An Ethical Risk Management Approach for Medical Devices
Lila Carden,1 Bolanle Oladapo2 1College of Technology, Technology Project Management Program, University of Houston, Houston, Texas, 77204-4023, USA; 2Technology Project Management Program, College of Technology, University of Houston, Houston, Texas, 77204-4023, USACorrespondence: Lila CardenColleg...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2021-06-01
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| Series: | Risk Management and Healthcare Policy |
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| Online Access: | https://www.dovepress.com/an-ethical-risk-management-approach-for-medical-devices-peer-reviewed-fulltext-article-RMHP |
| _version_ | 1818865548519276544 |
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| author | Carden L Oladapo B |
| author_facet | Carden L Oladapo B |
| author_sort | Carden L |
| collection | DOAJ |
| description | Lila Carden,1 Bolanle Oladapo2 1College of Technology, Technology Project Management Program, University of Houston, Houston, Texas, 77204-4023, USA; 2Technology Project Management Program, College of Technology, University of Houston, Houston, Texas, 77204-4023, USACorrespondence: Lila CardenCollege of Technology, Technology Project Management Program, University of Houston, College of Technology Building, 4730 Calhoun Road, Room 300, Houston, Texas, 77204-4023, USATel +1 713-743-4171Fax +1 713-743-4032Email lcarden@uh.eduIntroduction: The Food and Drug Administration (FDA) audits and validates devices before mass production to ensure high standards, safety, and quality of medical devices being marketed. Despite those measures in place, consumers’ trusts in medical devices are still dwindling based on safety and privacy risks that eventually influence the health of patients.Methods: The method employed in this study is conceptual and includes a selection of a company that develops medical devices to use as an example organization to apply the hybrid risk management framework, defined herein in the results and discussion section.Results: The results include a hybrid risk management approach including activities and tools and techniques by risk management phases.Discussion: The discussion includes how to apply the hybrid risk management framework using Abbott Laboratories as an example.Conclusion: To mitigate the chances that risks (adverse events) occur during the manufacturing and use of medical devices, this study has focused on providing a hybrid risk management approach for organizations noting the use of ISO 14971 activities as well as the PMBOK activities.Keywords: risks, medical devices, risk management, ethics |
| first_indexed | 2024-12-19T10:49:18Z |
| format | Article |
| id | doaj.art-2f6e5d358bd34bb1bee4c4d764e31296 |
| institution | Directory Open Access Journal |
| issn | 1179-1594 |
| language | English |
| last_indexed | 2024-12-19T10:49:18Z |
| publishDate | 2021-06-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Risk Management and Healthcare Policy |
| spelling | doaj.art-2f6e5d358bd34bb1bee4c4d764e312962022-12-21T20:25:04ZengDove Medical PressRisk Management and Healthcare Policy1179-15942021-06-01Volume 142311231865491An Ethical Risk Management Approach for Medical DevicesCarden LOladapo BLila Carden,1 Bolanle Oladapo2 1College of Technology, Technology Project Management Program, University of Houston, Houston, Texas, 77204-4023, USA; 2Technology Project Management Program, College of Technology, University of Houston, Houston, Texas, 77204-4023, USACorrespondence: Lila CardenCollege of Technology, Technology Project Management Program, University of Houston, College of Technology Building, 4730 Calhoun Road, Room 300, Houston, Texas, 77204-4023, USATel +1 713-743-4171Fax +1 713-743-4032Email lcarden@uh.eduIntroduction: The Food and Drug Administration (FDA) audits and validates devices before mass production to ensure high standards, safety, and quality of medical devices being marketed. Despite those measures in place, consumers’ trusts in medical devices are still dwindling based on safety and privacy risks that eventually influence the health of patients.Methods: The method employed in this study is conceptual and includes a selection of a company that develops medical devices to use as an example organization to apply the hybrid risk management framework, defined herein in the results and discussion section.Results: The results include a hybrid risk management approach including activities and tools and techniques by risk management phases.Discussion: The discussion includes how to apply the hybrid risk management framework using Abbott Laboratories as an example.Conclusion: To mitigate the chances that risks (adverse events) occur during the manufacturing and use of medical devices, this study has focused on providing a hybrid risk management approach for organizations noting the use of ISO 14971 activities as well as the PMBOK activities.Keywords: risks, medical devices, risk management, ethicshttps://www.dovepress.com/an-ethical-risk-management-approach-for-medical-devices-peer-reviewed-fulltext-article-RMHPrisksmedical devicesrisk managementethics |
| spellingShingle | Carden L Oladapo B An Ethical Risk Management Approach for Medical Devices Risk Management and Healthcare Policy risks medical devices risk management ethics |
| title | An Ethical Risk Management Approach for Medical Devices |
| title_full | An Ethical Risk Management Approach for Medical Devices |
| title_fullStr | An Ethical Risk Management Approach for Medical Devices |
| title_full_unstemmed | An Ethical Risk Management Approach for Medical Devices |
| title_short | An Ethical Risk Management Approach for Medical Devices |
| title_sort | ethical risk management approach for medical devices |
| topic | risks medical devices risk management ethics |
| url | https://www.dovepress.com/an-ethical-risk-management-approach-for-medical-devices-peer-reviewed-fulltext-article-RMHP |
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