Training
Safety Issues:
User does not know how to properly use the device.
Work Item Expectation:
- Define what "good training" looks like (e.g. appropriate for role, appropriate for use, appropriate for home use).
- Determine method to measure compliance and effectiveness of manufacturing and/or hospital training programs (e.g. test, spot check).
- Determine how to enforce good training practices on manufacturers and/or providers.
- Note: Review HE75 for prescriptive design
Group Leader:
Glenn Scales, CBET, Duke University Health System