|1:00 pm - 1:05 pm
Welcome & Overview
|Cindi Fitzpatrick, BSN
Safe Use Initiative
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
1:05 pm - 1:45 pm
University of Michigan Health System
UCLA Medical Center
Scripps Memorial Hospital La Jolla
|1:45 pm – 1:55 pm
Surgical Fire Mitigating Strategies
|Priscilla Callahan-Lyon, MD
Division of Nonprescription Clinical Evaluation (DNCE)
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
|1:55 pm – 2:00 pm
Everyone Has a Role
Wrap up & Adjourn
|Cindi Fitzpatrick, BSN
Safe Use Initiative
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
Coordinator: Welcome and thank you for standing by. I would like to inform all parties today's conference call is being recorded. If you have any objections, you may disconnect at this time. I will now turn the call over to Ms. Cindi Fitzpatrick. Ma'am, you may begin.
Cindi Fitzpatrick: Welcome. Thanks for your patience today. I'm your Web leader, Cindi Fitzpatrick, with the FDA. I'm happy to welcome you to our one-hour Webinar, Practical Advice for Preventing Surgical Fires: Safety Strategies from the Front Lines. This Webinar is being presented to you by the Preventing Surgical Fires Initiative.
We begin the Webinar with the agenda and a review of the learning objectives, followed by a short explanation of how we define surgical fires and why FDA is involved in trying to prevent surgical fires. Then I'll introduce you to our invited speakers prior to each of their presentations.
After our invited speakers from University of Michigan Health System, UCLA Medical Center and Scripps Memorial Hospital La Jolla share their experiences and best practices, one of our FDA clinical staff will talk about surgical fire mitigating strategies and recommendations.
We'll close the meeting with a brief description of the Preventing Surgical Fires Initiative. Please note that the order of the presenters is changed from the alphabetical order they were listed at some points on the Web.
There won't be time for a question and answer period during the Webinar, but I'll be providing contact information at the end in case you have questions for our speakers or FDA staff.
Okay, just a quick run-through of the learning objectives. By the end of the presentation you'll be able to identify the factors that contribute to surgical fires; identify the lessons learned from the experiences and interventions of the presenters and surgical prevention tools and mitigating strategies; and identify the Preventing Surgical Fires Initiative efforts. And you'll be able to facilitate the adoption of risk-reduction practices in your health care setting.
A surgical fire is a fire in, on or around the patient who is undergoing a medical or surgical procedure. A surgical fire can happen in many settings -- hospital, ambulatory surgery center, health clinic, urgent care center, doctor's office.
Although surgical fires are relatively infrequent, they are preventable. The root causes are known and so are the solutions. No surgery is completely free of risk, but some surgeries are more high-risk than others.
Reducing the risk of surgical fires requires awareness of the risks, good education, effective communication between members of the surgical team, and implementation of fire risk assessment and reduction activities within surgical facilities.
A fire can occur whenever the three elements of the fire triangle come together. This is one graphic representation of the fire triangle. You'll see others throughout the Webinar.
Two of FDA's centers regulate these three elements -- the ignition source, the oxidizer and the fuel. FDA's regulatory authority includes assessing the safety and effectiveness of these products; determining if the products can be marketed; and overseeing the product labeling.
But FDA's regulatory authority alone cannot prevent fires. So FDA is collaborating with public and private stakeholders to optimize the safe use of products of the fire triangle. The collaboration is called the Preventing Surgical Fires Initiative, and we'll talk more about the initiative after our hospital presenters have shared their stories with you.
At this time I want to welcome and briefly introduce our first speakers, who are affiliated with the University of Michigan Health System in Ann Arbor, Michigan.
Shawn Murphy is the Associate Hospital Administrator and Director of Nursing in the operating rooms and post-anesthesia department of the University of Michigan. She is heavily involved in surgical fire prevention, and works closely with her colleagues on various surgical prevention efforts.
Jahan Azizi is a biomedical engineer and risk management consultant with the University of Michigan Health System’s Risk Management Department. He served on a team that initiated an internal study of surgical fires at this hospital, and is a founding member of the institution's Surgical Fire Prevention Committee.
Steve Burdick is an instructional designer and educational program lead with the University of Michigan's Learning Management Services. His work strives to meet the continuing education requirements for thousands of healthcare professional staff. He's developed education about surgical fire prevention at the University of Michigan Health System.
