F.D.A. Steps Up Oversight of Infusion Pumps

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The New York Times reports the Food and Drug Administration plans to “tighten their oversight” of medical devices, including infusion pumps that automatically deliver drugs and food to hospital patients. Last week the FDA issued guidelines requiring manufacturers of the pumps to provide the agency with more test data than previously required for approval. One reason for this action is that the FDA has received reports over the past five years of 710 patient deaths, and some officials suspect the actual number may be far higher.

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