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The Safety and Medico-Legal Responsibilities of the Pacemaker Implantation Team

  • Chapter
The Pacemaker Clinic of the 90’s

Part of the book series: Developments in Cardiovascular Medicine ((DICM,volume 175))

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Abstract

There is no doubt that thanks to the large-scale availability of pacemakers and cardioverter-defibrillators, the life expectancy and quality of life of numerous patients has much improved. Pacemakers are used since a long time, they have proven their value, and they have become big business for the industry, scientists, and cardiologists.1 Although technical innovation has resulted in safer and more effective pacemakers, thereby reducing the number of adverse effects and improving patient compliance, it has also created three areas of potential conflicts of interest:

  1. 1.

    Innovation may still have to prove its value for the patient. Extensive clinical testing and patient follow-up studies are then required, for which recognized end-points within the framework of evidence-based medicine are needed.2

  2. 2.

    As pacemakers are widely used, innovation may yield enormous financial rewards to the industry and cardiologists. This could interfere with safety priorities, the patient-doctor relation, and the cardiologists’ independence of the industry.3, 4

  3. 3.

    As pacemakers and cardioverter-defibrillators are potentially life-saving devices, cardiologists may adopt a liberal policy in terms of the indication for use. This might lead to technical and budgetary disputes on what should be considered an appropriate indication.5

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References

  1. Starr A. The thoracic-surgical industrial complex. Ann Thorac Surg 1986;42:124–133.

    Article  PubMed  CAS  Google Scholar 

  2. Evidence-Based Medicine Working Group. Evidence-based medicine: a new approach to teaching the practice of medicine. JAMA 1992;268:2420–5.

    Article  Google Scholar 

  3. Rowdin MA. Physicians’ conflict of interests. The limitations of disclosure. N Engl J Med 1989;321:1407.

    Google Scholar 

  4. Relman AS. Dealing with conflicts of interest. N Engl J Med 1985;313:749–51.

    Article  PubMed  CAS  Google Scholar 

  5. Kellie SE, Kelly JT. Medicare peer review organization preprocedure review criteria. An analysis of criteria for three procedures. JAMA 1991;265:1265–70.

    Article  PubMed  CAS  Google Scholar 

  6. Beauchamp TL, Childress JF. Principles of biomedical ethics. New York: Oxford University Press, 1989:342–6.

    Google Scholar 

  7. Gutheil TG, Bursztajn H, Brodsky A. Malpractice prevention through the sharing of uncertainty. N Engl J Med 1984;311:49–52.

    Article  PubMed  CAS  Google Scholar 

  8. Koornneef F, Gaalen van GL, Mol de BAJM. A risk assessment and control model for the failing Björk-Shiley convexo-concave heart valve. Int J Tech Assess Health Care (in press).

    Google Scholar 

  9. Lowery A, Puelo J. Good manufacturing practices. In: Gruting CW van (ed.) Medical devices. International perspectives on health and safety. Amsterdam: Elsevier, 1994:175–95.

    Google Scholar 

  10. Mol de BAJM, Kallewaard M, McLellan RB, Herwerden van LA, Defauw JJ, Graaf van der Y. Single-leg fractures in explanted Bj örk-Shiley valves. Lancet 1994;343:9–12.

    Article  PubMed  Google Scholar 

  11. Gerlis L. Good Clinical practice in clinical research. Lancet 1989;i: 1008–9.

    Article  Google Scholar 

  12. Shapiro MF, Charrow RP. The role of data audits in detecting scientific misconduct. JAMA 1989;261:2505–11.

    Article  PubMed  CAS  Google Scholar 

  13. Leiper JM, Lawson DH. Why do doctors not report adverse drug reactions? Neth J Med 1985;28:546–50.

    PubMed  CAS  Google Scholar 

  14. Pollard MR. Pharmaceutical innovation in the United States. Factors affecting future performance. Int J Tech Assess Health Care 1993;9:167–73.

    Article  CAS  Google Scholar 

  15. Kessler DA, Pape SM, Sundwall DN. The federal regulation of medical devices. N Engl J Med 1987;317:357–66.

    Article  PubMed  CAS  Google Scholar 

  16. Kessler DA. FDA’s revitalization of Medical Device Review and Regulation. Biomed Instr Tech 1994:220–6.

    Google Scholar 

  17. Pochin EE. The acceptance of risk. Br Med Bull 1975;31:184–90.

    PubMed  CAS  Google Scholar 

  18. Gray D, Hampton JR, Bernstein SJ, Kosecoff J, Brook RH. Audit of coronary angiography and bypass surgery. Lancet 1990;335:1317–20.

    Article  PubMed  CAS  Google Scholar 

  19. Brennan TA, Leape LL, Laird NM, Herbert LE, Localio AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370–7.

    Article  PubMed  CAS  Google Scholar 

  20. Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA, Herbert LE, Newhouse JP, Weiler PC, Hiatt HH. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 1991;324:377–84.

