Marko Oydanich, MS, is a medical student at Rutgers New Jersey Medical School in Newark, NJ. Email:
Rotem Naftalovich, MD, MBA, is head of neurosurgical anesthesia at Rutgers New Jersey Medical School in Newark, NJ, and a Captain in the Medical Corps of the U.S. Army, Fort Sam Houston, TX. Email:
Biomed Instrum Technol. 2022 Apr 1;56(2):37-40. doi: 10.2345/1943-5967-56.2.37.
Fluid-warming systems are crucial in surgical and trauma settings because of their key role in preventing or treating hypothermia and enabling proper resuscitation of blood products that are stored cold. Recently, several manufacturers have issued warnings of the possibility of aluminum leaching from their fluid warmers and cautioned about the potential for aluminum toxicity in patients who underwent fluid resuscitation with these devices. Studies suggest that one of the main factors affecting aluminum leaching in this setting is the coating of the aluminum plate itself. Coating, often with a biocompatible material, appears to reduce aluminum leaching by 100- to 200-fold compared with an uncoated plate. Nonetheless, leaching with the coating is still at a level exceeding U.S. regulations. A few aluminum-free warming systems are available on the market, but these are not carried by all providers and some clinicians may be less familiar with their use. Medical device manufacturers will likely design future warming systems with less potential for aluminum blood contact. In the meantime, the risk of inadequate resuscitation, consequent to the proper fluid warmer no longer being available, is contrasted with the risk of potential toxicity. In the situation described here, the regulators deferred the ultimate decision of which fluid warmer to use in a given situation to the risk-benefit decision of the clinician.
在外科和创伤环境中，液体加温系统至关重要，因为它们在预防或治疗低体温以及使冷藏储存的血液制品适当复苏方面发挥着关键作用。最近，几家制造商发布了关于其液体加温器可能存在铝浸出的警告，并警告在使用这些设备进行液体复苏的患者中可能存在铝毒性。研究表明，影响这种情况下铝浸出的一个主要因素是铝板本身的涂层。与未涂层的板相比，涂层（通常是生物相容性材料）似乎可使铝浸出减少 100-200 倍。尽管如此，涂层的浸出水平仍超过美国法规。市场上有一些无铝加温系统，但并非所有供应商都有供应，一些临床医生可能不太熟悉其使用方法。医疗器械制造商可能会设计出未来具有更少铝与血液接触风险的加温系统。同时，由于适当的液体加温器不再可用而导致复苏不充分的风险，与潜在毒性的风险形成对比。在描述的情况下，监管机构将在特定情况下使用哪种液体加温器的最终决定推迟到临床医生的风险效益决策。
