Skip to main content Accessibility help
×
Hostname: page-component-78c5997874-mlc7c Total loading time: 0 Render date: 2024-11-05T12:30:15.408Z Has data issue: false hasContentIssue false

25 - Next-Generation Ethical Development of Medical Devices

Considering Harms, Benefits, Fairness, and Freedom

from Part IV - Society

Published online by Cambridge University Press:  18 October 2019

Ali E. Abbas
Affiliation:
University of Southern California
Get access

Summary

Each year hundreds of new biomedical devices and therapies are developed to attempt to solve unmet medical needs.  However, many fail due to unforeseen challenges of complex ethical, regulatory, and societal issues.  We propose that a number of these issues can be effectively transformed into drivers of innovation for medical solutions if ethical analysis is considered early, iteratively, and comprehensively in the research and development process.

Type
Chapter
Information
Next-Generation Ethics
Engineering a Better Society
, pp. 387 - 410
Publisher: Cambridge University Press
Print publication year: 2019

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

AdvaMed.org. (2016). Code of Ethics. Retrieved from www.advamed.org/issues/code-ethics/code-ethics.Google Scholar
Banta, H. D., & van Beekum, W. T. (1990). The regulation of medical devices and quality of medical care. Quality Assurance in Health Care. 2(2), 127136.Google Scholar
Beauchamp, T. L., & Childress, J. F. (2013[1979]). Principles of biomedical ethics, Seventh Edition. New York, NY: Oxford University Press.Google Scholar
Beauchamp, T. L. (2011). Making principlism practical: A commentary on Gordon, Rauprich, and Vollman. Bioethics 25(6), 301303.CrossRefGoogle Scholar
Beauchamp, T. L. (2007). The four principles approach to health care ethics. In R. E. Ashcroft, A. Dawson, H. Draper, , & McMillan, J. R. (Eds.), Principles of health care ethics (2nd edition, pp.310. New York, NY: Wiley.Google Scholar
Beekman, V., Brom, , & , F. W. (2007). Ethical tools to support systematic public deliberations about the ethical aspects of agricultural biotechnologies. Journal of Agricultural and Environmental Ethics, 20(1), 312.Google Scholar
Beever, J., & Brightman, A. O. (2016). Reflexive principlism as an effective approach for developing ethical reasoning in engineering. Science and Engineering Ethics, 22(1), 275291.CrossRefGoogle ScholarPubMed
Boenink, M., Cuijpers, Y., van der Laan, A. L., van Lente, H., & Moors, E. (2011). Assessing the sociocultural impacts of emerging molecular technologies for the early diagnosis of Alzheimer’s disease. International Journal of Alzheimer’s Disease, Article ID# 184298, 1–9.Google Scholar
Boulos, M., Kamel, N., Brewer, A. C., Karimkhani, C., Buller, D. B., & Dellavalle, R. P. (2014). Mobile medical and health apps: State of the art, concerns, regulatory control and certification. Online Journal of Public Health Informatics, 5(3), p. e229.Google Scholar
Brey, P. A. E. (2010). Values in technology and disclosive computer ethics. In Floridi (Ed.), Luciano, The Cambridge handbook of information and computer ethics (pp. 4158). Cambridge, MA: Cambridge University Press.Google Scholar
Brey, P. A. E. (2012). Anticipatory ethics for emerging technologies. Nanoethics 691), 113.CrossRefGoogle Scholar
Brown, E. T., Cohn, J. A., Kaufman, M. R., Reynolds, W. S., & Dmochowski, R. R. (2016). Lessons learned from mesh litigation for prolapse and incontinence. Current Bladder Dysfunction Report, 11(1), 7378.CrossRefGoogle Scholar
Consumer Reports. (2012). Dangerous medical implants and devices. Consumer Reports. Retrieved from www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/index.htmGoogle Scholar
Davis, M. (1991). Thinking like an engineer: The place of a code of ethics in the practice of a profession. Philosophy & Public Affairs, 20(2), 150167.Google Scholar
Davis, M. (2001). The professional approach to engineering ethics: Five research questions. Science and Engineering Ethics, 7(3), 379390.Google Scholar
Davis, M. (2001b). Three myths about codes of engineering eEthics. IEEE Technology and Society Magazine, 20(3), 814.Google Scholar
Fries, R. C. (2012). Reliable design of medical devices. Boca Raton, FL: CRC Press.Google Scholar
Geiger, J. D, & Hirschl, R. B. (2015). Innovation in surgical technology and techniques: Challenges and ethical issues. Seminars in Pediatric Surgery, 24(3), 115121.CrossRefGoogle ScholarPubMed
Halme, D. G., & Kessler, D. A. (2006). FDA regulation of stem-cell-based therapies. New England Journal of Medicine, 355(1), 17301735.Google Scholar
HHS.gov. (1979). The Belmont Report. Retrieved from www.hhs.gov/ohrp/regulations-and-policy/belmont-report/Google Scholar
Hofmann, B. (2017). Toward a method for exposing and elucidating ethical issues with human cognitive enhancement technologies. Science and Engineering Ethics, 23(2), 413429.Google Scholar
