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REGULATORY HISTORY OF CPR DEVICES PowerPoint PPT Presentation


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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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Regulatory history of cpr devices l.jpg

REGULATORY HISTORY OF CPR DEVICES

Elizabeth Tritschler, MSE

Circulatory Support and Prosthetics Devices Branch

Division of Cardiovascular Devices


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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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