Ms. Murphy, would you like to begin?
Shawn Murphy: Yes. Thank you, Cindi. I'm going to begin with a review of three fires that occurred in our ORs [Operating Rooms]. After that, Jahan will discuss the elements of the fire triangle in the OR [Operating Room] environment, and Steve Burdick will speak to you about our approach to education in the operating room.
So if you can go to the next slide, please, we'll get started. So the first procedure where we experienced a fire was during a Mohs reconstruction case. There were no flammable solutions or chemicals on the field. Supplemental oxygen was delivered through a nasal cannula at a flow rate of 2 liters per minute, and the oxygen was shut off as the surgery took place.
A monopolar cautery was used and was set at 20 watts. A stray spark ignited a dry sponge on the field. At that time, the sponge was quickly removed from the field. It was thrown to the floor and it was doused with water, and the flame was extinguished.
There was no injury to the patient or to the staff, and the surgery proceeded. However all the sponges on the field were dampened at that point to prevent ignition of another dry sponge on the field.
Next slide, please. The second case where we experienced a fire was an ascending aortic aneurysm. The patient in this case was intubated, as you would expect. Again, a monopolar electrosurgical unit was in use when the surgeon inadvertently brushed a dry lap sponge with an activated cautery tip while the sternum was being closed.
The sponge was immediately removed from the field by the surgeon, and immersed in a basin of sterile water. Again, thankfully there was no injury to the patient, to the surgeon or to the staff, and the closure continued with no further incident.
Next slide, please. The third instance where we experienced a surgical fire was during an anterior cruciate ligament reconstruction. This interestingly did not involve an ESU [Electrosurgical Unit]; rather it was a fiber optic light cord, and that was the ignition source.
While the team was closing, the fiberoptic light cord was disconnected from the arthroscope itself, and it was left on the field unholstered. The surgeon noted that something smelled peculiar, and the inappropriate placement of the light cord was discovered at that time.
The drape was doused with saline, as this was readily available on the field. There was a small hole in the drape. And interestingly in this case, the odor was the cue to the team, because there was no flame or smoke; rather just a melting away of the drape. And again very fortunately, there was no harm to the patient, to the surgical team or the staff.
The fact that we did not have a suitable holster for the light cord was noted to be a contributing factor, and I'm calling this out intentionally because Jahan will share some information in a bit about the temperature of the distal end of fiber optic light cords. And I think you'll find when he shares that information with you, I think you'll find it's worthy of a second review of how your teams handle these in the surgical field.
Next slide, please. This is a useful diagram of the fire triangle that we use in our training to depict the three elements of fire. The source of ignition, which is generally within the control of the surgeon - but I will point out that it could be any member of the team at the sterile field.
The fuel source, of course. In the cases that I reviewed, the fuel sources were the sponges and drapes. And then a source of oxidation, which is usually within the purview of the anesthesia provider.
Next slide, please. At this point, I'm going to turn the presentation over to Jahan. He'll speak to you in more detail about the elements of the fire triangle in the OR [Operating Room] environment, and he'll also share some of his work on oxygen dissipation in the OR [Operating Room]. Thank you.
Jahan Azizi: Thank you, Shawn. So as Shawn indicated, those are the fuel sources. We had the ignition source. And the ignition source was the fiber optic light source.
One of the interesting parts with that was when we were measuring the distal temperature of the light cord, there was a direct correlation between the age of the light bulb and the temperature. So if you have a brand new light bulb, it could be as high at 670 degrees Fahrenheit. So you have to be mindful, as the light bulb is aged, that the temperature drops. So when you put a brand new light bulb, it's not going to act the same as an older one.
The other one is fuel source. Obviously we have alcohol, drapes, gauzes, body hair, and ointment.
Next slide, please. And oxidizing source is oxygen and gas cylinders; nitrous oxide; even regular air room at 21% oxygen; anesthesia machine and the wall outlet.
Next slide, please. So again, some of the precautions that we need to take into consideration are: connect the light source to scope before turning on. Turn off [the light source] prior to disconnecting. And never lay it on the drapes. In addition to the event that Shawn mentioned, we had a couple other near-misses with the light cord, which singed the drapes.
