Original Article

In Vitro Testing of the 0.6 M² SciMed Membrane Oxygenator for Use in Neonatal Extracorporeal Membrane Oxygenation

¹ Departments of Neonatology, George Washington University School of Medicine, Washington, D.C.
² Cardiovascular Perfusion, George Washington University School of Medicine, Washington, D.C.
³ Biomedical Engineering, Children’s National Medical Center and George Washington University School of Medicine, Washington, D.C.

^* Address correspondence to: Krisa P. Van Meurs, M.D. Stanford University School of Medicine Department of Pediatrics, 750 Welch Road, Suite 315 Palo Alto, CA 94304 (415) 723-5711

Abstract

Prior to the introduction of the 0.6 M² SciMed membrane oxygenator, the 0.8 M² membrane was the only oxygenator FDA-approved for long-term bypass. The performance of the 0.6 M² SciMed membrane oxygenator was examined using a modified test protocol suggested by the Association for Advancement of Medical Instrumentation for testing gas exchange devices. Four 0.6 M² SciMed membrane oxygenators were tested in vitro using filtered ovine blood and a customized test circuit designed to provide a continuous source of deoxygenated, CO₂-laden blood. Venous blood delivered to the test membrane had an oxygen saturation of 65 ± 2%. Testing confirmed good oxygenation throughout the manufacturer’s specified blood flow range. Transfer rates of CO₂ measured for the 0.6 M² SciMed membrane oxygenator were comparable to those of the 0.8 M² membrane up to a blood flow rate of 400 ml/minute. Further increases in blood flow did not augment CO₂ transfer rates. Use of the 0.6 M² SciMed membrane oxygenator for neonatal extracorporeal membrane oxygenation (ECMO) should be limited to the lower blood flow range and to infants not likely to experience significant hypercarbia, if such infants can be accurately identified.