. "3 Non–Food and Drug Administration Sources of Adverse Event Data." Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report. Washington, DC: The National Academies Press, 2011.
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Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics - Workshop Report
Real-world populations (that is, not in the context of a clinical trial).
A population denominator.
Followup for adverse events.
The mission of the NCDR is “to improve the quality of cardiovascular patient care by providing information, knowledge, and tools; implementing quality initiatives; and supporting research that improves patient care and outcomes.” Although the NCDR was not set up primarily for postmarket surveillance, Masoudi said, it is one of its benefits. The NCDR is actually a suite of cardiovascular-disease registries (see Box 3-1). Several of the NCDR registry programs are focused on procedures and devices, Masoudi noted.
The data-collection platform is similar in all the NCDR registries, using electronic data collection to capture a wide array of detailed demographic and clinical characteristics for each patient, details of procedures that are performed, and inhospital complications. The data include detailed information on the devices used for each procedure.
Each institution that submits data to the NCDR receives quality benchmark reports that can be used to support self-assessment and quality improvement by the institution.
CathPCI Registry—for diagnostic catheterization and percutaneous coronary intervention (PCI) procedures. Includes data since 1998 from over 1,100 hospitals on more than 9 million patients.
ICD Registry—tracking implantable cardioverter defibrillators (ICDs). Includes data from 1,445 hospitals on more than 250,000 patients.
CARE Registry—for carotid artery revascularization and endartectomy procedures.
ACTION-GWTG Registry (Get With The Guidelines)—acute–myocardial-infarction patients.
PINNACLE Registry (Practice Innovation and Clinical Excellence)—an ambulatory care, practice-based registry.
IMPACT Registry (Improving Pediatric and Adult Congenital Treatment)—tracking cath procedures for congenital heart conditions.