Next slide, please. Some of the precautions that we set with the ESU [Electrosurgical Unit] include: do not use in the presence of flammable solutions; wait at least three minutes for alcohol to dry; do not use near oxygen or nitrous oxide; another precaution that we set is to always use a holster. And we found out that the holsters that are on the market are about 200 or 300 degrees. But, with the light cord, the temperature can go up to 600 or 700 degrees Fahrenheit. We need to perhaps look at a different holster technology. Last, ensure that the electrodes are the same and that the active electrode tip is connected firmly. And obviously never alter or modify the devices.
Next slide, please. So there's a lot of information on this slide. This represents findings from the investigation that we did with the Mohs reconstruction by a medical engineer and risk management to explore the rate of oxygen dispersal from the surgical field after the direct flow of the oxygen has been shut.
After observing several procedures, we placed an oxygen sensor on a mannequin within 1 inch of a nasal cannula, delivering oxygen at 5 liters per minute. It took about 15 minutes for the oxygen to disperse to 30%, which is at the safe level. We then applied suction to the area and reduced the time to 60 seconds.
As you can see in this slide, it could take up to three or four minutes for the oxygen to disperse. So it's important that to add a suction tip or smoke evacuator to the field to do that.
It is recommended that an electrocautery unit should never be used near an open oxygen source, it must be turned off and staff should wait 30 seconds. In addition, it is recommended to use a smoke evacuator or suction at the opposite side of the surgical site.
So our investigation is really in line with these recommendations. When you do not use suction or evacuation, the oxygen lingered because of the property of oxygen obviously is heavy. It sits in the area. And if you create some tenting, that could even take much longer. As I said, for up to 15 minutes the oxygen [concentration] was above 30%.
Next slide, please. A task force was created as a result of those three incidents and we looked at ways to try to remedy this [these occurrences].
We've been working on this for about 18 months; one of the results of this investigation is linked to the policy. From that policy we created our own educational module which Steve will talk about in more detail. Next slide, please.
Steve Burdick: Thank you, Jahan. This is Steve Burdick. Very briefly, my role in all this has been to work with the OR [Operating Room], risk management and safety management services to arrive at a good educational solution for fire safety risk management in the OR [Operating Room], and also to do a formal needs assessment and arrive at the outcomes that we want.
What I'm about to tell you is more of an evolutionary story how we started and how we ended up where we are. I will tell you that the committee that we're on, the effort built upon work developed years earlier when we had a - we rolled out a fire safety education module for all clinical staff.
In that early version, limitations in our system's ability to distinguish procedural area staff from other clinicians required us to combine procedural fire safety information with information intended for non-procedural staff.
As you can imagine, this impacted thousands of clinicians on staff. And as you can imagine, there was pushback from both audiences due to the length and the perceived relevance of the information in the education. So feedback from the first version, the non-tailored version of this activity, was that it was lengthy, but much was learned.
Next slide, please. Previous click, please. So what we did was we - no, if you leave it - I'm sorry. If you could back up, back up one, please. The feedback from the first version - I'm sorry.
The committee addressed the issue and a solution was designed so that we are better able to tailor fire safety content based on specific screening criteria. In this case, we opted to screen clinicians in the audience based upon their potential use of ignition devices. Before the activity begins, a learner is asked whether they use an ESU [Electrosurgical Unit], a laser, a fiber optic device, and so on.
And go on. Next slide, please. Answering yes to any of these screening questions links them to a module that is tailored for procedural area staff.
Click once, please. Next click. Thank you. Okay, so next slide, please. The content of the module is structured around the fire triangle, using examples relevant to procedural areas.
Next slide, please. We relied heavily upon case studies and storytelling to convey salient messages.
Next slide, please. In this case, we illustrate what happens in an oxygen-rich, above-the-xiphoid procedure, in which electrocautery is introduced to complete the fire triangle.
Next slide. And next slide. I think you're - okay, thank you. We wanted to augment the stories with education about - could you back up one slide, please? Thank you. We wanted to augment these case studies with education about fire risk score assessment, based on this document which has been used sporadically in the ORs [Operating Rooms].
Next slide, please. So we developed this easy-to-use, interactive tool where a learner scores the fire risk level of a particular procedure. And if you can kind of click through this - one, two, and one more click. Okay. We get a score high, in this case, and then so if you - leave it here for a second.
Comments and feedback from nurses that try this activity said, "Well this is nice to know the score, but what's next? What must I do? What are the interventions?"
Next slide. So we referenced documents - the original document, and then highlighted the interventions appropriate to a particular procedure or score or role.
