RATIONALE: Anaphylaxis in infants and young children is increasing. Currently available epinephrine auto-injectors (EAIs) are not FDA approved for patients weighing <15 kg, and therefore, EAIs are prescribed off-label for these patients. Ultrasound studies suggest currently marketed 0.15 mg EAIs have needle lengths that may strike bone in ;29-43% of patients weighing <15 kg, resulting in possible intraosseous injection. An EAI with a shorter needle length has been developed to help potentially minimize the risk of striking bone during epinephrine injection in patients weighing 7.5 to 15 kg. A human factors usability study was completed to validate the 0.1 mg EAI user interface. METHODS: This study was conducted with parents of severely allergic children to evaluate simulated use of the 0.1 mg EAI by the intended user group. Fifteen participants were enrolled and received training on the 0.1 mg EAI. Approximately 24-hours later, participants completed a simulated emergency-use scenario using the 0.1 mg EAI with an infant mannequin. The primary endpoint was successful simulated administration of a meaningful epinephrine dose. RESULTS: All 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 device against the thigh for the length of time defined for this critical task; however, the device was pressed long enough for complete delivery of the 0.1 mg dose. CONCLUSIONS: This study validated the user interface of the 0.1 mg EAI for the intended users, uses, and use environments.
Instructions for use (IFUs) often are used as risk control measures for medical devices with the potential to expose users or others to use-related hazards and hazardous situations that are not entirely mitigated by device design. In the authors' extensive experience observing representative users interact with medical devices in simulated-use studies, individuals' engagement with medical device IFUs varies widely. This variance raises questions regarding how various user groups use IFUs and the factors that make an IFU stronger or weaker for its intended users, uses, and use environments. An online survey was conducted to examine (1) first-time use of medical device IFUs, (2) how first-time use strategies vary across typical user groups for medical devices (e.g., patients, lay caregivers, and healthcare professionals), and (3) which design elements promote initial engagement with IFUs. The results showed that IFUs are used in a variety of ways, including as preparation before use, as guides during use, and as troubleshooting resources during use, as well as that IFUs are not used at all. Overall, the user groups tested responded similarly across all of the survey questions. Bullet point organization, figures, and logical flow were reported to be the most engaging design elements. Small font size and poor organization and flow were reported to be the least engaging design elements. IFU designers can use various usability testing methods to assess their assumptions regarding how a product's users will use the IFU and to make the IFU more engaging.
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. A human factors usability study was completed to validate the 0.1-mg EAI user interface. 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. 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. This study validated the user interface of the 0.1-mg EAI for the intended users, uses, and use environments.
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