The heparin saga continues with contaminated devices, the FDA still has to investigate, even though in April a warning letter was sent. 81 deaths and many allergic reactions had been traced back to the contaminated heparin without devices.
Medical device manufacturers may be on the hot seat as this investigation continues, as most of the cases were reported by families. The whole scenario here with the contamination is a shame that it even happened, and the fact that it was stated to be an economical decision, less expensive. BD
WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration has received reports of 11 deaths and other adverse events associated with medical devices that contain heparin, a widely used blood thinner that has sparked Congressional inquiries about the agency's oversight of drug manufacturing. The FDA, in documents posted on its Web site Thursday, said it can't determine at this time whether the devices cited in the reports contain contaminated heparin.
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