Document Detail


Reprocessing and sterilization of single-use electrophysiological catheters: removal of organic carbon and protein surface residues.
MedLine Citation:
PMID:  19714986     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Although evidence to date indicates that reprocessing electrophysiological (EP) catheters results in clean, sterile devices, some concerns persist with regard to the risk of residual contamination. We examined the ability of a defined reprocessing procedure coupled with a validated sterilization protocol to remove organic carbon and protein residues from worst-case soiled EP catheters resulting in clean, sterile devices. Total organic carbon (TOC) determinations indicated that detergent residues on reprocessed used catheters were nominal and significantly lower than organic carbon levels present on new catheters. Determination of the mean residual organic carbon and protein contaminants on soiled and reprocessed EP catheters further indicated that TOC and protein were reduced (> or =99% of residue removed) below previously reported levels and current accepted standards. Moreover, reprocessed end-of-life catheters (six clinical uses, plus five reprocessings) were examined for residual microorganisms and found to be sterile. End-of-life catheters that had been inoculated with >10(6) CFU Bacillus atrophaeus spores and subjected to a half-cycle ethylene oxide exposure were also found to be sterile. Our data indicate that EP catheter cleaning and reprocessing using defined protocols effectively removes detergent residues and biological contamination, and provides sterile devices.
Authors:
Bruce R Lester; Nicole P Boser; Keith Miller; Mark Schnapf; Beth A Jacques; Brian F Sullivan; George L Marchin
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of AOAC International     Volume:  92     ISSN:  1060-3271     ISO Abbreviation:  J AOAC Int     Publication Date:    2009 Jul-Aug
Date Detail:
Created Date:  2009-08-31     Completed Date:  2009-09-24     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9215446     Medline TA:  J AOAC Int     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1165-73     Citation Subset:  IM    
Affiliation:
SterilMed, Inc., R&D Division, 11400 73rd Ave North, Maple Grove, MN 55369, USA. blester@sterilmed.com
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MeSH Terms
Descriptor/Qualifier:
Bacteria / chemistry,  growth & development
Carbohydrates / analysis
Carbon / analysis*
Catheterization*
Detergents / analysis
Electrophysiology / instrumentation*
Endotoxins / analysis
Equipment Reuse*
Organic Chemicals / analysis*
Proteins / analysis*
Sterilization / methods*
Chemical
Reg. No./Substance:
0/Carbohydrates; 0/Detergents; 0/Endotoxins; 0/Organic Chemicals; 0/Proteins; 7440-44-0/Carbon

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


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