Methods of Failure and Reliability Assessment for Mechanical Heart Pumps

Abstract

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.

Hazard Analysis and Risk Assessment in the Development of Biomedical Drug Formulation Equipment

“…Actions taken for risk reduction include both procedural 6 and design 10 changes. An example of a design improvement to our system prompted by FMEA was pressure monitoring and disabling of pumps when system pressure rises above a set level.…”

“…The detailed methodology for the PHL, PHA, and FMEA techniques are well accepted and published in the biomedical literature and standards. [1][2][3][4][5][6][7][8][9][10]12,13 The methodology associated with the FuHA technique is provided in Table 2.…”

In Vitro Evaluation of an Axial Flow Pump: Mock-Pump Interaction and an Approach to Control

“…Mock circulatory loops have been used in many different stages of rotary blood pump development, including hydrodynamic performance evaluation, interaction studies between pumps, endurance testing and control algorithms assessment, amongst others (3,8,22,23). Cardiovascular physical models include distributed parameters or lumped element designs, for both systemic and total circulation, depending on the application (5,6,12,24,25).…”

Durability improvement of polymer chamber of pulsatile extracorporeal life support system in terms of mechanical change

“…Hence, in order to obtain the CE mark or KFDA approval for these applications, which require its prolonged utilization, in the near future, the long-term reliability or durability testing of the T-PLS is required. Since 1980, reliability tests or optimum control have been conducted for artificial hearts by other research groups [4,6,13,15,22,28,35]. The existing methods of analyzing the reliability of an artificial heart are based on fault tree analysis (FTA) or failure mode and effect analysis (FMEA) [4].…”