By John W. Boretos
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Extra resources for Contemporary Biomaterials
Sample text
This is a broad definition. It contains another word, protheses, whose definition can be found in Dorland's Medical Dictionary. "The replacement of an absent part by an artificial substitute. " Note in particular the underlined clause. The definition is clear as far as it goes; a hearing aid or eyeglasses aid or augment a natural function. But is a blood oxygenator or a renal dialyzer a prosthesis? Accordingly, examining the legal definition, protheses will not help us here; rather the phrase medical device is the term to consider.
This definition of safety and effectiveness should be kept in mind when considering the role of biomaterials. At first sight, the magnitude of the need for biomaterials would seem to be relatively simple to assess. Unfortunately, trustworthy, quantitative data are difficult to amass. The estimates presented here are based on conversations with a number of people in industry as well as studies that have been carried out by the Stanford Research Institute. Although the numbers can be challenged they appear to be the best available.
Thorac. Surg. 20:239-248, 1975. , Perier, P. and Maxwell, S. Continuing improvements in valvular bioprostheses. J. Thorac. Cardiovasc. Surg. 83:27—42, 1982. , 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.