Ethylene oxide on electrophysiology catheters following resterilization: Implications for catheter reuse

被引:23
作者
Ferrell, M
Wolf, CE
Ellenbogen, KA
Wood, MA
Clemo, HF
Gilligan, DM
机构
[1] VIRGINIA COMMONWEALTH UNIV MED COLL VIRGINIA,DEPT INTERNAL MED,DIV CARDIOL,RICHMOND,VA
[2] VIRGINIA COMMONWEALTH UNIV MED COLL VIRGINIA,DEPT PATHOL,TOXICOL LAB,RICHMOND,VA
[3] VIRGINIA COMMONWEALTH UNIV,RICHMOND,VA
关键词
D O I
10.1016/S0002-9149(97)00785-6
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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. After 15 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 allowing a 14-day waiting period after resterilization or by incorporating a detoxification period immediately after EtO exposure. (C) 1997 by Excerpta Medica, Inc.
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页码:1558 / 1561
页数:4
相关论文
共 15 条
[1]  
[Anonymous], 1985, IARC Monogr Eval Carcinog Risk Chem Hum, V36, P189
[2]  
*ANSI AAMI, 1988, ST29 ANSI AAMI, P687
[3]   SAFETY OF REUSING CARDIAC ELECTROPHYSIOLOGY CATHETERS [J].
ATON, EA ;
MURRAY, P ;
FRASER, V ;
CONAWAY, L ;
CAIN, ME .
AMERICAN JOURNAL OF CARDIOLOGY, 1994, 74 (11) :1173-1175
[4]   REPEATED USE OF ABLATION CATHETERS - A PROSPECTIVE-STUDY [J].
AVITALL, B ;
KHAN, M ;
KRUM, D ;
JAZAYERI, M ;
HARE, J .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 1993, 22 (05) :1367-1372
[5]  
BOMMER J, 1985, LANCET, V2, P1382
[6]   SUCCESS OF REUSE OF CARDIAC ELECTRODE CATHETERS [J].
DUNNIGAN, A ;
ROBERTS, C ;
MCNAMARA, M ;
BENSON, DW ;
BENDITT, DG .
AMERICAN JOURNAL OF CARDIOLOGY, 1987, 60 (10) :807-810
[7]  
EDINBORO LE, 1993, THER DRUG MONIT, V15, P220
[8]   GENOTOXIC RISK FOR HUMANS DUE TO WORK PLACE EXPOSURE TO ETHYLENE-OXIDE - REMARKABLE INDIVIDUAL-DIFFERENCES IN SUSCEPTIBILITY [J].
FUCHS, J ;
WULLENWEBER, U ;
HENGSTLER, JG ;
BIENFAIT, HG ;
HILTL, G ;
OESCH, F .
ARCHIVES OF TOXICOLOGY, 1994, 68 (06) :343-348
[9]  
*NAT TOX PROGR, TECHN REP SER US DEP, V326
[10]   REUSE OF PACING CATHETERS - A SURVEY OF SAFETY AND EFFICACY [J].
ODONOGHUE, S ;
PLATIA, EV .
PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY, 1988, 11 (09) :1279-1280