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

Frank Altieri, Alan Berson, Harvey Borovetz, Ken Butler, Glenn Byrd, Arthur A. Ciarkowski, Rosalie Dunn, O. Howard Frazier, Bartley Griffith, David W. Hoeppner, Jal S. Jassawalla, Robert H. Kormos, Robert T.V. Kung, Bette Lemperle, Jeffrey P. Lewis, George M. Pantalos, D. Glenn Pennington, Victor L. Poirier, Peer M. Portner, Gerson RosenbergRhona Shanker, John T. Watson

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

Jointly developed by members of the American Society for Artificial Internal Organs and the Society of Thoracic Surgeons along with staff from the Food 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 submissions for long-term, mechanical circulatory support systems. The recommendation includes a definition of system failure, a discussion of an appropriate reliability model, a suggested in vitro reliability test plan, reliability considerations for animal implantation tests, in vitro and animal in vivo performance goals, the qualification of design changes during the Investigational Device Exemption clinical trial, the development of a Failure Modes Effects and Criticality Analysis, and the reliability information for surgeons and patient candidates. The document will be periodically reviewed to assess its timeliness and appropriateness within five years.

Original languageEnglish (US)
Pages (from-to)108-114
Number of pages7
JournalASAIO Journal
Volume44
Issue number1
DOIs
StatePublished - 1998

All Science Journal Classification (ASJC) codes

  • Biophysics
  • Bioengineering
  • Biomaterials
  • Biomedical Engineering

Fingerprint

Dive into the research topics of 'Long-term mechanical circulatory support system reliability recommendation: American Society for Artificial Internal Organs and Society of Thoracic Surgeons: Long-term mechanical circulatory support system reliability recommendation'. Together they form a unique fingerprint.

Cite this