Durability testing of a completely implantable electric total artificial heart.
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.
Zapanta
Conrad M
CM
Division of Artificial Organs, Department of Surgery, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, PA 17033, USA.
Snyder
Alan J
AJ
Weiss
William J
WJ
Cleary
Thomas J
TJ
Reibson
John D
JD
Rawhouser
Marjorie A
MA
Lewis
Jeffrey P
JP
Pierce
William S
WS
Rosenberg
Gerson
G
D004581:Electronics; D006354:Heart, Artificial / Q000009:adverse effects; D006801:Humans