Hostname: page-component-cd9895bd7-dk4vv Total loading time: 0 Render date: 2024-12-23T06:55:59.157Z Has data issue: false hasContentIssue false
  • English
  • Français

TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT

Part of: Special Collection - Methods

Published online by Cambridge University Press:  29 December 2015

Cornelia Henschke ,
Dimitra Panteli ,
Matthias Perleth  and
Reinhard Busse
Cornelia Henschke
Affiliation:
Department of Health Care Management, Technische Universität [email protected]
Dimitra Panteli
Affiliation:
Department of Health Care Management, Technische Universität Berlin
Matthias Perleth
Affiliation:
Medical Consultancy Department, Federal Joint Committee
Reinhard Busse
Affiliation:
Department of Health Care Management, Technische Universität Berlin
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices.

Methods: Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model.

Results: The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low.

Conclusions: Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

Keywords

Health technology assessmentMedical devicesClassification
Type
Methods
Information
International Journal of Technology Assessment in Health Care , Volume 31 , Issue 5 , 2015 , pp. 324 - 330
Copyright
Copyright © Cambridge University Press 2015 

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

REFERENCES

1. European Parliament and Council of the European Union. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. http://ec.europa.eu/consumers/sectors/medical-devices/files/revision_docs/2007-47-en_en.pdf (accessed June 3, 2015).Google Scholar
2. Robinson, JC. Value-based purchasing for medical devices. Health Aff (Millwood). 2008;27:1523–1531.Google Scholar
3. Cutler, DM. The lifetime costs and benefits of medical technology. J Health Econ. 2007;26:1081–1100.Google Scholar
4. Sorenson, C, Drummond, M, Wilkinson, G. Use of innovation payments to encourage the adoption of new medical technologies in the English NHS. Health Policy Technol. 2013;2:168–173.Google Scholar
5. Horton, R. Offline: A serious regulatory failure, with urgent implications. Lancet. 2012;379:106.Google Scholar
6. Heneghan, C. The saga of Poly Implant Prosthèse breast implants. BMJ. 2012;344:e306.Google Scholar
7. Cohen, D. How safe are metal-on-metal hip implants? BMJ. 2012;344:e1410.Google Scholar
8. Maisel, WH, Sweeney, MO, Stevenson, WG, Ellison, KE, Epstein, LM. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA. 2001;286:793–799.Google Scholar
9. Hillman, BJ. Government health policy and the diffusion of new medical devices. Health Serv Res. 1986;21:681–711.Google Scholar
10. Borgonovi, E, Busse, R, Kanavos, P. Financing medical devices in Europe: Current trends and perspectives for research. Eurohealth. 2008;14:1–3.Google Scholar
11. Kramer, DB, Xu, S, Kesselheim, AS. Regulation of medical devices in the United States and the European Union. N Engl J Med. 2012;366:848–855.Google Scholar
12. Kaplan, AV, Baim, DS, Smith, JJ, et al. Medical device development: From prototype to regulatory approval. Circulation. 2004;109:3068–3072.Google Scholar
13. Zentner, A, Busse, R. Bewertung von Arzneimitteln – Wie gehen andere Länder vor? Gesundheit Ges Wiss 2011;11:25–34.Google Scholar
14. Draborg, E, Gyrd-Hansen, D, Poulsen, PB, et al. International comparison of the definition and the practical application of health technology assessment. Int J Technol Assess Health Care. 2005;21:89–95.Google Scholar
15. Migliore, A, Ratti, M, Cerbo, M, et al. Health technology assessment: Managing the introduction and use of medical devices in clinical practice in Italy. Expert Rev Med Devices. 2009;6:251–257.Google Scholar
16. Hutton, J, McGrath, C, Frybourg, JM, et al. Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems). Int J Technol Assess Health Care. 2006;22:10–18.Google Scholar
17. Drummond, M, Griffin, A, Tarricone, R. Economic evaluation for devices and drugs - same or different? Value Health. 2009;12:402–404.Google Scholar
18. Campillo-Artero, C. A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe. Health Policy. 2013;113:38–44.Google Scholar
19. WHO. Development of medical device policies. WHO Medical device technical series. 2011. http://whqlibdoc.who.int/publications/2011/9789241501637_eng.pdf?ua=1 (accessed June 3, 2015).Google Scholar
