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

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.

Improvements in prehospital medication storage practices in response to research.

UNLABELLED: Previously the authors showed that prehospital medications were stored outside their recommended temperature range. In response, the state office of emergency medical services (EMS) issued regulations regarding temperature control and monitoring of prehospital medications. OBJECTIVE: To determine the impact of previous research (on medication storage conditions) on current practices among the mobile intensive care units (MICUs) within the state. METHODS: A statewide, structured telephone survey of MICU directors was conducted between April and December 2000. Questions focused on changes in storage and monitoring practices (including modifications to vehicles, medication boxes, and the use of temperature monitoring devices) since the authors' previous research. RESULTS: Thirty-three of 35 (94%) programs (100 vehicles) participated in the survey. Eighty-five percent changed their practices since the research five years ago. Of the five that did not change, three already had temperature control measures in place, while two have not made any changes. Twenty-one (63%) of the programs reported changing specifically because of state regulations. Eighty-one percent of the programs have taken some measure to control temperature. Currently, 63% of the 100 vehicles in use have both heating and cooling devices specifically for the medications, whereas 14% have only a heater and 23% have neither. Thirty-one (94%) MICUs monitor the temperature in some manner: 42% in the vehicle, 58% in the medication box. Of these, 68% are using 30-day electronic temperature data recorders, whereas 32% are using non-recording digital thermometers. CONCLUSIONS: This survey demonstrates a positive impact from previous research. Most of the MICUs in the state have changed their practices in controlling and monitoring prehospital medication storage temperature.