Left ventricular assist system reliability testing

In 1984, the National Heart, Lung, and Blood Institute (NHLBI) began a Device Readiness Testing Program (DRTP) for the left ventricular assist system (LVAS). The protocol for device reliability includes both in vitro and in vivo studies. For in vitro studies, a PC-based network is being used to monitor and record the status of each test unit at each of four test sites, as well as to relay information to the program office. Failure of the LVAS to deliver at least 4 1/min is automatically detected and transmitted to the NHLBI. This is the first such computer-monitored research contract program for the NHLBI. This system has been of great value administratively, both for the timeliness of information and in planning for present and future needs. These aspects are especially important in a high-cost, high-visibility program. Unanticipated benefits accrued from ongoing examination of quality control charts which gave clues to potential parameters which might be useful in predicting failures