Overview of the 2012 Food and Drug Administration circulatory system devices panel meeting on the reclassification of external counterpulsation, intra-aortic balloon pump, and non-roller-type cardiopulmonary bypass blood pump devices.

MedStar author(s):
Citation: American Heart Journal. 166(3):414-20, 2013 Sep.PMID: 24016488Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): CongressesSubject headings: *Cardiopulmonary Bypass/cl [Classification] | *Cardiopulmonary Bypass/is [Instrumentation] | *Counterpulsation/cl [Classification] | *Counterpulsation/is [Instrumentation] | *Heart-Assist Devices/cl [Classification] | Humans | Intra-Aortic Balloon Pumping/cl [Classification] | Intra-Aortic Balloon Pumping/is [Instrumentation] | United States | United States Food and Drug AdministrationLocal holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0002-8703
Name of journal: American heart journalAbstract: The Food and Drug Administration held a Circulatory System Devices Advisory Panel meeting, December 5 and 6, 2012, to review the classification or potential reclassification of the following device types: external counterpulsation, intra-aortic balloon pump (IABP), and non-roller-type cardiopulmonary bypass blood pumps. These 3 devices are preamendment (Medical Device Amendments of 1976) class III devices. The advisory panel discussed the data and provided recommendations for reclassification of these devices. The panel recommended reclassification of ECP to class II for stable angina pectoris and to retain a class III for all other indications. For IABP, the recommendation was to reclassify IABP to class II for several indications (acute coronary syndrome, cardiac and noncardiac surgery, and heart failure complications) and remain class III for all other indications. As for non-roller type, the panel recommended that for cardiopulmonary bypass and temporary circulatory bypass, these devices should be reclassified to class II while retaining a class III device status for all other indications, including ventricular support both for hemodynamically unstable patients and for prophylactic support in high-risk percutaneous interventions. 2013.All authors: Fatemi O, Minha S, Torguson R, Waksman RDigital Object Identifier: Date added to catalog: 2014-02-24
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Journal Article MedStar Authors Catalog Article Available 24016488

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

The Food and Drug Administration held a Circulatory System Devices Advisory Panel meeting, December 5 and 6, 2012, to review the classification or potential reclassification of the following device types: external counterpulsation, intra-aortic balloon pump (IABP), and non-roller-type cardiopulmonary bypass blood pumps. These 3 devices are preamendment (Medical Device Amendments of 1976) class III devices. The advisory panel discussed the data and provided recommendations for reclassification of these devices. The panel recommended reclassification of ECP to class II for stable angina pectoris and to retain a class III for all other indications. For IABP, the recommendation was to reclassify IABP to class II for several indications (acute coronary syndrome, cardiac and noncardiac surgery, and heart failure complications) and remain class III for all other indications. As for non-roller type, the panel recommended that for cardiopulmonary bypass and temporary circulatory bypass, these devices should be reclassified to class II while retaining a class III device status for all other indications, including ventricular support both for hemodynamically unstable patients and for prophylactic support in high-risk percutaneous interventions. 2013.

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