Reports To Feds On Deadly Bacteria Outbreaks Arrived Late
Reports alerting federal officials that contaminated medical scopes appeared to be spreading deadly superbugs among hospital patients sometimes arrived months late – or not at all, according to federal records and interviews.
Medical device makers are required to file reports to the Food and Drug Administration within 30 days of learning that a product may pose safety risks. But as duodenoscopes were tied to the transmission of drug-resistant bacteria among patients in at least eight U.S. hospitals from 2012-2014, the agency wasn't notified of some outbreaks until long after they occurred, an ongoing USA TODAY investigation finds. And in some cases, the disclosures never were filed.
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Medical device makers are required to file reports to the Food and Drug Administration within 30 days of learning that a product may pose safety risks. But as duodenoscopes were tied to the transmission of drug-resistant bacteria among patients in at least eight U.S. hospitals from 2012-2014, the agency wasn't notified of some outbreaks until long after they occurred, an ongoing USA TODAY investigation finds. And in some cases, the disclosures never were filed.
Hey, check out all the research scientist jobs. Post your resume today!