Identify potential use errors, root causes, and their consequences.
Evaluate against FDA recognized standards/guidelines:
- FDA Medical Device Technical Guide
- AAMI / ANSI HE75:2009
- ISO 14971-1:2007, ISO 62366,
- IEC 60601-1-6:2010, IEC 60601-1-8 Ed.
- Other human factors/HCI standards
Consider use errors as identified in the Usability Safety Framework:
- Patient identification error
- Mode error
- Data accuracy error
- Visibility error
- Consistency error
- Recall error
- Feedback error
- Data integrity Error
Focus on formal evaluation – summative testing with representative users