Operation Fire Safety
Surgical fires can result in disfiguring injuries and death for patients. To raise awareness of fire safety issues in the OR, the U.S. Food and Drug Administration has launched an education program for medical professionals using safeguards found in NFPA codes and standards.
NFPA Journal®, January/February 2012
By Fred Durso, Jr.
Catherine Reuter’s tracheotomy operation in 2002 was supposed to be a simple one. Doctors at the Washington, D.C., hospital where the procedure was taking place assured her daughter, Catherine Reuter Lake, that the operation would take no longer than a half hour.
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NFPA's Rich Bielen answers questions about surgical fires and how NFPA 99 mitigates the risks.
A Delaware hospital group uses NFPA 99 to develop a fire-risk assessment to safeguard staff and patients
Thirty minutes passed, then an hour, with no update on Reuter’s status. Finally, 90 minutes later, doctors approached Reuter Lake with the grim news: an electrosurgical device ignited the alcohol-based antiseptic rubbed on her mother’s skin, and she had been badly burned during the operation. Doctors were unaware that the "poof" sounds they admitted hearing a few times during the procedure were fires igniting on Reuter’s body as she lay face up on the operating table beneath a surgical drape. "I thought what they were telling me was a sick joke," says Reuter Lake. "I was waiting for the punch line. Who gets set on fire in an operating room?"
Reuter suffered second- and third-degree burns on her face, shoulder, and neck. She died at the age of 73 in 2004 after a series of what Reuter Lake describes as "medical errors and complications" that kept her mother hospitalized after her burn. "This is where hospitals miss the boat completely," says Reuter Lake, of Boonsboro, Maryland. "How dare they take their employees, place them in an operating room with all of these flammable aspects, and not train them. If you work in an OR and your hospital has not provided you with any surgical fire training, you have no business being in that OR."
Similar incidents have gotten the attention of the U.S. Food and Drug Administration (FDA), which regulates surgical components that might cause fires. Initiated in October during NFPA’s Fire Prevention Week, the FDA’s Preventing Surgical Fires Initiative educates health care professionals on the root causes of fires in operating rooms and highlights risk-reduction practices and safety procedures that match provisions in NFPA 99, Health Care Facilities, and NFPA 101®, Life Safety Code®.
"The initiative complements our codes very well," says Richard P. Bielen, NFPA’s department manager for Fire Protection Systems Engineering and staff liaison for NFPA 99. "NFPA provides the framework on what to do, and the FDA gives you the details. They put some flesh on the bones."
Few, but not forgotten
Operating room fires are rare compared to the number of annual surgeries in the U.S. In its most recent analyses of the data, the National Center for Health Statistics reported 22 million in-patient surgical procedures in the U.S. in 2009 and 50 million outpatient procedures in 2006. The FDA estimates that about 600 surgical fires occur annually, though the actual figure is likely higher; fires not resulting in death or serious injury tend to be underreported, since only about half of U.S. states are required to report "adverse events" at health care facilities. And while not all of those fires produce burns, the FDA points out that "some result in injury, disfigurement, or even death."
The number of surgical fires may be relatively small, but the FDA considered the yearly burn reports it receives through its voluntary reporting system to be important examples of safety shortfalls. Surgical devices, for example, must adhere to the FDA’s pre-market clearance process to ensure appropriate safety labels accompany the products. "There’s information on the flammability of alcohol-based skin preps and information on not letting the liquid pool that really clarifies the risks," says Karen Weiss, director of the FDA’s Center for Drug Evaluation and Research Safe Use Initiative, which fosters collaboration with partnering agencies to promote safe medication use. "We know labeling is one aspect to maximize safety, but it isn’t sufficient. People don’t always read the label. That alone won’t change people’s behaviors and practices."
After analyzing fire risks in the operating room, the FDA discovered that some or all components of the fire triangle — a heat source (electrosurgical units or lasers), fuel (flammable antiseptics or drapery), and oxygen — might be present during surgical procedures. Since the FDA doesn’t regulate clinical practices, it enlisted the help of nearly 20 organizations to create a series of recommended safeguards.
"We recognize there were a lot of best practices and solutions already out there," says Stephanie Joseph, a biomedical engineer with the division of Patient Safety Partnerships in the FDA’s Center for Devices and Radiological Health. "We felt it was critical to go out with a unified voice as a partnership, rather than publish something independent."
Many of the FDA recommendations align with provisions in NFPA 99. The FDA, for example, advocates the safe use of flammable skin preparation agents. The "germicides and antiseptics" section of Chapter 15 in NFPA 99 requires ample drying time after placing these liquids on the skin before applying surgical drapes or using electrosurgical tools that might generate sparks. Solution-soaked materials should be removed from the operating room, and "pooling" of flammable liquids should be avoided or else wicked away and allowed to completely dry.
