The safety of reusing ablation catheters with temperature control and the need for a validation protocol and guidelines for reprocessing

• The objective of this study was to evaluate the safety of reusing ablation catheters with temperature control, which has not previously been reported. A review of previously conducted studies on the feasibility of reusing electrode catheters is also presented. From September 1994 to December 1997, 74 deflectable ablation catheters with temperature control (Cordis-Websters and Osypkas) were used during mean 7.6 +/- 8.0 ablation sessions. The catheter tests included visual inspection for surface defects using a magnification glass, impedance measurements, evaluation of the catheter deflection capability, and the integrity of the thermistor and thermocouple. The catheters were sterilized by Sterrad after each use. A total of 41 catheters were rejected after an average 9.1 +/- 8.8 uses (range 1-31). The main reasons for rejection were inaccurate temperature measurements by the thermistor or thermocouple (19%), breakage of or defect in the internal pulling wire (12%), loss or disturbance of electrogram (9%), and loss of deflection capability (8%). The reuse of the catheters has not resulted in any major catheter failures or any major adverse clinical complications. There were no local or systemic infections. It can be concluded that these types of ablation catheters will sustain repeated uses and resterilizations without untoward harm to the patient provided that a thorough validation protocol and guidelines for quality control and rejection of catheters are used. There seems to be no rational for setting a limit for the number of reuses, since most failures occurred at any time of reuse.

Nyckelord

Catheter Ablation/adverse effects/*economics/*instrumentation

Equipment Reuse

Equipment Safety

Evaluation Studies

Humans

Practice Guidelines

Quality Control

Reproducibility of Results

MEDICINE

MEDICIN

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