A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe

Health Policy

Volumn 113, Issue 1-2, 2013, Pages 38-44

  Campillo Artero, Carlos ^a  

^a Balearic Health Service   (Spain)

Author keywords

Clinical safety; Effectiveness; Efficacy; Medical devices; Regulation

Indexed keywords

BREAST IMPLANT; COST EFFECTIVENESS ANALYSIS; DEVICE RECALL; DRUG ELUTING STENT; EUROPE; EUROPEAN UNION; GOVERNMENT; HIP PROSTHESIS; LAW; MEDICAID; MEDICAL DEVICE; MEDICAL DEVICE REGULATION; MEDICARE; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; REVIEW; UNITED STATES;

CLINICAL SAFETY; EFFECTIVENESS; EFFICACY; MEDICAL DEVICES; REGULATION;

BIOMEDICAL TECHNOLOGY; CONSUMER HEALTH INFORMATION; DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; EQUIPMENT SAFETY; EUROPE; EUROPEAN UNION; GOVERNMENT REGULATION; HUMANS; MEDICAL DEVICE LEGISLATION; PATIENT SAFETY; RISK ASSESSMENT;

EID: 84887612094     PISSN: 01688510     EISSN: 18726054     Source Type: Journal    
DOI: 10.1016/j.healthpol.2013.03.017     Document Type: Review

References (48)

