Aluminium release and fluid warming: provocational setting and devices at risk

Abstract

Background Fluid warming, recommended for fluid rates of > 500 ml h-1, is an integral part of patient temperature management strategies. Fluid warming devices using an uncoated aluminium containing heating element have been reported to liberate aluminium resulting in critical aluminium concentrations in heated fluids. We investigated saline solution (0.9%), artificially spiked with organic acids to determine the influence of fluid composition on aluminium release using the uncoated enFlow® device. Additionally, the Level1® as a high volume fluid warming device and the ThermoSens® device were investigated with artificial spiked fluid at high risk for aluminum release and a clinically used crystalloid solution. Results Saline solution spiked with lactate more than acetate, especially at a non neutral pH, led to high aluminium release. Next to the enFlow® device, aluminium release was observed for the Level1® device, but not for the coated ThermoSens®-device. Conclusion Uncoated aluminium containing fluid warming devices lead to potentially toxic levels of aluminium in heated fluids, especially in fluids with non-neutral pH containing organic acids and their salts like balanced electrolyte solutions.

The results of designing a new prototype device and algorithm in closed method intraperitoneal hyperthermia model in rats

“…However, it is known that these types of hyperthermia devices and fluid warming devices have been withdrawn from the market and restricted in human use due to the risk of heavy metal poisoning, especially when the heated fluid comes into direct contact with the heater, such as aluminum, as stated in a bulletin issued by the FDA in 2021. [ 12 - 17 ]…”

Verification of an intravenous fluid warmer: A prospective, two-center observational trial

“…15 The newer cartridge has been extensively tested in a bench environment for the release of aluminum, other potentially toxic elements, and organic molecules with favorable results. 16 – 22 Additional bench testing also confirmed that the newer parylene-coated enFlow design warmed fluids as efficiently as the previous design; however, the performance of the parylene-coated enFlow has not been evaluated in a clinical setting. 16 …”

“…15 The newer cartridge has been extensively tested in a bench environment for the release of aluminum, other potentially toxic elements, and organic molecules with favorable results. [16][17][18][19][20][21][22] Additional bench testing also confirmed that the newer parylene-coated enFlow design warmed fluids as efficiently as the previous design; however, the performance of the parylene-coated enFlow has not been evaluated in a clinical setting. 16 To further assess this improved design in a clinical setting, this trial evaluated the efficacy of the new parylenecoated enFlow IV fluid and blood warming system in maintaining normothermia in patients undergoing surgery.…”

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

“…9 Numerous previous studies have documented concerns over aluminum leaching from fluid warmers. 5,9,11 –17…”

“…9 Numerous previous studies have documented concerns over aluminum leaching from fluid warmers. 5,9,[11][12][13][14][15][16][17] In addition to aluminum, the FDA has established Permitted Daily Exposures (PDEs) for all elements of toxicological concern within finished drug products. 18 The FDA considers daily exposure below these PDE levels to be protective of public health for all patient populations and is established for three different routes of administration: oral, parenteral, and inhalational.…”