Design hazards of electrosurgical devices

The tremendous lifesaving value of adjunct electrosurgery to the medical profession is not without potential hazards. The hazards, which can be classified as radio-frequency burn hazards, shock hazards, electrocution hazards, and explosion hazards, may result from equipment design circuitry, possible failure modes, or operator error. The three basic electrosurgery systems currently being marketed--grounded output systems, referred-to-ground output systems, and floating output systems--are described, and the hazard potential of each system, as well as the hazard potentials of modifications of these systems, are identified. The authors propose a safety system to eliminate most of the hazards cited for the other systems, recommend minimum circuit performance requirements, and evaluate an electrosurgery standard.