A proposed framework to improve the safety of medical devices in a Canadian hospital context

Julie Polisena,1,2 Jeffrey Jutai,3 Rana Chreyh41Canadian Agency for Drugs and Technologies in Health, Ottawa, ON, Canada; 2Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada; 3Interdisciplinary School of Health Sciences, Faculty of Healt...

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Autores principales:	Polisena J, Jutai J, Chreyh R
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2014
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/d6fc2e683daa411089af5f953e506614
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spelling	oai:doaj.org-article:d6fc2e683daa411089af5f953e5066142021-12-02T00:48:35ZA proposed framework to improve the safety of medical devices in a Canadian hospital context1179-1470https://doaj.org/article/d6fc2e683daa411089af5f953e5066142014-05-01T00:00:00Zhttp://www.dovepress.com/a-proposed-framework-to-improve-the-safety-of-medical-devices-in-a-can-a16875https://doaj.org/toc/1179-1470 Julie Polisena,1,2 Jeffrey Jutai,3 Rana Chreyh41Canadian Agency for Drugs and Technologies in Health, Ottawa, ON, Canada; 2Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada; 3Interdisciplinary School of Health Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada; 4Biomedical Engineering, The Ottawa Hospital, Ottawa, ON, CanadaPurpose: Medical devices are used to monitor, replace, or modify anatomy or physiological processes. They are important health care innovations that enable effective treatment using less invasive techniques, and they improve health care delivery and patient outcomes. Devices can also introduce risk of harm to patients. Our objective was to propose a surveillance system framework to improve the safety associated with the use of medical devices in a hospital.Materials and methods: The proposed medical device surveillance system incorporates multiple components to accurately document and assess the appropriate actions to reduce the risk of incidents, adverse events, and patient harm. The assumptions on which the framework is based are highlighted. The surveillance system was designed from the perspective of a tertiary teaching hospital that includes dedicated hospital staff whose mandate is to provide safe patient care to inpatients and outpatients and biomedical engineering services.Results: The main components of the surveillance system would include an adverse medical device events database, a medical device/equipment library, education and training, and an open communication and feedback strategy. Close linkages among these components and with external medical device/equipment networks to the hospital must be established and maintained. A feedback mechanism on medical device-related incidents, as well as implementation and evaluation strategies for the surveillance system are described to ensure a seamless transition and a high satisfactory level among the hospital staff. The direct cost items of the proposed surveillance system for consideration, and its potential benefits are outlined.Conclusion: The effectiveness of the proposed medical device surveillance system framework can be measured after it has been implemented in a Canadian hospital facility.Keywords: surveillance system, safety, training, adverse events, devise failure, maintenancePolisena JJutai JChreyh RDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2014, Iss default, Pp 139-147 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Polisena J Jutai J Chreyh R A proposed framework to improve the safety of medical devices in a Canadian hospital context
description	Julie Polisena,1,2 Jeffrey Jutai,3 Rana Chreyh41Canadian Agency for Drugs and Technologies in Health, Ottawa, ON, Canada; 2Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada; 3Interdisciplinary School of Health Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada; 4Biomedical Engineering, The Ottawa Hospital, Ottawa, ON, CanadaPurpose: Medical devices are used to monitor, replace, or modify anatomy or physiological processes. They are important health care innovations that enable effective treatment using less invasive techniques, and they improve health care delivery and patient outcomes. Devices can also introduce risk of harm to patients. Our objective was to propose a surveillance system framework to improve the safety associated with the use of medical devices in a hospital.Materials and methods: The proposed medical device surveillance system incorporates multiple components to accurately document and assess the appropriate actions to reduce the risk of incidents, adverse events, and patient harm. The assumptions on which the framework is based are highlighted. The surveillance system was designed from the perspective of a tertiary teaching hospital that includes dedicated hospital staff whose mandate is to provide safe patient care to inpatients and outpatients and biomedical engineering services.Results: The main components of the surveillance system would include an adverse medical device events database, a medical device/equipment library, education and training, and an open communication and feedback strategy. Close linkages among these components and with external medical device/equipment networks to the hospital must be established and maintained. A feedback mechanism on medical device-related incidents, as well as implementation and evaluation strategies for the surveillance system are described to ensure a seamless transition and a high satisfactory level among the hospital staff. The direct cost items of the proposed surveillance system for consideration, and its potential benefits are outlined.Conclusion: The effectiveness of the proposed medical device surveillance system framework can be measured after it has been implemented in a Canadian hospital facility.Keywords: surveillance system, safety, training, adverse events, devise failure, maintenance
format	article
author	Polisena J Jutai J Chreyh R
author_facet	Polisena J Jutai J Chreyh R
author_sort	Polisena J
title	A proposed framework to improve the safety of medical devices in a Canadian hospital context
title_short	A proposed framework to improve the safety of medical devices in a Canadian hospital context
title_full	A proposed framework to improve the safety of medical devices in a Canadian hospital context
title_fullStr	A proposed framework to improve the safety of medical devices in a Canadian hospital context
title_full_unstemmed	A proposed framework to improve the safety of medical devices in a Canadian hospital context
title_sort	proposed framework to improve the safety of medical devices in a canadian hospital context
publisher	Dove Medical Press
publishDate	2014
url	https://doaj.org/article/d6fc2e683daa411089af5f953e506614
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A proposed framework to improve the safety of medical devices in a Canadian hospital context

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