Safety and Efficacy of Extracorporeal Membrane Oxygenation Heating Units

Abstract

Background Patient temperature during extracorporeal membrane oxygenation (ECMO) is commonly managed by dedicated heating units (HUs) that are integrated into ECMO circuitry. Currently, no HU has received approval for ECMO by the FDA in the United States. Older FDA-approved HUs have been implicated in life-threatening patient infections and are no longer manufactured or available for use in the United States. Methods We performed laboratory tests to evaluate the safety and efficacy of the Micro-Temp and the HTP-1500 HU systems that are potentially suitable for use in ECMO and describe our initial experience with the HTP-1500 HU after being placed in clinical service. Results Both units demonstrated similar heating efficacy, with the HTP-1500 achieving steady-state temperature approximately 5 h earlier than the Micro-Temp. Microorganisms were detected in the water compartment of all HUs prior to and after performing the manufacturer's recommended cleaning procedure, and after implementation of the HTP-1500 into clinical use we observed a decrease in the rate of bloodstream infection/ECMO days which did not reach statistical significance. Conclusion Based on the results of this analysis and our institutional experience, we believe that integration of the HTP-1500 HU, an easily replaceable HU, into ECMO systems may reduce the risk of bacterial contamination and thus nosocomial infection when the devices are cleaned and maintained according to manufacturer's guidelines.