NORC Supports Effort to Create List of U.S. Blood Pressure Devices Validated for Clinical Accuracy
CHICAGO, April 29, 2020 — The accurate measurement of blood pressure (BP) is essential for the diagnosis and management of hypertension, a pressing issue that continues to impact the health of the nation, yet there is a lack of available information around clinically accurate BP measurement devices in the United States. With nearly half of U.S. adults suffering from high BP, the American Medical Association (AMA) enlisted NORC at the University of Chicago to support the development of criteria for determining which BP devices are validated for clinical accuracy (VDL Criteria TM), as well as the development of processes for the submission of device documentation by manufacturers and the review of those submissions by an independent committee.
“About 103 million American adults have high blood pressure. Both diagnosing and effectively managing hypertension heavily rely on accurate blood pressure measurements,” said Laurie Imhof, senior research director in the Health Sciences department at NORC. “Unfortunately, there has not previously been a simple way for physicians and patients to determine the clinical validation of devices. The AMA enlisted NORC to help solve this problem with the first-of-its-kind US Blood Pressure Validated Device Listing.”
The goal of the new US Blood Pressure Validated Device Listing (VDL TM) is to create a resource that fills this need for physicians and their patients by developing the VDL Criteria to determine which BP devices have been validated for clinical accuracy. Validating a device means a manufacturer has taken steps to ensure the BP measurement readings of such device meet the evidence-based guidelines or gold-standard recommendations for providing a clinically accurate BP measurement.
Inaccurate BP measurements can lead to a misclassification of a patient’s BP status, which puts patients at risk of harm if a diagnosis or treatment plan is based on these inaccurate BP readings. BP measurement devices that do not provide accurate BP readings can adversely impact clinical decisions. Meanwhile, automated BP measurement devices are being used more frequently to measure BP in the clinical, ambulatory, and home settings, and both guidelines and scientific statements, national and international, now recommend using only BP devices that have been independently validated.
“With the expected increase in telehealth visits, the need for accurate self-measured blood pressure readings taken at home has never been more important,” said Karen Kmetik, AMA’s group vice president for Improving Health Outcomes. “Until now, U.S. health care professionals have had no convenient way to determine whether a patient’s BP device has been validated for clinical accuracy. The new US Blood Pressure Validated Device Listing is an important step towards a game-changing capability. Utilizing it will help patients and physicians better partner to manage high blood pressure.”
An all-volunteer Independent Review Committee (IRC) has been established to independently review documents submitted by BP manufacturers, determine alignment with the approved VDL Criteria, and come to consensus on which BP devices qualify for listing on the VDL.
The IRC is comprised of experienced, qualified professionals who are selected based on the following evaluation criteria:
- Extensive publication history on topics related to BP device testing, measurement, and clinical impact
- Knowledge of international validation protocols for BP measurement 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
Each member of the IRC is cleared by the AMA to ensure relevant expertise in BP measurement and to limit or address potential conflicts of interest.
Facilitated by NORC, all manufacturer-submitted documentation has been assigned to and reviewed by at least two members of the IRC. The IRC members have conferred as needed, and any outstanding questions have been brought back to NORC to communicate to the manufacturers. Such manufacturers have been contacted by NORC and given an opportunity to reply and provide clarifying documentation.
The IRC approved 16 devices for the initial release of the VDL. The names of those devices will be released on April 29, 2020, and can be viewed at www.validateBP.org. Future manufacturer submissions for the inclusion of a BP device in the VDL will be accepted on a rolling basis (based on indicated deadlines for submission) and reviewed by the IRC on an ongoing basis.
Device manufacturers interested in submitting a device for inclusion in the VDL should email VDLsubmission@norc.org for additional information. The next deadline for device submission is June 24, 2020.
“Both diagnosing and effectively managing hypertension heavily rely on accurate blood pressure measurements. Unfortunately, there has not previously been a simple way for physicians and patients to determine the clinical validation of devices. The AMA enlisted NORC to help solve this problem with the first-of-its-kind US Blood Pressure Validated Device Listing.”
About NORC at the University of Chicago
NORC at the University of Chicago conducts research and analysis that decision-makers trust. As a nonpartisan research organization and a pioneer in measuring and understanding the world, we have studied almost every aspect of the human experience and every major news event for more than eight decades. Today, we partner with government, corporate, and nonprofit clients around the world to provide the objectivity and expertise necessary to inform the critical decisions facing society.
Contact: For more information, please contact Eric Young at NORC at young-eric@norc.org or (703) 217-6814 (cell).