel Digital Flow-Imaging IV Infusion Device.
Robert D Butterfield1, Nathaniel M Sims2
1RDB Consulting Poway CA 92064 USA.
IEEE Open Journal of Engineering in Medicine and Biology
|February 11, 2026
Summary
The novel SAFEflow infusion device demonstrated superior flow accuracy and occlusion detection compared to legacy pumps. Its advanced design offers benefits in performance, size, and weight, potentially requiring updated regulatory standards.
Area of Science:
- Biomedical Engineering
- Medical Device Technology
Background:
- Legacy infusion pumps (LIPs) are widely used but have limitations.
- A novel servo-controlled, gravity-driven infusion device, SAFEflow (SF), has received FDA clearance.
- SF utilizes real-time flow measurement and feedback control via video imaging.
Purpose of the Study:
- To assess the performance and potential utility of the SAFEflow infusion device.
- To compare SF's functional characteristics against legacy infusion pumps (LIPs).
Main Methods:
- Type-tests of critical metrics were performed using AAMI and IEC standards.
- Computational simulations were utilized for performance assessment.
- SF's performance was benchmarked against two widely-used LIPs.
Main Results:
- SF exhibited superior flow performance (mean flow rate accuracy: -4.3% to +4.5%) across its 1-600 ml/h range.
- Occlusion detection was more consistent and rapid with SF, requiring less user interaction.
- SF demonstrated reduced weight, smaller size, and a lower parts count compared to LIPs.
Conclusions:
- The SAFEflow infusion device offers superior infusion performance.
- SF's advanced architecture presents functional advantages over legacy infusion pumps.
- Current regulatory evaluation standards may need revision for this new class of infusion device.
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