Key result
In vitro testing of the Penn State/3M electric total artificial heart demonstrated a 1- and 2-year reliability of 96.1% and 59.9%, respectively, at 80% confidence.
In vitro durability testing of the Penn State/3M electric total artificial heart demonstrated a 1-year reliability of 96.1% and a 2-year reliability of 59.9%.
Early TAH reliability data warrant further testing; leaves open clinical applicability until in vivo validation.
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.
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Zapanta et al. (2005) studied this question. Penn State/3M electric total artificial heart (ETAH) was evaluated on 1 and 2 year reliability. In vitro testing of the Penn State/3M electric total artificial heart demonstrated a 1- and 2-year reliability of 96.1% and 59.9%, respectively, at 80% confidence.
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