In this issue of Linkedin based Blood Pressure Digest, I published a newsbyte on the concerns expressed by Hypertension Canada about the reliability of some home blood pressure devices. So, what is an approved blood pressure monitor? Hypertension Canada‘s president, Dr. Ross Tsuyuki stated that less than half of those available online were approved.
Dr Ross Tsuyuki is the Professor and Chair of the Department of Pharmacology, Professor of Medicine (Cardiology). Also, he is EPICORE Centre Director, at the Faculty of Medicine & Dentistry, University of Alberta. He has kindly agreed to answer my questions on reliability of home blood pressure monitors, now and in the future.
Question 1: Regulatory control of approved blood pressure monitors
What constitutes reliability of a blood pressure monitor? How is regulatory control organized in Canada with regards to blood pressure devices?
What we care about is whether a blood pressure device is accurate (measures the “true” blood pressure). And whether it is precise (provides a consistent value each time). The scientific studies to determine this are often called validation studies. Interestingly, there is no regulatory control on blood pressure devices in terms of their accuracy and precision. That is, a manufacturer doesn’t have to prove that their device is accurate or precise in order to sell it.
Questions 2: Challenges in reliability of approved blood pressure monitors
What are the most typical challenges with reliability of home blood pressure devices? How do you address them ?
A group of us has recently written about this. We call for the urgent need to regulate blood pressure devices.
Why is this important – a blood pressure device that is “off” by 10 mmHg may lead to many thousands of people treated unnecessarily for hypertension, or, many thousands of people not, or undertreated. In situations when their blood pressure elevates (that is, overtreatment or undertreatment). Given that about 1 in 4 Canadians has hypertension, this is important.
Hypertension Canada has a program called the Device Recommendation Program which lists devices that we have reviewed and approved.
For the public, we have just launched our revised website on all matters relating to hypertension.
We urge patients to check our website first before purchasing a home blood pressure monitor. Do not buy an unvalidated device.
Question 3: New ways to monitor blood pressure
We expect a shift from stand-alone monitors to wireless and wearable devices. We expect the entrance of such innovations are smart rings and even graphene tattoos. What challenges in reliability will it bring, in your opinion?
Yes, we are seeing a growing number of “cuffless” devices. The problem is that nobody demonstrated these device’s validity. So at this point, we only recommend devices with a cuff.
Approved blood pressure monitors: the process of approval in the USA and in Canada
In the United States, the approval process for blood pressure monitors involves a set of criteria developed by the American Medical Association (AMA). Input is expected from various stakeholders including clinicians, healthcare organizations, BP device manufacturers, and the Food and Drug Administration (FDA). Experts designed this process to ensure approval of blood pressure monitors for clinical accuracy.
The criteria, known as the VDL (Validated Device Listing) Criteria, apply to approved blood pressure monitors used in clinical, community, or home settings. A device must meet specific requirements to get on the list, including:
- Automated devices with cuff sizes tested for the intended population.
- Active FDA 510(k) pre-market clearance record and documentation.
- Independent validation testing following accepted protocols like ISO 81060-2:2018, ANSI/AAMI/ISO 81060-2:2013, and others.
- Documentation that a device is an equivalent model variant.
The AMA has convened an independent review committee comprised of experts to assess whether a blood pressure measurement device satisfies the VDL Criteria. This committee includes members with extensive experience in BP device testing and clinical impact, and they conduct independent reviews of manufacturer submissions.
In Canada, Hypertension Canada provides a list of recommended blood pressure monitoring devices. Experts tested these devices and obtained valid readings. It’s important for Canadian patients to purchase a home blood pressure monitor approved by Hypertension Canada, especially one used on the upper arm.
Overall, these processes in both countries focus on ensuring that blood pressure monitors used outside clinical settings are accurate and reliable for monitoring health.
For more detailed information, you can visit the American Medical Association, the US Blood Pressure Validated Device Listing, and Validate BP.
