FDA Steps Up Publicity For Its “Preventing Surgical Fires” Initiative

FDA launched an initiative in October 2011 entitled “Preventing Surgical Fires”.  It has more recently issued an article pitched at patients and healthcare consumers which is intended to raise awareness of the initiative and engage patients in the fight against surgical fires which apparently occur between 550 and 650 occasions per year in the United States alone, resulting in injury, disfigurement or even death.


The October guidance can be found here and the new consumer article can be found here.

From the article:

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.

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.

But, says Karen Weiss, M.D., M.P.H., program director of the Safe Use Initiative, FDA’s regulatory authority is not enough to prevent these accidents from happening.

The article goes on to outline measures healthcare professionals could and should take to avoid fire risk, as well as encourage patients to ask searching questions about adoption of these measures.

We’re unable to locate any guidance on the subject in Europe.

Source: FDA