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FDA Surgical Fire Prevention Initiative and Recommendations


Surgical fires are fires that occur in, on or around a patient who is undergoing a medical or surgical procedure. An estimated 550 to 650 surgical fires occur in the United States per year, some causing serious injury, disfigurement, and even death.

 

Despite the fact that the root causes of surgical fires are well-understood, surgical fires still occur. Many healthcare organizations have developed tools, implemented strategies, and conducted education and outreach efforts to reduce the risk of fires.

 

To supplement these efforts, FDA and its partners are launching the “Preventing Surgical Fires” initiative to increase awareness of factors that contribute to surgical fires, disseminate surgical fire prevention tools, and promote the adoption of risk reduction practices throughout the healthcare community.

 

The FDA is advising health care professionals and health care facility executives and staff on factors that increase the risk of surgical fires, particularly the delivery of supplemental oxygen to patients. The FDA is recommending practices to help prevent these fires including the safe use of medical products used during surgical procedures. These products include medical gases, alcohol-based skin preparation agents, electrosurgical units (ESUs), lasers, and fiber optic light sources.

 

The FDA continues to receive reports of surgical fires some resulting in second and third-degree degree patient burns. Deaths are less common and are typically associated with fires occurring in the patient’s airway.

Surgical fires can occur at any time all three elements of the fire triangle are present:

 

  • Ignition source (e.g., ESUs, lasers, and fiber optic light sources)
  • Fuel source (e.g., surgical drapes, alcohol-based skin preparation agents, the patient)
  • Oxidizer (e.g., oxygen, nitrous oxide, room air)

 

Most surgical fires occur in oxygen-enriched environments, when the concentration of oxygen is greater than in ordinary room air. When supplemental oxygen is delivered to the patient, 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. In an oxygen-enriched environment, materials that may not normally burn in room air can ignite and burn.

 

Recommendations to reduce the risk of surgical fires:

 

  • Conduct a fire risk assessment at the beginning of each procedure. The highest risk procedures involve an ignition source, delivery of supplemental oxygen, and the operation of the ignition source near the oxygen (e.g., head, neck, or upper chest surgery).
  • Use supplemental oxygen safely.
  • Evaluate if supplemental oxygen is needed for each patient. Any increase in oxygen concentration in the surgical field increases the chance of fire.
  • If supplemental oxygen is necessary, particularly for surgery in the head, neck, or upper chest area:
  • Deliver the minimum concentration of oxygen needed to maintain adequate oxygen saturation for your patient.
  • Use a closed oxygen delivery system such as an endotracheal tube or laryngeal mask whenever possible, especially if high concentrations of supplemental oxygen (greater than 30 percent) are being delivered.
  • Take additional precautions to exclude oxygen from the field if using an open delivery system. These precautions include draping techniques that avoid accumulation of oxygen in the surgical field, the use of incise or fenestrated drapes which may help isolate oxygen from the surgical site, blowing air to wash out excess oxygen, or alternatively, scavenging oxygen from the field.
  • Use alcohol-based (flammable) skin preparation agents safely.
  • Prevent alcohol-based antiseptics from pooling during skin preparation. For example use the appropriate size applicator for the surgical site.
  • Remove alcohol-soaked materials from the prep area.
  • Allow adequate drying time, as prescribed in the labeling, for the specific product. If the product is used on hairy areas or in skin folds, extend the drying time.
  • Ensure the skin is dry before draping the patient and beginning surgery.
  • Use devices and other surgical equipment safely.
  • Consider alternatives to using an ignition source for surgery of the head, neck, and upper chest if high concentrations of supplemental oxygen (greater than 30 percent) are being delivered. If an ignition source must be used, know that it is safer to do so after allowing time for the oxygen concentration to decrease. It may take several minutes for a reduction of oxygen concentration in the area even after stopping the gas or lowering its concentration.
  • When not in use, place ignition sources, such as ESUs and electrocautery devices, in a holster and not on the patient or drapes.
  • Understand that surgical drapes and other fuel sources can ignite easily and burn in an oxygen-enriched environment, even if the products are described as “flame-resistant.”
  • Encourage communication among members of your surgical team.
  • Ensure the anesthesia professional delivering the gases is communicating with the surgeon controlling the ignition source and the clinician applying the skin preparation agent.
  • Plan how to manage a surgical fire. For example, understand how to extinguish a fire burning on a patient, develop evacuation procedures, conduct fire drills, and keep saline handy to put out a fire.


See FDA Guidance on Preventing Surgical Fires

See FDA Notice  

 

 

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