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Titolo:
ETHYLENE-OXIDE ON ELECTROPHYSIOLOGY CATHETERS FOLLOWING RESTERILIZATION - IMPLICATIONS FOR CATHETER REUSE
Autore:
FERRELL M; WOLF CE; ELLENBOGEN KA; WOOD MA; CLEMO HF; GILLIGAN DM;
Indirizzi:
VET ADM MED CTR,CARDIOL SECT 111,1201 BROAD ROCK BLVD RICHMOND VA 23249 VIRGINIA COMMONWEALTH UNIV MED COLL VIRGINIA,DEPT INTERNAL MED,DIV CARDIOL RICHMOND VA 00000 VIRGINIA COMMONWEALTH UNIV MED COLL VIRGINIA,DEPT PATHOL,TOXICOL LAB RICHMOND VA 00000 VIRGINIA COMMONWEALTH UNIV RICHMOND VA 00000
Titolo Testata:
The American journal of cardiology
fascicolo: 12, volume: 80, anno: 1997,
pagine: 1558 - 1561
SICI:
0002-9149(1997)80:12<1558:EOECFR>2.0.ZU;2-Q
Fonte:
ISI
Lingua:
ENG
Tipo documento:
Article
Natura:
Periodico
Citazioni:
15
Recensione:
Indirizzi per estratti:
Citazione:
M. Ferrell et al., "ETHYLENE-OXIDE ON ELECTROPHYSIOLOGY CATHETERS FOLLOWING RESTERILIZATION - IMPLICATIONS FOR CATHETER REUSE", The American journal of cardiology, 80(12), 1997, pp. 1558-1561

Abstract

Reuse of electrophysiology catheters, is an important cost-saving option for many laboratories, However, to be reused safely, catheters must undergo resterilization with ethylene oxide (EtO). Residual EtO levels on resterilized catheters may be high and could pose a risk to patients. Resterilized diagnostic electrophysiology catheters were tested for residual EtO using headspace gas chromatography after both a standard resterilization with an aeration process and after a resterilization process that incorporated a detoxification period. The Food and Drug Administration's maximum permissible level of EtO for implantable products, 25 parts per million (ppm), was used as the cutoff for acceptable catheter residuals. At day 2 after standard resterilization, the residual level of EtO on catheters was high at 41 +/- 6 ppm. However, these levels decreased with shelf time, decreasing to 26 +/- 3 ppm by day 7 and to 14 +/- 2 ppm by day 14 after sterilization, at which time all catheters were <25 ppm (p <0.001), Detoxification periods of 6, 12, and 15 hours were tested and 15 hours was found to be optimal. After15 hours of detoxification, residual EtO was 19 +/- 1 ppm by day 2 and all catheters were <25 ppm, In summary, electrophysiology catheters that have undergone resterilization have residual EtO levels that are twice the Food and Drug Administration's limit for implantable products, Residual EtO levels may be substantially reduced either by allowinga 14-day waiting period after resterilization or by incorporating a detoxification period immediately after EtO exposure. (C) 1997 by Excerpta Medica, Inc.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 28/09/20 alle ore 14:35:41