ABOUT CLINICAL VALIDATION:
What is Clinical Validation for a Blood Pressure Monitor?
One of the most common questions we hear is “What does clinical validation mean?”. When you see a “Clinically Validated for Accuracy” symbol on a LifeSource product, it means that the product has been thoroughly tested and has stood up to the medical industry’s world-class protocols.
In recent years, physicians have come to see the value of monitoring blood pressure at home to compliment treatment of their hypertensive patients. One of the most important considerations when home monitoring is recommended is the patient having access to accurate devices with validations performed under strict protocols. At LifeSource, because we are confident in the accuracy of our devices and the ability to be able to fulfill the strict requirements of healthcare professionals, all our blood pressure monitors are rigorously tested and validated independently to meet clinical standards.
The clinical validation tests verify the accuracy of the device according to certain criteria, like whether they have high, low, or normal blood pressure, and pre-existing diseases. Essentially, this means that the blood pressure monitor has been confirmed to give accurate and reliable results.
This helps give physicians, healthcare professionals, and people taking their measurements at home confidence that they’re using a reliable device – no matter if it’s used in a healthcare facility or the comfort of your living room.
What are the different protocols?
The most common validation protocols you’ll often see are the British and Irish Hypertension Society (BIHS, formerly British Hypertension Society), the European Society of Hypertension International Protocol (ESH-IP), and the Association for the Advancement of Medical Instrumentation (AAMI).
In order to be approved for sale in Canada, Health Canada requires that medical devices that measure blood pressure pass the ISO 81060-2:2013 protocol, based on the ESH-IP protocol.
While each of the protocols have many similarities, there are some differences in their testing requirements. In many cases, however, a product that passes one protocol may also satisfy the criteria of other protocols as well. In fact, there is a movement to create a universal standard for clinical validation.
Some of the basic requirements are that the validation is performed by an independent party, using one of the established protocols (ex. BHS Protocol – revised 1993, or ESH International Protocol 2010) by persons meeting certain requirements, such as formal training. Often, the full report is published in a peer-reviewed journal. Publication in a peer-reviewed journal, because of their rigorous review processes, ensures that the information contained in the report meets standard practices within the field.
Understanding the Grading Criteria
The British Hypertension Society (BHS) uses the following criteria:
|Grade||≤ 5||≤ 10||≤ 15|
Grades are derived from percentages of readings within 5, 10, and 15 mmHg. To achieve a grade, all three percentages must be equal to or greater than the tabulated values. BHS grades are formatted with two grades (ex. A/A): one for the systolic reading and the other for the diastolic reading.
The ESH International Protocol and ISO Standard use a Pass/Fail grading system.
Are LifeSource blood pressure monitors approved by Health Canada or recommended by Hypertension Canada?
All LifeSource blood pressure monitors have clearance from Health Canada. This is a requirement to sell in the Canadian market.
LifeSource also takes the steps of seeking approval from Hypertension Canada, and we display the recommendation on relevant products.
Clinical Validation Studies
|UA-767 Series (including UA-767FAM)||BHS||A/A||Rogoza, A.N. et. al (2000). Validation of A&D UA-767 Device for the Self-Measurement of Blood Pressure. Blood Pressure Monitoring (Issue 5), pp. 227-231.|
|UA-767 Plus Series (including UA-651CN, UA-767PCNSAC, and UA-767PCNLAC)||BHS||A/A||Kobalava, Z.D, et al (2003). Validation of the UA-767 Plus Device for Self-Measurement of Blood Pressure. Clinical Pharmacology and Therapy, Volume 12 (Issue 2).|
|UA-787 Series (including UA-787EJCN)||ESH||Pass||Longo, D. et al (2003). Performance of the UA-787 Oscillometric Blood Pressure Monitor According to the European Society of Hypertension Protocol. Blood Pressure Monitoring (Issue 8), pp. 91-95.|
|UA-651CNBLE||ESH||Pass||Benetti, E., Fania, C. & Palatini, P. (2015). Validation of the A&D BP UA-651 Device with a Wide-Range Cuff for Home Blood Pressure Measurement According to the European Society of Hypertension International Protocol (Revision 2010). Blood Pressure Monitoring, Volume 20 (Issue 3), pp. 164-167.|
|UA-651CN||BHS||A/A||Kobalava, Z.D, et al (2003). Validation of the UA-767 Plus Device for Self-Measurement of Blood Pressure. Clinical Pharmacology and Therapy, Volume 12 (Issue 2).|
|UA-1030TCN||BHS||A/A||Zeng, W., et. al. (2013). Validation of the A&D UA-1020 Upper-Arm Blood Pressure Monitor for Home Blood Pressure Monitoring According to the British Hypertension Society Protocol (Issue 18), pp. 177-181, 272-277.|
|UA-1200CNBLE||ISO 81060-2:2013||Pass||Kario, K., eta. al. (2018). Validation of the A&D BP UA-1200BLE Device for Home Blood Pressure Measurement According to the ISO 81060-2:2013 Standard. Blood Pressure Monitoring (Vol. 0), pp. 1-3.|
|UB-1100CNBLE (clinical equivalence to UB-543)||ESH||Pass||Fania, C., Benetti, E., and Palatini, P. (2015). Validation of the A&D BP UB-543 Wrist Device for Home Blood Pressure Measurement According to the European Society of Hypertension International Protocol Revision 2010. Blood Pressure Monitoring, Volume 20 (Issue 4), pp. 237-240.|