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Design validation and labeling comprehension study for a new epinephrine autoinjector.
Eric S Edwards1, Evan T Edwards, Ronald Gunn
1Intelliject Inc, Richmond, VA, USA. eric.edwards@intelliject.com
Summary
The novel Auvi-Q epinephrine autoinjector (EAI) and its instructions were effective for training both adults and children on proper simulated injection technique. Labeling features ensured safe and effective EAI use.
Area of Science:
- Medical Devices
- Patient Safety
- Anaphylaxis Treatment
Background:
- A novel epinephrine autoinjector (Auvi-Q) was developed to reduce use-related hazards.
- Effective patient and caregiver training is crucial for correct epinephrine autoinjector (EAI) use.
Purpose of the Study:
- Validate the final design of the Auvi-Q device.
- Assess the effectiveness of the patient information leaflet (PIL) in training users on proper Auvi-Q administration.
Main Methods:
- Healthy adult and pediatric participants (n=40) were trained using only the Auvi-Q PIL and labeling.
- Participants attempted a simulated injection, relying on device labeling, voice prompts, and visual cues.
Main Results:
- High success rates were observed: 100% of adults and 95% of pediatric participants completed the simulated injection on the first attempt.
- Most participants found the instructions easy to follow and effective for safe and correct Auvi-Q use.
- Minor issues were noted in a small percentage of participants, but all injections were completed successfully.
Conclusions:
- The Auvi-Q's patient information leaflet and labeling effectively communicate instructions for correct use.
- The study supports the final design and intended instructions for use of the Auvi-Q epinephrine autoinjector.
