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

Allergy and Asthma Proceedings
Evan T EdwardsAdam Shames

Abstract

Background: Anaphylaxis in infants and young children is increasing. Historically, epinephrine auto-injectors (EAI) were not available in a dose or platform designed for patients who weighed <15 kg, and, therefore, 0.15-mg EAIs were prescribed for these patients. Results of ultrasound studies indicate that currently marketed 0.15-mg EAIs have needle lengths that may strike bone in ∼29 to 43% of patients who weigh <15 kg and result in possible intraosseous injection. An EAI with a more weight-appropriate 0.1-mg dose and shorter needle length has been developed to potentially help minimize the risk of striking bone during epinephrine injection in patients who weigh 7.5-15 kg. Objective: A human factors usability study was completed to validate the 0.1-mg EAI user interface. Methods: This study was conducted with parents of children who were severely allergic so to evaluate simulated use of the 0.1-mg EAI by the intended user group. Fifteen participants were enrolled and received training on using the 0.1-mg EAI. Approximately 24 hours later, the participants completed a simulated emergency-use scenario by using the 0.1-mg EAI with an infant manikin. The primary end point was successful simulated administration of a meaningful epi...Continue Reading

Citations

Nov 19, 2020·The World Allergy Organization Journal·Victoria CardonaMargitta Worm

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Anaphylaxis

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.

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