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The Effects of Heating on EpiPen Epinephrine Auto-Injector Device Integrity and Function | Abstract
Journal of Allergy & Therapy

Journal of Allergy & Therapy
Open Access

ISSN: 2155-6121

Abstract

The Effects of Heating on EpiPen Epinephrine Auto-Injector Device Integrity and Function

Julie C. Brown*, Alex Q. Cooper, Hannah G. Parish, Pingping Qu

Background: Temperatures above manufacturers’ recommendations (20-25ºC; excursions 15-30ºC) can be encountered frequently. The dashboards of cars in the sun can exceed 85ºC on a 37ºC day. Objective: To evaluate the integrity and function of EpiPens after being heating to high temperatures.Methods: For 97 pars of same-dose, same-lot, post-consumer expired EpiPens (51 0.3mg and 46 0.15mg), one was heated in a 77°C oven then cooled to room temperature (heated-cooled), while the other was kept in usual conditions (control). Both were then activated, and the decrease in device mass was measured to estimate the amount of solution fired. Paired t-tests were used to determine if there was significant average difference in mass between heated-cooled devices and control devices. Regression models compared heated-cooled versus control device outcomes while adjusting for device dose (0.3mg vs. 0.15mg) and expiration date, with interaction terms. Malfunctioning devices were dissected and examined for damage. Results: Heated-cooled devices lost less mass when firing, versus controls (0.275 vs. 0.283, paired t-test p-values <0.0074). The effect of heating did not differ after adjusting for dose or expiration date. Most (92%) of the EpiPens were difficult to remove from their carrier tubes, with visible melting around the top rim. Eight heated-cooled devices fired improperly (7) or failed to fire (1); none had damage or visible melting on dissection, but one had blackened liquid within. Controls all functioned normally.Conclusion: Heating EpiPen devices to 77°C melted carrier tubes and impaired device function. Devices exposed to extreme heat should be replaced

Published Date: 2021-02-10; Received Date: 2021-01-20

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