A Call to FDA: Eradicating Operating Room Airway Fires Through an Industry and Clinical Partnership!

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In the U.S., over 600 Operating Room Fires occur annually [1] . This is typically the result of arc-producing surgical instruments, such as electrocautery pencils and CO2 lasers being used around enriched oxygen and/or pharmaceutical gases being mechanically delivered to the patient during surgery, causing an ignition. Surgical drapes, endotracheal tubes (often petroleum based), or other surgical instruments can serve as a fuel source to perpetuate the reaction known as the “fire triangle.”

preventing_surgical_fires

These fires can result in catastrophic injuries to a patient, or even death. These fires also leave medical professionals and the hospitals they service open to lawsuits and other disciplinary actions.

airway-victims.png

(Source: NBCnews.com, 2008) [2]

Some action has been taken to address this complication.  The U.S. Food and Drug Administration has initiated a Surgical Fire Prevention Campaign [3] . While the campaign appropriately identifies the risk factors associated with O.R. fires, it is lacking an industry-wide call to action to eliminate airway fires altogether. The campaign aims to educate OR staff on protocol and best practices to prevent fires given the existing conditions in the OR, but does very little to call on industry (surgical device and pharmaceutical developers) to further develop and evolve their products in such a way that they play less of a role, or are eliminated entirely as a contributor in OR fires. Also, resources like the Anesthesia Patient Safety Foundation’s Fire Prevention Algorithm[4] have been established and advocated by FDA, however, Anesthesia is only in control of the oxidizer and not the ignition sources used by the Surgeons, or the fuel sources. More synergy between all relevant healthcare entities is needed.

 

 

 

I am advocating for the formation of an FDA mandated congress of clinical professionals, surgical device manufacturers, pharmaceutical manufacturers, hospital administrators, government (FDA) and non-profit enforcing agencies (Joint Commissions) to partner [5] , with the goal to eliminate operating room fires in the next 10 years. To accomplish this goal:

·         Anesthesia gases may need to be reformulated

·         Surgical instruments may need to be better labeled for proper usage.

·         Non-flammable drapes and Endotracheal Tubes may need to be developed from sources other than organic/petroleum-based ignitable materials.

·         Industry must explore alternative technologies to the high-arc electrocautery and laser technologies, such as lower temperature tissue dissectors (e.g., ultrasonic, glow plasma, and cryogenics instruments) that arc less or don’t arc at all.

 

References/Hyperlinks:

[1]http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/default.htm

[2] http://www.nbcnews.com/id/26874567/ns/health-health_care/t/fire-or-hundreds-are-hurt-every-year/#.V7HPOk36vIU

[3] http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm275189.htm

[4] http://www.apsf.org/newsletters/html/2012/winter/01_firesafety.htm

[5]https://www.jointcommission.org/sentinel_event_alert_issue_29_preventing_surgical_fires/

 

 

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2 Responses to “A Call to FDA: Eradicating Operating Room Airway Fires Through an Industry and Clinical Partnership!”

  1. puertoricozika Says:

    Thanks for posting this important issue. I agree with you that we must work on engaging a team of people, not only those who are in the operating room, but those responsible for developing and supplying the equipment. Having experience first hand the culture of the operating room, I have to say that if I had to design a protocol for change, I would use the ecological model and address problems at all levels. For example, there are members of the team who do not think that “under their watch” a fire could occur. Some others are only worried about knowing what is the protocol when the Joint Commission officers are doing their inspections. Some others are in disbelief that it could happen because these are rare events.
    At the organizational level, patient safety must be priority but unfortunately the concept is not reinforced or reminded to the team members. Barriers to this include a high turnover of employees and managers in the operating room, which makes it difficult as there has to be continuous training to those who are new to the system.
    In addition, our safety checklist only includes the “time out” and team members see it as a routine step and are not paying real attention to what is going on.
    As the American College of Surgeons have created a “risk calculator” to predict the risk of the patient in the preoperative period, I also recommend to consider adding to this checklist the potential risk for fire, i.e. neck surgery, use of gases and cautery in the oral cavity, etc. By making it mandatory, it could raise the awareness in the operating room as the procedure is started. From the policy level, we should advocate for evidence based standardized protocols for all operating rooms and surgical centers.

    1. http://riskcalculator.facs.org/RiskCalculator/ReportSelect.jsp

    • mcunni25 Says:

      Puertoricozika,

      Thank you for your insightful post on my blog post! Your recommendation to add an element to the ACS checklist that addresses fire risk is an excellent suggestion, particularly for surgeries that involve using electrocautery in the oral cavity, as you have mentioned.
      It is a material fact that a significant portion of surgeries in the oral cavity and head and neck are performed on children- Tonsillectomy, Adenoidectomy, BMT with tube insertion are some of the highest volume surgical procedures in the United States. Many of these procedures are performed in the presence of an enriched oxygen environment. To make matters worse, many pediatric anesthesiologists don’t like to use an endotracheal tube with a cuff, as there is some literature that suggests that it may cause an increased risk of stridor. With that said, an uncuffed endotracheal tube in a child’s oral cavity (in the presence of enriched oxygen) with a cautery pencil presents a serious risk.
      Thank you for your support on my stance. It means a lot!

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