In vitro hematological testing of rotary blood pumps: remarks on standardization and data interpretation.

Pump test procedures using blood will have to meet several standards not only to obtain reliable results in vitro but also to allow comparison of results of different investigators. This article reviews some of the issues that should be considered in pump testing, especially referring to the discussions held at the International Workshops on Rotary Blood Pumps in 1988 and 1991. The test loop itself should meet some requirements such as constant physiological temperature, standardized circulating volume, control of pressure and flow, and exact definition of the blood-contacting surface. Specifications have to be made concerning the test fluid blood, including sampling technique, anticoagulation, blood gases, pH, and glucose level. Only fresh blood should be used. Heparin is recommended for anticoagulation because it will be used also in vivo. Different procedures for cleaning and rinsing of plastic materials for reuse are mentioned. Bacterial overgrowth, which can lead to extreme oxygen consumption and acidosis, may be avoided through addition of antibiotics (e.g., gentamicin). To be able to compare data of the different working groups, a new modified index of hemolysis (MIH) has been defined.