Waldmann Andreas D, Rose Edward A, Pedro Michael J
Clinical Operations, Vyaire Medical, Zürich, Switzerland.
Department of Medical Affairs, Vyaire Medical, Mettawa, IL, USA.
SAGE Open Med. 2021 Jun 19;9:20503121211026849. doi: 10.1177/20503121211026849. eCollection 2021.
Intravenous fluid warming devices with surface heating systems transfer heat using aluminum blocks, which if uncoated elute toxic levels of aluminum into the infusate. This study examined extractable aluminum detected from prolonged use of the updated version of the enFlow cartridge, which uses a parylene-coated aluminum heating block.
In dynamic bench tests, we measured the concentration of aluminum that leached into three solutions (Sterofundin ISO, Plasma-Lyte 148, and whole blood) that were continuously pumped (0.2 and 5.5 mL min) and warmed to 40°C by the enFlow cartridge (parylene-coated) for 5 h. Prolonged quasi-static bench tests measured aluminum concentration in 16 solutions which were gently rocked within the enFlow cartridge (parylene-coated) for 72 h at 40°C. Aluminum concentrations were measured using inductively coupled mass spectroscopy and matrix blank corrected. Measured aluminum concentrations were compared to a Tolerable Exposure limit to calculate Margins of Safety based on the US Food and Drug Administration maximum recommended concentration in parenteral fluids (25 μg L). A parallel pilot in vivo animal study was performed using mice injected with fluids warmed for 72 h by the enFlow cartridge (parylene-coated).
The enFlow cartridge (parylene-coated) demonstrated low toxicological risks in all tests. Sterofundin ISO resulted in the highest aluminum concentration after simulated prolonged use of the enFlow cartridge (parylene-coated) (3.11 μg device), which represents a 99.2% decrease from the enFlow cartridge (uncoated) and Margin of Safety of 1.7. Dynamic tests at two different flow rates with three challenge solutions resulted in concentrations less than the method detection limits (20.6 or 41.2 μg L) of the analysis method. The animals in the in vivo study showed no evidence of toxicity.
Observed toxicological risk levels associated with the enFlow cartridge (parylene-coated) intravenous fluid warmer were below those set by the Food and Drug Administration and suggest that the use of enFlow cartridge (parylene-coated) is safe with a variety of intravenous solution types and in different therapeutic scenarios.
带有表面加热系统的静脉输液加温装置利用铝块传递热量，若铝块未涂层，会将有毒水平的铝洗脱到输注液中。本研究检测了从长时间使用更新版enFlow药筒中检测到的可提取铝，该药筒使用聚对二甲苯涂层铝加热块。
在动态台架试验中，我们测量了连续泵送（0.2和5.5 mL/分钟）并由enFlow药筒（聚对二甲苯涂层）加热至40°C达5小时后，三种溶液（Sterofundin ISO、Plasma-Lyte 148和全血）中铝的浸出浓度。长时间准静态台架试验测量了16种溶液中的铝浓度，这些溶液在enFlow药筒（聚对二甲苯涂层）中于40°C轻轻摇晃72小时。使用电感耦合质谱法测量铝浓度并进行基质空白校正。将测得的铝浓度与可耐受暴露限值进行比较，以根据美国食品药品监督管理局肠胃外输液的最大推荐浓度（25 μg/L）计算安全边际。使用经enFlow药筒（聚对二甲苯涂层）加热72小时的液体注射小鼠进行了一项平行的体内动物预试验。
enFlow药筒（聚对二甲苯涂层）在所有试验中均显示出低毒理学风险。在模拟长时间使用enFlow药筒（聚对二甲苯涂层）后，Sterofundin ISO导致的铝浓度最高（3.11 μg/装置），这比未涂层的enFlow药筒降低了99.2%，安全边际为1.7。使用三种挑战溶液在两种不同流速下进行的动态试验得出的浓度低于分析方法的方法检测限（20.6或41.2 μg/L）。体内研究中的动物未显示出毒性迹象。
观察到的与enFlow药筒（聚对二甲苯涂层）静脉输液加温器相关的毒理学风险水平低于食品药品监督管理局设定的水平，这表明在各种静脉输液类型和不同治疗场景下使用enFlow药筒（聚对二甲苯涂层）是安全的。
