Risk management for surgical energy-driven devices used in the operating room.

Complications related to energy sources in the operating room are not well-recognized or published, despite occasionally dramatic consequences for the patient and the responsible surgeon. The goal of this study was to evaluate the risks and consequences related to use of energy sources in the operating room.

PATIENTS AND METHODS: Between 2009 and 2015, 876 adverse events related to health care (AERHC) linked to energy sources in the operating room were declared in the French experience feedback data base "REX". We performed a descriptive analysis of these AERHC and analyzed the root causes of these events and of the indications for non-elective repeat operations, for each energy source.

RESULTS: Five different energy sources were used, producing 876 declared AERHC: monopolar electrocoagulation: 614 (70%) AERHC, advanced bipolar coagulation (thermofusion): 137 (16%) AERHC, ultrasonic devices: 69 (8%) AERHC, traditional bipolar electrocoagulation: 32 AERHC, and cold light: 24 AERHC. The adverse events reported were skin burns (27.5% of AERHC), insulation defects (16% of AERHC), visceral burns or perforation (30% of AERHC), fires (11% of AERHC), bleeding (7.5% of AERHC) and misuse or miscellaneous causes (8% of AERHC). For the five energy sources, the root causes were essentially misuse, imperfect training and/or cost-related reasons regarding equipment purchase or maintenance. One hundred and forty-six non-elective procedures (17% of AERHC) were performed for complications related to the use of energy sources in the operating room.

CONCLUSION: This study illustrates the risks related to the use of energy sources on the OR and their consequences. Most cases were related to persistent misunderstanding of appropriate usage within the medical and paramedical teams, but complications are also related to administrative decisions concerning the purchase and maintenance of these devices.