US Senate Health, Education, Labor, and Pensions Committee. January 13, 2016.
Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients.
Insufficient sterilization of duodenoscopes and other medical equipment has been linked tohealth 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 Administrationto augment identification and prevention of safety issues associated with medical devices.
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