How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

English version České info

Background:
Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings.

Methods and Findings:
We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys.

Conclusions:
Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting.

Please see later in the article for the Editors' Summary.

Vyšlo v časopise: How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review. PLoS Med 9(7): e32767. doi:10.1371/journal.pmed.1001276
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1001276

Souhrn

Zdroje

1. PricewaterhouseCoopers (2011 January) Medical technology innovation scorecard. London: PricewaterhouseCoopers.

2. LahiriA, WatersR (2006) Locoregional silicone spread after high cohesive gel silicone implant rupture. J Plast Reconstr Aesthet Surg 59 : 885–886.

3. CurfmanGD, RedbergRF (2011) Medical devices—balancing regulation and innovation. N Engl J Med 365 : 975–977.

4. DePonte SL (2010 October 8) Urgent medical device recall: recall PleuraSeal™ lung sealant system—product catalog number—PLS-005. Available: http://www.covidien.com/recall/pages.aspx. Accessed 28 January 2012.

5. MaiselWH (2008) Semper fidelis—consumer protection for patients with implanted medical devices. N Engl J Med 358 : 985–987.

6. ChallonerDR, VodraWW (2011) Medical devices and health—creating a new regulatory framework for moderate-risk devices. N Engl J Med 365 : 977–979.

7. ThompsonM, HeneghanC, BillingsleyM, CohenD (2011) Medical device recalls and transparency in the UK. BMJ 342: d2973.

8. KramerDB, XuS, KesselheimAS (2012) Medical device regulation in the United States and European Union. N Engl J Med 366 : 848–855.

9. MaiselWH (2004) Medical device regulation: an introduction for the practicing physician. Ann Intern Med 140 : 296–302.

10. Institute of Medicine (2010) Public health effectiveness of the FDA 510(k) clearance process: balancing patient safety and innovation: workshop report. Washington (District of Columbia): The National Academies Press.

11. GottliebS (2011 October 3) How the FDA could cost you your life. Wall Street Journal A17.

12. FraserAG, DaubertJC, Van de WerfF, EstesNA3rd, SmithSCJr, et al. (2011) Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Eur Heart J 32 : 1673–1686.

13. KaplanAV, BaimDS, SmithJJ, FeigalDA, SimonsM, et al. (2004) Medical device development: from prototype to regulatory approval. Circulation 109 : 3068–3072.

14. MeierB, RobertsJ (2011 October 26) Venture capitalists put money on easing medical device rules. New York Times A1.

15. WoodsK (2012) Device regulation in the European Union: response from MHRA. Lancet 379 : 515 doi:10.1016/S0140-6736(08)61345-8.

16. DhruvaSS, BeroLA, RedbergRF (2009) Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 302 : 2679–2685.

17. ChenCE, DhruvaSS, BeroLA, RedbergRF (2011) Inclusion of training patients in US Food and Drug Administration premarket approval cardiovascular device studies. Arch Intern Med 171 : 534–539.

18. DhruvaSS, BeroLA, RedbergRF (2011) Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes 4 : 165–171.

19. Department of Health and Human Services (1994) Office of Device Evaluation annual report for fiscal year 1994. Washington (District of Columbia): US Department of Health and Human Services.

20. KramerDB, MallisE, ZuckermanBD, ZimmermanBA, MaiselWH (2010) Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000–2007. Am J Ther 17 : 2–7.

21. GollaherDL, GoodallS (2011 February) Competitiveness and regulation: the FDA and the future of America's biomedical industry. Boston Consulting Group. Available: http://www.bcg.com/documents/file72060.pdf. Accessed 28 January 2012.

22. JugoR (2007 November) The FDA PMA filing and approval experience: an empirical and descriptive analysis. J Med Device Regul 4.

23. JugoR (2008 February) The FDA PMA versus the EU CE Mark filing and approval experience: an empirical and descriptive analysis. J Med Device Regul 5.

24. JugoR (2008 August) An analysis of the reasons and merits for FDA PMA disapproval. J Med Device Regul

25. US Government Accountability Office (2009 January) FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process. Available: http://www.gao.gov/new.items/d09190.pdf. Accessed 28 January 2012.

26. ZuckermanDM, BrownP, NissenSE (2011) Medical device recalls and the FDA approval process. Arch Intern Med 171 : 1006–1011.

27. Safe Medical Devices Act. US Public Law 101-629, 104 Stat 4511.

28. HallRF (2011 April 13) Written statement: a delicate balance: FDA and the reform of the medical device approval process. U.S. Senate Committee on Aging. Available: http://aging.senate.gov/events/hr233hr.pdf. Accessed 28 January 2012.

29. MaiselWH (2010) Premarket notification: analysis of FDA recall data [presentation]. Institute of Medicine Meeting 3: Public Health Effectiveness of the FDA 510(k) Clearance Process; 28 July 2010; Washington, District of Columbia. Available: http://iom.edu/~/media/Files/Activity%20Files/PublicHealth/510kProcess/2010-JUL-28/05%20Maisel.pdf. Accessed 28 January 2012.

30. VillarragaML, GuerinHL, LamT (2007) Medical device recalls from 2004 to 2006: a focus on Class I recalls. Food Drug Law J 62 : 581–592.

31. Battelle Memorial Institute (2010 September) 510(k) premarket notification evaluation. Available: http://www.advamed.org/NR/rdonlyres/255F9405-677D-45B1-BAC8-0D4FD5017054/0/510kPremarketNotificationEvaluation.pdf. Accessed 28 January 2012.

32. US Government Accountability Office (2011 April 13) Medical devices: FDA's premarket review and postmarket safety efforts. Available: http://www.gao.gov/products/GAO-11-556T. Accessed 28 January 2012.

33. HeneghanC, ThompsonM, BillingsleyM, CohenD (2011) Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. BMJ Open 1: e000155.

34. DavisS, GilbertsonE, GoodallS (2011 January) EU medical device approval safety assessment: a comparative analysis of medical device recalls 2005–2009. Available: http://www.eucomed.org/uploads/Press%20Releases/BCG%20study%20report.pdf. Accessed 28 January 2012.

35. MakowerJ, MeerA, DenendL (2010 November) FDA impact on U.S. medical technology innovation: a survey of over 200 medical technology companies. Arlington (Virginia): National Venture Capital Association.

36. PricewaterhouseCoopers (2011) Improving America's health V: a survey of the working relationship between the life sciences industry and FDA. London: PricewaterhouseCoopers.

37. Food and Drug Administration (2011 November 17) 515 program intiative. Available: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm240310.htm. Accessed 28 January 2012.

38. HauserRG, KallinenLM, AlmquistAK, GornickCC, KatsiyiannisWT (2007) Early failure of a small diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm 4 : 892–896.

39. RumsfeldJS, PetersonED (2010) Achieving meaningful device surveillance: from reaction to proaction. JAMA 304 : 2065–2066.

40. Curfman G (2011 July 20) Testimony of Gregory D. Curfman, M.D. Hearing: Regulatory Reform Series #5 FDA medical device regulations: impact on American patients and jobs. Available: http://republicans.energycommerce.house.gov/Media/file/Hearings/Oversight/072011/Curfman.pdf. Accessed 28 January 2012.

41. US Food and Drug Administration (2011) Performance report to Congress for the Medical Device User Fee Amendments of 2007. Available: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/MDUFMA/UCM243386.pdf. Accessed 28 January 2012.