Next slide, please. This slide is just an enlargement of part of that document that separates out the oxygen delivery, fuel and draping, and heat -- ignition source.
One more click, please. And this is just an enlargement of the heat piece of it, with the interventions. Note that the audience in this is for both surgeons and nursing, in this case, back to reinforce what Shawn was telling you earlier.
Okay, next slide, please. To reinforce the message, a post-test is provided for learners to guess and check their new knowledge.
Next slide, please. These examples illustrated electrocautery as an ignition source.
And one more slide, please. We also developed similar activities for laser, fiber optic lighting and defibrillation.
So in conclusion, what we were able to do is by tailoring the message to clinicians in procedural areas, we were able to make the content much more relevant and shorten the amount of education time involved. Thank you.
Cindi Fitzpatrick: Thank you, Mr. Burdick, Mr. Azizi, and Ms. Murphy. Next we'll hear from the University of California at Los Angeles Medical Center, Erik Eggins and Virginia Broughton.
Erik Eggins is the Director of Safety at this hospital institution, and is responsible for all the safety programs for UCLA's three-hospital system. Erik and his team have responded to and investigated real fire incidents in both surgical and non-surgical areas.
Erik has been training employees in fire prevention, and in 2006 started an annual specialty training program called “Fire Safety in an Oxygen-Enriched Environment.” He and his team have trained over 1000 employees.
Virginia Broughton is an administrative nurse and quality assurance coordinator in the main operating room in the Santa Monica hospital location, part of the UCLA hospital system. She and Erik work closely to administer mandatory annual fire safety training for staff working in oxygen-rich areas.
Erik Eggins: So okay. Thank you very much. So I'm Erik Eggins, and...
Virginia Broughton: Virginia Broughton.
Erik Eggins: So we'll be doing an overview of our program that we provide in all three of our hospitals.
Next slide, please. Starting with the program overview, just give you a general idea of how our organization provides the training and how we decide who we provide the training to. Basically we provide training in any atmosphere over 20% oxygen, where an ignition source might be introduced.
So primarily we're talking about the operating room, both outpatient/in-patient; GI [ Gastrointestinal] labs; labor and delivery rooms; mainly the procedure rooms; and dermatology.
Next slide, please. In our overview of the training itself, we provide a pre-test to assess staff knowledge, so that's right at the beginning. We do a 30-minute lecture. A 20-minute safety video is shown, and then a post-test to compare before and after knowledge. And then we do some question and answer with the staff to ensure that everyone's on the same page.
Next slide. So this is just an example of our pre- and post-test. It's the exact same test given at the front end of the training and at the very end of the training. We actually go over it line by line with the employees to ensure that everyone has the correct answers.
Next slide. On the 30-minute lecture course outline, first we introduce specific to the area or just in general terms how many OR [Operating Room] fires happen across the country on a yearly basis; how it's been reported; any media reports; impact on organizations; how they impact both in a continuity aspect as well as how you recover from the actual fire.
We also go over the fire triangle as mentioned by the University of Michigan, in the same fashion. We go over the hazards, specific to the area. So if they have specific hazards, we go over those for each area. And again it varies depending on what location we're doing the training in.
We go over alarm detection and suppression systems, again depending on the area. It may be in an older building. It may be in a new building. So some buildings may be sprinkler and others may not. But we go over each individual portion of the training with them, with the group, covering the fire extinguishers; oxygen-enriched and oxygen shut-off valves; any compartmentalization features.
Next slide, please. Continue with prevention. The medical equipment issues are discussed and how to control heat sources and manage fuels. We talk about lasers and ESUs [Electrosurgical Units], as University of Michigan described, and Ginny can expand a little bit further on that.
Virginia Broughton: Okay. I'm just going to talk about some safety quick tips. We don't have a slide for this, so I'm just going to speak to it. A lot of this will be preaching to the choir, so to speak, but just some things that we are constantly educating the staff on. Education is really key.
The appropriate grounding pad site, obviously with appropriate hair removal is needed, avoiding bony prominences, scar tissue. We certainly have an increase in tattoos these days, so be careful about placing grounding pads over tattoos, because it [the tattoo] can be heat source depending on the ink that's used.
The ESU [Electrosurgical] cord should be kept free from coils and kinks during use. They should not be secured with metal or piercing clamps.