1. Zuckerman D.M., Brown P., Nissen S.E. Medical device recalls and the FDA approval process. Archives of Internal Medicine 2011, 171:1006-1011.
2. Redberg R.F., Dhruva S.S. Medical device recalls and the FDA approval process. Archives of Internal Medicine 2011, 171:1011-1012.
3. Institute of Medicine Public health effectiveness of the FDA 510(k) clearance process: Measuring postmarket performance and other selected topics: workshop report 2010, National Academies Press, Washington, DC.
4. Institute of Medicine Public health effectiveness of the FDA 510(k) clearance process: balancing patient safety and innovation: workshop report 2010, National Academies Press, Washington, DC.
5. Institute of Medicine Medical devices and the public's health. The FDA 510(k) clearance process at 35 years 2011, National Academies Press, Washington, DC.
6. Horton R. Offline: a serious regulatory failure, with urgent implications. Lancet 2012, 379:106.
7. Horton R. Offline: the scandal of device regulation in the UK. Lancet 2012, 379:204.
8. Fraser A.G., Daubert J.C., Van der Werf F., et al. Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. European Heart Journal 2011, 32:1673-1686.
9. Curfman G.D., Redberg E.F. Medical devices-balancing regulation and innovation. New England Journal of Medicine 2011, 365:975-977.
10. Curfman G.D., Morrissey S., Drazen J.M. The Medical Device Safety Act of 2009. New England Journal of Medicine 2009, 360:1550-1551.
11. Garber A.M. Modernizing device regulation. New England Journal of Medicine 2010, 362:1161-1163.
12. Challoner D.R., Vodra W.W. Medical devices and health-creating a new regulatory framework for moderate-risk devices. New England Journal of Medicine 2011, 365:977-979.
13. Cingolani E., Stevens S., Shehata M., Diamond G.A., Kaul S. Medical device regulatory reform. Insights from the Watchman left atrial appendage closure technology for stroke prophylaxis in atrial fibrillation. Archives of Internal Medicine 2011, 171:1670-1672.
14. Hauser R.G. Here we go again-another failure of posmarketing device surveillance. New England Journal of Medicine 2012, 366:873-875.
15. Resnic F.S., Normad S.L. Postmarketing surveillance of medical devices-filling in the gaps. New England Journal of Medicine 2012, 365:875-877.
16. Henegan C., Thompson M., Billingsley M., Cohen D. Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. British Medical Journal Open 2011, 1:e000155. [accessed 22.06.12]. http://bmjopen.bmj.com/content/1/1/e000155.full.pdf+html.
17. Kramer D.B., Xu S., Kesselheim A.S. Regulation of medical devices in the United States and European Union. New England Journal of Medicine 2012, 366:848-855.
18. Cohen D. Notified bodies: are they fit for purpose?. British Medical Journal 2012, 341:e7177. [accessed 30.11.2012]. http://www.bmj.com/content/345/bmj.e7177.pdf%2Bhtml.
19. McCulloch P. The EU's system for regulating medical devices. British Medical Journal 2012, 345:e7126. [accessed 30.11.12]. http://www.bmj.com/content/345/bmj.e7126.pdf%2Bhtml.
20. Cohen D. How safe are metal-on-metal hip implants?. British Medical Journal 2012, 344:e1410. [accessed 22.06.2012]. http://www.bmj.com/content/344/bmj.e1410.pdf%2Bhtml.
21. Cohen D., Billingsley M. Europeans are left to their own devices. British Medical Journal 2011, 342:d2748. [accessed 22.06.12]. http://www.bmj.com/content/342/bmj.d2748.pdf%2Bhtml.
22. Godlee F. Serious risk from metal-on-metal hip implants. British Medical Journal 2012, 344:e1539. [accessed 22.06.12]. http://www.bmj.com/content/344/bmj.e1539.pdf%2Bhtml.
23. Cohen D. Patients are let down by poor device regulation, warn surgeons. British Medical Journal 2012, 345:e1136. [accessed 30.11.12]. http://www.bmj.com/content/345/bmj.e1136.pdf%2Bhtml.
24. Kmietowocz Z., Cohen D Device licensing bodies sometimes put business before safety, and investigation finds. British Medical Journal 2012, 345:e7138. [accessed 30.11.12]. http://www.bmj.com/content/345/bmj.e7138.pdf%2Bhtml.
25. Viscusi W.K., Vernon J.M., Harrington J.E. Economics of regulation and antitrust 1995, MIT Press, Boston.
26. Dhruva S.S., Bero L., Redberg R.F. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. Journal of the American Medical Association 2009, 302:2679-2685.
27. European Commission. Press release. Medical devices: European Commission calls for immediate actions-tighten controls, increase surveillance, restore confidence. ; 2012 [accessed 22.06.12]. http://europa.eu/rapid/pressReleasesAction.do%3Freference=IP/12/119%26format=HTML%26aged=0.
28. The Commission of the European communities. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. ; 2012 [accessed 22.06.12]. http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1993/L/01993L0042-20031120-en.pdf.
29. BCG, Boston Consulting Group EU medical device approval safety assessment. A comparative analysis of medical device recalls 2005-2009 2011, BCG, Boston, MA.
30. Altenstetter C. EU and member state medical devices regulation. International Journal of Technology Assessment in Health Care 2003, 19:228-248.
31. Fraser A.G., Krucoff M.W., Brindis R.G., Komajda M., Smith S.C. Commentary: International collaboration needed on device clinical standards. British Medical Journal 2011, 342:d2952. [accessed 22.06.12]. http://www.bmj.com/content/342/bmj.d2952.
32. US Government Accountability Office Testimony before the special committee on aging, U.S. Senate. Medical devices. FDAs premarket review and postmarket safety efforts 2011, GAO, Washington, DC.
33. US Government Accountability Office Report to congressional addressees. Medical devices. FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process 2009, GAO, Washington, DC.
34. Wilmshurst P. The regulation of medical devices. Unsatisfactory, unscientific, and in need of a major overhaul. British Medical Journal 2011, 342:d2822. [accessed 22.06.12]. http://www.bmj.com/content/342/bmj.d2822.
35. Freemantle N. Commentary: evaluating and regulating device therapy. British Medical Journal 2011, 342:d2839. [accessed 22.06.12]. http://www.bmj.com/content/342/bmj.d2839.
36. Cohen D. EU approval system leaves door open for dangerous devices. British Medical Journal 2012, 345:e7173. [accessed 30.11.12]. http://www.bmj.com/content/345/bmj.e7173.pdf%2Bhtml.
37. Coombes R Europe's plan to tighten regulation of devices will not reach US standards. British Medical Journal 2012, 345:e6303. [accessed 30.11.12]. http://www.bmj.com/content/345/bmj.e6303.pdf%2Bhtml.
38. European Commission. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals. COM(2012) 540 final; 2012.
39. Heneghan C., Langton D., Thompson M. Ongoing problems with metal-on-metal hip implants. British Medical Journal 2012, 244:e1349. [accessed 22.06.12]. http://www.bmj.com/content/344/bmj.e1349.pdf%2Bhtml.
40. Langton D.J., Jameson S.S., Joyce T.J., Gandhi J.N., Sidaginamale R., Mereddy P., et al. Accelerating failure rate of the ASR total hip replacement. Journal of Bone and Joint Surgery British 2011, 93:1011-1016.
41. Wijns W., Kolh P., Danchin N., Di Mario C., Falk V., Folliguet T., et al. Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). European Association for Percutaneous Cardiovascular Interventions. European Heart Journal 2010, 31:2501-2555.
42. Messe S.R., Kasner S.E. Is closure recommended for patent foramen ovale and cryptogenic stroke? Patent foramen ovale in cryptogenic stroke. Not to close. Circulation 2008, 118:1999-2004.
43. Tricoci P., Allen J.M., Kramer J.M., Califf R.M., Smith S.C. Scientific evidence underlying the ACC/AHA clinical practice guidelines. Journal of the American Medical Association 2009, 301:831-841.
44. Grunkemeier G.L., Ruyun J., Starr A. Prosthetic heart valves: objective performance criteria versus randomized clinical trial. Annals of Thoracic Surgery 2006, 82:776-780.
45. Griffin S.C., Claxton K.P., Palmer S.J., Sculpher M.J. Dangerous omissions: the consequences of ignoring decision uncertainty. Health Economics 2011, 20:212-224.
46. Claxton K., Longo R., Longworth L., McCabe C., Wailoo A. The value of innovation 2009, Centre for Health Economics, University of York, Leeds University, School of Health and Related Research, University of Sheffield, York.
47. Campillo-Artero C., Bernal-Delgado E Disinvestment in health: fundamentals, clarifications, experiences and perspectives. Gaceta Sanitaria 2012, [accessed 22.06.12]. http://www.elsevier.es/sites/default/files/elsevier/eop/S0213-9111(12)00086-6.pdf.
48. García-Armesto S., Campillo-Artero C., Bernal-Delgado E. Disinvestment in the age of cost-cutting sound and fury. Tools for the Spanish National Health System. Health Policy 2013, 110:180-185.