Acceptance Criteria for Reprocessed AcuNav® Catheters: Comparison Between Functionality Testing and Clinical Image Assessment

The AcuNav®-catheter is a vector-phased array ultrasound catheter that has shown great utility for both diagnosis and electrophysiological interventions. To test the feasibility of limited catheter reuse and to ensure that reprocessed catheters would produce acceptable clinical images, the present study compared the 2-D and Doppler image quality, as determined by clinical assessment, with the catheter's functional status as determined by the FirstCall 2000™ transducer tester. Reprocessed catheters from four functional categories, two acceptable and two unacceptable, were used to collect images, 2-D and Doppler, from a porcine heart. The images were blinded and then rated by clinical evaluation. The study found that catheter images from all functional categories were found to be clinically acceptable except for those from the lowest unacceptable category. In addition, examination of tip deflection characteristics showed no significant difference between new and reprocessed catheters. We conclude that reprocessed AcuNav® catheters that pass functional tests are able to produce clinical images, 2-D and Doppler, which are equivalent to their new counterparts. (E-mail: blester@sterilmed.com)