Comparison of In Vivo Clinical Performance and Shaft Temperature and In Vitro Tissue Temperature and Transection Times Between New and Reprocessed Harmonic Scalpels

Abstract

The ultrasonic harmonic scalpel (HS) uses ultrasound energy to achieve surgical dissection. To test the feasibility of limited HS reuse and to insure that reprocessed HS function in a substantially equivalent manner to their new counterparts, this study compared in vivo mesenteric vessel and liver cutting characteristics, scalpel shaft temperatures during in vivo usage and in vitro tissue temperature dissipation characteristics between new and reprocessed ACE™36 series HS. The study found that new and reprocessed ACE™-36 HS exhibit identical performance with respect to in vivo dissection characteristics and postcut shaft temperatures. The in vitro studies show tissue temperature elevations and durations adjacent to dissection sites to be substantially equivalent for reprocessed versus new devices. Finally, cut times and extended use performance for new and reprocessed devices exhibit no statistical differences. We conclude that reprocessed HS scalpels that pass acceptance tests exhibit functional and safety capabilities that are equivalent to their new counterparts.