Stephanie Joseph: Hello. My name is Stephanie Joseph and I'm an engineer with the US Food and Drug Administration (FDA). Today we'll be talking about surgical fires and how to prevent them. An estimated 600 surgical fires occur in the United States each year. Some of these fires don't injure anyone but some are devastating, causing disfiguring second- and third-degree burns to the patient. If the fire occurs in the patient's airway it can be fatal.
The FDA regulates many of the medical products used in the surgical setting, such as medical gases, alcohol-based skin preparation agents, electrosurgical units, surgical drapes, and lasers. Because of this, we get reports of fires in our adverse event reporting databases. What's most alarming is that these fires are preventable. So, the FDA is committed to working with partners from the clinical community and from patient safety organizations, and we've just launched a fire prevention initiative.
Working together, our aim is to raise awareness about the factors that increase the risk for surgical fires, and we encourage clinicians and facilities to take concrete steps to prevent them.
I'm joined today by Dr. Kenneth Silverstein who is Chair of the Department of Anesthesiology and Medical Director of Perioperative Services at Christiana Care Health System in Wilmington, Delaware. Dr. Silverstein is one of our partners in this initiative and he's had personal experience with surgical fires.
Surgical Fires: A First-Hand Experience
Dr. Silverstein, thank you for being here. Can you tell us a little more about your experience with fires?
Kenneth L. Silverstein, MD: Absolutely. Thank you for having me. Christiana Care experienced a very first-hand experience with surgical fires in 2003. Just separated by only 8 months in time, we had 2 separate incidents. One was during a carotid endarterectomy and the other during a pacemaker implantation. What we learned from that experience was the devastating impact that a surgical fire can have on patients. The patient who was undergoing carotid endarterectomy was awake and sedated with a regional anesthetic and actually faired quite well and was able to successfully have their surgery completed 1 week after the fire. The patient having the pacemaker had a much more tumultuous clinical course and required treatment in the burn center. We really saw first-hand the impact on patients. Beyond that, we saw the impact that surgical fires can have on the institution, the cost associated with it, and most prominently the impact on the staff. The psychological impact on the staff who was involved in the care of these patients was really profound.
The Fire Triangle
Stephanie Joseph: Thank you for sharing your story. It really highlights the importance of prevention of surgical fires. Surgical fires can occur when all 3 elements of the fire triangle are present. There is the ignition source, such as an electrosurgical unit or a laser; the fuel source, such as surgical drapes, alcohol-based skin preparation agents, the patient's own tissue, hair, or skin; and the third element is an oxidizer, such as supplemental oxygen, nitrous oxide, or even the oxygen present in room air. The FDA recommends that surgical personnel conduct a fire risk assessment at the beginning of each case. Dr. Silverstein, you've developed a fire risk assessment tool. Can you tell us more about it and how you're using it at your facility?
Dr. Silverstein: Absolutely. After these events, as mandated by the Joint Commission, we entertained a root cause analysis. As a result of the root cause analysis, we determined the importance that the fire triangle and its elements play in the incidence of fires in an operating room setting. While it is important to have fuel, an oxidizer, and a heat source, it's really the proximity of the heat source and the oxygen that matter. What we learned in our root cause process is that high concentrations of oxygen are really the bad actor here. All of the other things contribute in a much smaller degree.
The root cause was clearly the high concentration of oxygen and the fire triangle, as you've pointed out. One of the most important contributing factors was that we found that the staff had a general lack of appreciation for what constitutes risk for fire in an operating room setting. As simple as it seems in terms of the science, it was really profound to see how the staff did not appreciate the risk that existed. To assess risk is critical in terms of raising that awareness. At that time, consciousness was high amongst all staff. That quickly waned, and so our challenge was to come up with a way in which the awareness for the staff of the presence of risk in a particular case was there in every single situation every single time.
Fire Risk Assessment Score
So, we developed the fire risk assessment score and then incorporated that into something that is done in every single case, which is the universal protocol or the process by which a patient is confirmed to be the correct patient having the correct procedure at the correct time. By marrying the fire risk assessment to the universal protocol, we found a way to introduce into the consciousness of the staff an awareness of the elements of the fire triangle in every single procedure.
I could just describe very briefly how the risk score is created. We ask 3 simple questions around the elements of the fire triangle and a "Yes" answer gets 1 point. The first question is whether you have an open oxygen source. The second is whether you have a heat source. The third question is whether they're in close proximity. Saying "Yes" to all of those questions gives you a score of 3, which is the highest level of risk. We don't discuss fuel in the operating room setting because it's felt to be omnipresent.
Once we've determined that the risk is a 3, for instance, we have a set of protocols that are associated with that and are adhered to. They're in existent policy format.
