2021年9月15日訊 據美國食品與藥物管理局(FDA)15日發布的安全告警[1]指出有多家廠商的輸液、輸血加溫器因使用含鋁加熱元件並與輸注液直接接觸,導致加溫過程中可能溶解出高含量鋁(>25 mcg/L),使患者暴露在鋁毒風險,特別是高風險族群如腎功能較差者、新生兒、嬰兒、孕婦和老年人,該名單中也不乏全球知名的快速輸液系統品牌。

鋁毒可能造成的不良反應如骨骼病變、腦病變、神經系統傷害,FDA建議各醫療機構應改使用不含鋁、不同加熱機制的輸液加溫器作為病患體溫管理的替代方案。

參考資料:
[1].Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices – Letter to Health Care Providers – U.S. Food & Drug Administration.
[2].Important Safety Alerts – Smiths Medical Level 1 Fast Flow Fluid Warming System and Level 1 NORMOFLO Irrigation System – 香港衛生署
[3].Recalls and safety alerts- LEVEL 1® Fast Flow and Irrigation Fluid Warming Systems (2021-08-11) – Government of Canada
[4].FDA Issues Recall, Warning For Certain Fluid Warming Devices Which May Release Too Much Aluminum -AboutLawsuits.com
[5].Not All Rapid Infusers Are Created Equal – Belmont Medical Technologies
[6].Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum – U.S. Food & Drug Administration.
[7].Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum – U.S. Food & Drug Administration.
[8].Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers.
[9].Vyaire Medical Recalls the enFlow Fluid Warming System Disposable Cartridges Due to Potential Risk of Exposure to Elevated Levels of Aluminum Exposure to Patients
[10].What’s in your Fluid Watmer – Belmont Medical Technologies.
[11].Aluminum Toxicity during Fluid Administration – Belmont Medical Technologies.
[12].FDA食品藥物消費者專區-消費者紅綠燈

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