Postmarket surveillance of medical devices: current capabilities and future opportunities

Article

Abstract

Recalls of cardiac implantable electrical devices (CIEDs) currently impact hundreds of thousands of patients worldwide. Premarket evaluation of CIEDs cannot be expected to eliminate all performance defects. Robust postmarket surveillance systems are needed to promote patient safety and reduce harm. Challenges impacting existing surveillance mechanisms include underreporting of defects, low rates of return of explanted CIEDs, lack of integration of surveillance into normal workflow, underutilization of existing resources including registries, a lack of capacity of aging resources, multiple proprietary platforms that lack interoperability, and the unmet need for common data variables as well as newer methods to generate, synthesize, analyze, and interpret evidence in order to respond rapidly to safety signals. Long-term solutions include establishing a unique device identification system; promoting expanded use of registries for surveillance and post-approval studies; developing additional methods to combine evidence from diverse data sources; creating tools and implementing strategies for universal automatic, triggered electronic event reporting; and refining methods to rapidly identify and interpret safety signals. Protection from litigation and creation of financial and other incentives by legislators, regulators, payers, accreditation organizations, and licensing boards can be expanded to increase participation in device surveillance by clinicians and health care facilities. Research to evaluate the comparative effectiveness of surveillance strategies is needed. Interim solutions to improve CIED surveillance while new initiatives are launched and the system strengthened are also presented.

