Quantification of safe aluminium levels released into infusion solutions by the Level 1 Fast Flow Fluid Warmer: a reply

Carrillo, Juan Antonio Cabrera; Borton, L. K.

doi:10.1111/anae.15174

Cited by 2 publications

(4 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Cabrera responded by defending the assumptions and conclusions in his study. [21] Perl et al compared aluminium elution using the uncoated enFlow warmer heating uids including saline, with or without combinations of sodium acetate, sodium lactate, and with or without sodium hypochlorite or hydrochloric acid, infused at 4 ml.min − 1 over 60 minutes. [22] There was no elution of aluminium in pure normal saline, while the addition of either acetate or lactate signi cantly increased aluminium leaching at a level that increased over time.…”

Section: Resultsmentioning

confidence: 99%

“…Discussions about aluminium leaching from aluminium-based uid heaters continue regarding measurement methodology, experimental set-up, and result interpretation. [17,21,22] In the interim, the FDA and European regulatory agencies will continue to provide guidance to practitioners. Parylene-coated aluminium block heaters appear to be safe and effective in the prevention of hypothermia in adults and children.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Aluminium leaching in fluid warming devices – A Review

Bayoro

Hoolihan

Pedro

et al. 2022

Preprint

View full text Add to dashboard Cite

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.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Aluminium leaching in fluid warming devices – A Review

Bayoro

Hoolihan

Pedro

et al. 2022

Preprint

View full text Add to dashboard Cite

show abstract

“…They found that the amount of aluminum leached from the system did not reach clinically significant levels, although their findings were subject to debate. [8][9][10] The original enFlow cartridge (uncoated) fluid warmer was recently redesigned with a parylene coating on the fluid-contacting portion of the aluminum heating block. This redesigned device, known as the enFlow cartridge (parylene-coated) (Figure 1), is identical to the original enFlow cartridge (uncoated) except for the parylene coating applied to the aluminum heating blocks.…”

Section: Introductionmentioning

confidence: 99%

“…They found that the amount of aluminum leached from the system did not reach clinically significant levels, although their findings were subject to debate. 8 – 10 …”

Section: Introductionmentioning

confidence: 99%

Fluid warming with parylene-coated enFlow cartridge: Bench and pilot animal study of aluminum extraction due to prolonged use

Waldmann¹,

Rose

Pedro

2021

SAGE Open Medicine

View full text Add to dashboard Cite

Objectives: 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. Methods: 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−1) 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−1). A parallel pilot in vivo animal study was performed using mice injected with fluids warmed for 72 h by the enFlow cartridge (parylene-coated). Results: 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−1), 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−1) of the analysis method. The animals in the in vivo study showed no evidence of toxicity. Conclusion: 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.

show abstract

Quantification of safe aluminium levels released into infusion solutions by the Level 1 Fast Flow Fluid Warmer: a reply

Cited by 2 publications

References 7 publications

Aluminium leaching in fluid warming devices – A Review

Aluminium leaching in fluid warming devices – A Review

Fluid warming with parylene-coated enFlow cartridge: Bench and pilot animal study of aluminum extraction due to prolonged use

Contact Info

Product

Resources

About