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FDA warning on surgical fires

Accreditation Insider, August 28, 2018

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This summer, FDA issued an alert reminding healthcare professionals and facility staff of “factors that increase the risk of surgical fires on or near a patient.” The agency also recommended practices to reduce the occurrence of surgical fires, including “the safe use of medical devices and products commonly used during surgical procedures.”

The alert is targeted at healthcare professionals involved in surgical procedures—such as surgeons, surgical technicians, anesthesiologists, anesthesiologist assistants, certified registered nurse anesthetists, physician assistants, and nurses—and staff responsible for patient safety and risk management.

“Although surgical fires are preventable, the FDA continues to receive reports about these events,” read the alert. “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.”

This report comes 13 months after the FDA warned that certain lithium battery–powered medical carts had been overheating, igniting, smoking, burning, or exploding. In some cases, firefighters have had to bury medical carts to put out the flames.

When fires break out

ECRI Institute estimates that, based off the nonprofit research organization’s reporting data from Pennsylvania that has been scaled to encapsulate the entire country, there are between 90 and 100 surgical fires in the U.S. every year, down from 550–650 in 2007. ECRI Institute estimates that about 10%–15% of these surgical fires are major, leading to serious injuries or disfiguration.

In 2016, a man in Florida was getting a cyst removed from his forehead when a surgical tool caught cloth on fire during surgery, causing third-degree burns on his face, according to a news report. Another news report out of Chicago said that in 2012, a man having a catheter implanted in his chest suffered surgical fire burns so painful that he “prayed to God to just let me die.”

In rare cases, as the FDA noted, surgical fires can be fatal. For example, a 65-year-old woman undergoing surgery at an Illinois hospital in 2009 died six days after being burned during a “flash fire” in the OR.

It’s not just patients who can be harmed. Healthcare workers are also at danger of being injured when surgical fires occur. Plus, medical equipment and devices are at risk of damage, too.

Fire starters

“A surgical fire can occur when all elements of the fire triangle are present,” Scott Lucas, PhD, PE, director of ECRI Institute’s Accident and Forensic Investigation team, explained via email. Those three elements, he wrote, are a fuel, such as drapes, gauze, breathing tubes, or prepping agents; an oxidizer, such as oxygen or nitrous oxide; and an ignition source, such as a laser or electro-surgical pencil.

“Procedures involving the face, head, neck and upper chest (above the xiphoid) are of the greatest risk, particularly in the presence of supplement oxygen,” Lucas wrote in the email.

Lucas also noted that more than 70% of surgical fires involve oxygen enrichment, which OSHA defines as any atmosphere that contains more than 22% oxygen. He added that “alcohol-based prepping agents also pose a high risk of fire if the agent has not dried prior to beginning the procedure.” The recommended drying time for prepping agents should be listed in product instructions, Lucas wrote.

In its alert, the FDA wrote that it “reviews product labeling for drugs and devices that are components of the fire triangle to ensure the appropriate warnings about the risk of fire are included.”



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