A protocol for the evaluation of the cavitation potential of mechanical heart valves.

To assure the safety and effectiveness of prosthetic heart valves, the Food and Drug Administration requires performance testing prior to human use. Guidance for such testing is currently undergoing revision to include in vitro tests for cavitation potential. This work describes a test procedure to determine the minimum ventricular dp/dt associated with bubble formation. Cavitation bubbles as small as 0.5 mm diameter existing for 0.02 msec should be detectable by video imaging techniques.