Performance and microbiological safety testing after multiple use cycles and hydrogen peroxide sterilization of a 5-mm vessel-sealing device.

OBJECTIVE

To evaluate the functional and microbiological safety of a single-use laparoscopic vessel-sealing device in a multiuse setting.

STUDY

DESIGN

Ex vivo study.

SAMPLE POPULATION: Twelve 5-mm LigaSure Maryland jaw devices.

METHODS

Handsets underwent repeated test cycles until failure. The handset packaging was opened, and handsets were agitated in phosphate-buffered saline (PBS). The PBS was removed, centrifuged, and submitted for culture. Canine ovariectomy was simulated on cadaveric tissue, after which vascular seal quality was evaluated by pressure testing of sealed porcine carotid arteries. The handsets were cleaned and sterilized with hydrogen peroxide gas and repackaged.

RESULTS

Mean ± SD cycles to failure was 7.7 ± 2.8, with a minimum of 4 and a maximum of 12 use cycles achieved. Eleven of the 12 handsets failed by failure of handset activation after depression of the activation trigger. Only 1 handset failed to hold an adequate vascular seal under 300 mm Hg of pressure. No handset exhibited positive bacterial culture at any cycle.

CONCLUSION

The sterilization method used in this study resulted in an excellent microbiological safety profile. Most of the handsets failed by activation button failure.

CLINICAL SIGNIFICANCE: Under the conditions of this study, hydrogen peroxide sterilization achieved microbiological safety. Handsets can successfully be reused until activation button failure without negative effects on the vascular seal or increased risk of infection to the patient.