Usability and preference of epinephrine auto-injectors: Auvi-Q and EpiPen Jr.

BACKGROUND: Despite the importance of prompt epinephrine auto-injector (EAI) treatment during anaphylaxis, proper administration technique is often lacking among patients and caregivers. OBJECTIVE: To compare usability and participant preference of Auvi-Q and EpiPen Jr EAIs in a simulated life-threatening allergic emergency-use scenario. METHODS: In this randomized, crossover, human-factors usability study, untrained adults (18-65 years) were tasked with using 0.15 mg Auvi-Q and EpiPen Jr trainers to simulate epinephrine administration to a child-sized manikin. Only written instructions on the device label and/or device voice instructions were available to participants. Endpoints included completing injection tasks per device instructions (primary endpoint), completing key injection tasks, and participant preference/ratings of devices. Completion of injection tasks were evaluated using a McNemar test for paired dichotomous data. RESULTS: Ninety-six adults were included in study analyses. Significantly more participants completed all injection tasks per device instructions with Auvi-Q (85.4%) vs EpiPen Jr (19.8%; P < .001). Significant differences were also observed for completion of key injection tasks (Auvi -Q, 94.8%; EpiPen Jr, 72.9%; P < .001). No digital/hand injection errors were seen with Auvi-Q, whereas 14 participants (14.6%) would have accidentally received a digital/hand injection with EpiPen Jr (P < .001). Overall, significantly more participants preferred Auvi-Q over EpiPen Jr (91.7% vs 6.3%; P < .001 [2.1% no preference]). Median scores for 8 EAI characteristics were also higher for Auvi-Q vs EpiPen Jr. CONCLUSION: In this study, untrained adults preferred and were more likely to use Auvi-Q correctly vs EpiPen Jr, highlighting the importance of device design for successful epinephrine administration during a life-threatening allergic emergency.

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

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 epinephrine dose. Results: All the participants simulated administration of a meaningful epinephrine dose. Fourteen participants successfully used the 0.1-mg EAI per the instructions for use in the simulated emergency-use scenario. One participant did not press the EAI against the thigh for the length of time defined for this critical task; however, the EAI was pressed long enough for complete delivery of the 0.1-mg dose. Conclusion: This study validated the user interface of the 0.1-mg EAI for the intended users, uses, and use environments.

Faster Use and Fewer Failures with Needle-Free Nasal Glucagon Versus Injectable Glucagon in Severe Hypoglycemia Rescue: A Simulation Study.

BACKGROUND: During severe hypoglycemic episodes, people with diabetes depend on others to help with treatment. We compared needle-free nasal glucagon and commercially available injectable glucagon for ease of use by caregivers of people with diabetes and by others in treating simulated episodes of severe hypoglycemia. METHODS: Sixteen instructed caregivers and 15 noninstructed acquaintances administered nasal and injectable glucagon to manikins, simulating unconscious people with diabetes during severe hypoglycemia episodes. RESULTS: With nasal glucagon, 15 caregivers (94%) and 14 acquaintances (93%) administered a full dose (mean time 0.27 and 0.44 min, respectively). One caregiver and one acquaintance did not administer nasal glucagon because they did not fully depress the plunger on the device. Two caregivers deliberately administered both insulin and nasal glucagon, believing that insulin would also help the patient. With injectable glucagon, eight caregivers (50%) injected glucagon (mean time 1.89 min), but only two (13%) administered the full dose. Three acquaintances (20%) injected a partial dose of injectable glucagon (mean time 2.40 min); none gave a full dose. Errors included injecting diluent only, bending the needle, and injecting with an empty syringe. Two caregivers and one acquaintance injected insulin because they confused insulin with injectable glucagon. CONCLUSIONS: More than 90% of participants delivered full doses of nasal glucagon, while 13% and 0% of caregivers and acquaintances delivered full doses of injectable glucagon, indicating that nasal glucagon is easier for nonmedically trained people to administer. Thus, nasal glucagon has the potential to substantially improve treatment for patients experiencing a life-threatening episode of severe hypoglycemia.