They should not be activated in the presence of flammable gases or solutions, and with the increase in the use of alcohol-based preps -- ChloraPrep, DuraPrep -- be mindful of making sure that you avoid pooling of those preps and that they dry appropriately, which can always be very challenging as the surgeon is anxiously waiting to address the patient.
Caution should be used during head/neck surgery in the presence of combustible gases prior to activation of any ESU [Electrosurgical Unit]. There should be a conversation with anesthesia to lower the O2 [oxygen] percent and mix it with room air. But there should be that conversation amongst the team so that you make sure that all your safety measures are in place.
Again you want to take measures to prevent tenting of gases under drapes. Be mindful of your and trauma cases. There may be a likelihood of petroleum products or gasoline that has gotten on the patient. Even if you wash that off, it saturates the skin and you could still get vapors that can accumulate under the drapes.
So there needs to be a discussion again during your time-outs as to whether you should even use an ignition source in that case, and alternatives and safety measures that can be taken to prevent that from becoming a problem.
Obviously you should be using the appropriate electrode with the appropriate designated cautery unit. Use only manufacturer-approved adaptors. And this is something that sometimes there's that where the surgeon may have somebody activate a foot pedal. The end-user should always be the one that activates the cautery source.
Holstering has already been discussed, but it really is important. I know that this is a huge challenge. Cauteries are used. They're set down. They're picked up, as you know. So the scrub person needs to be continually vigilant in holstering those when they're not in use, and keep those in plain sight.
Remove the bioburden from the cautery tip. Don't use a scalpel. They should be removed without using a scalpel. And the bioburden should be removed away from the field.
Down here, bear with me. Just some other additional heat sources on the field. Your fiber optic light cords. Again they get very, very hot. We recently had kind of a near-miss situation where a physician - it was actually at the end of the case. The physician disconnected from their headlight actually, and threw the cord up on the drapes.
And one of the staff noticed a little bit of smoldering and they put it out. But they do get very, very, very hot, and there's that kind of end-of-the-case rush to get that patient out of the room, but those need to be secured, again, in a safe manner.
The other things, laser fibers. Lasers should always be on a standby mode when not in use. A laser time-out is done at UCLA prior to activation to ensure that all our safe measures are in place for our patient, for our staff. We have wet sponges around the site, et cetera. Argon beamers, again, another heat source. They should be holstered when not in use.
And I think that the bottom line for us here at UCLA, we have the really great relationship with our safety department. They come anytime to educate the staff. We are constantly vigilant in our Wednesday morning meetings.
We'll just do spot in-services, just highlighting certain things that may have happened the week prior or that we've heard about, just to constantly bring that to the front of the staff's mind.
Education is constant; not just once a year. We also have our safety department come and do rounds with us, and we have a very collaborative approach with maintaining a safe environment at UCLA. Thank you very much.
Erik Eggins: Thanks, Ginny. So continuing on with the presentation, so obviously we're talking about the any hot topics that have come up in the past -- near-misses and so forth -- but we also talk about our response protocols.
So we go over our R.A.C.E. acronym, which is spelled out on your slide. We review our fire extinguisher use, types and locations; and our acronym of how to use the fire extinguisher, which is on your slide.
As well as we just cover and make sure that everyone is aware of the type of fire extinguisher again that we have in our operating rooms, which we replace all of our fire extinguishers with clean-agent fire extinguishers -- one type of fire extinguisher, ABC fire extinguisher -- that can be used on any type of fire, any class of fire. And we thought it would be a great tool for our procedure rooms.
You can go to the next slide, please. We also review extinguishing in a patient and on a patient. We talk about some of the similar things, similar cases that University of Michigan covered.
Next slide. And then our safety video is shown. We have two types that we currently are showing. We rotate between the years, because we do require this training annually. And they're identified on your slide as the vendors that provide our DVDs, our videos. And they're pretty good, up-to-date videos that show some real scenarios acted out by actors. So these are very good DVDs to maintain.
Next slide. And so at the conclusion of the training, shortly thereafter, we try and do a hands-on fire extinguisher training session with the staff. It probably follows about 30 days after the actual training, where we actually use our digital fire extinguisher training system pictured on the slide, where we'll have staff actually use the fire extinguisher.
It looks sounds, feels, acts, reacts to the simulated fire like a real fire extinguisher. So its good practice, good hands-on experience for the staff. They seem to enjoy the training.
