Design validation and labeling comprehension study for a new epinephrine autoinjector.

Background: To facilitate the correct use of epinephrine autoinjectors (EAIs) by patients and caregivers, a novel EAI (Auvi-Q) was designed to help minimize use-related hazards.

Objective: To support validation of Auvi-Q final design and assess whether the instructions for use in the patient information leaflet (PIL) are effective in training participants on proper use of Auvi-Q.

Methods: Healthy participants, 20 adult and 20 pediatric, were assessed for their ability to complete a simulated injection by following the Auvi-Q instructions for use. Participants relied only on the contents of the PIL and other labeling features (device labeling and its instructions for use, electronic voice instructions and visual prompts).

Results: The mean ± SD age of the adult and pediatric participants was 39.4 ± 11.6 and 10.9 ± 2.3 years, respectively. In total, 80% of adult and 35% of pediatric participants had prior experience with EAIs. All adults and 95% of pediatric participants completed a simulated injection on the first attempt; 1 pediatric participant required parental training and a second attempt. Three adult and 4 pediatric participants exhibited a noncritical issue while successfully completing the simulated injection. Most participants agreed that the injection steps were easy to follow and the PIL facilitated understanding on using Auvi-Q safely and effectively.

Conclusion: The PIL and other labeling features were effective in communicating instructions for successful use of Auvi-Q. This study provided validation support for the final design and anticipated instructions for use of Auvi-Q.