Usability and Validation of a New Device for the Administration of Somatostatin Analog Therapy: An Open-Label, Randomized Study Using a Simulated Placebo Gel

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SUN 281-290-Comparative Effectiveness/Health Outcomes/Quality Improvement/Patient or Provider Education/Endocrine Emergencies
Sunday, June 16, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SUN-288
Susan L. Smith*1, Adam Shames2 and Fabien Jeannerot1
1Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ, 2Core Human Factors, Wynnewood, PA
Background: Somatostatin analogs (SSAs) are used for the treatment of conditions associated with excess growth hormone secretion. To potentially improve treatment options for health care providers (HCPs) and non-professional caregivers (NPCs), we designed a pre-filled, disposable syringe with an integrated passive sharps injury prevention feature for the administration of Somatuline® Depot (SD; lanreotide).

Aim: This summative usability and validation study evaluated the usability, safety, and reliability of a new device filled with a simulated gel to mimic the injection dynamics of SD.

Methods: The study consisted of 4 groups of participants representing potential users who performed a series of tasks while their behavior was recorded. The participants were randomized as follows: Group A, 16 trained HCPs; Group B, 15 trained NPCs; Groups C & D, 31 untrained HCPs. All groups were evaluated for comprehension of the labeling, including the instructions for use (IFU) and the correct operation of the device up to 9 injections into an injection pad. 19 specific injection tasks were evaluated, including delivery of a full dose and needle shield activation. The first injection per participant was considered separately from later injections as influence of learning may occur with rapid repeated use of the device. The remaining injections assessed whether the sharps injury prevention feature worked as intended. Participants were given an opportunity to use the product independently and in as realistic a manner as possible.

Results: 65 participants completed the study, each performing up to 9 injections for a total of 579 devices to establish the reliability of the device. 61/65 HCPs and NPCs delivered a full dose of simulated gel and activated the needle safety mechanism. 15/19 injection tasks were completed successfully by 100% of participants. 5 HCPs and 2 trained NPCs made >4 errors that prevented effective use of the device. However, the 7 participants recognized their errors immediately and disposed of the device in a safe manner.

Conclusions: In this summative usability and validation study, 94% of participants delivered a full dose into an injection pad and successfully activated the needle safety mechanism. This study demonstrated that the device is safe and effective for its intended users, uses, and use environments.

Disclosure: SLS: Employee, Ipsen Biopharmaceuticals, Inc.. AS: Investigator, Ipsen Biopharmaceuticals, Inc.. FJ: Employee, Ipsen Biopharmaceuticals, Inc..

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