Why you need to include human factors in clinical and empirical studies of in vitro point of care devices? Review and future perspectives
Author(s)
Borsci, S
Buckle, P
Hanna, GB
Type
Journal Article
Abstract
Use of in-vitro point of care devices - intended as tests performed out of laboratories and near patient - is increasing in clinical environments. International standards indicate that interaction assessment should not end after the product release, yet human factors methods are frequently not included in clinical and empirical studies of these devices. Whilst the literature confirms some advantages of bed-side tests compared to those in laboratories there is a lack of knowledge of the risks associated with their use. This article provides a review of approaches applied by clinical researchers to model the use of in-vitro testing. Results suggest that only a few studies have explored human factor approaches. Furthermore, when researchers investigated people-device interaction these were predominantly limited to qualitative and not standardised approaches. The methodological failings and limitations of these studies, identified by us, demonstrate the growing need to integrate human factors methods in the medical field.
Date Issued
2016-02-29
Date Acceptance
2016-02-10
Citation
Expert Review of Medical Devices, 2016, 13 (4), pp.405-416
ISSN
1745-2422
Publisher
Expert Reviews (formerly Future Drugs)
Start Page
405
End Page
416
Journal / Book Title
Expert Review of Medical Devices
Volume
13
Issue
4
Copyright Statement
© 2016 Taylor & Francis. This is an Author's Accepted Manuscript of an article published in Expert Review of Medical Devices, available online at: http://www.tandfonline.com/10.1586/17434440.2016.1154277.
Identifier
http://www.ncbi.nlm.nih.gov/pubmed/26878393
Subjects
Acceptance
Clinical Studies
Ergonomics
Human Factors
In Vitro Test
Interaction
POC
Point-of-care
Satisfaction
Usability
Biomedical Engineering
Publication Status
Published
Coverage Spatial
England