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By John W. Boretos

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Example text

Hertz, L. Death caused by fracture of Beall mitral prosthesis. Am. J. Cardiol. 34:371, 1974. (12) Duma, R. J. (ed) Infections of Prosthetic Heart Valves and Vascular Grafts. University Park Press, Baltimore, 1977. Section II Properties, Structure, and Performance of Biomaterials Predicting Performance of Materials: Introductory Comments and Critique Alan S. Michaels Massachusetts Institute of Technology Cambridge, Massachusetts Lehigh University Bethlehem, Pennsylvania This conference topic addresses one of the most critical aspects of materials selection and development for in vivo prosthetic applications: namely, the identification and determination of the essential macroscopic mechanical, physical, and chemical properties of such materials; the establishment of relationships between these properties and the in vivo properties-requirements for specific prosthetic needs; and predicting the long-term performance characteristics of these materials under in vivo conditions.

Surgical error in handling materials have caused device failure. 11 Finally, the patient who continues to abuse himself by intravenously injecting addicting drugs without sterilization illustrates a patient related cause of failure for biomaterials and devices. 13 Thus, the genesis and elucidation of material failure is highly important and may be multifactorial. A poor choice or mismatch in materials or less than optimum design, a device fabricated and sold without adequate quality control, use by a surgeon ignorant of the limitations of the material, a patient who fails to heed the advice of his physician all will invariably lead to device failure.

Almost all have been new applications of a well known class of compounds. In practically no instance has the material used in the clinical application of an implantable device been designed from the molecule up to meet specific long term in vivo conditions. In most instances the private sector has supplied proprietary materials that were the results of much earlier synthesis and discoveries in the private domain. Rarely has a biomaterial been the direct result of government sponsored investment in material science research for health care.

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