Document Detail


Implant retrieval, analysis, and database: a challenge for the medical devices industry.
MedLine Citation:
PMID:  10171617     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
S D Bruck
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of long-term effects of medical implants     Volume:  2     ISSN:  1050-6934     ISO Abbreviation:  J Long Term Eff Med Implants     Publication Date:  1992  
Date Detail:
Created Date:  1993-05-27     Completed Date:  1993-05-27     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  9110830     Medline TA:  J Long Term Eff Med Implants     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  93-7     Citation Subset:  T    
Affiliation:
Biomaterials and Medical Devices Consulting Group, Stephen D. Bruck Associates, Inc., Rockville, MD 20848.
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MeSH Terms
Descriptor/Qualifier:
Academies and Institutes*
Biocompatible Materials / standards*
Humans
Product Labeling / legislation & jurisprudence,  standards
Prostheses and Implants / adverse effects,  standards*
Prosthesis Failure
Registries*
United States
United States Food and Drug Administration / legislation & jurisprudence*
Chemical
Reg. No./Substance:
0/Biocompatible Materials

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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