Document Detail


Functional properties and performance of new and reprocessed coronary angioplasty balloon catheters.
MedLine Citation:
PMID:  16506183     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The need of health costs control has prompted the reuse of devices originally manufactured for single use only. To assess reprocessing feasibility of disposable medical devices, hygienic, technical, and functional aspects must be taken into account in addition to economical, ethical, and legal implications. This study aims to characterize coronary angioplasty catheters and to evaluate performance changes induced by reprocessing. Multiple analysis including crossing profile, slipperiness, compliance, mechanical, and burst pressure tests were performed at different steps of the protocol on 25 catheters reprocessed up to two times. The results highlighted that both use and reprocessing can affect the features of angioplasty catheters. Mechanical stress caused by clinical inflation and thermal-chemical stress undergone by polymers during cleaning and sterilization procedures caused partial modifications of material properties, inducing an overall shrinking effect on balloons. Compliance tests reported a maximum variation of 6.2% from nominal values, showing the conformity of reprocessed devices with manufacturers' original specifications (+/-10%). The burst pressure of reprocessed devices was 80% higher than the rated burst pressure certified by manufacturers, thus reducing concerns of breakage during reuse. A strict dependence on device model in the behavior of catheters was found, especially for balloons crossing profile and slipperiness. Main changes occurred after the first reprocessing cycle, while a second cleaning and sterilization did not introduce further significant alterations. On the whole, the magnitude of modifications introduced up to two reprocessing cycles did not compromise catheters performance.
Authors:
Mariangela Fedel; Francesco Tessarolo; Paolo Ferrari; Christian Lösche; Nikou Ghassemieh; Giovanni Maria Guarrera; Giandomenico Nollo
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of biomedical materials research. Part B, Applied biomaterials     Volume:  78     ISSN:  1552-4973     ISO Abbreviation:  J. Biomed. Mater. Res. Part B Appl. Biomater.     Publication Date:  2006 Aug 
Date Detail:
Created Date:  2006-08-14     Completed Date:  2006-09-14     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  101234238     Medline TA:  J Biomed Mater Res B Appl Biomater     Country:  United States    
Other Details:
Languages:  eng     Pagination:  364-72     Citation Subset:  IM    
Affiliation:
Department of Materials Engineering and Industrial Technologies, University of Trento, Trento, Italy. mariangela.fedel@ing.unitn.it
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MeSH Terms
Descriptor/Qualifier:
Angioplasty, Transluminal, Percutaneous Coronary / economics,  instrumentation*
Disposable Equipment / economics
Equipment Failure / economics
Equipment Reuse / economics
Equipment Safety / economics
Humans
Materials Testing*

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


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