There's the rub: FDA pulls fire alarm in OR

January 12th, 2015

The FDA is reiterating the threat of surgical fires in the operating room due to factors like the delivery of supplemental oxygen to patients and use of alcohol based antiseptics. The FDA is launching a surgical fire prevention initiative to promote safer practices and to share fire prevention resources.

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 year. 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.

In addition to lasers and cautery devices, a spark can arise from the use of high-speed drills or fiber optic cables. What can burn in the OR? Almost anything: sponges, drapes, towels, hoods, masks, anesthesia circuits, multiple types of dressings, and the aforementioned alcohol prep solutions. And therein, literally, lies the rub, because applying the alcohol to kill pathogens at the surgical site brings fuel to a potential fire.

The FDA cites the following key elements in safe of 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.

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.

FDA recommendations to 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.

Additional Resources:

FDA

• Preventing Surgical Fires Initiative⁵

Fire Risk Assessment Checklist & Training Materials:

• Christiana Care - Surgical Fire Risk Assessment^{6 7}
• Association of periOperative Registered Nurses (AORN) - Fighting Fire^{8 9}

Surgical Fire Prevention:

• Anesthesia Patient Safety Foundation - Fire Safety Video^{10 11}
• American Society of Anesthesiologists - Operating Room Fires^{14 15}
• The Joint Commission’s Sentinel Event Alert, Issue 29: Preventing Surgical Fires ^{16 17}

Other Related Information:

• Center for Medicare & Medicaid Services (CMS) - Use of Alcohol-based Skin Preparations in Anesthetizing Locations¹⁸