Aluminium leaching in fluid warming devices – A Review

Abstract

Current guidelines recommend the use of an intravenous fluid warmer to prevent perioperative hypothermia. Among the various methods of warming intravenous fluids, contact warmers are among the most effective and accurate, particularly in clinical conditions requiring rapid infusions of refrigerated blood or fluids. Contact warmers put the infusate in direct contact with a heating block. Some fluid warmers use heating blocks manufactured from aluminium. Several recent publications, however, have shown that uncoated aluminium blocks can leach potentially toxic amounts of aluminium into the body. In this review we performed a systematic literature review on aluminium leaching with contact fluid warmers and describe what manufacturer and competent authorities did in the past years to ensure patient safety. The search resulted in five articles describing the aluminium leaching. Four different devices (Level 1 Fluid Warmer from Smiths Medical, ThermaCor from Smisson-Cartledge Biomedical, Recirculator 8.0 from Eight Medical International BV, enFlow from Vyaire) were shown to leach high levels of aluminium when heating certain intravenous fluids. One manufacturer (Vyaire) voluntarily removed their product from the market, while three manufacturers (Eight Medical International BV, Smisson-Cartledge Biomedical, and Smiths Medical) revised the instructions for use for the affected devices. The enFlow fluid warmer was subsequently redesigned with a parylene coating over the heating block. The scientific literature shows that by using a thin parylene layer on the heating block, the leaching of aluminium can be nearly eliminated without affecting the heating performance of the device.

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.…”

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 aluminium, other potentially toxic elements, and organic molecules with favorable results. [16][17][18][19][20][21][22] Additional bench testing also con rmed that the newer parylene-coated enFlow design warmed uids as e ciently 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 study evaluated the e cacy of the new parylene-coated enFlow IV uid and blood warming system in maintaining normothermia in patients undergoing surgery.…”