Comparison of performance characteristics between new and reprocessed electrophysiology catheters

Abstract

Electrophysiology (EP) catheter reprocessing is widespread and previous studies have examined clinical performance, sterility and safety of these reprocessed devices. Here we compare the intrinsic engineering characteristics, electrical, mechanical and safety, between new and reprocessed devices. New (58 devices) and clinically used (five times)/reprocessed (165 devices) EP catheters from five manufacturers were employed to examine and compare catheter electrode continuity, electrode isolation, electrical leakage current, shaft torsion and stiffness characteristics as well as tip buckling and bond strengths. Electrode continuity, isolation and leakage currents for both new and reprocessed EP catheters were within acceptance criteria for electrode continuity (<30 Omega) and shaft electrical leakage (<0.5 mA) as well as electrode isolation (>200 Omega). In addition, reprocessed catheters were equivalent when compared with their new counterparts. While catheter shaft torque forces varied five fold amongst manufacturers, comparison between new and reprocessed devices within a manufacturer showed no significant differences. Likewise shaft stiffness showed no significant difference between new and reprocessed devices. Average tip buckling forces for all catheters were substantially below the acceptance criteria of 0.45 lb (between 0.04 and 0.1 lb) with differences between new and reprocessed catheters not being significant. All bond strengths for both new and reprocessed catheters exceeded the acceptance criteria specified in ISO 10555-1. This study found that reprocessed EP catheters which had undergone five actual clinical use/reprocessing cycles met and exceeded acceptance criteria specified by industry standards as well as individual manufacturer's criteria for both electrical and safety characteristics. We conclude that reprocessed EP catheters exhibit electrical, mechanical and safety characteristics which are equivalent to their new counterparts.