After contaminated medical scopes led to numerous antibiotic-resistant bacteria outbreaks, a Senate report blamed the infection in part on lack of transparency from hospitals. But one outspoken advocate of such transparency concealed a device-linked outbreak at his own facility, revealing the limits of federal regulations, Kaiser Health News reports.
Jeffrey Tokar, M.D., director of gastrointestinal endoscopy at Fox Chase Cancer Center, and his co-authors wrote in an article for the Annals of Internal Medicine last September, that providers must "strive to establish an environment of open information exchange with patients about what is being done to maximize their safety."
However, KHN notes that the article contained no mention of the fact that Fox Chase had reported a medical device may have infected three patients that May. While the hospital filed its report within the deadline set by federal regulations, it didn't become public knowledge until the Senate investigation included details about it.
Despite the reporting requirements, the Food and Drug Administration is also required to redact the names of providers who submit such reports, according to the article. Experts argue this rule prevents hospital leaders from being too afraid to report potential outbreaks.
"There are early warning signals but one has to be careful not to scare the public," Tokar's co-author Michael Kochman, a gastroenterologist at the University of Pennsylvania Health System, told KHN. "Within 30 days of an event, it may not be known if an infection was truly related to a device."
However, the Senate report addressed these requirements and concluded hospitals apply too high a standard and put reporting off too long. Moreover, it found manufacturers fell short of reporting requirements in many cases during the outbreaks.
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