Even a level 1 procedure is deemed to be low risk -- not no risk -- and has certain protocols associated with it. To address the highest-level risk procedure, we look specifically at things such as how the drapes are applied, whether an occlusive drape is used -- and that's mandated as part of policy in a level 3 procedure. We observe appropriate drying times for alcohol-based prep solutions, a sound practice, but it's absolutely mandated in a level 3. We look at appropriate safe use of electrosurgical units and other heat sources. There's a great deal of attention that's paid to that, particularly for level 3 procedures. Oxygen concentration is monitored and very carefully delivered, and it's mandated to be started at a low level at 30% in procedures that are the highest risk.
Stephanie Joseph: Once the risk is assessed at the beginning of the case, is that static or can it escalate as the case progresses?
Dr. Silverstein: That's a great question. It's quite a dynamic environment in the operating room and although we've assessed the risk to be at a certain level, things can change. A closed oxygen system can become an open oxygen system inadvertently. Disconnection of an endotracheal tube from the anesthesia equipment would suddenly flood a surgical field with high concentrations of oxygen. So, it's not appropriate to rest on the initial assessment but to be monitoring throughout the procedure for such changes. We've actually had a specific example in which gauze started to smolder remote from the oxygen source because of channeling of oxygen through the drapes. So, when we made the assessment that a risk level might be a 2, it can convert to a level 3, which is the highest level of risk.
Communication Among the Surgical Team
Stephanie Joseph: The FDA and our partners in the Surgical Fire Prevention Initiative are also encouraging improved communication among all members of the surgical team as it's important to fire prevention. Can you tell us how communication is encouraged at your facility among the surgical team?
Dr. Silverstein: Communication is key. We learned that not only was there a general lack of awareness among the staff of what constituted risk, but there was a complete disconnect between the anesthesia provider, for instance, on one side of the drape who was administering 100% oxygen through an open system to a patient, and immediately on the other side of the drape was a surgeon wielding a flame thrower, an electrosurgical unit. There was no communication. Before the operation begins determining the risk score and communicating that creates the opportunity, at least at that point in time, to have communication among the members of the team about where the elements of the fire triangle exist in place and time.
It can't stop there. That has to continue throughout the procedure. If I'm taking care of a patient and I have to increase the oxygen concentration during the procedure, I'm required to communicate that to the surgeon. The person who's handling the scrub aspect of the procedure, the surgical assistant, will acknowledge the increase in oxygen concentration and may even go so far as to remove the heat source from the field during certain parts of an operation. Embedding this into the universal protocol was really the genius behind it, if you will. It's the novel aspect of this. The universal protocol is an easier sell. It's mandated by Centers for Medicare & Medicaid Services and the Joint Commission; you have to verify patient identification and site of surgery. We've taken it a step further. The World Health Organization in 2009 came out with their safe surgery communication tool, their checklist. They published some validation about that tool in the New England Journal of Medicine in January 2009. We've incorporated the checklist into our universal protocol. We do a 2-stage preoperative briefing before every single procedure. Now, we took the World Health Organization checklist and we added the fire risk assessment process to it. So, we have a checkbox that says that we've completed the fire risk assessment as part of the universal protocol.
The universal protocol is about communication. It's the cockpit take on the world in the operating room. It levels the hierarchy. It says that we're all there. We all introduce ourselves with our first names before the procedure starts. We talk about what the tough parts of the procedure are going to be. We make sure that we have the correct patient there, and we assess the risk for fire by understanding the elements of the fire triangle and where they are. It's 1 piece of the puzzle, an important piece, but we've built a culture of communication really stemming our work around fire safety and fire prevention.
Organizational Changes to Reduce the Risk for Fires
Stephanie Joseph: Let's talk about another piece of that puzzle, and that's organizational change. How did you successfully implement these new fire prevention procedures at your facility?
Dr. Silverstein: Organization change is tough. The creation of a culture of communication and safety is hard work. It requires persistence. It requires leadership. It requires buy-in at the highest levels of the organization. It requires being out in the trenches and working with individual practitioners one by one to have them understand the rationale. Sometimes you introduce a behavior, like a checklist, and people don't fully understand the reason for doing it. We share stories. We've had checklist epiphanies, as I call them, where people have had situations in which the checklist has really made a difference in the care of a patient. You have to capitalize on that. As I said, persistence matters a lot in terms of leading change.
Stephanie Joseph: Dr. Silverstein, thank you for being here with us today, sharing your insights, and being part of this important initiative.
Dr. Silverstein: It was my pleasure.
Stephanie Joseph: For those of you watching, you can find out more about the FDA's Preventing Surgical Fires Initiative on our Website. You can also download educational materials and other resources to help reduce the risk for fire at your facility. We hope you'll join our partnership to help eliminate surgical fires. Thank you for watching.