A pen device for injection of recombinant human growth hormone: a European usability engineering study.

Abstract:

OBJECTIVE:The Aluetta™ reusable pen device and instructions for use (IFU) for growth hormone (r-hGH; Saizen®, Merck KGaA, Darmstadt, Germany) administration were tested for Human-Factors Usability, to ensure it could be used safely and effectively by the intended users in the intended use environment. RESEARCH DESIGN AND METHODS:Usability testing was conducted under simulated conditions in three groups of participants: pediatric or adult patients with growth hormone deficiency (GHD), participants without GHD, and healthcare professionals (HCPs). The testing comprised a 45-minute training session, a 2-hour testing session, and a participant-feedback session. RESULTS:Twenty-six participants completed the training session and performed all critical tasks related to the pen use across three scenarios. The most difficult tasks were related to the preparation, checking, and maintenance of the device; only 8% of use errors occurred during tasks related to the injection process. Eighty-five percent considered the pen safe and effective to use without further modifications and the training to be clear and effective. CONCLUSIONS:The pen device and associated materials benefited from Human Factors Engineering throughout the development process. These evaluations show that patients and HCPs could safely and effectively use the pen device, and the IFU and training were clear and effective.

journal_name

Expert Opin Drug Deliv

authors

Cachemaille A,Warren SE,Moss S

doi

10.1080/17425247.2020.1774549

subject

Has Abstract

pub_date

2020-07-01 00:00:00

pages

1041-1048

issue

7

eissn

1742-5247

issn

1744-7593

journal_volume

17

pub_type

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