FDA focusing on patients catching fire in operating rooms

EAST NAPLES, Fla. - Frank Komorowski was lying in a Naples, Fla. operating room, under the sleepy twilight of anesthesia, when he heard a nurse yelling.

"Oh, my God! He's on fire!" Komorowski recalled in a court deposition. "And the next thing I remember is ... smelling my skin burning."

Komorowski, then 68, suffered second-degree burns to his shoulder, chest and neck, and his hair was singed after he underwent surgery on March 19, 2008, to insert a pacemaker at NCH Downtown Naples Hospital.

Operating room fires are rare, but they can be devastating, causing severe burns, gross facial disfigurement, even death. Hospital employees also live with the memories and trauma. And along with injuries, expensive equipment can be damaged.

The U.S. Food and Drug Administration this week will hold a webinar aimed at helping to stop surgical fires, which it calls a persistent problem.

Komorowski's case is among 550 to 650 surgical fires that occur yearly, according to the FDA Safety Initiative, which began a push to educate health-care professionals in October.

For a surgical fire to occur, the FDA says three factors must be present: an oxidizer, such as oxygen and nitrous oxide; an ignition source, including lasers, drills, and cauterizing devices; and a fuel, such as tracheal tubes, sponges and drapes.

Mike Bruley, an expert in surgical fires, said oxygen is a common culprit. Bruley has investigated four patient burning cases this year, as vice president of accident and forensic investigations at the Pennsylvania-based ECRI Institute. All were caused by oxygen, he said.

ECRI is an independent, nonprofit group that tests medical devices and researches how to improve patient care.

Operating rooms normally have a heavy oxygen concentration, which increases if oxygen is used during surgery.

"The high oxygen concentration can cause that fine body hair to be extremely flammable -- a ripple of flames that spreads across the skin, traveling at 10 feet per second," Bruley said. "Oxygen makes other things a fuel."

Three recent cases that made headlines illustrate the problem:

-- In November, a 29-year-old Florida woman was having surgery to remove three cysts on her head when her face erupted in flames. The cauterizing tool was engulfed in flames after being fueled by her oxygen mask.

-- In June 2011, a surgeon was performing a tracheotomy at a New York hospital when his electronic scalpel, which sparks, set off the oxygen supply and prompted a minor explosion that caused severe burns on a 52-year-old patient's neck and chest.

-- In May 2011, a Pennsylvania jury found a nurse anesthetist negligent and liable for $250,000 in damages for injuries to a 72-year-old woman who suffered second-degree burns to her face and chest, and burns to her larynx, trachea and lungs, in September 2006. Testimony showed he administered extra oxygen but didn't tell the surgeon, who activated an electrocautery device that ignited the surgical drapes and prompted a flash fire.

Many blame alcohol because it's flammable, but Bruley said it causes only about 4 percent of fires -- and those shouldn't happen at all if the alcohol solution is left to dry for three minutes, as manufacturers recommend.

An alcohol-based antiseptic that wasn't given time to dry caused 72-year-old Catherine Reuter to suffer second- and third-degree burns to her upper airway, chest, throat, face, and ear, during a tracheal operation in Washington, D.C., in December 2002. She was sedated for seven weeks due to pain and suffered multiple infections until she died two years later, never returning home. Her story and photos are featured on her daughter's site, surgicalfire.org, which she created to raise awareness.

"I was so horrified over the last images I had of my mom,'' Catherine Reuter Lake, of Maryland, told the Naples Daily News. "She said 'If it could happen to me, it could happen to other people.'"

In the Naples case, an alcohol-based antiseptic, DuraPrep, hadn't fully dried before nurses told the surgeon he could operate, which caused an electrical cauterizing device to ignite, according to Komorowski's attorney, Mark Weinstein, citing depositions in the case.

Another nurse said the burns occurred where alcohol was pooled around Komorowski's neck.

NCH attorney Ashley Withers of Naples maintained NCH wasn't negligent because the surgeon, who isn't a hospital employee, caused it. NCH's expert believes oxygen under the surgical drape caused it to ignite.

Collier County Circuit Judge Hugh Hayes ruled last week there was adequate evidence to prove the hospital was liable, no matter what caused the fire. A jury will determine damages.

"The bottom line," attorney Weinstein argued before the judge, "is they set the man on fire."