Influence of multiple reuse and resterilization cycles on the performance of a bipolar vessel sealing device (LigaSure) intended for single use.

Objective: To determine the number of use/cleaning/resterilization cycles that can be safely applied to a vessel sealing device intended for single use (LigaSure).

Study Design: Ex vivo study.

Sample Population: LigaSure Small Jaw handsets (n = 6) and LigaSure Impact handsets (n = 6).

Methods: Handsets underwent simulated splenectomy/cleaning/resterilization cycles until failure, defined as leaking vascular seal or blade retraction failure. Functional testing included assessment of vascular seal integrity, handset activation/tissue release, and cutting blade wear/retraction. Vascular seal failure was defined as a leak occurring at <300 mm Hg. Cycles to failure were recorded. Sealed vessels were evaluated by histology at first handset use and failure.

Results: Vascular seals created with the Small Jaw handset failed at a mean (95% CI) of 17.2 cycles (9.6-24.8) and a minimum of 10 cycles. Vascular seals created with the Impact failed at a mean of 20 cycles (18.4-21.6) and a minimum of 17 cycles. The majority of seal failures (73%; 95% CI 39%-94%) immediate leaked during vessel filling. The rate of vascular seal failure increased after the initial failure. Failure was associated with histologic disparities in tissue apposition.

Conclusion: Repeated use and resterilization resulted in failure of the vascular seal due to inadequate tissue apposition after a minimum of 10 cycles.

Clinical Significance: Surgeons reusing and resterilizing LigaSure handsets (ForceTriad platform) should consider discarding handsets after 9 cycles for the Small Jaw and after 16 cycles for the Impact. Handsets should be immediately discarded after any intraoperative identification of vascular seal failure.