Background: Hysterectomy is the most common major gynecological operation in developed countries. The rate of intraoperative complications related to the laparoscopic approach during hysterectomy is a relevant issue. The failure mode and effect analysis (FMEA) method is a prospective approach, which tries to identify possible errors before they occur.
Methods: In this study we applied the FMEA method to laparoscopic approach to hysterectomy in order to reduce the theorized risk of intraoperative complications. We selected a team who analyzed and deconstructed the total laparoscopic hysterectomy (TLH) process recording on the FMEA worksheet phases and activities of the entire procedure. Each activity-related failure mode and their potential effects were developed. The team also described actions to eliminate or decrease the likelihood of mistakes.
Results: A numerical value reflecting the risk was assigned to each activity. Five activities were identified as high priority risk, and for each activity actions were then taken to mitigate the identified risk. After introduction of these actions, the risk scores for each activity were recalculated, and we obtained a total risk reduction of 55%.
Conclusions: It is our opinion that the systematic implementation of the FMEA model can reduce the risk of human error during laparoscopic surgery, improving patient safety.