FDA Issues Safety Communication Regarding Surgical Fires

On May 29, 2018, the FDA issued a Safety Communication entitled “Recommendations to Reduce Surgical Fires and Related Patient Injury: FDA Safety Communication” in which the FDA discusses the factors that increase the risk of surgical fires on or near a patient and also recommends practices to reduce these fires from occurring, including the safe use of medical devices and products commonly used during surgical procedures.

The FDA’s Safety Communication warns that most surgical fires occur in oxygen-enriched environments, when the concentration of oxygen exceeds 30 percent. When supplemental oxygen is delivered to a patient in an operating room, 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 or endotracheal tube. In an oxygen-enriched environment, materials that may not normally burn in room air can ignite and burn.

Surgical fires can occur at any time when all three of the following elements are present:

1. Oxidizer (e.g., oxygen, nitrous oxide);

2. Ignition source (e.g., electrosurgical units (ESUs), electrocautery devices, lasers, and fiber-optic illumination systems); and,

3. Fuel source (e.g., surgical drapes, alcohol-based skin preparation agents, the patient’s tissue, hair, or skin).

The FDA states that surgical fires are preventable yet it continues to receive reports of surgical fires. Surgical fires can result in patient burns and other serious injuries, disfigurement, and death – deaths are less common and are typically associated with fires occurring in a patient’s airway.

The FDA warns that any increase in oxygen concentration in the surgical field increases the chance of fire and at concentrations of approximately 30 percent, a spark or heat can ignite a fuel source.

The FDA’s recommendations to reduce surgical fires include: if supplemental oxygen is necessary, particularly for surgery in the head, neck, or upper chest area, titrate to the minimum concentration of oxygen needed to maintain adequate oxygen saturation; when appropriate and possible, use a closed oxygen delivery system; if using an open delivery system, take additional precautions to exclude oxygen and flammable/combustible gases from the operative field, such as draping techniques that avoid accumulation of oxygen in the surgical field; allow adequate drying time and prevent alcohol-based antiseptics from pooling during skin preparation and assess for pooling or other moisture to ensure dry conditions prior to draping; use the appropriate size applicator for the surgical site; and, be aware of other surgical suite items that may serve as a fuel source such as products that may trap oxygen (surgical drapes, towels, sponges, and gauze), products made of plastics (including some endotracheal tubes, laryngeal masks, and suction catheters), and patient-related sources such as hair and gastrointestinal gases.

Source

If you or a family member were the victim of a surgical fire in the United States, you should promptly find a medical malpractice attorney in your state who may investigate your surgical fire claim for you and represent you in a surgical fire case, if appropriate.

Visit our website or call us toll-free in the United States at 800-295-3959 to be connected with medical malpractice lawyers in your state who may assist you.

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This entry was posted on Friday, July 20th, 2018 at 5:22 am. Both comments and pings are currently closed.

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