Human factors study of a newly approved prefilled syringe of epinephrine for the treatment of anaphylaxis

Allergy and Asthma Proceedings
Ronald B MossDennis J Carlo

Abstract

Epinephrine remains the treatment of choice for acute anaphylaxis. However, currently available autoinjectors are costly, and studies have demonstrated human factor issues that result in incorrect use as well as device failures. A recent U.S. Food and Drug Administration approved prefilled syringe of epinephrine for the treatment of anaphylaxis was examined in a prospective human factors validation study to determine the likelihood that the product would be used effectively by intended users. A total of 82 participants were enrolled in this prospective study, including adults with and without epinephrine injector experience, adolescents with and without epinephrine injector experience, and lay caregivers with and without epinephrine injector experience. Half of the participants in each user group were trained to use the newly approved prefilled epinephrine syringe before its first use in the study. Critical tasks that could cause harm and compromise the successful use of epinephrine were assessed and included five categories: (1) open the case, (2) retrieve prefilled syringe, (3) remove needle cap, (4) insert needle in the thigh by using a needle pad, and (5) press plunger until it stops. The participants were scored by an inde...Continue Reading

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