In vitro study to estimate particle release from a centrifugal blood pump

Centrifugal pumps have been increasingly used in clinical settings. Like roller pumps, centrifugal pumps can cause debris release due to mechanical stress. The objectives of this study were to evaluate in vitro the particle release from a centrifugal pump, Gyro Pump (Japan Medical Materials Co., Osaka, Japan), which is a pivot-bearing supported pump clinically used in Japan, and to identify the released particles. In the clean room Class 10,000, the pump was operated for 24 h at 4000 rpm and 6 L/min in a mock loop filled with lactated Ringer's solution. After 24 h, the sample fluid and a blank were filtered with a 0.45-microm membrane filter for microscopic counting, followed by observation with a scanning electron microscope and element analysis with an X-ray spectrometer. Microscopic countings were 128 +/- 42 in the test samples (n = 10) of the Gyro Pump and 98 +/- 42 in the blank samples (n = 10) (P = 0.12). The oxygen/carbon atomic ratio of the particles in the test samples was 0.32 +/- 0.06, which was similar to the ratio of the particles in the blank sample (0.34 +/- 0.06). The profiles of elements with an X-ray spectrometer showed that the released particles from the Gyro Pump were not derived from the pump materials. In conclusion, an in vitro test system has been established for estimation of particle release from a centrifugal pump. Based upon the results with the system, the Gyro Pump with a pivot-bearing system has little risk to release debris particles even in a severe condition.