An Ethical Risk Management Approach for Medical Devices

INTRODUCTION: 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.