Ergonomics and Management of Floseal Kit in Five Surgical Specialties and Medico-legal Implications

Introduction: Controlling bleeding is one of the most closely monitored aspects of surgery and is considered both a potential complication and a possible source of malpractice, representing a significant risk for the surgeon. Floseal (Baxter Healthcare Corporation) is a hemostatic matrix composed of gelatin and thrombin, designed to control bleeding in surgical settings where standard techniques are ineffective or impractical. This study aimed to provide a comprehensive overview of the use of Floseal kits across a variety of surgical procedures. Particular attention was given to the ergonomic characteristics, usability, and effectiveness of the device in relation to procedural complexity and the associated risk of hemorrhage. Methodology: Data from 95 clinical cases were collected through a survey of a sample of surgeons from three hospitals in the Tuscany Region (Italy). The survey gathered information on the use of Floseal kits across different types of surgeries, as well as the ergonomic aspects of their application. Additionally, a qualitative ergonomic analysis was performed through indirect observation of videos showing Floseal's use during surgical procedures. Based on these findings, potential medico-legal implications were also evaluated. Results: The survey results indicated that 93% of procedures required only one Floseal kit, with the highest usage observed in open surgeries (76%). The device was rated as highly effective, receiving scores of 4-5 on a Likert scale, and demonstrated excellent ease of use in 73% of cases. In terms of ergonomics, Floseal showed outstanding ease of application without significant difficulties, even in complex procedures such as robotic and laparoscopic surgeries. Discussion: Attention to proper usage is essential to avoid errors, such as application in non-expandable areas or the risk of intravascular thrombosis. Proper preparation of the device is necessary to ensure rapid intervention times. Additionally, some considerations are discussed regarding the potential role of AI in improving device ergonomics and its applications in surgical practice. Conclusion: Floseal is a highly effective and user-friendly hemostatic device with broad applicability across various surgical specialties. The limited kit consumption per procedure (93% of surgeries required only one kit) contributes to waste reduction and optimal hemorrhage management. Moreover, the ergonomic design and usability of the device enhance its effectiveness in controlling bleeding during surgery.