The 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).
The VDL Criteria apply to BP devices for use in clinical, community, or home settings. These BP devices must meet the following criteria to be formally listed on the VDL:
- Part I
- Automated devices with cuff sizes tested with and available for the intended population
- Part II
- Active FDA 510(k) pre-market clearance record and documentation
- Documentation of independent validation testing (provided by a qualified third party or peer-reviewed publication) following one of these accepted protocols:
- ISO 81060-2:2018
- ANSI/AAMI/ISO 81060-2: 2013
- ANSI/AAMI/ISO 81060-2: 2009
- ANSI/AAMI SP10: 2002
- BHS Revised Protocol: 1993
- Part III
- Documentation that a device is an equivalent model variant
The complete VDL Criteria can be viewed here:Download VDL Criteria
To ensure an independent, objective, and transparent process, the AMA has convened committees of leaders and experts to provide governance and oversight of the US Blood Pressure Validated Device Listing (VDL).
The Advisory Group provides insights and recommendations on industry trends, emerging technologies, and regulations related to BP devices and testing protocols, as well as essential input on clinical and consumer perspectives. The group is currently comprised of the representatives from the following organizations: American College of Cardiology, American College of Physicians, American Heart Association, American Pharmacists Association, CDC/CMS Million Hearts, Columbia University Hypertension Center, Consumer Technology Association, Food & Drug Administration, National Medical Association, Preventative Cardiovascular Nurses Association and Stanford Hypertension Center.
Independent Review Committee
An independent review of device qualifications by a committee of experts is vital to determining which BP measurement devices are included on the VDL. This Independent Review Committee is comprised of experienced, qualified professionals who review manufacturer submissions for consideration. After careful independent review, the experts convene and come to consensus regarding final determinations on which BP devices meet the VDL Criteria, and therefore qualify to be listed on the VDL.
Members of the Independent Review Committee must have relevant expertise, as demonstrated by any combination of the following:
- Extensive publication history on topics related to BP device testing, measurement, and clinical impact.
- Knowledge of international validation protocols for BP devices – prior experience conducting clinical testing with BP devices or similar medical devices.
- Prior experience conducting clinical testing with BP devices or similar medical devices
- Prior experience reviewing documentation in certification, standards development, and clinical trials, in a similar capacity.
Geisinger Wyoming Valley Medical Center
MD | PhD; IRC Co-chair.
Johns Hopkins University School of Medicine
Harvard Medical School
MD | MSCE; IRC Co-chair.
University of Pennsylvania
MD | MACP | FAHA
Maria Delgado- Lelievre,
University of Miami Soffer Clinical Research Center
MD | MPH | FAHA | FASH;
Kaiser Permanente Washington Medical Group
Saint Barnabas Medical Center (retired)
Beth Israel Deaconess Medical Center
MD | MHHS
University of Vermont
MD | FAHA
College of Medicine, Mayo Clinic
University of Pennsylvania
University of Texas- Southwestern
William B. White,
MD | FAHA
University of Connecticut
Contact us for more information on the Independent Review Committee, including terms and process to be considered for membership.
Submit a device for review
It is essential to providers and patients that the VDL contains all validated devices currently available on the market. Device manufacturers, and organizations with manufacturing partners, are strongly encouraged to review the VDL Criteria and submit the required documentation for consideration. The VDL will be updated following each Independent Review Committee cycle to include all BP devices that meet the VDL Criteria.