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Introducing New Techniques, Technology, and Medical Devices

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Difficult Decisions in Surgical Ethics

Part of the book series: Difficult Decisions in Surgery: An Evidence-Based Approach ((DDSURGERY))

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Abstract

Introducing new procedures, technologies, and medical devices to one’s practice inherently presents a surgeon with ethical dilemmas regarding their safety and efficacy. This chapter provides an overview of the history of surgical innovation and how new medical devices and surgical procedures are regulated, with discussion on ethical dilemmas surgeons may face as they expand their armamentarium of surgical techniques. Above all, this chapter aims to encourage innovation that is safe and appropriate, and to equip surgeons for the decision-making and discussions that should accompany surgical innovation.

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References

  1. Semmelweiss. Br Med J. 1893;1:26. https://doi.org/10.1136/bmj.1.1671.26.

    Article  Google Scholar 

  2. Elliot GF. The germ-theory. Br Med J. 1870;1:488–9. https://doi.org/10.1136/bmj.1.489.488-a.

    Article  Google Scholar 

  3. Nakayama DK. Antisepsis and asepsis and how they shaped modern surgery. Am Surg. 2018;84(6):766–71. https://doi.org/10.1177/000313481808400616.

    Article  PubMed  Google Scholar 

  4. Caruso JP, Sheehan JP. Psychosurgery, ethics, and media: a history of Walter freeman and the lobotomy. Neurosurg Focus. 2017;43(3):E6. https://doi.org/10.3171/2017.6focus17257.

    Article  PubMed  Google Scholar 

  5. Weil M. Rosemary Kennedy, 86; President’s Disabled Sister. Washington Post. January 8, 2005; page B06. Accessed July 2020. https://www.washingtonpost.com/wp-dyn/articles/A58134-2005Jan8.html.

  6. Beitner MM, Ren-Fielding CJ, Fielding GA. Reducing complications with improving gastric band design. Surg Obes Relat Dis. 2016;12(1):150–6. https://doi.org/10.1016/j.soard.2015.08.520.

    Article  PubMed  Google Scholar 

  7. Public Warning Against Hoxsey Cancer Treatment. Food and Drug Administration. U.S. Dept Health, Education, Welfare. Vol. 74. April 4, 1956.

    Google Scholar 

  8. Lapkin A. The Bizarre history of a bogus doctor who prescribed goat gonads. National Geographic Family. July 15, 2016. Accessed February 12, 2021. https://www.nationalgeographic.com/news/2016/07/documentary-interview-medicine-science/.

  9. Day M. Disgraced tracheal transplant surgeon is handed 16 month prison sentence in Italy. BMJ. 2019;367:16676. https://doi.org/10.1136/bmj.16676.

    Article  Google Scholar 

  10. Ernest Armory Codman. Wikipedia. Wikimedia Foundation. 10 May 2020. Accessed 22 July 2020. https://en.wikipedia.org/wiki/Ernest_Amory_Codman.

  11. Riskin DJ, Longaker MT, Gertner M, Krummel TM. Innovation in surgery: a historical perspective. Ann Surg. 2006;244(5):686–93. https://doi.org/10.1097/01.sla.0000242706.91771.ce.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Brown K, Solomon MJ, Young J, Seco M, Bannon PG. Addressing the ethical grey zone in surgery: a framework for identification and safe introduction of novel surgical techniques and procedures. ANZ J Surg. 2019;89:634–8. https://doi.org/10.1111/ans.15104.

    Article  PubMed  Google Scholar 

  13. van de Graaf FW, Zaimi I, Stassen LPS, Lange JF. Safe laparoscopic cholecystectomy: a systematic review of bile duct injury prevention. Int J Surg. 2018;60:164–72. https://doi.org/10.1016/j.ijsu.2018.11.006.

    Article  PubMed  Google Scholar 

  14. van de Graaf FW, Lange MM, Spakman JI. Comparison of systematic video documentation with narrative operative report in colorectal cancer surgery. JAMA Surg. 2019;154(5):381–9. https://doi.org/10.1001/jamasurg.2018.5246.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Development & Approval Process: Drugs. FDA. 28 October 2019. Accessed February 12, 2021. https://www.fda.gov/drugs/development-approval-process-drugs.

  16. Classify Your Medical Device. FDA. 20 February 2020. Accessed February 12, 2021. https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device.

  17. Premarket Notification 510(k). FDA. 13 March 2020. Accessed February 12, 2021. https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k.

