US Blood Pressure Validated Device Listing
Blood pressure measurement devices that have been validated for clinical accuracy as determined through an independent review process.
High blood pressure (BP) that is uncontrolled is the major cause of mortality and disability. For the diagnosis and treatment of hypertension, reliable blood pressure measurement is critical. If the BP measurement instrument has been validated for clinical accuracy, that is a crucial aspect of correct measurement.
The American Medical Association (AMA) enlisted the help of the National Opinion Research Center at the University of Chicago (NORC) to design and manage an independent process to determine which BP devices on the market in the United States meet the AMA's established criteria for clinical accuracy (the "Validated Device Listing (VDL) Criteria"). If a BP device meets the VDL Criteria for clinical accuracy validation, it is evaluated by an Independent Review Committee made up of medical specialists in the field. The "US Blood Pressure Verified Device Listing" or "VDL" is a formal list of BP devices that have been validated for clinical accuracy as a consequence of this independent evaluation procedure.
The Validation page has more information about the VDL Criteria, governance structure, and procedures for BP device makers to submit device documentation to the Independent Review Committee.
More links
- US Blood Pressure Validated Device ListingThe AMA convened experts with relevant technical and clinical practice expertise to develop a set of criteria (VDL Criteria) to aid in determining which automated blood pressure (BP) measurement devices in the United States have been validated for clinical accuracy. The VDL Criteria were refined and finalized with input from key stakeholders including clinicians, health care organizations, BP device manufacturers, and the Food and Drug Administration (FDA).