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Repeated use of ablation catheters: a prospective study
1Electrophysiology Laboratory, University of Wisconsin-Milwaukee Clinical Campus, Sinai Samaritan Medical Center 53201.
Journal of the American College of Cardiology
|November 1, 1993
Summary
This study found that Webster/Mansfield ablation catheters can be safely reused approximately five times, with careful inspection after each use to ensure safety and efficacy.
Area of Science:
- Medical Devices
- Cardiology
- Electrophysiology
Background:
- Increasing trend of reusing deflectable ablation catheters in clinical settings.
- Lack of existing data on the safety and efficacy of reused ablation catheters.
Purpose of the Study:
- To investigate the changes in electrical, physical, and mechanical properties of ablation catheters after repeated use.
- To assess the impact of these changes on the safety and efficacy of ablation procedures.
Main Methods:
- Prospective study of 69 Webster/Mansfield deflectable catheters over 1 year (336 procedures).
- Evaluation of electrical integrity, mechanical capabilities (deflection, torquing, tip integrity), and physical changes after each use.
- Sterilization via ethylene oxide gas; examination under 30x magnification.
Main Results:
- Common reasons for rejection: tip electrode glue separation (4.3 uses) and loss of deflection (5.0 uses).
- Electrical discontinuity observed after an average of 10 uses.
- No significant decrease in torquing ability; no major catheter failures or clinical complications reported with reuse.
- Estimated savings of $128,133 with catheter reprocessing.
Conclusions:
- Webster/Mansfield catheters can be reused an average of five times.
- Recommend post-use inspection for tip electrode integrity and deflection.
- Testing for electrical integrity is also advised to ensure continued safety and efficacy.