Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry

To reduce the risk of application error, the federal legislator has demanded a development process which is oriented towards usability (DIN EN 62366). Therefore, the research question concerns the application of this standard by medical device manufacturers. Questionnaires were filled out by five tr...

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Veröffentlicht in:Biomedizinische Technik 2013-02, Vol.58 (1), p.67-78
Hauptverfasser: Geissler, Norman, Byrnes, Trevor, Lauer, Wolfgang, Radermacher, Klaus, Kotzsch, Susanne, Korb, Werner, Hölscher, Uvo M
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container_issue 1
container_start_page 67
container_title Biomedizinische Technik
container_volume 58
creator Geissler, Norman
Byrnes, Trevor
Lauer, Wolfgang
Radermacher, Klaus
Kotzsch, Susanne
Korb, Werner
Hölscher, Uvo M
description To reduce the risk of application error, the federal legislator has demanded a development process which is oriented towards usability (DIN EN 62366). Therefore, the research question concerns the application of this standard by medical device manufacturers. Questionnaires were filled out by five trained interviewers in fully standardized face-to-face interviews at MEDICA Düsseldorf 2010. The results are based on 65 interviews. Almost all companies evaluated usability as relevant for product development; however, the understanding of usability through companies can still be improved as well as increasing the amount of trained usability experts in the process.
doi_str_mv 10.1515/bmt-2012-0040
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source MEDLINE; De Gruyter journals
subjects Equipment and Supplies - statistics & numerical data
Ergonomics - statistics & numerical data
Germany
Industry - statistics & numerical data
Patient Safety - statistics & numerical data
Safety Management - utilization
Surveys and Questionnaires
title Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry
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