Frequently Asked Questions
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Validation
- I can't find my blood pressure device on the VDL. Has it been validated?
Only devices reviewed and approved through the independent validation process have met the criteria for validation and are approved for listing. If a device is not listed, it may not have been submitted by the manufacturer or the review is still in process.
- 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.
- 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 VDL™ 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.
- I’m interested in having my device listed on the VDL. How can I learn more about the process?
We appreciate your interest in the VDL and encourage you to submit your device for review. Please visit our “Submit a Device” page for information on the VDL Criteria to review, then contact [email protected] for more information on steps to get started.
- 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 internationally 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.
Obtaining a Device
- How can I share the VDL with my patients/practice?
We encourage you to share the VDL with patients and colleagues. Clicking the “Share” button will allow you to copy a link to “validateBP.org” that can be pasted in email or text messages. Coming soon, you will have the option to print a flyer with a scannable QR code that can be given to a patient. You may also print the full VDL list, a filtered list, or a list of your “favorite” devices by clicking the “Print” icon.
- Can you recommend a blood pressure device for my needs?
While we are unable to recommend specific devices, we encourage you to find devices with the features or characteristics that will meet your needs. You may need to contact a local or online retailer, or the manufacturer's customer service, for more details on particular devices. For more information on which device features might best fit your needs, please reach out to your healthcare provider.
- Can I purchase devices on validatebp.org?
The VDL is intended only to be a reference when considering BP devices to use or purchase. As such, we do not sell any of the devices listed and encourage you to contact a local or online retailer directly for questions about purchasing a device.