Expert review of medical devices · 2024
Usability of the zilucoplan prefilled syringe for the treatment of generalized myasthenia gravis: insights from a human factors validation study.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Domanska Barbara, Franchini Alessandra, Boroojerdi Babak, Ashraghi Mohammad, Ruzhansky Katherine, Leite Maria Isabel
Аннотация
BACKGROUND: Generalized myasthenia gravis (gMG) is a chronic, autoimmune neuromuscular disease, often accompanied by high treatment burden. The objective of this usability study was to validate that the zilucoplan prefilled syringe (PFS) can be used safely and effectively.
METHODS: The study recruited 75 participants representing five distinct user groups (injection-naïve gMG patients, injection-experienced gMG patients, injection-naïve caregivers, injection-experienced caregivers, and healthcare professionals), who each simulated an injection without being directed to use the instructions for use (IFU). Participants were then asked to repeat the process as directed by the IFU. Participants were assessed and use errors identified using performance-based criteria.
RESULTS: 73/75 (97.3%) participants were able to safely administer the dose of medication during the first simulated use, with or without the IFU. When utilizing the IFU, all 75 (100.0%) participants were able to administer the medication. The rate of use errors was low, with pass rates for observation-based tasks ranging from 85.3% to 100.0%, and in general, after participants were instructed to refer to the IFU, the rate of use errors was reduced.
CONCLUSIONS: This human factors study demonstrated that the zilucoplan PFS is safe and effective for intended users, including patients with gMG and their caregivers.
METHODS: The study recruited 75 participants representing five distinct user groups (injection-naïve gMG patients, injection-experienced gMG patients, injection-naïve caregivers, injection-experienced caregivers, and healthcare professionals), who each simulated an injection without being directed to use the instructions for use (IFU). Participants were then asked to repeat the process as directed by the IFU. Participants were assessed and use errors identified using performance-based criteria.
RESULTS: 73/75 (97.3%) participants were able to safely administer the dose of medication during the first simulated use, with or without the IFU. When utilizing the IFU, all 75 (100.0%) participants were able to administer the medication. The rate of use errors was low, with pass rates for observation-based tasks ranging from 85.3% to 100.0%, and in general, after participants were instructed to refer to the IFU, the rate of use errors was reduced.
CONCLUSIONS: This human factors study demonstrated that the zilucoplan PFS is safe and effective for intended users, including patients with gMG and their caregivers.