Levels of leachable elements from long-term use of enFlow fluid warmer

Abstract

Objective: In the delivery of intravenous fluids, in-line warming devices frequently transfer heat using a metal heating plate, which if uncoated can risk elution. This bench study examined extractable elements detected following long-term use of the parylene-coated enFlow® Disposable IV/Blood Warmer. Methods: We tested 16 clinically relevant challenge fluids typical of the surgical setting, including commercially available single donor blood and blood products as well as intravenous saline and electrolyte solutions. After 72 h of warming at 40°C (104°F) via the enFlow, analytical chemistry identified and quantified the most clinically significant extractable elements (arsenic, barium, cadmium, copper, and lead) to estimate chemical exposure. We also measured the extracted concentrations of these five elements following simulated use of the device with three solutions (Sterofundin ISO, Plasma-Lyte 148, and whole blood) that were pumped through the warmed device at two different flow rates (0.2 and 5.5 mL min−1). Results: Across all scenarios of acute and long-term exposures for different populations, the enFlow demonstrated low toxicological risks as measured by the calculation of tolerable exposure for extracted arsenic, barium, cadmium, copper, and lead. Conclusion: The results suggest biological safety for the use of parylene-coated enFlow with a variety of intravenous solutions and in different therapeutic scenarios.