Avoiding a Lemon: Performance Consistency of Single-Use Ureteroscopes.

INTRODUCTION AND OBJECTIVES

Single-use flexible ureteroscopes are increasingly popular because of high repair costs of reusable ureteroscopes. As new single-use ureteroscopes enter the market, the consistency of performance of these devices has been questioned. Our objective was to compare two single-use ureteroscopes: the Pusen PU3022a (Zhuhai Pusen) and the LithoVue (Boston Scientific) with emphasis on physical and optical performance consistency.

METHODS

Ten LithoVue and 10 Pusen ureteroscopes were evaluated in never-used condition. The following parameters were recorded: maximal tip deflection with an empty working channel, 200 μm laser fiber, and 1.9F basket; image resolution at 10, 20, and 50 mm; and irrigation flow rate; all ureteroscopes were then fully deflected for 200 cycles. Maximum deflection was remeasured. Mean values for each parameter were compared. To examine within-manufacturer consistency, the variance was calculated and an F-test performed to evaluate for equivalence.

RESULTS

Both ureteroscopes provided max deflection over 270°. The Pusen flexed to a greater degree than LithoVue. The Pusen lost more deflection with a laser fiber in the working channel. LithoVue had higher resolution at 10 mm, but the ureteroscopes were similar at 20 and 50 mm. Although the working channel diameter is identical, irrigation flow was higher with the Pusen. However, its working channel was 7 cm shorter than LithoVue. After 200 cycles of deflections, LithoVue had less deflection loss, although one ureteroscope was excluded from analysis because of mechanical failure. Variability was minimal and not significant between manufacturers at all measured parameters.

CONCLUSIONS

LithoVue and the newer PU3022a have similar "out-of-the-box" performance characteristics and seem durable. These two single-use flexible ureteroscopes performed consistently regardless of the manufacturer.