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REGULATORY HISTORY OF CPR DEVICES

REGULATORY HISTORY OF CPR DEVICES. Elizabeth Tritschler, MSE Circulatory Support and Prosthetics Devices Branch Division of Cardiovascular Devices. REGULATORY HISTORY OF CPR DEVICES. 1976. 1984. Early 1990s. 1998. 2004.

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REGULATORY HISTORY OF CPR DEVICES

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  1. REGULATORY HISTORY OF CPR DEVICES Elizabeth Tritschler, MSE Circulatory Support and Prosthetics Devices Branch Division of Cardiovascular Devices

  2. REGULATORY HISTORY OF CPR DEVICES 1976 1984 Early 1990s 1998 2004 1st Generation: 1970’s-present devices to mechanically assist in chest compression 2nd Generation: 1980’s-presentdevices to provide compression depth and rate feedback 3rd Generation: 1990’s-presentdevices to enhance CPR hemodynamics Tritschler 2

  3. 1st GENERATION CPR DEVICES:External Cardiac Compression Devices 1976 1984 Early 1990s 1998 2004 May 28, 1976: Medical Devices Amendment to the Food, Drug, and Cosmetic Act First marketing clearance for an External Cardiac Compression Device December 9, 1976: Tritschler 3

  4. 1st GENERATION CPR DEVICES:External Cardiac Compression Devices 1976 1984 Early 1990s 1998 2004 • chestpiece, with or without backboard • automated or manual • compressions at fixed or user-determined rates Tritschler 4

  5. 1st GENERATION CPR DEVICES:External Cardiac Compression Devices 1976 1984 Early 1990s 1998 2004 • Intended to ASSIST rescuers by • reducing work required to compress chest • distributing load evenly over sternum Tritschler 5

  6. 1st GENERATION CPR DEVICES:External Cardiac Compression Devices 1976 1984 Early 1990s 1998 2004 • 21 CFR 870.5200 • Class III • Product Code DRM • Marketing Application: 510(k) to demonstrate substantial equivalence to a predicate device • Clinical data generally not necessary Tritschler 6

  7. 2nd GENERATION CPR DEVICES:Cardiopulmonary Resuscitation Aid Devices 1984 1998 2004 1976 Early 1990s August 24, 1984: First marketing clearance for a Cardiopulmonary Resuscitation Aid Device Tritschler 7

  8. 2nd GENERATION CPR DEVICES:Cardiopulmonary Resuscitation Aid Devices 1984 1998 2004 1976 Early 1990s • audible indicators of compression rate (i.e., metronome) • visual indicators of compression depth (based on feedback from a force gauge) Tritschler 8

  9. 2nd GENERATION CPR DEVICES:Cardiopulmonary Resuscitation Aid Devices 1984 1998 2004 1976 Early 1990s • Intended to ASSIST rescuers by • Providing feedback regarding rate and depth of compressions, thereby enhancing compliance with AHA Guidelines for CPR Tritschler 9

  10. 2nd GENERATION CPR DEVICES:Cardiopulmonary Resuscitation Aid Devices 1984 1998 2004 1976 Early 1990s • 21 CFR 870.5200 • Class III • Product Code LIX • Marketing Application: 510(k) to demonstrate substantial equivalence to a predicate device • Clinical data generally not necessary Tritschler 10

  11. 3rd GENERATION CPR DEVICES:Devices to Enhance CPR Hemodynamics Early 1990s 1976 1984 1998 2004 • Examples: • interposed abdominal compression devices • active compression and decompression devices • circumferential chest compression devices • minimally invasive open-chest cardiac massage Alternative Cardiopulmonary Resuscitation Devices. Prehospital Emergency Care 2003; 7:31-41. Tritschler 11

  12. 3rd GENERATION CPR DEVICES:Devices to Enhance CPR Hemodynamics Early 1990s 1976 1984 1998 2004 • Regulatory Decisions made by the Agency: • No preamendment or previously cleared predicate device exists for CPR devices intended to enhance hemodynamics • Devices intended to enhance CPR hemodynamics require clinical data to support such claims Tritschler 12

  13. 3rd GENERATION CPR DEVICES:Devices to Enhance CPR Hemodynamics Clinical Study Endpoints: • Survival to ICU admission and/or 24 hours • End tidal carbon dioxide (EtCO2) • Presence of a pulse during CPR • Neurological evaluations at 30 days or 1 year based on CPC, Glascow Coma Score, and/or quality of life assessments Alternative Cardiopulmonary Resuscitation Devices. Prehospital Emergency Care 2003; 7:31-41. Tritschler 13

  14. 3rd GENERATION CPR DEVICES:Devices to Enhance CPR Hemodynamics Early 1990s 1976 1984 1998 2004 June 19, 1998: Meeting of Circulatory System Devices Panel regarding a PMA for an active compression and decompression (ACD) device Panel Recommendation: Not Approvable Tritschler 14

  15. SUMMARY:Where are we TODAY? Early 1990s 1976 1984 1998 2004 • over 30 external cardiac compression devices cleared for marketing • a handful of cardiopulmonary resuscitation aid devices cleared for marketing • no devices intended to enhance CPR hemodynamics have been approved for marketing in the U.S. Tritschler 15

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