    Article  PubMed  CAS  Google Scholar 

  21. Spencer FC. The urgent need for major reform of the professional liability system. Ann Thorac Surg 1987:44:335–7.

    Article  PubMed  CAS  Google Scholar 

  22. Localio AR, Lawthers AG, Brennan TA, Laird NM, Herbert LE, Peterson LM, Newhouse JP, Weiler PC, Hiatt HH. Relation between malpractice claims and adverse events due to negligence. N Engl J Med 1991;325:245–51.

    Article  PubMed  CAS  Google Scholar 

  23. O’Connor GT and others, on behalf of the Northern New England Cardiovascular Disease Study Group. A regional prospective study of in-hospital mortality associated with coronary artery bypass grafting. JAMA 1991;266; 803–9.

    Article  CAS  Google Scholar 

  24. Williams SV, Hash DB, Goldfarb N. Differences in mortality from coronary artery bypass graft surgery at five teaching hospitals. JAMA 1991;266:810–5.

    Article  PubMed  CAS  Google Scholar 

  25. Hannan EL, Kilburn H, O’Donnell JF, Lukacik G, Shields EP. Adult open heart surgery in New York State. An analysis of risk factors and hospital mortality rates. JAMA 1990:264:2768–74.

    Article  PubMed  CAS  Google Scholar 

  26. Black N. Medical litigation and the quality of care. Lancet 1990;335:35–8.

    Article  PubMed  CAS  Google Scholar 

  27. Manual BM. Professional liability — A no-fault solution. N Engl J Med 1990;322:627–30.

    Article  Google Scholar 

  28. Appelbaum PS, Grisso Th. Assessing patients’ capacities to consent to treatment. N Engl J Med 1988;319:1635–8.

    Article  PubMed  CAS  Google Scholar 

  29. Freireich EJ. Should the patient know? JAMA 1979;241:928.

    Article  PubMed  CAS  Google Scholar 

  30. Nobel JJ. Adverse effects reporting. In: Gruting CW van (ed.), Medical devices. International perspectives on health and safety. Amsterdam: Elsevier, 1994:275–87.

    Google Scholar 

  31. Redelmeier DA, Tversky A. Discrepancy between medical decisions for individual patients and for groups. N Engl J Med 1990;323:1162–4.

    Article  Google Scholar 

  32. Fielder JH. Getting the bad news about your artificial heart valve. Hastings Center Report 1993;23(II):22–8.

    PubMed  CAS  Google Scholar 

  33. Sandman PM. Emerging communication responsibilities of epidemiologists. J Clin Epidemiol 1991;44(suppl.I):41S–45S.

    Article  PubMed  Google Scholar 

  34. Hammel D, Block M, Geiger A, Böcker D, Stadibauer, Breithardt G, Scheid HH. Single-incision implantation of cardioverter-defibrillators using nonthoracotomy lead systems. Ann Thorac Surg 1994;58:1614–6.

    Article  PubMed  CAS  Google Scholar 

  35. Markewitz A, Kaulbach H, Mattke S, Dorwarth U, Weinhold Ch, Hoffman E, Steinbeck G, Reichart B. One-incision approach for insertion of implantable cardioverter-defibrillators. Ann Thorac Surg 1994;58:1609–13.

    Article  PubMed  CAS  Google Scholar 

  36. Kruse JM. Experiences from the re-use of implantable pulse generators. Clin Prog Electrophysiol Pacing 1985;3:61–3.

    Google Scholar 

  37. Hill JD. An impending crisis involving biomaterials. Ann Thorac Surg 1994;58:1571.

    Article  PubMed  CAS  Google Scholar 

  38. Galletti PM. Embargo on biomaterials. Science, May 20, 1994.

    Google Scholar 

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Authors
  1. Bas A. J. M. de Mol
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Editor information

Editors and Affiliations

  1. Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands

    N. M. Van Hemel

  2. Heart Lung Institute, University Hospital Utrecht, Utrecht, The Netherlands

    F. H. M. Wittkampf

  3. Department of Cardiology, University Clinic Gasthuisberg, Leuven, Belgium

    H. Ector

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© 1995 Springer Science+Business Media Dordrecht

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de Mol, B.A.J.M. (1995). The Safety and Medico-Legal Responsibilities of the Pacemaker Implantation Team. In: Van Hemel, N.M., Wittkampf, F.H.M., Ector, H. (eds) The Pacemaker Clinic of the 90’s. Developments in Cardiovascular Medicine, vol 175. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-0347-3_14

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  • DOI: https://doi.org/10.1007/978-94-011-0347-3_14

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-4154-6

  • Online ISBN: 978-94-011-0347-3

  • eBook Packages: Springer Book Archive

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