We also do OR [Operating Room] evacuation drills. We partner with our office of emergency preparedness. We try and do that annually, where we actually use mock patients and evacuate one or two OR [Operating Room] suites using the full OR [Operating Room] surgical team to participate in that, including surgeons, anesthesiologists and so forth.
Next slide, please. Some of the - just mention some of the challenges and experiences that we face here at the Health System at UCLA. Physician training is a must. We try and get buy-in from physicians.
We have an anesthesia representative that contributes to the conversation, and he acts as a champion on our behalf. And hopefully that will help with getting physicians more involved in the training.
Again as Ginny mentioned, we talk about time-outs. We really are trying to capture near-misses and small incidents. We have small sparks, flashes, mainly due to the medical equipment malfunctioning or a piece of equipment - a connector not connecting properly or so forth. So we try and jump on that as quickly as we can with our clinical engineering, our biomedical staff.
And we ensure - one of the challenges is ensuring that new employees receive the training before they start working in the OR [Operating Room] environment, instead of waiting for the follow-up year training. But for the most part, we haven't had any major incidents to report, which is good, which we are happy about. So but we again try and stay on top of it as quickly as possible.
Next slide, please. And pretty much that's our program that we have. And our contact information is listed here, and just to clarify, Virginia Broughton is actually working at our main hospital in our Westwood facility. So her contact information's up there. We thank you for your time.
Cindi Fitzpatrick: Thank you. Thank you, Mr. Eggins and Ms. Broughton. At last, but certainly not the least of our invited speakers, we'll hear from Dr. David Dockweiler, who is the Operating Room Medical Director at Scripps Memorial Hospital in La Jolla.
There, Dr. Dockweiler has implemented improvements in surgery fire safety through a combination of environmental, behavioral and process changes. In that vein, he has developed a fire risk assessment which has been incorporated into their time-out processes, and he has been instrumental in developing educational videos and visuals for the operating room staff. Dr. Dockweiler?
David Dockweiler: Good morning. I would like to address the practical aspects of implementing a program designed to reduce the risk of surgical fires in a busy, non-academic private practice setting.
This program's not intended to stand alone, but has as its foundation concurrent use of outside educational materials, such as those provided by FDA, APSF and the ECRI.
As we all know, surgical fires are relatively rare events, and partly because of this fact it's somewhat difficult to get people on board with the fact that we, as caregivers, need to be vigilant in preventing their occurrence. Incredible as it may sound, I have even had surgeons remark as we do our assessment, "You mean there is risk of fire?" Unfortunately when fires do happen, as they do indeed, they can be horrific.
Next slide, please. For many, the real problem is the failure to appreciate the potential for problems and actively take measures to prevent it. This is no news to anyone listening here. But until you actually reach people on a visceral level and get them to put fire up on their list of things they never want to see, this is going to be tough going.
You can make all the policies and protocols you want, but if people don't actually believe there's a problem, it's going to be difficult; and it's made all the more so by the fact that the individuals we are all trying to reach are smart, question rules and guidelines, and don't much care to be dictated to.
So then you see it's a sales job of massive proportions. And the difficulty in selling it is compounded by the happy fact that surgical fires occur infrequently.
Anesthesiologists have formal training in both fire prevention and electrical safety as part of our training, and even we have a great deal of room for improvement in our awareness and prevention of surgical fires. Paradoxically, the advent of non-flammable anesthetics -- while making our operating theaters vastly safer -- has served to somewhat erode our level of vigilance in this area.
So what we have tried to do is make changes in the machinery of the operating room, and by that I mean the ergonomics of our workplace. And we've mandated these, and we do it whenever possible. We try to make it hard to make mistakes, and not easy.
Next slide. We took a page from the FAA's playbook, and we mandated placement of permanent warning or advisory placards on our anesthesia machines to warn of possible hazardous conditions. FAA does this in the cockpit of aircraft to warn of similar hazardous conditions.
And these placards were placed by the oxygen flow meters found on our machines. And as you can read, I hope, these serve as a constant and not-so-subtle reminder that fire danger is present and real, and especially that the open delivery of oxygen greatly increases the risk of operating room fires.
Next slide. This is another view. You see the placard integrates cleanly with the anesthesia machine and is quite prominent when turning on the oxygen flow meter. You can't miss it as you're reaching for the knob. It doesn't get in the way of the workflow, and it accentuates the fact that surgical fire's really all about the oxygen.
