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Methods of Failure and Reliability Assessment for Mechanical Heart Pumps
Author(s) -
Patel Sonna M.,
Allaire Paul E.,
Wood Houston G.,
Throckmorton Amy L.,
Tribble Curt G.,
Olsen Don B.
Publication year - 2005
Publication title -
artificial organs
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 76
eISSN - 1525-1594
pISSN - 0160-564X
DOI - 10.1111/j.1525-1594.2004.29006.x
Subject(s) - reliability engineering , reliability (semiconductor) , bridge (graph theory) , medicine , heart failure , food and drug administration , risk analysis (engineering) , computer science , intensive care medicine , engineering , surgery , power (physics) , physics , quantum mechanics
Artificial blood pumps are today's most promising bridge‐to‐recovery (BTR), bridge‐to‐transplant (BTT), and destination therapy solutions for patients suffering from intractable congestive heart failure (CHF). Due to an increased need for effective, reliable, and safe long‐term artificial blood pumps, each new design must undergo failure and reliability testing, an important step prior to approval from the United States Food and Drug Administration (FDA), for clinical testing and commercial use. The FDA has established no specific standards or protocols for these testing procedures and there are only limited recommendations provided by the scientific community when testing an overall blood pump system and individual system components. Product development of any medical device must follow a systematic and logical approach. As the most critical aspects of the design phase, failure and reliability assessments aid in the successful evaluation and preparation of medical devices prior to clinical application. The extent of testing, associated costs, and lengthy time durations to execute these experiments justify the need for an early evaluation of failure and reliability. During the design stages of blood pump development, a failure modes and effects analysis (FMEA) should be completed to provide a concise evaluation of the occurrence and frequency of failures and their effects on the overall support system. Following this analysis, testing of any pump typically involves four sequential processes: performance and reliability testing in simple hydraulic or mock circulatory loops, acute and chronic animal experiments, human error analysis, and ultimately, clinical testing. This article presents recommendations for failure and reliability testing based on the National Institutes of Health (NIH), Society for Thoracic Surgeons (STS) and American Society for Artificial Internal Organs (ASAIO), American National Standards Institute (ANSI), the Association for Advancement of Medical Instrumentation (AAMI), and the Bethesda Conference. It further discusses studies that evaluate the failure, reliability, and safety of artificial blood pumps including in vitro and in vivo testing. A descriptive summary of mechanical and human error studies and methods of artificial blood pumps is detailed.