IMEDA. (2013). International Medical Device Manufacturers Association Code of Ethical Conduct for Interactions with Healthcare Professionals. Retrieved from http://cocir.org/fileadmin/4.1_Business_and_Innovation/Code_of_Conduct/IMEDA_Code_of_Ethics_NEW_01_09_2013.pdf. (Accessed 9.8.16).Google Scholar
Kisselburgh, L. et al.(2014). Effectively engaging engineers in ethical reasoning about emerging technologies: A cyber-enabled framework of scaffolded, integrated, and reflexive analysis of cases. Proceedings of the 121st ASEE Annual Conference & Exposition, Indianapolis, IN, June 2014 (pp. 1561–1563).Google Scholar
Kucklick, T. R. (2012). The medical device R&D handbook (2nd edition). Boca Raton, FL: CRC Press.Google Scholar
Kuhlmann-Capek, M. J. et al. (2015). Enmeshed in controversy: Use of vaginal mesh in the current medicolegal environment. Female pelvic medicine and reconstructive surgery, 21(5), 241243.Google Scholar
Lu, L., ARbit, H. M., Herrick, J. L., Segovis, S. G., Maran, A., & Taszemski, M. J. (2015). Tissue engineered constructs: Perspectives on clinical translation. Annuls of Biomedical Engineering, 43(3), 796804.Google Scholar
Martin, T., Rayne, K., Kemp, N. J., Hart, J., & Diller, K. R. (2005). Teaching for adaptive expertise in biomedical engineering ethics. Science and Engineering Ethics, 11(2), 257276.Google Scholar
Medical Device Manufacturers Association. (2009). Medical Device Manufacturers Association Revised Code of Conduct on Interactions with Healthcare Providers. Retrieved from https://c.ymcdn.com/sites/www.medicaldevices.org/resource/resmgr/Docs/MDMA_Code_July09.pdf.Google Scholar
Mepham, B. (2000). A framework for the ethical analysis of novel foods: The ethical matrix. Journal of Agricultural and Environmental Ethics, 12(2), 165176.Google Scholar
Merryman, W. D. (2008). Development of a tissue engineered heart valve for pediatrics: A case study in bioengineering ethics. Science and Engineering Ethics, 14(1), 93101.Google Scholar
Millar, K., Thorstensen, E., Tomkins, S., Mepham, B., & Kaiser, M. (2007). Developing the Ethical Delphi. Journal of Agricultural and Environmental Ethics, 20(1), 5363.Google Scholar
NSPE.org. (2014). Frequently asked questions about engineering. Retrieved from www.nspe.org/resources/press-room/resources/frequently-asked-questions-about-engineering.Google Scholar
Özdemir, V. et al. (2015). A Code of Ethics for Ethicists: What would Pierre Bourdieu Say? “Do Not Misuse Social Capital in the Age of Consortia Ethics.” The American Journal of Bioethics, 15(5), 6467.Google Scholar
Pennell, C. P., Hirst, A., Sedrakyan, A., &McCulloch, P. G. (2016). Adapting the IDEAL framework and recommendations for medical device evaluation: A modified Delphi survey. International Journal of Surgery, 28(2016), 141148.Google Scholar
Pirates of the Caribbean: Curse of the Black Pearl. (2003). Dir. Verbinski, G. Perfs. Depp, J., Rush, G., Bloom, O., Knightley, K., et al. Walt Disney Pictures, DVD.Google Scholar
Rawls, J. (1972). A theory of justice (pp. 4182). Oxford: Oxford University Press.Google Scholar
RAPS.org. (2016). Code of ethics for regulatory affairs professionals. Retrieved from www.raps.org/ethics.Google Scholar
Rest, J. R., Narvaez, D., Bebeau, M. J., & Thoma, S. J. (1999). Postconventional moral thinking: A Neo-Kohlbergian approach. Mahwah, NJ: Lawrence Erlbaum Associates, Inc.Google Scholar
Saarni, S. I., Braunack-Mayer, A., Hofmann, B.,& van der Wilt, G. J. (2011). Different methods for ethical analysis in health technology assessment: An empirical study. International Journal of Technology Assessment in Health Care, 27(4), 305312.Google Scholar
Singer, W. (2015). The ongoing search for the neuronal correlate of consciousness. Open MIND, 36(T). Ed.Google Scholar
Metzinger, T. & Windt, J. M.. Frankfurt am Main: MIND group. doi: 10.15502/9783958570344CrossRefGoogle Scholar
Spielthenner, G. (2015). Why comply with a code of ethics? Medical Health Care and Philosophy, 1892), 195202.Google Scholar
Stankovic, B. & Stankovic, M. (2014). Educating about biomedical research ethics. Medical Health Care and Philosophy, 17(4), 541548.Google Scholar
Steneck, N. H. (2007). Introduction to the responsible conduct of research. Washington, DC: Office of Research Integrity.Google Scholar
Tjan, A. K. (2010, August 9). The power of ignorance. Harvard Business Review. Retrieved from https://hbr.org/2010/08/the-power-of-ignorance. (Accessed 9.8.16).Google Scholar
Tuana, N. (2013). Embedding philosophers in the practices of science: Bringing humanities to the sciences. Synthese, 190(11), 19551973.Google Scholar
Van Buskirk, G. E. & Andresen, M. C. (2008). Creating a code of conduct for a medical device company. Retrieved from www.raps.org/WorkArea/DownloadAsset.aspx?id=4027. (Accessed 9.8.16).Google Scholar
Wright, D. (2011). A framework for the ethical impact assessment of information technology. Ethics and Information Technology, 13(3), 199226.Google Scholar

Save book to Kindle

To save this book to your Kindle, first ensure [email protected] is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×