FDA Issues Safety Guidance on Preventing Surgical Fires

The US Food and Drug Administration (FDA) says it continues to receive reports of surgical fires, which can result in burns, other serious injuries, disfigurement, and death. Such fires are largely preventable.

In a safety communication issued May 29, the FDA recommends practices to reduce the risk for surgical fires, including safe use of medical devices and products commonly used during surgical procedures.

The agency notes that surgical fires can occur whenever the elements of the "fire triangle" are present: an oxidizer (eg, oxygen and nitrous oxide); an ignition source (eg, electrosurgical units [ESUs], electrocautery devices, lasers, and fiberoptic illumination systems); and a fuel source (eg, surgical drapes, alcohol-based skin preparation agents, and patient's tissue, hair, or skin).

Most surgical fires occur in oxygen-enriched environments (ie, environments in which the concentration of oxygen exceeds 30%). Such environments can occur when supplemental oxygen is given to a patient in an operating room, the FDA says. An open oxygen delivery system, such as a nasal cannula or mask, poses a greater risk for 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," the FDA says.

To reduce the risk for surgical fires, the FDA says healthcare providers and hospital staff who perform surgical procedures should be educated on the factors that increase the risk for surgical fires, as well as how to manage fires. Such education should include periodic fire drills, instruction on how to use CO₂ fire extinguishers, and evacuation procedures.

The FDA recommends that staff perform a fire risk assessment at the beginning of each surgical procedure and ensure communication between the anesthesiologist delivering medical gases, the surgeon controlling the ignition source, and the operating room staff who apply skin preparation agents and drapes.

The FDA also recommends a series of actions to promote the safe use of oxidizers, including determining whether the patient needs supplemental oxygen. If supplemental oxygen is necessary, particularly for surgery in the head, neck, or upper chest, the FDA advises that oxygen concentration be titrated to the minimum needed to maintain adequate oxygen saturation. When appropriate and possible, use of a closed oxygen delivery system is advised. When using an open delivery system, the FDA says additional precautions to exclude oxygen and flammable/combustible gases from the operative field should be taken, such as use of draping techniques that avoid accumulation of oxygen in the surgical field.

Plan and Practice

To ensure safe use of any devices that may serve as an ignition source, the FDA suggests the following:

• Consider alternatives to use of an ignition source for surgery of the head, neck, and upper chest if high concentrations of supplemental oxygen (>30%) are being delivered.

• If an ignition source must be used, be aware that it is safer to allow time for the oxygen concentration in the room to decrease before using such a source. It may take several minutes for the oxygen concentration to be reduced in the area, even after stopping the gas or lowering the concentration.

• Inspect all instruments for evidence of insulation failure (eg, device, wires, and connections) prior to use. Do not use if any defects are found.

• In addition to serving as an ignition source, use of monopolar energy can directly result in unintended patient burns from capacitive coupling and intraoperative insulation failure. If a monopolar ESU is used, do not activate when near or in contact with other instruments; use a return electrode monitoring system; and keep tips of cautery instruments clean and free of char and tissue.

• When not in use, place ignition sources, such as ESUs, electrocautery devices, fiberoptic illumination light sources, and lasers, in a designated area away from the patient in a holster or a safety cover. Ignition sources should not be placed directly on the patient or surgical drapes.

• Be aware that other items that generate heat, such as drills and burrs, argon beam coagulators, and fiberoptic illuminators, can also serve as potential ignition sources.

The FDA provides the following advice to ensure the safe use of surgical suite items that may serve as a fuel source:

• Allow adequate drying time. Prevent alcohol-based antiseptics from pooling during skin preparation, and assess for pooling or the presence of moisture to ensure dry conditions prior to draping.

• Use the appropriate-sized applicator for the surgical site. For example, do not use large (26 mL) applicators for cases involving the head and neck.

• Be aware of other surgical suite items that may serve as a fuel source, including products that may trap oxygen, such as surgical drapes, towels, sponges, and gauze — even those that claim to be flame-resistant; products made of plastics, including some endotracheal tubes, laryngeal masks, and suction catheters; and patient-related sources, such as hair and gastrointestinal gases.

The FDA also encourages providers to plan and practice how to manage a surgical fire. Such planning includes how to stop the main source of ignition and how to extinguish the fire through use of fire blankets, water, or saline, and how to use a CO₂ extinguisher if the fire persists. For airway fires, the patient should be disconnected from the breathing circuit, and the tracheal tube should be removed. The patient should be moved to a safe environment, and the airway should be reestablished to resume respiratory care.

Providers and other staff are encouraged to report surgical fire events to MedWatch, the FDA's safety information and adverse event reporting program.

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Cite this: FDA Issues Safety Guidance on Preventing Surgical Fires - Medscape - Jun 04, 2018.