Human factors engineering validation study for a novel 0.1-mg epinephrine auto-injector

Area of Science:

• Pediatric Allergy and Immunology
• Human Factors Engineering
• Emergency Medicine

Background:

• Anaphylaxis incidence is rising in infants and young children.
• Current 0.15-mg epinephrine auto-injectors (EAI) may have excessive needle length for patients under 15 kg, risking bone contact.
• A new 0.1-mg EAI with a shorter needle is designed for children weighing 7.5-15 kg.

Purpose of the Study:

• To validate the user interface of the new 0.1-mg EAI through a human factors usability study.
• To assess the ease of use and effectiveness of the 0.1-mg EAI in a simulated emergency scenario.

Main Methods:

• A usability study involving 15 parents of allergic children.
• Participants received training on the 0.1-mg EAI.
• Simulated emergency-use scenario with an infant manikin 24 hours post-training.

Main Results:

• All participants successfully simulated administration of a meaningful epinephrine dose.
• 14 out of 15 participants used the 0.1-mg EAI correctly per instructions.
• One participant had a minor deviation in device contact time, but dose delivery was complete.

Conclusions:

• The user interface of the 0.1-mg EAI is validated for its intended users, uses, and environments.
• The new device offers a potentially safer option for epinephrine administration in young children.
• Successful simulated use supports the clinical readiness of the 0.1-mg EAI.