Keywords

Surveillance Medical devices Cardiac implantable electrical devices 

References

  1. 1.
    U.S. Food and Drug Administration. Medical devices. List of device recalls. Available at: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/default.htm. Accessed 29 June 2012.
  2. 2.
    Code of Federal Regulations. Title 21. Subpart C. Section 7.40. Recalls (Including Product Corrections)—Guidance on Policy, Procedures, and Industry Responsibilities.Google Scholar
  3. 3.
    U.S. Food and Drug Administration. FDA 101: product recalls: from first alert to effectiveness checks. http://www.fda.gov/consumer. Accessed 29 June 2012.
  4. 4.
    Swerdlow, C. D., Gunderson, B. D., Ousdigian, K. T., et al. (2010). Downloadable software algorithm reduces inappropriate shocks caused by implantable cardioverter-defibrillator lead fractures. A prospective study. Circulation, 122, 1449–1455.PubMedCrossRefGoogle Scholar
  5. 5.
    Code of Federal Regulations (21CFR812.2).Google Scholar
  6. 6.
    U. S. Food and Drug Administration. Center for Drug Evaluation and Research. Development and approval process (Drugs). Available online at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm. Accessed 3 Nov 2012
  7. 7.
    U.S. Food and Drug Administration. Total product life cycle data sources and disclaimers. Information at: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco. Accessed 6 June 2012.
  8. 8.
    Medical Device Amendments of 1976, Public Law No. 94–295. Stat 539.Google Scholar
  9. 9.
    Council, N. R. (2011). Medical devices and the public's health: the FDA 510(k) clearance process at 35 years. Washington, DC: The National Academies.Google Scholar
  10. 10.
    Proceedings Document from the Policy Conference on Pacemaker and ICD Performance. Presented by the Heart Rhythm Society and the Food and Drug Administration, September 16, 2005. Available at: http://www.hrsonline.org/ClinicalGuidance/Proceedings-from-Sept-2005-Policy-Conf.cfm. Accessed 29 June 2012.
  11. 11.
    Carlson, M. D., Wilkoff, B. L., Maisel, W. H., Carlson, M. D., Ellenbogen, K. A., Saxon, L. A., et al. (2006). Recommendations from the Heart Rhythm Society Task Force on device performance policies and guidelines. Heart Rhythm, 3, 1250–1273.PubMedCrossRefGoogle Scholar
  12. 12.
    Maisel, W. H., Hauser, R. G., Hammill, S. C., Hauser, R. G., Ellenbogen, K. A., Epstein, A. E., et al. (2009). Recommendations from the Heart Rhythm Society Task Force on lead performance policies and guidelines. Heart Rhythm, 6, 869–885.PubMedCrossRefGoogle Scholar
  13. 13.
    Epstein, A. E., Baker, J. H., Beau, S. L., et al. (2009). Performance of the St Jude Medical Riata Leads. Heart Rhythm, 6, 204–209.PubMedCrossRefGoogle Scholar
  14. 14.
    St. Jude Medical Corporation. Dear Doctor Letter. Important product information. Riata Silicone Leads. Available online at: http://www.sjmprofessional.com/Resources/product-notices-advisories/riata-important-information-us.aspx. Accessed 4 November 2012.
  15. 15.
    U. S. Food and Drug Administration. St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall—failures with lead insulation. December 21, 2011. Available online at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284390.htm. Accessed 4 November 2012.
  16. 16.
    Hauser, R. G. (2012). Here we go again—another failure of postmarketing device surveillance. The New England Journal of Medicine, 366, 873–875.PubMedCrossRefGoogle Scholar
  17. 17.
    Resnic, F. S., & Normand, S. T. (2012). Postmarketing surveillance of medical devices—filling the gaps. The New England Journal of Medicine, 366, 875–877.PubMedCrossRefGoogle Scholar
  18. 18.
    Swerdlow, C. D., & Friedman, P. A. (2006). Advanced ICD troubleshooting: part II. PACE, 29, 70–96.PubMedCrossRefGoogle Scholar
  19. 19.
    Greenspon, A. J., Patel, J. D., Lau, E., et al. (2012). Trends in permanent pacemaker implantation in the United States from 1993 to 2009. Journal of the American College of Cardiology, 60, 1540–1545.PubMedCrossRefGoogle Scholar
  20. 20.
    Gross, T. P., & Kessler, L. G. (1996). Medical device vigilance at FDA. Studies in Health Technology and Informatics, 28, 17–24.PubMedGoogle Scholar
  21. 21.
    Varma, N., Epstein, A. E., Irimpen, A., et al. (2010). Efficacy and safety of automatic remote monitoring for implantable cardioverter defibrillator follow-up: the Lumos-T safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation, 122, 325–332.PubMedCrossRefGoogle Scholar
  22. 22.
    Pron, G., Ieraci, L., & Kaulback, K. (2012). Internet-based device assisted remote monitoring of cardiovascular implantable electronic devices: an evidence-based analysis. Ontario Health Technology Assessment Series, 12, 1–86.PubMedGoogle Scholar
  23. 23.
    Crossley, G. H., Chen, J., Choucair, W., et al. (2009). Clinical benefits of remote vs transtelephonic monitoring of implanted pacemakers. Journal of the American College of Cardiology, 54, 2012–2019.PubMedCrossRefGoogle Scholar
  24. 24.
    Kirkpatrick, J. N., Ghani, S. N., Burke, M. C., & Knight, B. P. (2007). Postmortem interrogation and retrieval of implantable pacemakers and defibrillators: a survey of morticians and patients. Journal of Cardiovascular Electrophysiology, 18, 478–482.PubMedCrossRefGoogle Scholar
  25. 25.
    U. S. Food and Drug Administration. Classification of devices. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm. Accessed online 4 Nov 2012.
  26. 26.
    Feigel DW. CDRH Vision—total product life cycle. Available at: http://www.fda.gov/ohrms/dockets/ac/01/slides/3799s1_11_Feigal. Accessed online 4 Nov 2012.
  27. 27.
