PO2-22: Usability and safety of FlexPro® PenMate®, a growth hormone (GH) injection system, in patients, caregivers and healthcare professionals

Abstract

Introduction: FlexPro® PenMate® (PenMate®) (Novo Nordisk A/S, Denmark) aims to reduce needle anxiety caused by needle phobia by hiding the needle during subcutaneous injection . This study validated the safety and usability of PenMate® and the instructions for use (IFU) in patients with GH deficiency (GHD), Turner syndrome (TS), Noonan syndrome (NS) and children born small for gestational age (SGA) . Methods: Participants were enrolled according to FDA Human Factors Engineering (HFE) guidelines: children/adolescents (1017 years) with GHD/SGA (n=16) or TS/NS (n=15), adult patients with GHD/caregivers of patients with GHD/SGA/TS/NS (≥18 years, n=19), and healthcare professionals managing patients with GHD/SGA/TS/NS (n=15) . After training, all performed three handling scenarios and one IFU comprehension scenario . Participants completed post-test questionnaires on PenMate® use, training and IFU using a 7-point scoring scale: 1 = strongly disagree, 7 = strongly agree . Task failures, use errors, close calls and operational difficulties were recorded . Results: Patient demographics (mean [range]) were: GHD/SGA (88% male; age 14 [10-16] years), TS/NS (100% female; age 14 [1117 years]), adult patients/caregivers (58% female; age 44 [18-71] years) . Eighteen handling-use errors, 11 close calls and 19 operational difficulties were committed by 14, 11 and 17 participants, respectively . No task failures or potential serious or non-serious use errors were observed . PenMate® use, training and IFU were rated positively (mean ratings, 6-7) and 5/6 IFU excerpts were interpreted correctly . Conclusions: PenMate® was considered easy to use . The IFU was considered helpful . No potentially serious or non-serious user errors were recorded . Handling use errors were not related to PenMate® .