Usability of devices for self-injection: results of a formative study on a new disposable pen injector

Jakob Lange,1 Philipp Richard,1 Nick Bradley21Ypsomed AG, Burgdorf, Switzerland; 2Bergo, Glasgow, United KingdomAbstract: This article presents a late-stage formative usability study of a pen-injector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primar...

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Autores principales:	Lange J, Richard P, Bradley N
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2014
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/01ae33b3a0c84bdca71dc66498709cbf
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spelling	oai:doaj.org-article:01ae33b3a0c84bdca71dc66498709cbf2021-12-02T00:41:31ZUsability of devices for self-injection: results of a formative study on a new disposable pen injector1179-1470https://doaj.org/article/01ae33b3a0c84bdca71dc66498709cbf2014-06-01T00:00:00Zhttp://www.dovepress.com/usability-of-devices-for-self-injection-results-of-a-formative-study-o-a17176https://doaj.org/toc/1179-1470 Jakob Lange,1 Philipp Richard,1 Nick Bradley21Ypsomed AG, Burgdorf, Switzerland; 2Bergo, Glasgow, United KingdomAbstract: This article presents a late-stage formative usability study of a pen-injector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to confirm that the pen could be used without recurring patterns of use errors leading to hazardous situations, to evaluate the comprehension of the instructions for use (IFU), and to determine if training is necessary. In the study, a total of 36 participants in six groups (health care providers, caregivers, adolescents, diabetics with retinopathy, diabetics with neuropathy, and patients with arthritis) each read the IFU, prepared the device, and performed two simulated injections into an injection pad. Any use errors, near misses, or deviations from the IFU procedure were recorded. The overall success rate (injection completed by the participant without need for assistance) was 94% for the first and 100% for the second injection. Ninety-two percent of the participants reported that they felt confident using the device, 100% found the IFU helpful, and 75% found the device positively comfortable to use. Overall, a total average of 3.35 deviations and errors per user and injection were recorded (there were no near misses). Subtracting the errors without any potential for negative consequences for the injection or the user (trivial deviations), as well as those related to attaching and removing the pen needle (independent of the design of the pen itself), led to an average of 1.31 potentially relevant deviations per user and injection. It was concluded that the pen injector together with the IFU could be safely and efficiently used by all user groups without any training, and thus that the device and IFU in their current form are well suited for use in a range of specific applications.Keywords: human-factor engineering, injection pen, handling study, user error, instructions for use, UnoPen™Lange JRichard PBradley NDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2014, Iss default, Pp 195-203 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Lange J Richard P Bradley N Usability of devices for self-injection: results of a formative study on a new disposable pen injector
description	Jakob Lange,1 Philipp Richard,1 Nick Bradley21Ypsomed AG, Burgdorf, Switzerland; 2Bergo, Glasgow, United KingdomAbstract: This article presents a late-stage formative usability study of a pen-injector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to confirm that the pen could be used without recurring patterns of use errors leading to hazardous situations, to evaluate the comprehension of the instructions for use (IFU), and to determine if training is necessary. In the study, a total of 36 participants in six groups (health care providers, caregivers, adolescents, diabetics with retinopathy, diabetics with neuropathy, and patients with arthritis) each read the IFU, prepared the device, and performed two simulated injections into an injection pad. Any use errors, near misses, or deviations from the IFU procedure were recorded. The overall success rate (injection completed by the participant without need for assistance) was 94% for the first and 100% for the second injection. Ninety-two percent of the participants reported that they felt confident using the device, 100% found the IFU helpful, and 75% found the device positively comfortable to use. Overall, a total average of 3.35 deviations and errors per user and injection were recorded (there were no near misses). Subtracting the errors without any potential for negative consequences for the injection or the user (trivial deviations), as well as those related to attaching and removing the pen needle (independent of the design of the pen itself), led to an average of 1.31 potentially relevant deviations per user and injection. It was concluded that the pen injector together with the IFU could be safely and efficiently used by all user groups without any training, and thus that the device and IFU in their current form are well suited for use in a range of specific applications.Keywords: human-factor engineering, injection pen, handling study, user error, instructions for use, UnoPen™
format	article
author	Lange J Richard P Bradley N
author_facet	Lange J Richard P Bradley N
author_sort	Lange J
title	Usability of devices for self-injection: results of a formative study on a new disposable pen injector
title_short	Usability of devices for self-injection: results of a formative study on a new disposable pen injector
title_full	Usability of devices for self-injection: results of a formative study on a new disposable pen injector
title_fullStr	Usability of devices for self-injection: results of a formative study on a new disposable pen injector
title_full_unstemmed	Usability of devices for self-injection: results of a formative study on a new disposable pen injector
title_sort	usability of devices for self-injection: results of a formative study on a new disposable pen injector
publisher	Dove Medical Press
publishDate	2014
url	https://doaj.org/article/01ae33b3a0c84bdca71dc66498709cbf
work_keys_str_mv	AT langej usabilityofdevicesforselfinjectionresultsofaformativestudyonanewdisposablepeninjector AT richardp usabilityofdevicesforselfinjectionresultsofaformativestudyonanewdisposablepeninjector AT bradleyn usabilityofdevicesforselfinjectionresultsofaformativestudyonanewdisposablepeninjector
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Usability of devices for self-injection: results of a formative study on a new disposable pen injector

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