Impact of Parylene Coating On Heating Performance of Intravenous Fluid Warmer: A Bench Study

Bayoro, Danielle; Groepenhoff, Herman; Hoolihan, Daniel D.; Rose, Edward A.; Pedro, Michael J.; Waldmann, Andreas D.

doi:10.21203/rs.3.rs-970986/v1

Cited by 2 publications

(1 citation statement)

References 14 publications

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“…[7] Despite the additional layer between the actual heating surface and the uid, studies have found that there is no negative effect on the performance characteristics of the enFlow device. [25] A summary of the literature search is presented in Table 2.…”

Section: Resultsmentioning

confidence: 99%

Aluminium leaching in fluid warming devices – A Review

Bayoro

Hoolihan

Pedro

et al. 2022

Preprint

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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.

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Section: Resultsmentioning

confidence: 99%

Aluminium leaching in fluid warming devices – A Review

Bayoro

Hoolihan

Pedro

et al. 2022

Preprint

Self Cite

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Verification of an Intravenous Fluid Warmer: A Prospective, Two-Center Observational Trial

Lax

Mustola

Repo

et al. 2022

Preprint

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Background Avoiding inadvertent hypothermia during surgery is important. Intravenous fluid warmers used intraoperatively are critical for maintaining euthermia. We sought to prospectively evaluate the performance of the parylene-coated enFlow™ intravenous fluid warmer in patients undergoing surgery. Methods This was a prospective two-center observational clinical trial performed in inpatient surgical services of two large academic hospital systems. After informed consent, patients were enrolled in the study. All patients were adults scheduled for a surgery that was expected to last for at least 1 h with the administration of at least one liter of fluid warmed prior to infusion. Patient temperature was recorded in the preoperative unit, at the induction of anesthesia, and then every 15 or 30 minutes until the end of surgery. Temperature monitoring continued in the recovery unit. The parylene-coated enFlow™ intravenous fluid warmer was used in addition to the usual patient warming techniques. The primary outcome was the average core temperature, and secondary analyses assessed individual temperature measurements, temperature measurements during specific time periods, and rate of hypothermic events. Results Fifty patients (29 male) with a mean age of 64 years were included in the analysis. The mean surgical time was 195 minutes and patients received an average of 1142 ml of fluids. Core temperature dropped by only 0.3°C approximately 60 minutes after induction and recovered back to the baseline level approximately 60 minutes later. There was no correlation between flow rate and measured core body temperature. Conclusions The parylene-coated enFlow intravenous fluid warmer was able to warm fluids at all flow rates during prolonged surgery. The results showed that enFlow performed as expected. Trial registration The trial was registered prior to patient enrollment at clinicaltrials.gov (NCT04709627, Principal investigator: Mikko Lax, MD, Date of registration: 14 January 2021.)

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Impact of Parylene Coating On Heating Performance of Intravenous Fluid Warmer: A Bench Study

Cited by 2 publications

References 14 publications

Aluminium leaching in fluid warming devices – A Review

Aluminium leaching in fluid warming devices – A Review

Verification of an Intravenous Fluid Warmer: A Prospective, Two-Center Observational Trial

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