Applicable Standards and Guidelines

The following standards and guidelines pertain to the root cause analy-sis of medical device use errors and helped shape the guidance pro-vided in this book. 1. U.S. Food and Drug Administration (Silver Spring, Maryland): “Draft

Guidance for Industry and Food and Drug Administration StaffApplying Human Factors and Usability Engineering to Optimize Medical Device Design” (issued June 22, 2011).