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Durability Testing of a Completely Implantable Electric Total Artificial Heart

2005; Lippincott Williams & Wilkins; Volume: 51; Issue: 3 Linguagem: Inglês

10.1097/01.mat.0000159385.32989.7c

1538-943X

Conrad M. Zapanta, Alan J. Snyder, Jason Weiss, Thomas Cleary, John D. Reibson, Marjorie A. Rawhouser, Jeffrey Lewis, William S. Pierce, Gerson Rosenberg,

Cardiac Valve Diseases and Treatments

In vitro durability testing was conducted on the Penn State/3M electric total artificial heart (ETAH) to determine device durability and to evaluate device failures. A specialized mock circulatory loop was developed for this testing. Customized software continuously acquired data during the test period, and failures were analyzed using FMEA (failure modes and effects analysis) and FMECA (failure modes, effects, and criticality analysis) principles. Redesigns were implemented when appropriate. Reliability growth principles were then applied to calculate the 1 and 2 year reliability. The 1 and 2 year reliability of the Penn State/3M ETAH was shown to be 96.1% and 59.9%, respectively, at 80% confidence.