Next slide, please. So this is how we do our fire risk assessment. It's performed by the anesthesiologist. It's integrated into our time-out. It's quickly performed, and it negligibly disrupts our workflows.
And we chose this path because the presence of oxygen and nitrous oxide figure prominently in the vast majority of fires. And because they do, we task our anesthesiologists with assigning the fire risk.
Our assessment tool is simple. It's straightforward and integrates cleanly into our time-out checklist. And I strongly suspect that the fact that just the possibility of fire is mentioned and even considered in each and every case, goes a long way to greatly reducing the chance of a fire occurring.
Next slide, please. For every case, fire risk is assessed in the head of the anesthesia provider using a simple algorithm deemed to be low if the fire triangle is incomplete. These cases are relatively uncommon. There are things such as D&Cs, close reductions, joint manipulations, and exams under anesthesia. These merit no further discussion or action. They're mentioned only for sake of completeness, and we move on.
Next slide, please. Fire risk is assessed to be moderate by the anesthesia provider in cases where the fire triangle is complete. And these constitute the lion's share of cases. And again, the greatest gain in safety is achieved by bringing the possibility of fire into the collective consciousness of the team in the operating room.
When you hear the words moderate, everyone should know where the fire extinguishers are, as well as any other materials used to deal with a possible fire. Mention it. Place it in everyone's consciousness, and move on. It adds only seconds to the vast majority of cases.
Next slide, please. And finally, high fire risk. A fire risk is deemed to be high when the fire triangle is complete, and surgery is above the diaphragm with the presence of unconfined or poorly confined oxidants.
If, as an anesthesiologist, you hear the words high coming out of your mouth as you assign the fire risk and that means things should stop. This should trigger a discussion amongst the members of the team.
Should you reduce the Fi02 [ Fraction of Inspired Oxygen] of the gas delivered through that mask? Should you elect to intubate the patient? Should you scavenge loose oxygen from around the airway? Seal the drapes or prevent oxygen from entering the field? The idea is you manage, you minimize and you eliminate risk.
Simply by considering the possibility of surgical fire, I believe we are going a long way to making sure it never happens. I would like to thank you for your attention and we welcome any comments or observations which many enable us to improve our process and further patient safety.
The full video of our surgical time-out checklist will be posted on the FDA Web site, so that you might see how the fire risk assessment is implemented in actual clinical practice. Thank you.
Cindi Fitzpatrick: Thank you, Dr. Dockweiler. That concludes presentations from our invited speakers. Now Dr. Priscilla Callahan-Lyon will discuss surgical fire mitigating strategies.
After almost 20 years in clinical practice, Dr. Callahan-Lyon has been in the Division of Nonprescription Clinical Evaluation at FDA for a little over four years. This is the division that regulates the alcohol-based surgical prep solutions, and the safety issues associated with these solutions led to her involvement with this initiative. Doctor?
Priscilla Callahan-Lyon: Good afternoon. As Cindi noted, I'm in the division of non-prescription clinical evaluation and we regulate the surgical prep products, many of which are alcohol-based solutions.
Next slide. And in that realm, we know that these fires are rare. We know that there are patient injuries and deaths related to surgical fires, and many of them are related to the alcohol preps, as has been noted.
However, when we were doing our investigations from some of these issues, we also learned -- as has been noted -- that many of them are not necessarily related to the alcohol preps, and that was part of the reason for the beginning of this initiative. These patient injuries and deaths were totally preventable, and that was one of the reasons for proceeding with the initiative.
The risks have been outlined quite well by all of our other presenters. Surgical suites almost always have all three elements of the fire triangle present. They're frequently an oxygen-enriched environment, and the materials can become flammable and burn much more quickly and more intensely. And the nitrous oxide is also an oxidant.
In addition, the operating room area may be very tense. Emergencies may occur that require rapid decision-making and actions. So everyone needs to know what they should do. Members of the surgical team should all know their role if a fire occurs.
Now this is the FDA version, or at least the non-prescription evaluation version of the fire triangle. Very similar to the others that you have seen. And what I'd like to do now is go through some of the recommendations, many of which have already been mentioned by our other presenters.
One is the fire risk assessment as part of the pre-operative time-out period. The highest risk procedures are those that involve an ignition source and require supplemental oxygen. And if the ignition source is operated near the oxygen supply -- such as with head, neck and upper chest surgery -- the risk is even higher.
