On at least three occasions in 2007, surgeons at one Rhode Island hospital operated on the wrong side of their patients' heads. In one case, a resident neurosurgeon inserted a scalpel into the head of an 82-year-old patient. The surgeon noticed the error before reaching the skull and stitched up the wound, but the state health department fined the hospital $50,000.
This sort of error is not terrifically rare. Based on malpractice judgments and out-of-court settlements for things like operating on the wrong side of a patient, or on the wrong patient, or leaving a sponge or other surgical object inside of a patient, researchers at Johns Hopkins estimate that such errors—called "never events" by hospital risk managers—occur not never, but more than 4,000 times in the U.S. every year.
In recent years, the vogue solution in preventing this sort of error has been a seemingly simple one: using checklists. The idea is that using checklists could prevent this sort of surgical error, and their associated (often massive) costs.
The idea became widely popular in 2009, after surgeon and Harvard professor Atul Gawande published a book called The Checklist Manifesto that, true to its title, implored doctors to use even basic checklists to avoid egregious errors of omission. And, ideally, all errors. It was based on research he published in the New England Journal of Medicine in January of the same year, which found that implementing a system of checklists to ensure basic safety standards is extremely effective. In fact, use of a straightforward 19-point checklist was able to decrease the rate of death in or after surgery by almost half.
Doctors often have many concerns competing for limited space in their immediate attention. Even when faced with a procedure that they've performed thousands of times, a surgeon can overlook a basic tenet like, for instance, double checking that they are cutting on the correct side of a head. Most checklists also ensure that the necessary instruments, extra blood, and surgical equipment are on hand. They also lay the groundwork for good communication, asking that all members of the surgical team have introduced themselves, and that the surgeon has gone through the critical elements of the procedure with the team prior to cutting.
The extra steps that a checklist requires, Gawande evangelized, can make massive differences in mortality and complication rates.
And so it was believed, and decrees for use of such checklists went out across the land, and were also mandated or strongly encouraged internationally including in the United Kingdom and the Netherlands. Eighty-eight percent of Canadian hospitals now require checklists. The checklist train seemed poised to circle the globe until last week, when the New England Journal of Medicine (the same journal that minted Gawande's checklist meme) published new research that concluded, in a momentous twist of fate, that the checklist movement itself may be an error.
After implementing a checklist system at 101 hospitals in Ontario, Dr. David Urbach and colleagues monitored surgical errors and complications over a three-month period. 106,370 procedures later, the researchers concluded that the checklist implementation "was not associated with significant reductions in operative mortality or complications."
Urbach said the study is a reminder that ensuring patient safety is "not as easy as a checklist.”