Long-term mechanical circulatory support system reliability recommendation- American Society for Artificial Internal Organs and the Society of Thoracic Surgeons: Long-term mechanical circulatory support system reliability recommendation

Jointly developed by members of the American Society for Artificial Interna l Organs and the Society of Thoracic Surgeons along with staff from the Foo d and Drug Administration, the National Heart Lung and Blood Institute and other experts, this recommendation describes the reliability considerations and goals for Investigational Device Exemption and Premarket Approval subm issions for long-term, mechanical circulatory support systems. The recommen dation includes a definition of system failure, a discussion of an appropri ate reliability model, a suggested in vitro reliability test plan, reliabil ity considerations for animal implantation tests, in vitro and animal in vi vo performance goals, the qualification of design changes during the Invest igational Device Exemption clinical trial, the development of a Failure Mod es Effects and Criticality Analysis, and the reliability information for su rgeons and patient candidates. The document will be periodically reviewed t o assess its timeliness and appropriateness within five years.