Safety and efficacy of hydrogen peroxide plasma sterilization for repeated use of electrophysiology catheters.

ABSTRACT

OBJECTIVES: The purpose of this study was to evaluate a new technique for sterilizing nonlumen electrophysiology catheters that uses hydrogen peroxide gas plasma. BACKGROUND: The reuse of electrophysiology catheters may potentially result in a significant cost savings. While ethylene oxide sterilization appears to be safe and effective from a clinical standpoint, toxic ethylene oxide residuals, which exceed Food and Drug Administration standards, have been reported. METHODS: Ten nonlumen electrophysiology catheters were extensively evaluated. Each catheter was used five times and resterilized after each use with hydrogen peroxide gas plasma. Tests for sterility, mechanical and electrical integrity, chemical residuals and standard and electron microscopic inspection were performed. RESULTS: Loss of electrical integrity or mechanical integrity was not observed in any catheter. No evidence of microbial contamination was found. Surface integrity was preserved except for one ablation catheter that exhibited fraying of the insulation at the insulation-electrode interface. Surface inspection using standard magnification and electron microscopy revealed no significant change in surface characteristics associated with the sterilization process. Hydrogen peroxide was the only chemical residual noted, with an average concentration of 0.22% by weight, which is within accepted American Association for the Advancement of Medical Instrumentation limits. The cost for a standard electrophysiology catheter ranges from $200 to $800, and one sterilization cycle costs $10. If electrophysiology catheters are used five times, resterilization could potentially result in a savings of $2,000 per catheter, or $9,000 for five ablation procedures. CONCLUSIONS: Hydrogen peroxide gas plasma sterilization may provide a cost-effective means of sterilizing nonlumen electrophysiology catheters without the problem of potentially harmful chemical residuals. However, careful visual inspection of catheters, particularly at the insulation-electrode interface, is required if catheter reuse is performed.