FDA Seeks to Reduce Risk of Surgical Fires, Patient Injuries

Posted June 8, 2018

Medical devices and surgical instruments are a chief ignition source for surgical fires and play an important role in their prevention, according to a recent safety communication published by the Food and Drug Administration (FDA). To reduce the risk of these fires harming patients, the agency released a new set of recommendations in late May.

“Although surgical fires are preventable, the FDA continues to receive reports about these events. Surgical fires can result in patient burns and other serious injuries, disfigurement, and death. Deaths are less common and are typically associated with fires occurring in a patient's airway,” the FDA wrote.

As of 2015, an estimated 550 to 650 surgical fires occur in the United States per year, according to the FDA’s website. These fires can begin to burn when all three elements of what the agency calls the “fire triangle” are present: high concentrations of oxygen (e.g., oxygen gas, nitrous oxide), an ignition source (e.g., electrocautery devices, lasers, fiber-optics), and a fuel source (e.g., surgical drapes, alcohol, the patient’s hair).

“When supplemental oxygen is delivered to a patient in an operating room, an oxygen-enriched environment can be created. An open oxygen delivery system, such as nasal cannula or mask, presents a greater risk of fire than a closed delivery system, such as a laryngeal mask or endotracheal tube,” the FDA wrote. “In an oxygen-enriched environment, materials that may not normally burn in room air can ignite and burn.”

The FDA recommended that staff be trained in surgical fire risk factors, as well as how to manage fires when they do occur and how to use carbon dioxide fire extinguishers near or on patients. Training should also include fire and evacuation drills.

Specific recommendations from the agency include:

  • Conducting a fire risk assessment at the beginning of each surgical procedure.
  • Ensuring communication between the anesthesia professional delivering medical gases, the surgeon controlling the ignition source, and the operating room staff applying skin preparation agents and drapes.
  • Evaluating if supplemental oxygen is needed for the patient, and if so, using a closed oxygen system when appropriate.
  • When performing surgery on the head, neck, or upper chest, considering alternatives to an ignition source if high concentrations of supplemental oxygen are being delivered.
  • If using an ignition source, allowing time for the oxygen concentration in the room to decrease.
  • Inspecting all instruments for evidence of insulation failure.
  • Keeping tips of cautery instruments clean.
  • Storing instruments properly when not in use, away from the patient or surgical drapes.
  • Allowing adequate drying time for alcohol-based antiseptics and not allowing them to pool.
  • Being aware of products that may trap oxygen, such as surgical drapes, towels, sponges, and gauze.
  • Planning and practicing how to manage surgical fires.

The FDA also encouraged healthcare professionals to voluntarily report surgical fires through MedWatch, the agency’s safety information and adverse event reporting program.