Frequently Asked Questions (FAQs)

Background

• What does it mean for a device to be validated for clinical accuracy?

  Devices that are validated for clinical accuracy demonstrate meeting the AMA’s established criteria to validate clinical accuracy (the “Validated Device Listing (VDL) Criteria”). The VDL Criteria™ include active Food & Drug Administration (FDA) clearance, independent third-party testing following an international accepted protocol, and cuff sizes appropriate for the general population. A BP device manufacturer must be able to provide documentation to be reviewed to determine if a particular BP device meets the VDL Criteria.

• What is the US Blood Pressure Validated Device Listing (VDL)?

  The US Blood Pressure Validated Device Listing (VDL™) is the first U.S. list of blood pressure (BP) measurement devices (“BP devices”) developed to assist physicians and patients in identifying BP devices that have been validated for clinical accuracy.

• What role does NORC play in the VDL?

  The National Opinion Research Center at the University of Chicago (NORC) is an objective, non-partisan research institution that delivers reliable data and rigorous analysis to guide critical programmatic, business, and policy decisions. NORC is contracted by the AMA as an independent third party to manage the manufacturer submission and review process, including secure hosting and maintenance of the Submission Portal. NORC is the sole contact point between manufacturers and the Independent Review Committee.

• Why is the AMA championing this VDL?

  Until now, U.S. physicians have not had access to the information necessary to select automated BP devices for their practices or properly inform their recommendations of home BP devices for their patients.

  In November 2017, the American College of Cardiology (ACC), the American Heart Association (AHA) and other organizations published the “Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults.” The guideline underscores the importance of home BP measurement and automated measurement within the clinical setting.

  Excerpt from the 2017 AHA/ACC hypertension guideline: “If self-monitoring is used, it is important to ensure that the BP measurement device used has been validated with an internationally accepted protocol and the results have been published in a peer-reviewed journal.”
  (http://hyper.ahajournals.org/content/guidelines2017)

Device Details

• Do you provide BP devices to the public?

  No, we do not sell or distribute any blood pressure devices. If you need to obtain a validated blood pressure device, check your local retailer or pharmacy, or contact your local health department or insurance company for options that may be available to you.

• What about other types of devices besides upper arm?

  Currently, clinical guidelines do not support the use of finger and wrist devices for clinical decision making for the vast majority of patients, so these devices are not being included in the VDL. As part of this effort, an Advisory Group will convene to discuss emerging research, application of new technologies, and other emerging topics and how they could apply to the VDL in the future.

• Why aren’t wrist devices eligible for review?

  Currently, clinical guidelines do not support the use of wrist devices for clinical decision making for the vast majority of patients. An Advisory Group will convene to discuss wrist devices, as well as other emerging research, topics, and technologies, and pathways to be represented on the presented on the VDL in the future.

Stakeholders

• What does this mean for payors who cover BP devices for members?

  We encourage health plans to cover evidence-based services and validated devices that are essential for prevention and management of cardiovascular disease.

Submission & Device Selection

• Does this list mean the AMA endorses any of these devices?

  No, the VDL does not constitute an expressed or implied endorsement of the BP devices by the AMA. A BP device must pass a stringent independent review process to demonstrate that it fully meets the VDL Criteria for validation of clinical accuracy. Acceptance on the VDL does not constitute a recommendation, promotion, or endorsement of the BP device manufacturer corporation, its policies, its services, or its products by the AMA and any affiliated or partner organizations.

  Manufacturers and any of their partners related to device distribution are prohibited from using the AMA name and logo in the marketing or promotion of any VDL-listed product.

• How does the AMA process differ from the FDA process to approve blood pressure devices?

  The FDA reviews and clears non-invasive BP devices prior to sale in the U.S. market; however, the process for receiving FDA clearance does not require testing to demonstrate that a home BP device is validated for clinical accuracy. The FDA provided input on the VDL Criteria, and the FDA understands the AMA’s desire to provide increased guidance to physicians and care teams on BP devices.

  An active FDA 510k clearance is required as part of the VDL Criteria to be eligible for the VDL. Additionally, documentation from validation testing following an accepted protocol is reviewed by the Independent Review Committee. Only devices that have been reviewed by the Independent Review Committee and determined to meet the VDL Criteria are listed on the VDL.

• How often are devices added to the list?

  The list of devices is updated after the Independent Review Committee completes reviews of manufacturer submissions that were received in the current review cycle. We encourage you to check back regularly for updates as more devices are submitted and reviewed throughout the year.

• How trustworthy is this list now?

  The devices on the VDL have passed a strict review process to be considered validated for clinical accuracy. The manufacturers currently on the list represent some of the largest manufacturers based on BP devices sold in the U.S. market.

• I recently bought a BP device that isn’t on the list. Will it be added?

  The current list only includes specific device models that were submitted by the manufacturer and reviewed by the Independent Review Committee (IRC). Only devices that meet the VDL Criteria will be added to the list after review by the IRC. All manufacturers are encouraged to review the VDL Criteria and submit the required documentation for consideration.

• What does the submission process consist of?

  There are defined, open submission periods when device manufacturers can submit documentation for review. This documentation, and other device information, can be submitted electronically through a separate Submission Portal. The Portal provides manufacturers with step-by-step submission instructions to ensure the successful submission of each device to be reviewed.

  Each submission is then analyzed for accuracy and thoroughness before being assigned to two (2) reviewers on the Independent Review Committee. Each reviewer will make a determination based on the VDL Criteria, after which the Committee will convene to approve the determinations and final listing. NORC has been contracted as an independent third party to manage the submission and review process, including secure hosting and maintenance of the Submission Portal, and will serve as the sole point of contact for manufacturer communications. The AMA will have no role in the data submission process, nor in the BP device review and approval process.

• What types of BP devices made the VDL?

  Current guidelines recommend ambulatory BP and automated upper arm devices for use at home or in the community, and automated BP devices for use in the clinic setting. These device types are included in the VDL, and we encourage manufacturers of these different BP device types to submit applications for their devices in subsequent application cycles. The VDL Criteria does list devices eligible for review at this time.

• Who determines which devices are included on the list?

  An essential component of the VDL initiative is the Independent Review Committee, which reviews BP device manufacturer submissions to determine if a BP device meets the VDLTM Criteria. Given the nature of the review process, individuals on the Committee must have expertise in internationally recognized validation testing protocols, as demonstrated by: (1) publication history on topics related to BP device testing, international validation protocols, BP measurement and clinical impact; (2) prior experience conducting clinical testing on BP devices or similar medical devices; and (3) prior experience reviewing documentation in certification, standards development, clinical trials, and similar capacity.

  The AMA and NORC do not have a representative on the Independent Review Committee.