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

G. M. Pantalos, F. Altieri, A. Berson, H. Borovetz, K. Butler, G. Byrd, A. A. Ciarkowski, R. Dunn, O. H. Frazier, B. Griffith, D. W. Hoeppner, J. S. Jassawalla, R. H. Kormos, R. T.V. Kung, B. Lemperle, J. P. Lewis, D. G. Pennington, V. L. Poirier, P. M. Porther, Gerson Rosenberg & 2 others R. Shanker, J. T. Watson

Research output: Contribution to journalArticle

21 Citations (Scopus)

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)1852-1859
Number of pages8
JournalAnnals of Thoracic Surgery
Volume66
Issue number5
DOIs
StatePublished - Dec 1 1998

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Cardiovascular System
National Heart, Lung, and Blood Institute (U.S.)
Equipment and Supplies
United States Food and Drug Administration
Clinical Trials
In Vitro Techniques
Surgeons
Healthcare Failure Mode and Effect Analysis

All Science Journal Classification (ASJC) codes

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Pantalos, G. M. ; Altieri, F. ; Berson, A. ; Borovetz, H. ; Butler, K. ; Byrd, G. ; Ciarkowski, A. A. ; Dunn, R. ; Frazier, O. H. ; Griffith, B. ; Hoeppner, D. W. ; Jassawalla, J. S. ; Kormos, R. H. ; Kung, R. T.V. ; Lemperle, B. ; Lewis, J. P. ; Pennington, D. G. ; Poirier, V. L. ; Porther, P. M. ; Rosenberg, Gerson ; Shanker, R. ; Watson, J. T. / 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. In: Annals of Thoracic Surgery. 1998 ; Vol. 66, No. 5. pp. 1852-1859.
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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.",
author = "Pantalos, {G. M.} and F. Altieri and A. Berson and H. Borovetz and K. Butler and G. Byrd and Ciarkowski, {A. A.} and R. Dunn and Frazier, {O. H.} and B. Griffith and Hoeppner, {D. W.} and Jassawalla, {J. S.} and Kormos, {R. H.} and Kung, {R. T.V.} and B. Lemperle and Lewis, {J. P.} and Pennington, {D. G.} and Poirier, {V. L.} and Porther, {P. M.} and Gerson Rosenberg and R. Shanker and Watson, {J. T.}",
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Pantalos, GM, Altieri, F, Berson, A, Borovetz, H, Butler, K, Byrd, G, Ciarkowski, AA, Dunn, R, Frazier, OH, Griffith, B, Hoeppner, DW, Jassawalla, JS, Kormos, RH, Kung, RTV, Lemperle, B, Lewis, JP, Pennington, DG, Poirier, VL, Porther, PM, Rosenberg, G, Shanker, R & Watson, JT 1998, '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', Annals of Thoracic Surgery, vol. 66, no. 5, pp. 1852-1859. https://doi.org/10.1016/S0003-4975(98)01164-3

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. / Pantalos, G. M.; Altieri, F.; Berson, A.; Borovetz, H.; Butler, K.; Byrd, G.; Ciarkowski, A. A.; Dunn, R.; Frazier, O. H.; Griffith, B.; Hoeppner, D. W.; Jassawalla, J. S.; Kormos, R. H.; Kung, R. T.V.; Lemperle, B.; Lewis, J. P.; Pennington, D. G.; Poirier, V. L.; Porther, P. M.; Rosenberg, Gerson; Shanker, R.; Watson, J. T.

In: Annals of Thoracic Surgery, Vol. 66, No. 5, 01.12.1998, p. 1852-1859.

Research output: Contribution to journalArticle

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AU - Altieri, F.

AU - Berson, A.

AU - Borovetz, H.

AU - Butler, K.

AU - Byrd, G.

AU - Ciarkowski, A. A.

AU - Dunn, R.

AU - Frazier, O. H.

AU - Griffith, B.

AU - Hoeppner, D. W.

AU - Jassawalla, J. S.

AU - Kormos, R. H.

AU - Kung, R. T.V.

AU - Lemperle, B.

AU - Lewis, J. P.

AU - Pennington, D. G.

AU - Poirier, V. L.

AU - Porther, P. M.

AU - Rosenberg, Gerson

AU - Shanker, R.

AU - Watson, J. T.

PY - 1998/12/1

Y1 - 1998/12/1

N2 - 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.

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