The Curious FDA Reversal over Allegedly Flawed Endoscope Washers

Washington, DC: The curious about-face by the US Food and Drug Administration (FDA) over its position on an allegedly flawed endoscope cleaning machine has roots in a back-and-forth relationship between the federal regulator and Custom Ultrasonics Inc. (Custom) dating back to 1991. The history between the two parties, together with recent links to hospital infections, is of interest to anyone bringing an Endoscope lawsuit


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