FDA Safety Communication: Preventing Surgical Fires

Date Issued: Oct. 13, 2011

Audience:

• All health care professionals (surgeons, surgical technicians, anesthesiologists, CRNAs, nurses, etc.) involved in surgical procedures.
• Health care facility executives and staff responsible for patient safety and risk management.

Products:

Medical products used in surgical procedures, including medical gases, alcohol-based skin preparation agents, electrosurgical units (ESUs), lasers, and fiber optic light sources.

Purpose:

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. With support from partners in the health care community, the FDA is launching a surgical fire prevention initiative to promote safer practices and to share fire prevention resources.

Summary of Problem and Scope:

Surgical fires are rare events that can result in serious injury, disfigurement and death. According to ECRI Institute, an estimated 550 to 650 surgical fires occur in the United States per year¹. Surgical fires are preventable. However, 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:

1. Ignition source (e.g., ESUs, lasers, and fiber optic light sources)
2. Fuel source (e.g., surgical drapes, alcohol-based skin preparation agents, the patient)
3. 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.

FDA Activities:

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

In October 2010, the FDA sponsored a stakeholder meeting on surgical fire prevention. During this meeting, representatives from a variety of health care organizations identified barriers to safe practices in the operating room and discussed ways to collaborate to prevent surgical fires. As a result of these discussions and follow-up activities, the FDA and our partners are launching a surgical fire prevention initiative (www.fda.gov/PreventingSurgicalFires). The goals of this initiative include: increase awareness of the risks of surgical fires, disseminate surgical fire prevention tools, and promote the adoption of risk reduction practices throughout the health care community.

Additional Resources:

FDA

• Preventing Surgical Fires Initiative
• Consumer Update - FDA and Partners Working to Prevent Surgical Fires

Fire Risk Assessment Checklist & Training Materials:

• Christiana Care - Surgical Fire Risk Assessment
• Association of periOperative Registered Nurses (AORN) - Fighting Fire

Surgical Fire Prevention:

• Anesthesia Patient Safety Foundation - Fire Safety Video
• ECRI Institute - Surgical Fire Prevention
• American Society of Anesthesiologists - Operating Room Fires
• The Joint Commission’s Sentinel Event Alert, Issue 29: Preventing Surgical Fires

Other Related Information:

• Center for Medicare & Medicaid Services (CMS) - Use of Alcohol-based Skin Preparations in Anesthetizing Locations

Reporting Problems to the FDA:

Prompt reporting of adverse events will help the FDA identify and better understand the risks and adverse events associated with surgical fires. If you experience a surgical fire, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Contact Information:

If you have questions about this communication, please contact the FDA Safe Use Initiative at cdersafeuseinitia@fda.hhs.gov, or 301-796-7600

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

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¹ ECRI Institute New Clinical Guide to Surgical Fire Prevention. Health Devices October 2009