FDA and Partners Working to Prevent Surgical Fires

The FDA is building a coalition of public and private healthcare organizations to prevent a medical error—the surgical fire. A surgical fire occurs in, on or around a patient undergoing a medical or surgical procedure.


An estimated 550 to 650 surgical fires happen every year in U.S. operating rooms, according to the ECRI Institute, an organization that evaluates medical products and processes. Some fires cause disfiguring second- and third-degree burns. If the fire occurs in the patient's airway, it can be fatal.


“They’re rare but when they happen, they can be devastating,” says Weiss. “And they’re preventable if the surgical team works together to reduce the risk of fires,” stated Karen Weiss, M.D., M.P.H., program director of the Safe Use Initiative in the FDA’s Center for Drug Evaluation and Research.


Fires can occur when the three elements of the “fire triangle” come together:

  • Oxidizer: Gases used during surgery, such as oxygen and nitrous oxide, and room air
  • Fuel: Flammable objects, including surgical drapes, alcohol-based skin preparations, airway tubing, and even the patient’s hair or body
  • Heat: Tools such as electrosurgical (tissue-cutting) tools, lasers, fiber-optic lights and cables that can generate heat or sparks and cause a fire


Surgeries of the head, neck and upper chest pose a greater risk of fire, especially if the patient is receiving extra oxygen through a breathing mask or nasal tubing.


The FDA regulates the drugs (such as oxygen and alcohol-based skin preparation agents) and devices (including electrosurgical tools, lasers and surgical drapes) that are components of the fire triangle and reviews product labeling to ensure that appropriate warnings about the risk of fire are included.


FDA’s Preventing Surgical Fires Initiative is a collaborative effort to increase awareness of the risk of these fires and to encourage surgical personnel to work together to adopt practices that will prevent them from occurring. The initiative partners include associations that represent members of surgical teams, healthcare facilities, and healthcare engineering and patient safety organizations. See the announcement.