Challenges Associated with the Safety Signal Detection Process for Medical Devices

Josep Pane,1,2 Katia MC Verhamme,1 Dorian Villegas,2 Laura Gamez,3 Irene Rebollo,3 Miriam CJM Sturkenboom4 1Department of Medical Informatics, Erasmus Medical Center, University of Rotterdam, Rotterdam, Netherlands; 2Alcon, Fort Worth, USA; 3Novartis, Barcelona, Spain; 4Julius Global Health, Univers...

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Autores principales:	Pane J, Verhamme KMC, Villegas D, Gamez L, Rebollo I, Sturkenboom MCJM
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	signal detection safety surveillance post-market surveillance post-market data sources coding dictionaries medical devices Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/1dbb27fdff6f4006be022afb5488d526
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spelling	oai:doaj.org-article:1dbb27fdff6f4006be022afb5488d5262021-12-02T16:23:32ZChallenges Associated with the Safety Signal Detection Process for Medical Devices1179-1470https://doaj.org/article/1dbb27fdff6f4006be022afb5488d5262021-02-01T00:00:00Zhttps://www.dovepress.com/challenges-associated-with-the-safety-signal-detection-process-for-med-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Josep Pane,1,2 Katia MC Verhamme,1 Dorian Villegas,2 Laura Gamez,3 Irene Rebollo,3 Miriam CJM Sturkenboom4 1Department of Medical Informatics, Erasmus Medical Center, University of Rotterdam, Rotterdam, Netherlands; 2Alcon, Fort Worth, USA; 3Novartis, Barcelona, Spain; 4Julius Global Health, University Medical Center Utrecht, Utrecht, NetherlandsCorrespondence: Josep PaneDepartment of Medical Informatics, Erasmus Medical Center, University of Rotterdam, Rotterdam, 3000, CA, NetherlandsEmail jpanesalvado@gmail.comBackground: Previous safety issues involving medical devices have stressed the need for better safety signal detection. Various European Union (EU) national competent authorities have started to focus on strengthening the analysis of vigilance data. Consequently, article 90 of the new EU regulation states that the European Commission shall put in place systems and processes to actively monitor medical device safety signals.Methods: A systematic literature review was conducted to synthesize the current state of knowledge and investigate the present tools used for medical device safety signal detection. An electronic literature search was performed in Embase, Medline, Cochrane, Web of science, and Google scholar from inception until January 2017. Articles that included terms related to medical devices and terms associated with safety were selected. A further selection was based on the abstract review. A full review of the remaining articles was conducted to decide on which articles finally to consider relevant for this review. Completeness was assessed based on the content of the articles.Results: Our search resulted in a total of 20,819 articles, of which 24 met the inclusion criteria and were subject to data extraction and completeness scoring. A wide range of data sources, especially spontaneous reporting systems and registries, used for the detection and assessment of product problems and patient harms associated with the use of medical devices, were studied. Coding is remarkably heterogeneous, no agreement on the preferred methods for signal detection exists, and no gold standard for signal detection has been established thus far.Conclusion: Data source harmonization, the development of gold standard signal detection methodologies and the standardization of coding dictionaries are amongst the recommendations to support the implementation of a new proactive approach to signal detection. The new safety surveillance system will be able to use real-world evidence to support regulatory decision-making across all jurisdictions.Keywords: signal detection, safety surveillance, post-market surveillance, post-market data sources, coding dictionaries, medical devicesPane JVerhamme KMCVillegas DGamez LRebollo ISturkenboom MCJMDove Medical Pressarticlesignal detectionsafety surveillancepost-market surveillancepost-market data sourcescoding dictionariesmedical devicesMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 14, Pp 43-57 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	signal detection safety surveillance post-market surveillance post-market data sources coding dictionaries medical devices Medical technology R855-855.5
spellingShingle	signal detection safety surveillance post-market surveillance post-market data sources coding dictionaries medical devices Medical technology R855-855.5 Pane J Verhamme KMC Villegas D Gamez L Rebollo I Sturkenboom MCJM Challenges Associated with the Safety Signal Detection Process for Medical Devices
description	Josep Pane,1,2 Katia MC Verhamme,1 Dorian Villegas,2 Laura Gamez,3 Irene Rebollo,3 Miriam CJM Sturkenboom4 1Department of Medical Informatics, Erasmus Medical Center, University of Rotterdam, Rotterdam, Netherlands; 2Alcon, Fort Worth, USA; 3Novartis, Barcelona, Spain; 4Julius Global Health, University Medical Center Utrecht, Utrecht, NetherlandsCorrespondence: Josep PaneDepartment of Medical Informatics, Erasmus Medical Center, University of Rotterdam, Rotterdam, 3000, CA, NetherlandsEmail jpanesalvado@gmail.comBackground: Previous safety issues involving medical devices have stressed the need for better safety signal detection. Various European Union (EU) national competent authorities have started to focus on strengthening the analysis of vigilance data. Consequently, article 90 of the new EU regulation states that the European Commission shall put in place systems and processes to actively monitor medical device safety signals.Methods: A systematic literature review was conducted to synthesize the current state of knowledge and investigate the present tools used for medical device safety signal detection. An electronic literature search was performed in Embase, Medline, Cochrane, Web of science, and Google scholar from inception until January 2017. Articles that included terms related to medical devices and terms associated with safety were selected. A further selection was based on the abstract review. A full review of the remaining articles was conducted to decide on which articles finally to consider relevant for this review. Completeness was assessed based on the content of the articles.Results: Our search resulted in a total of 20,819 articles, of which 24 met the inclusion criteria and were subject to data extraction and completeness scoring. A wide range of data sources, especially spontaneous reporting systems and registries, used for the detection and assessment of product problems and patient harms associated with the use of medical devices, were studied. Coding is remarkably heterogeneous, no agreement on the preferred methods for signal detection exists, and no gold standard for signal detection has been established thus far.Conclusion: Data source harmonization, the development of gold standard signal detection methodologies and the standardization of coding dictionaries are amongst the recommendations to support the implementation of a new proactive approach to signal detection. The new safety surveillance system will be able to use real-world evidence to support regulatory decision-making across all jurisdictions.Keywords: signal detection, safety surveillance, post-market surveillance, post-market data sources, coding dictionaries, medical devices
format	article
author	Pane J Verhamme KMC Villegas D Gamez L Rebollo I Sturkenboom MCJM
author_facet	Pane J Verhamme KMC Villegas D Gamez L Rebollo I Sturkenboom MCJM
author_sort	Pane J
title	Challenges Associated with the Safety Signal Detection Process for Medical Devices
title_short	Challenges Associated with the Safety Signal Detection Process for Medical Devices
title_full	Challenges Associated with the Safety Signal Detection Process for Medical Devices
title_fullStr	Challenges Associated with the Safety Signal Detection Process for Medical Devices
title_full_unstemmed	Challenges Associated with the Safety Signal Detection Process for Medical Devices
title_sort	challenges associated with the safety signal detection process for medical devices
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/1dbb27fdff6f4006be022afb5488d526
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Challenges Associated with the Safety Signal Detection Process for Medical Devices

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