Aluminum Leaching from Fluid Warmers: Regulatory Deferral to Clinicians' Decision

Abstract

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.