Next slide. You should encourage communication among members of the team. This is particularly important between the anesthesiologist and the surgeon. But importantly, any member of the surgical team should feel able to speak up if they have a concern. And you need to be very certain that the surgeon does not begin the procedure until the prep agent has time to completely dry on the patient.
You should plan how to manage a surgical fire. Everyone should know what their action is going to be. You should conduct regular fire drills and make the training mandatory. Everyone should know where the fire extinguisher is. It should be the correct type of fire extinguisher. And everyone should know where the saline is, and it should be kept very handy.
In addition, there should be an evacuation plan. We've seen cases and heard reports of situations where the power goes out when the fire occurs, and you have to be able to evacuate that OR [Operating Room] in the dark.
You need to encourage the safe use of supplemental oxygen, particularly if it's an open delivery system. It should be a closed delivery system when possible. Every patient's oxygen needs should be evaluated individually, and extra precaution should be taken to remove the oxygen from the surgical field if there is an ignition source that's going to be used.
The alcohol-based skin prep agents should be used correctly. These are very flammable. You need to make sure that the alcohol-soaked drapes are removed after the prepping. Allow adequate drying time. Remember the drying takes longer if the area that's being prepped is hairy or if there's folds of skin.
If you have to re-prep or extend the surgical area, then you need to let it dry again. You need to use the correct amount of prep solution, and make very sure that the skin is dry before you drape the patient and proceed with the surgery.
Make certain that the surgical equipment is used correctly. If you have an ignition source near the supplemental oxygen, allow time for the oxygen concentration to decrease. Use the ignition sources correctly and put them in a holster when they're not being used. And make sure everyone remembers that things burn more quickly around oxygen, even those things that are labeled as flame-resistant.
So what is the FDA doing? We regulate the drugs. We regulate the oxygen, the skin preparation agents. We regulate the devices. And we have all of these things labeled appropriately with all the warnings, and they're reviewed very regularly. But we have come up with this initiative to increase OR [Operating Room] fire awareness and provide resources for healthcare providers.
So in conclusion, these are preventable events. You don't want them to happen in your OR [Operating Room]. You don't want to be a patient or staff member that has it happen to them. And we can all work together to prevent these fires.
Cindi Fitzpatrick: Thank you, Priscilla, and thank you to our invited guests. In the final few minutes, I'll talk briefly about the Preventing Surgical Fires Initiative.
As you've heard, we all play a very important role when it comes to preventing surgical fires. I want to explain how we at FDA, along with many initiative partners, are dedicated to surgical fire awareness and prevention.
Because the FDA's regulatory authorities alone are not sufficient to prevent surgical fires from happening, in order to initiate change, we reached out to partner organizations that are interested in this issue and can help us meet the goals to, increase awareness of factors that contribute to surgical fires; disseminate surgical fire prevention tools; and promote the adoption of risk reduction practices throughout the healthcare community.
On this slide and the next, you'll see a listing of the 24 partners who are committed to working with FDA to optimize the safety of products from the fire triangle. The partners include associations that represent members of the surgical team and healthcare facilities, and healthcare engineering, reporting, standard-setting and patient safety organizations.
The collaboration produced a Web site that is largely a collection of the good work that has been done by our partners -- their resources and tools. The recommendations for healthcare professionals that Priscilla just mentioned are housed here as well.
This slide is a screenshot of the Web site's “Resources and Tools for Preventing Surgical Fires.” The tools are linked or can be downloaded from our site. I really want to emphasize that all the resources, tools and materials on FDA's Preventing Surgical Fires Web site are available to all members of the public, and we invite and encourage you to use them freely.
Back to the Preventing Surgical Fires homepage for a second, I want to point out that we have created a separate page for this Webinar, which you can access from the homepage under the “Spotlight” section at the top right.
In the next month or so, we will post the Webinar materials here. An audio version will be available until December. And after December, and after December, a transcript and this Power Point presentation will remain on the site as an additional educational resource for you.
This is the URL to our Preventing Surgical Fires homepage you just saw. On this site you can also sign up for email updates, so you'll be notified when we add a new resource, or we have an educational or other activity to announce.
If you have questions or comments to share with us, including questions about this Webinar, please use this email address or phone number, also available on our Preventing Surgical Fires Web site.
On behalf of the Preventing Surgical Fires Work group and our invited speakers, we want to thank you for joining us today. And remember, working together we CAN help to prevent surgical fires.
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