Ventilator device distinctions in FDA guidance questioned by panel.
This article was originally published in The Gray Sheet
Executive Summary
FDA VENTILATOR GUIDANCE'S CRITICAL CARE USE DISTINCTION QUESTIONED by members of the agency's Anesthesiology and Respiratory Therapy Devices Panel at a Sept. 8 meeting in Rockville, Maryland. Commenting on the draft guideline's creation of a separate product code for continuous ventilators not intended for use in critical care settings, panel member Robert Kacmarek, PhD, Massachusetts General Hospital, Boston, said it seems "arbitrary to try to subcategorize those units and to believe that the medical community is going to, as a result, use ventilators that function equivalently in different settings simply" because they are labeled for use in those different settings.