20. Kirisits, A, Redekop, WK. The economic evaluation of medical devices. Appl Health Econ Health Policy. 2013;11:15–26.Google Scholar
21. McCulloch, P, Altman, DG, Campbell, WB, et al. No surgical innovation without evaluation: The IDEAL recommendations. Lancet. 2009;374:1105–1112.Google Scholar
22. Taylor, RS, Iglesias, CP. Assessing the clinical and cost-effectiveness of medical devices and drugs: Are they that different? Value Health. 2009;4:404–406.Google Scholar
23. Hulstaerta, F, Neyta, M, Vinck, I, et al. Pre-market clinical evaluations of innovative high-risk medical devices in Europe. Int J Technol Assess Health Care. 2012;28:278–284.Google Scholar
24. Ergina, PL, Cook, JA, Blazeby, JM, et al. Challenges in evaluating surgical innovation Lancet. 2009;374:1097–1104.Google Scholar
25. Bossuyt, PM, Irwig, L, Craig, J, et al. Comparative accuracy: Assessing new tests against existing diagnostic pathways. BMJ. 2006;332;1089–1092.Google Scholar
26. European Parliament and Council of the European Union. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042&from=EN (accessed June 3, 2015).Google Scholar
27. European Parliament and Council of the European Union. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of Member states relating to active implantable medical devices. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31990L0385&from=EN (accessed June 3, 2015).Google Scholar
28. European Parliament and Council of the European Union. Council Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0079&from=EN (accessed June 3, 2015).Google Scholar
29. Altenstetter, C. EU and member state medical devices regulation. Int J Technol Assess Health Care. 2003;19:228–248.Google Scholar
30. Altenstetter, C. Regulating health care technologies and medical supplies in the European Economic Area. Health Policy. 1996;35:33–52.Google Scholar
31. European Commission 2012. Proposal for a regulation of the European parliament and of the council on medical devices, and amending Directive 2001/83/EC, regulation (EC) No 178/2002 and regulation (EC) No 1223/2009. http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf (accessed June 3, 2015).Google Scholar
32. European Commission 2012. Proposal for a regulation of the European parliament and of the council on in vitro diagnostic medical devices. http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_541_en.pdf (accessed June 3, 2015).Google Scholar
33. OECD, Eurostat, WHO. A system of Health Accounts. OECD Publishing. 2011. http://www.who.int/nha/sha_revision/sha_2011_final1.pdf (accessed June 3, 2015).Google Scholar
34. Sorenson, C, Kanavos, P. Medical technology procurement in Europe: A cross-country comparison of current practice and policy. Health Policy. 2011;100:45–50.Google Scholar
35. Busse, R. Decision-making: The link between reference pricing and procurement. Brussels. 15.10.2008. http://www.mig.tu-berlin.de/fileadmin/a38331600/2008.lectures/Brussel_2008.10.15_rb_EHTI.pdf (accessed June 3, 2015).Google Scholar
36. Anand, K, Saini, SK, Singh, BK, et al. Global medical device nomenclature: The concept for reducing device-related medical errors. J Young Pharm. 2010;2:403–409.Google Scholar
37. GMDN Agency. The global medical device nomenclature. 2012. https://www.gmdnagency.org/ (accessed June 3, 2015).Google Scholar
38. Perleth, M, Busse, R, Schwartz, FW. Regulation of health-related technologies in Germany. Health Policy. 1999;46:105–126.Google Scholar
39. Krüger, LJ, Wild, C. Evidence requirements for the authorization and reimbursement of high-risk medical devices in the USA, Europe, Australia and Canada: An analysis of seven high-risk medical devices. Vienna: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBIHTA); HTA-Projektbericht 73. 2013Google Scholar
40. Olberg, B, Perleth, M, Busse, R. The new regulation to investigate potentially beneficial diagnostic and therapeutic methods in Germany: Up to international standard? Health Policy. 2014;117:135–145.Google Scholar
41. EUnetHTA. Joint Action 2, Work Package 8. HTA Core Model ® version 2.0; 2013. http://www.corehta.info/BrowseModel.aspx (accessed June 3, 2015).Google Scholar
42. Newland, Adrian, Chair, NICE Diagnostics Advisory Committee. NICE diagnostics assessment programme. Ann R Coll Surg. 2011;93:412–413.Google Scholar