By John W. Boretos
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Additional info for Contemporary Biomaterials: Material and Host Response, Clinical Applications, New Technology, and Legal Aspects
Despite all the progress which has been made in materials testing methods over the past many years, the ultimate test procedures depended upon for establishment of medical/surgical acceptability of biomaterials continue to be extended testing in living mammals, and/or trial evaluation in human subjects. This inescapable reliance upon retrospective performance data generated over extended periods of time in animals or humans cannot fail to delay signifi- cantly the clinical acceptance of current-generation candidate biomaterials, as well as to discourage development and evaluation of new materials.
As will be shown, our state-of-knowledge of structure/properties relationships in metallic, ceramic, and polymeric materials is sufficiently advanced today to permit us to make a rational selection of specific materials whose bulk mechanical properties and chemical stability potentially commend them for long-term, reliable in vivo service, and to manipulate and fabricate these materials in a manner which should optimize their durability for dependable prosthetic application. However, the mechanical, electrical, and chemical interac- tions between these materials and the living cells and biological fluids with which they are in continual contact often lead either to unpredictable deteriorative processes occurring within the prosthetic components per se, or to changes in cell-, tissue-, or biological-fluid composition and morphology which compromise prosthesis functionality, or threaten patient survival.
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. The term "device" was de- fined by the 1976 Amendments to the Food, Drug, and Cosmetic Act to mean: " . . " Given these definitions we can return to the question of magnitude of need. Where have we gone in the use of medical devices and the use of biomaterials that are crucial to they way they function?
Contemporary Biomaterials: Material and Host Response, Clinical Applications, New Technology, and Legal Aspects by John W. Boretos