  18. Rathi VK, Ross JS. Modernizing the FDA’s 510(k) pathway. N Engl J Med. 2019;381(20):1891–3. https://doi.org/10.1056/nejmp1908654.

    Article  PubMed  Google Scholar 

  19. Medical Device Exemptions 510(k) and GMP Requirements. FDA. 8 Fevruary 2021. Accessed February 12, 2021. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm.

  20. Walter JR, Ghobadi CW, Hayman E, Xu S. Hysteroscopic sterilization with Essure: summary of the U.S. Food and Drug Administration actions and policy implications for Postmarketing surveillance. Obstet Gynecol. 2017;129:10–9. https://doi.org/10.1097/aog.0000000000001796.

    Article  PubMed  Google Scholar 

  21. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. FDA. 10 February 2021. Accessed February 12, 2021. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

  22. Angelos P. Ethics and surgical innovation: challenges to the professionalism of surgeons. Int Jour Surg. 2013;11(S1):S2–5. https://doi.org/10.1016/s1743-9191(13)60003-5.

    Article  Google Scholar 

  23. Benz HL, Saha A, Tarver ME. Integrating the voice of the patient into the medical device regulatory process using patient preference information. Value Health. 2020;23(3):294–7. https://doi.org/10.1016/j.jval.2019.12.005.

    Article  PubMed  Google Scholar 

  24. Kshettry VF, Do H, Elshazly K, et al. The learning curve in endoscopic endonasal resection of craniopharyngiomas. Neurosurg Focus. 2016;41(6):E9. https://doi.org/10.3171/2016.9FOCUS16292.

    Article  PubMed  Google Scholar 

  25. Li B, Asche S, Yang R, Yueh B, Fina M. Outcomes of adopting endoscopic Tympanoplasty in an academic teaching hospital. Ann Otol Rhinol Laryngol. 2019;128(6):548–55. https://doi.org/10.1177/0003489419830424.

    Article  PubMed  Google Scholar 

  26. Strollo PJ, Soose RJ. MaurerJT, et al. upper-airway stimulation for obstructive sleep Apnea. New Engl J Med. 2014;370:139–49. https://doi.org/10.1056/NEJMoa1308659.

    Article  CAS  PubMed  Google Scholar 

  27. Brown EG, Anderson JE, Burgess D, Bold RJ. Examining the “halo effect” of surgical care within health systems. JAMA Surg. 2016;151(10):983–4. https://doi.org/10.1001/jamasurg.2016.1000.

    Article  PubMed  Google Scholar 

  28. American College of Surgeons. Statements on Principles. April 12, 2016. Accessed September 23, 2020. https://www.facs.org/about-acs/statements/stonprin.

  29. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. World Medical Association. 9 July 2018. Accessed February 14, 2021. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/.

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Author information

Authors and Affiliations

  1. Department of Otolaryngology – Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, USA

    Kelly C. Landeen

  2. Departments of Thoracic Surgery, Department of Pulmonology, Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, TN, USA

    Fabien Maldonado

  3. Department of Otolaryngology – Head and Neck Surgery, Department of Radiology and Radiological Sciences, Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, TN, USA

    Alexander Langerman

Authors
  1. Kelly C. Landeen
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  2. Fabien Maldonado
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  3. Alexander Langerman
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Corresponding author

Correspondence to Alexander Langerman .

Editor information

Editors and Affiliations

  1. The University of Chicago Medicine, University of Chicago, Chicago, IL, USA

    Vassyl A. Lonchyna

  2. Providence Children’s Surgical Services St. Vincent Hospital, Portland, OR, USA

    Peggy Kelley

  3. Department of Surgery MacLean Center for Clinical Medical Ethics, The University of Chicago, Chicago, IL, USA

    Peter Angelos

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Landeen, K.C., Maldonado, F., Langerman, A. (2022). Introducing New Techniques, Technology, and Medical Devices. In: Lonchyna, V.A., Kelley, P., Angelos, P. (eds) Difficult Decisions in Surgical Ethics. Difficult Decisions in Surgery: An Evidence-Based Approach. Springer, Cham. https://doi.org/10.1007/978-3-030-84625-1_49

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  • DOI: https://doi.org/10.1007/978-3-030-84625-1_49

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-84624-4

  • Online ISBN: 978-3-030-84625-1

  • eBook Packages: MedicineMedicine (R0)

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