Implant retrieval, analysis, and database: a challenge for the medical devices industry.
Despite the widespread use of various medical implant devices since the 1960s, there has not been any systematic effort developed for implant retrieval, analysis, and data banking.  Most medical implants fail prematurely because of selection of wrong materials and/or processing conditions, selection of wrong in vitro testing methods, inappropriate extrapolation to in vivo conditions, and/or ignorance of the state of the art.  Inasmuch as another federal effort is unlikely to deal effectively with these problems, it is proposed that the medical devices industry establish an independent Institute for Medical Implant Retrieval and Analysis using a small percentage of the profits gained from the sale of implants. In addition to carrying out in-house work, this Institute would support appropriate projects in selected academic institutions, with appropriate feedback to regulatory agencies internationally.
Bruck
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SD
Biomaterials and Medical Devices Consulting Group, Stephen D. Bruck Associates, Inc., Rockville, MD 20848.
D000047:Academies and Institutes; D001672:Biocompatible Materials / Q000592:standards*; D006801:Humans; D011356:Product Labeling / Q000331:legislation & jurisprudence / Q000592:standards; D019736:Prostheses and Implants / Q000009:adverse effects / Q000592:standards*; D011475:Prosthesis Failure; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*