Surgery & Anesthesia · 2009
WHO Surgical Safety Checklist
World Health Organization Surgical Safety Checklist
Estimates from the early 2000s suggested that surgery-related complications affected tens of millions of patients annually worldwide, and that a meaningful proportion of those complications were preventable. The aviation industry had demonstrated that structured checklists reduced error rates in complex, high-stakes procedural environments, but medicine had largely not adopted the principle for the operating room. Communication failures between surgeons, anesthesiologists, and nurses before and during surgery were a recurrent theme in adverse event reviews.
Atul Gawande, a surgeon at Brigham and Women's Hospital working with the WHO Patient Safety Programme, led the development and testing of a 19-item checklist structured around three pause points: a sign-in before the administration of anesthesia, a time-out before skin incision, and a sign-out before the patient left the operating room. Each pause point had a defined set of items covering identity confirmation, allergy review, equipment checks, antibiotic prophylaxis, and communication of key concerns. Alex Haynes coordinated data collection, and William Berry contributed to checklist design and analysis.
The pilot was run at eight hospitals across eight countries chosen to represent a range of resource levels, including facilities in Tanzania, the Philippines, India, and Jordan alongside high-income settings in the United States, Canada, England, and New Zealand. In patients undergoing non-cardiac surgery, major inpatient complications fell from 11.0% to 7.0% and in-hospital death fell from 1.5% to 0.8% after the checklist was introduced. The effect size was consistent across sites, including those in low-income settings, which the authors noted as significant for global surgical safety.
The trial used a before-after design at each site rather than randomizing individual patients or operating rooms, which was its principal methodological limitation. The authors acknowledged it explicitly: concurrent secular trends, Hawthorne effects, and unmeasured confounders could all have contributed to the outcome differences. Despite that limitation, the effect magnitudes were large enough that most surgical bodies accepted the results as sufficient evidence to recommend adoption. The paper appeared in the New England Journal of Medicine in January 2009.
Adoption spread rapidly through national surgical bodies and hospital accreditation standards. The Joint Commission, the NHS, and numerous national college equivalents incorporated checklist requirements into institutional standards within a few years of publication. Subsequent implementation studies found that the checklist's benefit depended heavily on whether the pause points were treated as genuine team communication moments or as a bureaucratic box-ticking exercise. Sites where the checklist was implemented with active team engagement showed greater reduction in adverse events than those where it was completed perfunctorily, a finding that shifted focus toward the behavioral and cultural dimensions of checklist use.
Key People
- Atul Gawande — Lead investigator; directed the WHO pilot program
- Alex Haynes — Co-author; coordinated data collection across eight sites
- William Berry — Co-author; contributed to checklist design and analysis
- Tejal Gandhi — Patient safety researcher; contributed to WHO Safe Surgery program design
N Engl J Med. 2009;360(5):491-499.
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