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Journal Article > Study
Bennett CL, Nebeker JR, Lyons EA, et al. JAMA. 2005;293:2131-2140.
This article summarizes the structure, funding, organization, and methods of an independent and clinically based surveillance program identifying serious and unrecognized adverse drug events (ADEs). The authors provide a detailed account of the process involved, from investigating a possible serious ADE to disseminating their findings to the Food and Drug Administration (FDA), manufacturers, conferences, journals, and the news media. They also share initial results of their operations with details of 16 drugs associated with serious ADEs, including tabular display of the cases reported and the inconsistencies in the dissemination of safety information. The authors conclude by sharing potential implications of the program's efforts and how this surveillance method may provide additional opportunity to detect and prevent serious ADEs.
Journal Article > Study
Garbutt J, Brownstein DR, Klein EJ, et al. Arch Pediatr Adolesc Med. 2007;161:179-185.
Though medical errors are common in pediatric patients, to date few studies have examined pediatricians' attitudes toward errors. This AHRQ-funded study surveyed pediatric residents and attending physicians regarding their experiences with reporting medical errors. The majority of physicians had direct experience with errors and supported disclosing errors to patients and their parents, but only a minority had disclosed a serious error. Respondents expressed dissatisfaction with current means of reporting errors (eg, incident reporting systems) and expressed a desire for formal training in error disclosure. These findings are similar to those previously reported in physicians caring for adult patients.
Wright S. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; January 5, 2010. Report No. OEI-06-09-00360.
Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients.
US Senate Health, Education, Labor, and Pensions Committee. January 13, 2016.
Insufficient sterilization of duodenoscopes and other medical equipment has been linked to health care–associated infection outbreaks. This report summarizes findings from a government investigation into existing methods for monitoring and reporting device problems and provides recommendations for Congress, hospitals, and the Food and Drug Administration to augment identification and prevention of safety issues associated with medical devices.