Article ID Journal Published Year Pages File Type
1143795 Procedia Manufacturing 2015 5 Pages PDF
Abstract

The U.S. Department of Veterans Affairs (VA) and the U.S. Food and Drug Administration (FDA) have partnered to create a common framework for highlighting “use-issues” that can affect the ability to safely and effectively use ever-changing medical devices as envisioned. By examining event reports and device histories across VA's Veterans Health Administration (VHA) and FDA's Medical Product Safety Network (MedSun), this initiative will strive to realize safer patient care through identification of causal factors associated with the top use-issues. Communication of these issues and their causes creates opportunities to improve device design, use, and serviceability of established and new medical devices.

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Physical Sciences and Engineering Engineering Industrial and Manufacturing Engineering