United States: Defending A "Never Event"

There are medical mishaps that have been deemed "Never Events" by the Centers for Medicare & Medicaid Services (CMS). This term refers generally to preventable occurrences so egregious that they should never occur. But they do occur. And when they do, litigation often follows. This article focuses on one such Never Event—the operating room fire—with strategies on how to defend it. Information provided in this article was derived from a review of the relevant literature and from the author's personal experience defending lawsuits arising from Never Events, including a jury trial involving a surgeon who was sued for a patient's injuries after a fire erupted in the operating room.

INTRODUCTION: DEALING WITH THE MEDICAL CALAMITY THAT SHOULD NEVER HAPPEN

A hospital can be an intimidating place for patients; it is where a person's vulnerability is heightened. In many instances, the patient enters the hospital in a compromised state seeking treatment and is poked and probed by strangers who give little explanation for their actions or the test results and other findings that their actions generate. Moreover, some treatment occurs while the patient is unconscious and in a nude or seminude state.

Patients submit because they know the treatment is intended to make them better and that the medical system is designed to heal them—even though they are made aware through the consent process that certain untoward events, such as infection, bleeding, or even death, may occur. People accept these risks while recognizing that some complications can occur even when everything is done appropriately.

Still, some complications are deemed unacceptable—complications so beyond the pale that they should never happen. These include operating on the wrong patient, leaving a sponge or some other foreign object inside a patient, and sending a newborn home with the wrong person. These are "Never Events."1 These are events that can occur only when health care providers fail to take appropriate measures to ensure patient safety. These are calamities that CMS identifies as events that are 100% preventable and, therefore, should never occur.2

Yet they do occur. Invariably, they are followed by a health care liability claim that, if not settled, can result in a lawsuit. This article focuses on one such Never Event—the operating room fire—and provides insight on how this Never Event can be defended at trial. Information provided in this article was derived from a review of the relevant literature and from the author's personal experience defending lawsuits arising from Never Events, including a jury trial involving a surgeon who was sued for a patient's injuries when a fire erupted during surgery.

HOW AND WHY OPERATING ROOM FIRES OCCUR

In 2007, a task force assembled by the American Society of Anesthesiologists put together a Practice Advisory for Prevention and Management of Operating Room Fires, which was updated in 2013.3 Both editions noted the three components of any fire: (1) an oxidizer, (2) an ignition source, and (3) fuel.

In the operating room setting, the oxidizer typically is oxygen or nitrous oxide provided to the patient during surgery. The ignition source frequently is the electrocautery device used by the surgeon for cutting and cauterization, but may involve other electrical equipment such as lasers, drills, fiber-optic light cables, and defibrillator paddles. The fuel generally is the surgical drape that covers the patient during surgery, but may involve sponges, flammable skin prepping solutions, gauze, and even the patient's hair.

Depending on the surgery, the oxidizer will be administered in a closed or a semiclosed breathing system. A closed breathing system involves intubation and administration of the oxidizer through the endotracheal tube directly into the patient's airway. An inflatable cuff is used to seal the airway and prevent oxygen leakage. Even if the surgery involves the airway, the risk of fire is extremely low because the cuff prevents oxygen from seeping into the operative site.

In a semiclosed breathing system, the oxygen is administered by mask or by nasal cannula. The risk of an operating room fire is increased with the semiclosed system because of the possibility that the oxidizer will escape. The natural dissipation of the oxidizer as it escapes into the operating room reduces the risk of a fire, but the risk still exists.

The real danger of an operating room fire arises when the patient receives an oxidizer by mask or by nasal cannula while an impermeable drape is covering the patient's face. Any oxidizer that seeps from the mask or cannula will pool under the drape. If the drape enveloping the oxidizer is shifted during the surgery, then a cloud of flammable gas may escape. Should that occur while the ignition source is being used, a spark from the ignition source in the presence of the oxidizer cloud can create a sudden burst of flame that may cause the fuel (eg, the drape) to ignite.

Much has been written on operating room fires and how to prevent them.3,4 This article does not rehash those publications, but rather focuses on what to do after an operating room fire lawsuit has been filed. Nevertheless, it is important to understand what these "prevention" articles say because they provide a map of how the operating room fire case will be prosecuted.

The American Society of Anesthesiologists' Task Force3 established 4 basic principles that should be applied to eliminate the risk of an operating room fire:

  • All members of the surgical team should collaborate throughout the procedure to minimize the presence of an oxidizer-enriched atmosphere in proximity to an ignition source.
  • The surgical drapes should be configured to minimize the pooling of oxidizers under the drapes and to channel the oxidizers away from the ignition source.
  • Flammable skin-prepping solutions should be allowed to dry before draping.
  • Gauze and sponges should be moistened when used in proximity to an ignition source.

Of these 4 principles, collaboration and communication by the surgical team are perhaps the most important. This includes a team assessment of the fire risk and how to minimize it before surgery commences. During the procedure, ongoing communication between the surgeon and the anesthesiologist regarding when the ignition source will be used, and cutting off the oxidizer for that period of time further minimizes the risk that the ignition source and the oxidizer will be present simultaneously. If these basic principles are followed, operating room fires might be eradicated. But because they continue to occur, several government agencies have addressed this Never Event and created protocols in an effort to eliminate it.

To read this article in full, please click here.

Footnotes

1. Never events. Patient Safety Network website. https://psnet.ahrq.gov/primers/primer/3/never-events. Accessed February 23, 2017.

2. Eliminating serious, preventable, and costly medical errors—never events. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2006-Fact-sheets-items/2006-05-18.html. Published May 18, 2006. Accessed December 28, 2016.

3. American Society of Anesthesiologists. Practice advisory for the prevention and management of operating room fires: an updated report by the American Society of Anesthesiologist Task Force on Operating Room Fires. Anesthesiology. 2013;118(2):1–20.

4. Thomas BJ. Risk management tips for prevention and management of intra-operative fires. Anesthesia & the Law—A Risk Management Newsletter. 2010:26.

Originally published by Journal of Healthcare Risk Management.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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