N Engl J Med 2010; 363:978-986September 2, 2010
Authors: Denise M. Dudzinski, Philip C. Hébert, Mary Beth Foglia, and Thomas H. Gallagher
“In 2003, the infection-control staff of a Toronto teaching hospital realized that the sterility of prostate-biopsy equipment had been inadvertently compromised by incomplete cleaning. Although the risk of infectious transmission was considered very low, hospital officials could not be certain that hundreds of men had not been exposed to harmful pathogens. The hospital faced a dilemma: should they disclose this adverse event that may have harmed many patients (a large-scale adverse event)? Or should they not disclose the event if the risk of harm was remote and if the disclosure would primarily cause anxiety to patients who would ultimately not be physically harmed by the event?  …Such large-scale adverse events are not uncommon. (Table 1Large-Scale Adverse Events.). Yet, whether and how to disclose such events to patients pose substantial challenges, especially when the majority are more likely to be harmed by the disclosure itself than by the event. In this article, we define large-scale adverse events, describe several representative cases, and recommend key elements of a policy concerning these events.”
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