124:
Human Factors Study of a Newly Approved Epinephrine Prefilled syringe (PFS) for the Emergency Treatment of Allergic Reactions (Type I) including Anaphylaxis
Saturday, March 3, 2018
South Hall A2 (Convention Center)
Ronald B. Moss, MD FAAAAI, Thomas Moll, PhD, Karen Daniels, Dennis J Carlo, PhD
RATIONALE:

Epinephrine remains the treatment of choice for acute anaphylaxis. However, currently available auto-injectors are costly and studies have demonstrated usability issues resulting in incorrect use (lacerations) as well as device failures. A recently approved epinephrine prefilled syringe for the treatment of acute allergic emergencies, including anaphylaxis was examined in a prospective human factors validation study.

METHODS:

A total of 82 participants were enrolled in this prospective study including adults, adolescents and lay caregivers, with and without epinephrine injector experience. Half of the participants in each user group were trained to use the epinephrine prefilled syringe prior to first use in the study. Critical tasks that could compromise the successful administration of epinephrine and cause harm were assessed and included five categories: Open the case (I), retrieve prefilled syringe (II), remove needle cap (III), insert needle in the thigh (IV), press plunger until it stops (V).

RESULTS:

A high rate of participants (81/82) were able to successfully administer a dose of epinephrine2. Use errors commonly seen with autoinjectors, such as accidental injection into digits, were not observed in this study. Additional observations made during the study will be discussed.

CONCLUSIONS:

In this prospective human factors study effecting correct epinephrine injection, a high rate of participants successfully completed the tasks using the epinephrine prefilled syringe. Epinephrine injection , USP (0.3mg/0.3ml) is a newly approved prefilled epinephrine syringe for the emergency treatment of allergic reactions, including anaphylaxis and should provide a good cost-effective alternative to current auto-injectors.