In Part One, I explored the concept of quality, discussed performance demands and the choices workers face when system demands exceed performance capabilities. Let us consider well-intentioned efforts to prevent wrong-site surgery, as well the bugaboo of airway mishaps.
Wrong-site, wrong-implant, wrong-patient errors occur at an alarming rate in the U.S. The Joint Commission came up with a safety procedure to prevent these adverse events. On July 1st, 2004 a mandatory “Universal Protocol” was instituted across the country. The protocol was comprised of three elements. One, assemble all the requisite documents, studies, lab results, consultations, etc. before the procedure. Two, identify the correct site and place a mark on it. Three, conduct a “time-out” before starting. Fast-forward seven years. A June 20th, 2011 article in the Washington Post lamented the truth that the Universal Protocol had failed to reduce the incidence of wrong-site surgery. Based upon state data, the Joint Commission estimated that wrong-site surgeries occur about 40 times a week in the U.S. Bear in mind this is only voluntarily reported wrong-site surgeries, not wrong-incidents or wrong implants or wrong-patients. The true number of these events is probably much higher, as a large number probably go unreported. Indeed, the problem may even be getting worse.
After years of experience, millions of surgeries and thousands of wrong-site incidents, we know with certainty that the Universal Protocol doesn’t work. Yet we continue doing it, expecting a different result. The definition of insanity comes to mind. If the protocol were a drug, there would be congressional hearings about it, it would be taken off the market and the Joint Commission would be litigated out of existence. Why has it failed? Because it was configured as another demand, a burden piled on an already heavily burdened system. Without re-engineering the system, such a demand will simply increase the likelihood of system failure.
The Universal Protocol is essentially a safety maneuver, much like checking the mirrors of your vehicle before backing up is a safety maneuver. Whether or not you perform it properly, perfunctorily or not at all is up to you. Maneuvers differ from mechanisms. Applying a vehicle’s brake before shifting its automatic transmission into gear is a safety mechanism. Engaging such a mechanism is mandatory. Defeating it requires concerted effort. What is needed to reduce wrong-site surgery is a safety mechanism. Instead of marking the correct site, block the incorrect site. Put a sock on the wrong foot, a legging over the wrong knee, a bandage over the wrong hip. Put a glove on the wrong hand, a sleeve over the wrong elbow, a bandage over the wrong shoulder. Put a shield over the wrong eye; a bandage over the wrong flank, the wrong hernia site, the wrong side of the neck and so forth. In order to operate on the wrong site, the operator would have to work at defeating a safety mechanism that was built into the system precisely to prevent this.
Airway mishaps during intubation occur with some degree of regularity in the U.S. The actual number of broken teeth and failed intubations is unknown. There is no central repository of such data. The American Society of Anesthesiologists has collected some numbers via their Closed Claims Project, but only on airway mishaps that generate legal claims and only from some of the nation’s malpractice insurers. If we factor in airway mishaps in the pre-hospital setting, the emergency department, wards and units throughout the hospital, outpatient surgery centers and even doctors’ offices, the true number of airway mishaps per year is probably enormous. The development of supraglottic airway devices, fiberoptic laryngoscopes, difficult airway algorithms and improved training has probably helped reduce the incidence, but mishaps continue to occur, often with devastating consequences.
Before the invention of the endotracheal tube, the dominant airway management paradigm during surgery was mask ventilation. As different iterations of the endotracheal tube came on line, new tools and techniques had to be developed to facilitate its placement. Direct laryngoscopy became the dominant paradigm, facilitated in large part by the invention of the Miller blade (1941) and the Macintosh blade (1943). Both devices are still widely used today. They work very well perhaps more than ninety percent of the time. But it’s the small percentage of difficult airways that get us into trouble. To further reduce the incidence of airway mishaps, we need to come up with a tool and a technique that work more than 99 percent of the time, perhaps even 99.9 percent of the time. Further, since we cannot reliably predict all difficult intubations, we should employ this tool/technique for all routine intubations.
Supraglottic airway devices, such as intubating laryngeal masks may help in certain circumstances. But no one would advocate their routine use for all intubations. Fiberoptic laryngoscopes such as the Glidescope, the C-Mac, and the McGrath may help. They certainly can improve the grade of view of the glottis. They may not reliably improve the ease of getting to it. They represent a slight modification of the current paradigm. The patient must still be positioned supine. The operator must still stand at the head of the bed. The operator must still insert a rigid laryngoscope blade into the patient’s mouth, retract the tongue, advance the blade into the oropharynx, elevate the jaw and expose the laryngeal inlet, all with one hand. A rigid stylet within the endotracheal tube must still be routinely employed.
Perhaps we could learn something from carpentry. Early in a carpenter’s training he learns how to swing a hammer and pound a nail. Then he puts the hammer in the toolbox and picks up a nail gun. It’s a completely different tool and a much better one. Further, it requires a completely different technique—a touch and squeeze rather than a swing and smash. The fiberoptic laryngoscope may be an improvement over the direct laryngoscope, but basically it’s a better hammer. Further, it requires essentially the same technique that has been in vogue since World War II. We need a metaphorical nail gun—a completely different and better tool— as well as a different and better technique.
The fiberoptic bronchoscope was invented in 1967, and has become a valuable tool in the management of difficult airways. Valuable for some, perhaps, but not for all. Many clinicians hesitate to use it in difficult or emergency situations because they simply are not facile in its use. And if they do employ it, chances are they do so with the same approach they use for direct laryngoscopy. The patient is supine, the operator stands at the head of the bed and so forth. This is akin to using a nail gun like a hammer, trying to pound the nail with it. Doable, but difficult. Approaching the patient from the front, standing at the right shoulder, is a much easier and more natural approach for flexible bronchoscopy. Elevating the head of the bed, all the way to ninety degrees if need be, reduces the tendency of the tongue to fall back against the posterior pharyngeal wall. Having an assistant stand at the patient’s left shoulder, open her mouth and thrust her jaw upward makes the task much easier. An operator can become very good at this technique very quickly. Difficult airways become easy. Broken teeth become unheard of. Airway mishaps become vanishingly rare. The rigid laryngoscope is relegated to the toolbox, where it belongs.
In Part Three, we will consider scientific revolutions and rarely occurring events.