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A Risk Assessment and Control Model for the Failing Björk-Shiley Convexo-Concave Heart Valve

Published online by Cambridge University Press:  10 March 2009

Floor Koornneef ,
Geerda L. van Gaalen  and
Bas A. J. M. de Mol
Floor Koornneef
Affiliation:
Delft University of Technology
Geerda L. van Gaalen
Affiliation:
Delft University of Technology and Academic Medical Center of the University of Amsterdam
Bas A. J. M. de Mol
Affiliation:
Delft University of Technology and Academic Medical Center of the University of Amsterdam
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Abstract

For risk assessment and control of the failing Björk-Shiley convexo-concave heart valve, we present a life cycle-based complex system model and a risk intensity assessment model, allowing consistent analysis of this complex medical problem and identification of all pertinent aspects of product-related risks to patients.

Type
Research Notes
Information
International Journal of Technology Assessment in Health Care , Volume 12 , Issue 1 , Winter 1996 , pp. 141 - 145
Copyright
Copyright © Cambridge University Press 1996

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References

REFERENCES

1.Agnell, M.Breast implants: Protection or paternalism? New England Journal of Medicine, 1992, 326, 1695–96.Google Scholar
2.Bignell, V., & Fortune, J.Understanding system failures. Manchester: Manchester University Press, 1984, 79–116.Google Scholar
3. CD IEC 65A (Sec) 123. Functional safety of electrical/electronic/programmable electronic systems: Generic aspects, part 1: General requirements. Draft norm. IEC. 04 1991.Google Scholar
4.Committee on Energy and Commerce. U.S. House of Representatives. The Bjork-Shiley heart valve: Earn as You Learn: Shiley Inc.'s breach of the honor system and FDA's failure in medical device regulation. Washington, DC: U.S. Government Printing Office, 1990.Google Scholar
5. DIN V 19250. Grundlegende Sicherheitsbetrachtungen für MSR-Schutzeinrichtunge. Draft norm. DIN, 05 1994.Google Scholar
6. DIN V 19251. MSR-Schutzeinrichtungen, Anforderungen und Maβnahmen zur gesicherten Funktion. Draft norm. DIN, 12 1993.Google Scholar
7.Fielder, J. H.Getting the bad news about your artificial heart valve. Hastings Center Report, 1993, 23, 22–28.CrossRefGoogle ScholarPubMed
8.Fielder, J. H. More bad news about Björk-Shiley c/c heart valves. Engineering and Medical Biology, 1994, 182–84.Google Scholar
9.Graaf van der, Y., Waard de, F., Herwerden van, L. A., & Defauw, J. J.Risk of strut fracture of Björk-Shiley valves. Lancet, 1992, 339, 257–61.CrossRefGoogle Scholar
10.Hale, A. R., & Koornneef, F. Safety in complex hospital systems. Proceedings of the NSC/BME, 1990.Google Scholar
11.Meulen van der, J. H. P., Steyerberg, E. W., Graaf van der, Y. et al. Age-thresholds for prophylactic replacement of Björk-Shiley convexo-concave heart valves. Circulation, 1993, 88, 156–64.CrossRefGoogle Scholar
12.Mol de, B. A., Kallewaard, M., McLellen, R. B. et al. Single-leg fractures in explanted Björk-Shiley valves. Lancet, 1994, 343, 9–12.CrossRefGoogle Scholar
13.Perrow, Ch.Normal accidents: Living with high-risk technologies. New York: Wiley and Sons, 1987.Google Scholar
14.Pochin, E. E.The acceptance of risk. British Medical Bulletin, 1975, 31, 184–90.CrossRefGoogle ScholarPubMed
15.Sandman, P. M.Emerging communication responsibilities of epidemiologists. Journal of Clinical Epidemiology, 1991, 44 (suppl. 1), 41S–45S.CrossRefGoogle ScholarPubMed
16.Swieten van, H. A., Mol de, B. A., Defauw, J. J. et al. Metallurgical analysis of the Björk-Shiley convexo-concave valve prosthesis to assess the cause of late outlet structure. In Bodnar, E. (ed.), Surgery for heart valve disease. London: ICR Publishers, 1990, 616–27.Google Scholar