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Pharma Compliance Info Senate report says FDA fails to ensure medical devices are safe Pharmacovigilance

Senate report says FDA fails to ensure medical devices are safe

America’s system for ensuring that medical devices are safe failed at every turn when dirty endoscopes began spreading deadly superbugs, according to a Senate investigation released Wednesday.Pharma Compliance Info Senate report says FDA fails to ensure medical devices are safe Pharmacovigilance
The report, from Sen. Patty Murray, a Washington Democrat, blames device manufacturers, hospitals, and the Food and Drug Administration for infections that sickened at least 250 people worldwide since 2012 and that may have contributed to dozens of deaths.
The series of outbreaks went on for years before safety problems with the endoscopes came to light in the media in 2015. The report says the events expose systemic weaknesses in the FDA’s approach to protecting the public from medical technology that may be harmful.
“This investigation clearly demonstrates the inability of FDA’s current device surveillance system to accurately identify the extent of device problems when they occur, which poses an unacceptable risk to patients,” Murray’s office wrote.

To read the article by John Tozzi, Washington Post News Service

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