    U. S. Food and Drug Administration. Center for Devices and Radiological Health. Strengthening our national system for medical device postmarket surveillance. 2012. Available at: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports. Accessed 4 Nov 2012.
  28. 28.
    U. S. Food and Drug Administration. Medical Device Epidemiology Network Initiative (MDEpiNet). Available at: http://www.fda.gov/MedicalDevices/ScienceandResearch/EpidemiologyMedicalDevices/MedicalDeviceEpidemiologyNetworkMDEpiNet. Accessed 4 Nov 2012.
  29. 29.
    U. S. Food and Drug Administration. Report of a meeting: leveraging registries with medical device data for postmarket surveillance throughout the total product life cycle. Held September 12, 2012. Information can be obtained at: http://www.gpo.gov/fdsys/pkg/FR-2012-08-30/pdf/2012-21437.pdf. Accessed 4 Nov 2012.
  30. 30.
    U.S. Food and Drug Administration. Manufacturer and User Facility Device Experience (MAUDE). Available at: http://www.fda.gov/scripts/cdrh/cfdocs/cfMAUDE. Accessed 6 June 2012.
  31. 31.
    U.S. Food and Drug Administration. Medical Product Safety Network (MedSun). Available at http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductsSafetyNetwork. Accessed 6 June 2012.
  32. 32.
    522 Post Market Surveillance Studies. Frequently asked questions. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance. Accessed 4 Nov 2012.
  33. 33.
    U. S. Food and Drug Administration. Report of a Public Workshop—design and methodology for postmarket surveillance studies under Section 522 of the Federal Food, Drug and Cosmetic Act, held March 7, 2012. Available at: http://www.fda.gov/MedicalDevicesRegulationandGuidance. Accessed 4 Nov 2012.
  34. 34.
    FDA Safety Communication: premature insulation failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc. Issued August 12, 2012. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm314930.htm. Accessed 4 Nov 2012.
  35. 35.
    U.S. Food and Drug Administration. The Sentinel initiative: a national strategy for monitoring medical product safety. Available at: http://www.fda.gov/Safety/FDASentinelInitiative/ucm089474.htm. Accessed 4 Nov 2012.
  36. 36.
    Platt, R., Wilson, M., Chan, K. A., Benner, J. S., Marchibroda, J., & McClellan, M. (2009). The New Sentinel Network—improving the evidence of medical product safety. The New England Journal of Medicine, 361, 645–647.PubMedCrossRefGoogle Scholar
  37. 37.
    The Brookings Institution. FDA Sentinel initiative strategic review: report of a meeting at Brookings Institution, September 26–27, 2011. Available at: http://www.brookings.edu/events/2011/09/26-sentinel-initiative. Accessed 29 June 2012.
  38. 38.
    112th Congress. S. 3187. Food and Drug Administration Safety and Innovation Act. 2012. Information available at: http://www.govtrack.us/congress/bills/112/s3187. Accessed online 29 June 2012.
  39. 39.
    Medical Device Epidemiology Network Initiative (MDEpiNet). Information available at: http://fda.gov/MedicalDevices/ScienceandResearch/EpidemiologyMedicalDevices/MedicalDeviceEpidemiologyNetwork. Accessed 29 June 2012.
  40. 40.
    Gliklich RE, Dreyer NA, eds. (2007) Registries for evaluating patient outcomes: a user’s guide. (Prepared by Outcome DEcIDE Center [Outcome Sciences, Inc. dba Outcome] under Contract No. HHSA29020050035I TO1.) AHRQ Publication No. 07-EHC001-1. Rockville, MD: Agency for Healthcare Research and Quality.Google Scholar
  41. 41.
    Caceres, M., Braud, R. L., & Garrett, H. E. (2010). A short history of the Society of Thoracic Surgeons national cardiac database: perceptions of a practicing surgeon. The Annals of Thoracic Surgery, 89, 332–339.PubMedCrossRefGoogle Scholar
  42. 42.
    Miller, M. A., Ulisney, K., & Baldwin, J. T. (2010). INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support): a new paradigm for translating registry data into clinical practice. Journal of the American College of Cardiology, 56, 738–740.PubMedCrossRefGoogle Scholar
  43. 43.
    Hammill, S. C., Stevenson, L. W., Kadish, A. H., et al. (2007). Review of the registry’s first year, data collected, and future plans. Heart Rhythm, 4, 1260–1263.PubMedCrossRefGoogle Scholar
  44. 44.
    The Centers for Medicare and Medicaid Services. National Coverage Determination (NCD) for implantable automatic defibrillators. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx. Accessed 29 June 2012.
  45. 45.
    Resnic, F. S., Gross, T. P., Marinac-Dabic, D., et al. (2010). Automated surveillance to detect post-procedure safety signals of approved cardiovascular devices. Journal of the American Medical Association, 304, 2019–2027.PubMedCrossRefGoogle Scholar
  46. 46.
    Blumenthal, D. (2010). Launching HITECH. New England Journal of Medicine, 362, 382–385.PubMedCrossRefGoogle Scholar
  47. 47.
    McDonough, J. E. (2012). The road ahead for the affordable care act. The New England Journal of Medicine, 367, 199–201.PubMedCrossRefGoogle Scholar
  48. 48.
    U. S. Department of Health and Human Services (2012) Office of the National Coordinator-Health Information Technology. Medicare and Medicaid EHR Incentive Programs. Stage 2 Final Rule. September 13, 2012.Google Scholar
  49. 49.
    Reason, J. (2000). Human error: models and management. BMJ, 320, 768–770.PubMedCrossRefGoogle Scholar
  50. 50.
    Labin J. Privacy Issues Surrounding Personal Identification Systems. April 1996. Available online at: http://www.ct.gov/dss/lib/dss/PDFs/diprivac.pdf. Accessed 4 Nov 2012.
  51. 51.
    American Board of Internal Medicine. Maintenance of Certification. Available online at: www.abim.org. Accessed 4 Nov 2012.

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  1. 1.Center for Medical Technology PolicyBaltimoreUSA

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