CENTRIFUGAL BLOOD PUMP CONTROLS FOR BLOOD VOLUME, TEMPERATURE
This article was originally published in The Gray Sheet
Executive SummaryCENTRIFUGAL BLOOD PUMP CONTROLS FOR BLOOD VOLUME, TEMPERATURE, flow rate and pressure are among the specific performance criteria included in a human factors study protocol recently submitted to FDA. For the protocol, which outlines specific ranges of pump parameters to assure their safe and effective use, "the volume of blood used will be controlled at 1,500cc +/- 100cc," attorney Edward Basile, of the D.C. law firm King & Spalding, states in an Aug. 31 letter on behalf of the Health Industry Manufacturers Association.
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