Summary of Operational Difficulties in the Simulated-Use Usability Study
Product Use Task | Issue | Number of Participants | Number of Instances | Description |
---|---|---|---|---|
Snap off syringe cap | Operational difficulty | Assistant: 1/15 | 2/30 | Initially twisted syringe cap before snapping off |
Remove injection needle cap | Operational difficulty | RS: 1/15 | 1/30 | Removed injection needle during cap removal |
Adjust drug dose | Operational difficulty | RS: 1/15 | 2/30 | Misunderstood plunger stopper alignment, but adjusted correct dose |
Note: Three instances of recapping the injection needle were also observed during the study; none of these issues were specifically related to the ranibizumab prefilled syringe or instructions for use, but rather were attributable to the participant's previous experience and/or professional training or to test artifact. Therefore, they are not included in the table.
RS = retina specialist.