Radiofrequency Ablation for Treatment of Leiomyomas: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database.

Radiofrequency ablation (RFA) is a relatively novel, increasingly popular treatment option for leiomyomas. We studied medical device-related reports of leiomyoma RFA devices to determine whether there are emerging device-related issues. The Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried from 2012 through November 2022. Sixty unique reports, including adverse events and device malfunctions, were analyzed for both laparoscopic and transcervical RFA devices. Forty-three injury reports were reviewed. The most common adverse event was infection. Of the injury cases, 34.9% required additional surgical intervention. Although the details of each event are limited, these reports highlight the importance of postmarket surveillance of new technologies and the necessity of improving the current system of implementation and monitoring.

An implementation of the learning curve cumulative summation test to evaluate a practicum for endometrial cancer ultrasound staging.

PURPOSE: The learning curve cumulative summation (LC-CUSUM) test is commonly used as a quantitative assessment of the individual learning process. This study aimed to evaluate the skill acquisition process for performing ultrasound staging of endometrial cancer using the LC-CUSUM test. METHODS: Sixty-seven ultrasound examinations performed by two operators were evaluated using the LC-CUSUM test according to their rate of success or failure to correctly stage myometrial invasion, serosa involvement, and pelvic and para-aortic lymph node involvement. The reference standard was the pathologic result. After the learning phase, the cumulative summation (CUSUM) test was applied to assess performance maintenance. RESULTS: The processes achieved satisfactory performance in the majority of the cases according to the established definitions. Operator 1 reached adequate performance within the 30th procedure for all the locations considered, while operator 2 performed fewer than 30 ultrasound examinations by the audit time. The CUSUM test confirmed that the target quality was preserved after the learning phase. Moreover, the ultrasound staging for endometrial cancer was highly accurate. CONCLUSION: Using the LC-CUSUM test made it possible to monitor the achievement and maintenance of a satisfactory performance quantitatively. The LC-CUSUM test could be a valuable instrument to survey diagnostic pathways in gynecological ultrasonography quantitatively.