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Introduction <p>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.</p> Methods <p>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.</p> Results <p>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.</p> Conclusion <p>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.</p>

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Usability and Acceptance of Autoinjector and Prefilled Syringe Devices by Patients with Generalized Myasthenia Gravis in a Human Factors Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月30日

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  • Kelly G. Gwathmey,
  • Panru Jing,
  • Scott Laorr,
  • Joe Koo,
  • Sanjay Rakhade,
  • Emmett Alton Sartor,
  • J. T. Tibung,
  • Jason Murray,
  • Christina Laskar

摘要

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.