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Ethical Challenges of Current Oversight and Regulation of Novel Medical Devices in Neurosurgery

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Ethics of Innovation in Neurosurgery

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Abstract

The use of medical devices has greatly improved outcomes of neurosurgical patients. However, the legislation that is in place to protect patients from harmful devices holds many loopholes which may result in unproven devices reaching the marketplace and making their way into patients’ bodies. This holds great ethical implication with regard to risk-benefit ratio, justice, and the informed consent procedure. In this chapter, the current legislative landscape is discussed together with its shortcoming and related ethical issues. At the end of this chapter, various manners of improvement are discussed for the neurosurgeon to consider.

This chapter is based on: Muskens IS, Gupta S, Hulsbergen A, Moojen WA, Broekman ML. Introduction of Novel Medical Devices in Surgery: Ethical Challenges of Current Oversight and Regulation. J Am Coll Surg. 2017 Aug 4.

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Author information

Authors and Affiliations

  1. Department of Neurosurgery, Haaglanden Medical Center, The Hague, The Netherlands

    Ivo S. Muskens, Alexander F. C. Hulsbergen, Wouter A. Moojen & Marike L. D. Broekman

  2. Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands

    Ivo S. Muskens, Alexander F. C. Hulsbergen, Wouter A. Moojen & Marike L. D. Broekman

  3. Department of Neurosurgery, Computational Neurosciences Outcomes Center (CNOC), Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

    Ivo S. Muskens, Saksham Gupta, Alexander F. C. Hulsbergen & Marike L. D. Broekman

  4. Department of Neurosurgery, Haga Teaching Hospital, The Hague, The Netherlands

    Wouter A. Moojen

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  1. Ivo S. Muskens
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  2. Saksham Gupta
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  3. Alexander F. C. Hulsbergen
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  4. Wouter A. Moojen
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  5. Marike L. D. Broekman
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Correspondence to Marike L. D. Broekman .

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Editors and Affiliations

  1. Department of Neurosurgery, Haaglanden Medical Center & Leiden University Medical Center, The Hague and Leiden, Zuid-Holland, The Netherlands

    Marike L. D. Broekman

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Muskens, I.S., Gupta, S., Hulsbergen, A.F.C., Moojen, W.A., Broekman, M.L.D. (2019). Ethical Challenges of Current Oversight and Regulation of Novel Medical Devices in Neurosurgery. In: Broekman, M. (eds) Ethics of Innovation in Neurosurgery. Springer, Cham. https://doi.org/10.1007/978-3-030-05502-8_3

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