Related Experiment Video
Updated: Jul 2, 2026

The Quantification of Injectability by Mechanical Testing
Published on: May 13, 2020
Usability and Acceptance of Autoinjector and Prefilled Syringe Devices by Patients with Generalized Myasthenia Gravis
Kelly G Gwathmey1, Panru Jing2, Scott Laorr2
1VCU Health, Virginia Commonwealth University, 1101 East Marshall Street, Richmond, VA, 23298, USA. kgg2125@cumc.columbia.edu.
Introduction:
Generalized myasthenia gravis (gMG) is a chronic autoimmune disorder that causes muscle weakness. This human factors (HF) validation study aimed to demonstrate that use of a prefilled syringe with needle safety device (PFS-SD) or autoinjector (AI) is safe and effective for patients with gMG, caregivers, and healthcare professionals (HCPs) to administer injectable medication in the intended use environments without preventable use errors.
Methods:
Patients with gMG, caregivers, and HCPs were randomized to the PFS-SD or AI. No training on either device use was provided. The safety and usability of both devices were assessed using simulated use scenarios, knowledge-based questions, and participant feedback.
Results:
The simulated use scenario was successfully completed by 94% and 96% of participants using the PFS-SD and AI, respectively, while 90% and 87% of participants, respectively, successfully administered their assigned dose. Device acceptability was reported by 93% and 100% of patient participants for the PFS-SD and AI, respectively.
Conclusion:
This HF validation study demonstrated that the PFS-SD and AI are safe and effective for use by patients with gMG, caregivers, and HCPs in the intended use environments.
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