A provision prohibiting flammable germicides and liquid antiseptics in operating rooms was added to the 2005 edition of NFPA 99, after a hospital fire involving germicides raised questions as to the liquid’s safety. However, the American Society for Healthcare Engineering submitted a Tentative Interim Amendment highlighting the antiseptic’s effectiveness in preventing infections and proposed the aforementioned safeguards to minimize fire risks. NFPA’s Standards Council issued the TIA in 2005, and the provisions on how to reduce the fire risk of the flammable liquids were carried forward in the code’s 2012 edition.
The latest edition of NFPA 99 also addresses another FDA recommendation: establishing a hazard assessment for health care occupancies based on the procedures conducted at the facilities. The FDA utilizes a qualitative risk assessment method that is easy to use and quick to conduct. NFPA 99 recommends conducting a hazard assessment that takes into account any dangers associated with surgical equipment and the nature of the environment. "The code doesn’t provide the details of the assessment," Bielen says, "but it does say an evaluation should be made of hazards that are encountered during surgical procedures, and that fire protection procedures should be developed."
The code’s annex offers examples of risk-assessment techniques that list probability calculations and incident severity measures outlined in NFPA 551, Guide for the Evaluation of Fire Risk Assessments. "To simplify this, look at the fire triangle," explains Bielen. "If you have all three sides of the triangle, you have a high risk for fire. If you have two sides, you have a medium risk. If you don’t have any, there’s no risk." (See "Assessing Hazards" on the facing page for an example of a fire risk assessment developed for Delaware hospitals.)
In its recommendations, the FDA also emphasizes that managing fires is just as critical as preventing them. Developing evacuation procedures and conducting fire drills, for example, are crucial components in NFPA 101. In the event of a fire at a hospital, the code’s provisions require relocating patients in immediate jeopardy to a smoke-barrier compartment. If conditions worsen, they will need to move to another compartment or, in a worst-case scenario, evacuate the building. The same procedures apply to ambulatory health care facilities, where patients are tended to for less than 24 hours. "It’s clear that the procedures in the Life Safety Code deal with surgical-site fires," says Robert Solomon, NFPA’s department manager for building and life safety codes. "There are criteria to isolate the fire and evacuate the immediate area if the event is not instantly controlled. In the OR, this process requires a highly orderly approach given the vulnerable state patients are in if they are under the effects of general anesthesia."
Reuter Lake launched a nonprofit and a website, SurgicalFire.org, following her mother’s death to spread the word about these and other safety procedures. As one of the partners in the FDA’s Preventing Surgical Fires Initiative, she hopes to enact a "pledge" program that recognizes hospitals with fire mitigation tactics in the operating room.
"I’d love to say things have changed drastically [since my mother’s death], but they haven’t," says Reuter Lake. "This isn’t rocket science. We’re not talking about faulty equipment — there’s no technological solution to this problem. These fires result from human error, and training will prevent human error."
Fred Durso, Jr. is staff writer for NFPA Journal.
A Delaware hospital group uses NFPA 99 to develop a fire-risk assessment to safeguard staff and patients
Surgeons at Christiana Hospital in Newark, Delaware, were performing a carotid endarterectomy to remove plaque buildup from a patient’s arteries in 2003 when oxygen from the patient’s mask met a spark from an electrosurgical tool and initiated a fire that caused second-degree burns on the victim’s face. Eight months later, a similar fire occurred at the hospital as doctors were implanting a pacemaker inside a patient, who received second- and third-degree burns to his neck and upper chest.
"For years we’ve done these procedures, and the staff didn’t know it was a potential problem for there to be 100 percent oxygen on one side of the paper drape and a spark thrower on the other side," says Dr. Kenneth Silverstein, chair of the Department of Anesthesiology and Medical Director of Perioperative Services for the Wilmington, Delaware-based Christiana Care Health System, of which Christiana Hospital is a part. "There was a lack of fire safety and prevention [awareness] among the staff."
Adhering to a provision in NFPA 99, Health Care Facilities, that requires a hazard assessment prior to performing a surgical procedure, Christiana Care introduced a mandatory fire risk assessment in 2004. Before each procedure, the operating team must identify any open oxygen and heat sources and rate fire risks on a scale of 0 to 3. With each score, a series of protocols must take place to mitigate potential dangers. For example, if the team determines that a certain operation is "high risk," the anesthesiologist must have saline on hand to suppress a fire, should one occur, and utilize draping techniques that minimize oxygen concentration.
"These assessments don’t take long to complete," says Silverstein, adding that Christiana Care has had no patient-related fires since the implementation of the assessment program. "And we’re talking about a quarter-million surgeries."
For more on Christiana Care’s fire risk assessment, visit christianacare.org/FireRiskAssessment.
— Fred Durso, Jr.