Root Cause Analysis for Medical Devices

I’m pleased to announce that a chapter, Root Cause Analysis, I co-authored with two of my Human Factors MD colleagues, Tim Reeves, PhD and Christina Mendat, PhD, was published this summer in Applied Human Factors in Medical Device Design.  

The chapter discusses why root cause analysis is vital for understanding the reasons why errors occur when people use medical devices.

Topics covered in the chapter include:

• Understanding the causes of use errors
• Root cause analysis methods
• Common pitfalls seen when performing a root cause analysis
• Examples of root cause analysis

This chapter should be of interest to human factors, engineers, and regulatory professionals working on medical devices and combination products.  

You can purchase a copy of the book at Amazon.