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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