Prospective randomized single-blinded in vitro and ex vivo evaluation of new and reprocessed laparoscopic trocars

Abstract

Background: Reprocessing of single-use medical instruments has been proposed as a mechanism for managing the rising costs of health care. We compared the performance of new and reprocessed laparoscopic trocars.

Study design: New and reprocessed laparoscopic trocars were evaluated. Testing consisted of visual and microscopic inspection, force of trocar insertion and removal through a porcine abdominal wall, trocar seal leak rate determination, and testing of blade shield speed.

Results: Three hundred twenty-eight reprocessed trocars and 199 new trocars were evaluated. Trocars undergoing force testing were inspected for imperfections. In this group, 28.2% of reprocessed and 3.79% of new trocars manifested some gross or microscopic imperfections (p = 0.063). D12LT trocars (Ethicon) required more force with insertion with reprocessed compared with new trocars (0.021). D5LT (Ethicon) new trocars required more force to remove than reprocessed trocars (p = 0.004). Both the shield cover time and the shield response time were found to be faster in the reprocessed (p = 0.0001) compared with the new trocars. Leak testing performed with probes (4.7 mm and 12.9 mm) in place demonstrated a significantly greater amount of leakage for the reprocessed trocars compared with the new trocars, both before and after insertion of the right-angled instrument (p = 0.0001).

Conclusions: When comparing new and reprocessed trocars, there are significant differences in visual trocar defects, insertion and extraction forces, shield response times, and trocar leak rates for some of the device comparisons. The clinical significance of these changes should be weighed against cost savings and environmental impact. Additional testing is necessary for a better understanding of the impact of trocar reprocessing.