Introduction: This test assessed the safety and usability of FlexPro® 30 mg/3 ml (Novo Nordisk A/S, Denmark), a pen-injector for injection of human GH in patients with GH deficiency (GHD), Turner syndrome (TS), Noonan syndrome (NS) and children born small for gestational age (SGA), and validated the instructions for use (IFU) and instructional video.
Methods: Children with GHD/SGA or TS/NS, adult patients, caregivers of patients with GHD/SGA/TS/NS and specialist/inpatient nurses were enrolled in accordance with FDA Human Factors Engineering (HFE) guidelines. Except for inpatient nurses, participants received training in using FlexPro® 30 mg/3 ml. All enrolled participants were tested on normal use (of new pen-injector), end-of-content use (almost depleted pen-injector), and IFU comprehension. Use errors, close calls and operational difficulties observed were recorded and evaluated based on participants subjective feedback. All participants completed a post-test questionnaire (21-item; 7-point scale: 1, strongly disagree, and 7, strongly agree).
Results: Ninety-four participants underwent evaluation (male/female (mean age years)): children with GHD/SGA (11/5 (13)) or TS/NS (1/15 (12)), adult patients/caregivers (10/22 (42)); nurses (2/28 (42)). No task failures, potential serious use errors or non-serious use errors were reported. 81% of participants recorded no use errors; 23 use errors (no potential for harm) were committed by 18 participants (>50% use errors were committed by untrained participants). Three close calls and four operational difficulties were reported by three and four participants respectively. All participants correctly interpreted three out of four IFU excerpts, and provided positive responses for their experience with FlexPro® 30 mg/3 ml and evaluation of the IFU and instructional video (mean ratings, 67).
Conclusions: Overall, participants reported positive experiences with FlexPro® 30 mg/3 ml, the IFU and instructional video. No task failures, potentially serious or non-serious use errors were observed. Use errors (no potential for harm) were committed more often by untrained, than trained, participants.
20 - 22 Sep 2014
European Society for Paediatric Endocrinology