Ventricular assist systems for temporary life support: device readiness testing

A description is given of a quality control and reliability program for establishing short-term ventricular-assist-device (VAD) safety and efficiency prior to clinical use. Experience in the clinical use of temporary VADs indicates that the pre-clinical reliability testing program works, since no device related failures occurred. The procedures have become much stricter, and a goal of 80% reliability for in vitro testing currently exists for the permanent, ventricular-assist system with strict guidelines on how to determine device-related failure. Animal testing requires total animal-months of continued usage consistent with the 80% in vitro reliability. A critical feature of the program has been freezing of device and system design throughout the quality control/assurance program, reliability testing, and clinical use.<>