Peer-reviewed article
Human factors validation study of a disposable autoinjector (Bmab 1200 autoinjector) for subcutaneous delivery of Ustekinumab.
Sam Moses K, Rohini Kamaraj, Suryaprakash Konda Ramachary Subramanian ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a technical validation study of a medical device (autoinjector) for administering ustekinumab, a medication for adult autoimmune conditions including psoriasis and Crohn's disease. The study tested whether 90 participants of varying ages and backgrounds could safely use the device without formal training. While the study included some adolescent participants, it is not focused on child well-being as a primary outcome and does not evaluate interventions affecting children's health, development, protection, or participation.
Key points
- 100% of participants successfully completed unaided dose injections
- 20 use errors were documented across 90 participants, none causing device damage or failed delivery
- Knowledge task success rate was 99.6% across 2,520 measured items
- Nine use errors occurred only among caregivers, classified as study artifacts or inattention
- All participants expressed confidence in safe dosing and found the device user-friendly
Limitations
This is a simulated-use, nonclinical study on foam pads rather than actual clinical use. The study focuses on device usability and safety rather than health outcomes for children or evaluation of a child-focused intervention.
Abstract
Ustekinumab is approved for treating moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The Bmab 1200 autoinjector is a simple, two-step device for subcutaneous ustekinumab biosimilar delivery. This was an in vitro, nonclinical, simulated-use human factors validation study to evaluate if intended users could safely and effectively use it. Ninety participants (recruited via purposive sampling) were enrolled (mean age: 43 years; range: 12-72 years), including adult and adolescent patients, lay caregivers, and healthcare professionals. Without formal training, participants performed simulated injections into foam pads. Test personnel observed, documented, debriefed, and reported any errors made by participants while completing assigned tasks and sub-tasks. Each participant was observed throughout the session and observational and performance data were collected in real time by data logger. Performance measures included injection success rates, use errors, and 24 knowledge tasks. Across these knowledge tasks, participants were required to locate, identify, and understand 28 distinct measures. Participants also provided feedback on usability and confidence levels. All participants (100%) completed unaided dose injections. A total of 20 use errors were documented: hand hygiene (n = 8), site preparation (n = 5), and device handling (n = 7), none causing device damage or failed delivery. The knowledge task success rate was 99.6% (2,511/2,520 measures). Nine use errors (study artifacts or inattention to instructions) occurred only among caregivers. All participants expressed confidence in safe dosing and found the device user-friendly. The Bmab 1200 autoinjector demonstrated high usability and safety across diverse users for ustekinumab biosimilar delivery in chronic autoimmune conditions.