Ethics of Regulated Biomedical Device Design

Nael Barakat; Nadia Sunny; Md Mehedi Hasan

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Conference: 2014 ASEE Annual Conference & Exposition
Location: Indianapolis, Indiana
Publication Date: June 15, 2014
Start Date: June 15, 2014
End Date: June 18, 2014
ISSN: 2153-5965
Conference Session: Graduate Ethics Education & Professional Codes
Tagged Division: Engineering Ethics
Page Count: 9
Page Numbers: 24.541.1 - 24.541.9
DOI: 10.18260/1-2--20432
Permanent URL: https://peer.asee.org/20432
Download Count: 1414

Paper Authors

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Nael Barakat Grand Valley State University

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Dr. Nael Barakat is a professor of Engineering at Grand Valley State University (GVSU), Grand Rapids, MI. He is a registered professional engineer in Ontario, Canada, and a fellow of the American Society of Mechanical Engineers (ASME). Dr. Barakat holds a Ph.D. in Mechanical Engineering from McMaster University, Canada. His areas of interest include Controls, Robotics, Automation, Systems dynamics and Integration, as well as Engineering Ethics, professionalism, and Education.
Dr. Barakat is serving as the chair of the Technology and Society (T & S) Division and as the ASME district B leader. He also serves as the treasurer and secretary for the ASEE Engineering Ethics Dvision.

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Nadia Sunny Grand Valley State University

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Nadia Sunny is pursuing a Master’s degree in Biomedical Engineering at Grand Valley State University, Michigan. She received her Bachelor’s in Chemical Engineering from Bangladesh University of Engineering and Technology in 2004 and Master’s in Business Administration from Institute of Business Administration, Dhaka University in 2008. She has a diverse work experience in mechanical fabrication company, urea process plant, telecommunication equipment vendor and bank. She received excellence awards from her employer in 2009, 2011 and 2012 for successful project management. Her areas of work and research interest are device design and regulation on medical devices.

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Md Mehedi Hasan Grand Valley State University

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I have been working as a research assistant in supply-demand planning of Lithium-ion batteries for electric drive vehicles while pursuing my MS in Product Design & Manufacturing Engineering in Grand Valley State University. I pursued my bachelor in Industrial & Production Engineering from Bangladesh University of Engineering & Technology in 2012. My areas of interests are manufacturing processes, quality management, supply chain management etc.

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Abstract

Ethics of Regulated Biomedical Device DesignHolding paramount the safety and welfare of humans is the most common theme that tops allpriorities in most codes of engineering ethics. This is based on a profound realization ofengineering impact on humans and their societies. Results of this impact are usually visualizedmuch faster when engineering products are used in a mode that interacts directly with human lifeand functionality, like in the biomedical engineering field. In this case ethical concerns increasesignificantly to become prominent in every step along the way of engineering a product, like inthe case of medical devices. As a translation to this scenario, these devices would have moregovernmental and oversight regulations corresponding to the level of concern for human life andwelfare.Three examples of the different issues which significantly impact biomedical engineeringinclude: safety of the user, need for clinical trials, and confidentiality of the patients’ results asthey are being used towards improving a treatment. These three examples represent differentfacets in medical device application which directly interact with the patient. Engineers’ firstresource to ensure that concerns related to these issues are resolved would be to look at industryregulations. As a regulatory body, the food and drug administration (FDA) is not expected toprovide guidelines for ethical decision making. However, the goal and spirit of FDA regulationsaims at a superior user safety and an effective medical device. Another resource that biomedicaldevice designers would use to look for support in dealing with these issues, would be the code ofethics provided by the relevant professional society, biomedical engineering society (BMES).However, these two resources have their practicality issues as well, which result in differentquestions to be handled by the biomedical engineer or biomedical device designer.This paper examines the applicability of an integrated approach for biomedical device designwhere a combination of both the professional code of ethics, and the FDA regulations, isconsidered to overcome ethical concerns and practicality issues. The proposed approachincorporates an analysis of the spirit of FDA regulations and its encouragement towards ethicaldecision making in biomedical device design. The analysis is extended to establish linksbetween an improved code of ethics and the spirit of FDA regulations.

Citation
Format

Barakat, N., & Sunny, N., & Hasan, M. M. (2014, June), Ethics of Regulated Biomedical Device Design Paper presented at 2014 ASEE Annual Conference & Exposition, Indianapolis, Indiana. 10.18260/1-2--20432

TY  - CPAPER
AB  -                      Ethics of Regulated Biomedical Device DesignHolding paramount the safety and welfare of humans is the most common theme that tops allpriorities in most codes of engineering ethics. This is based on a profound realization ofengineering impact on humans and their societies. Results of this impact are usually visualizedmuch faster when engineering products are used in a mode that interacts directly with human lifeand functionality, like in the biomedical engineering field. In this case ethical concerns increasesignificantly to become prominent in every step along the way of engineering a product, like inthe case of medical devices. As a translation to this scenario, these devices would have moregovernmental and oversight regulations corresponding to the level of concern for human life andwelfare.Three examples of the different issues which significantly impact biomedical engineeringinclude: safety of the user, need for clinical trials, and confidentiality of the patients’ results asthey are being used towards improving a treatment. These three examples represent differentfacets in medical device application which directly interact with the patient. Engineers’ firstresource to ensure that concerns related to these issues are resolved would be to look at industryregulations. As a regulatory body, the food and drug administration (FDA) is not expected toprovide guidelines for ethical decision making. However, the goal and spirit of FDA regulationsaims at a superior user safety and an effective medical device. Another resource that biomedicaldevice designers would use to look for support in dealing with these issues, would be the code ofethics provided by the relevant professional society, biomedical engineering society (BMES).However, these two resources have their practicality issues as well, which result in differentquestions to be handled by the biomedical engineer or biomedical device designer.This paper examines the applicability of an integrated approach for biomedical device designwhere a combination of both the professional code of ethics, and the FDA regulations, isconsidered to overcome ethical concerns and practicality issues. The proposed approachincorporates an analysis of the spirit of FDA regulations and its encouragement towards ethicaldecision making in biomedical device design. The analysis is extended to establish linksbetween an improved code of ethics and the spirit of FDA regulations.
AU  - Nael Barakat
AU  - Nadia Sunny
AU  - Md Mehedi Hasan
CY  - Indianapolis, Indiana
DA  - 2014/06/15
PB  - ASEE Conferences
TI  - Ethics of Regulated Biomedical Device Design
UR  - https://peer.asee.org/20432
DO  - 10.18260/1-2--20432
ER  -