fbpx Clinical Validation | A&D Medical Skip to main content

Clinical Validation

Clinically Validated for Accuracy

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 an A&D 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 A&D, 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.  

At A&D Medical, precision and reliability are such a part of who we are as a company that it's even a part of our tagline: Discover Precision.  

ABOUT PROTOCOLS

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 the United States, the Food and Drug Administration (FDA) 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:

 
Absolute difference between standard test and test device (mmHg)
Grade ≤ 5 ≤ 10 ≤ 15
A 60 85 95
B 50 75 90
C 40 65 85
D
Worse than C

 

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. 

ABOUT FDA CLEARANCE

Are your blood pressure monitors FDA approved?

All of A&D’s blood pressure monitors have FDA clearance.  This is a requirement to sell in the US market. 

Clinically Validated
 

CLINICAL VALIDATION STUDIES

Upper Arm

Series Protocol Result Citation
UA-767 Series (including UA-767FUA-767FAC 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.
ESH 2010 Pass, Recommended dabl Educational Trust, UA-651 Equivalence
Highest international standards (available prior to their most recent updates) Silver, Recommended Hypertension Canada (Canadian model: UA-767FAM)
UA-767 Plus Series (including UA-787EJUA-611UA-767PSAC, and UA-767PVS) 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).
Highest international standards (available prior to their most recent updates) Silver, Recommended Hypertension Canada
UA-787 Series (including UA-787EJ) 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.
ESH 2002 Pass, Recommended dabl Educational Trust
Highest international standards (available prior to their most recent updates) Silver, Recommended Hypertension Canada (Canadian model: UA-787EJCN)
UA-705 Series (including UA-705VUA-705VL) BHS A/A Verdecchia, P. et. al (2006). Validation of the A&D UA-705 Device for Self-Measurement of Blood Pressure According to the British Hypertension Society Protocol. Blood Pressure Monitoring (Issue 11), pp. 223-227.
BHS A/A, Recommended dabl Educational Trust, At Rest
UA-651BLE 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.
ESH 2010 Pass, Recommended dabl Educational Trust, Study extended to ESH-IP 2010 requirements
ESH 2010 Pass, Recommended dabl Educational Trust, With a wide range cuff study extended to ESH-IP 2010 requirements
Highest international standards (available prior to their most recent updates) Silver, Recommended Hypertension Canada
UA-611, UA-651 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).
Highest international standards (available prior to their most recent updates) Silver, Recommended Hypertension Canada (Canadian model: UA-651CN)
UA-1030T 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.
BHS A/A, Recommended dabl Educational Trust, multiple studies
Highest and most current international standards Gold, Recommended Hypertension Canada (Canadian model: UA-1030TCN)

Wrist BPMs

Series Protocol Result Citation
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.
ESH 2010 Pass, Recommended dabl Educational Trust, At rest
UB-1100BLE (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.
ESH 2010 Pass, Recommended dabl Educational Trust, At rest

Professional BPMs

Series Protocol Result Citation
TM-2430 Series BHS A/A Palatini, P. et al (1998). Validation of the A&D TM-2430 Device for Ambulatory Blood Pressure Monitoring and Evaluation of Performance According to Subjects’ Characteristics. Blood Pressure Monitoring (Issue 3), pp. 255-260.
BHS A/B Yip, G.W. et al (2012). Validation of the A&D TM-2430 Upper-Arm Blood Pressure Monitor for Ambulatory Blood Pressure Monitoring in Children and Adolescents, According to the British Hypertension Society Protocol. Blood Pressure Monitoring (Issue 17), pp. 76-79.
TM-2657P (clinical equivalence to TM-2656 series) BHS A/A Zeng, W., et. al. (2013). Validation of the Fully Automated A&D TM-2656 Blood Pressure Monitor According to the British Hypertension Society Protocol (Issue 18), pp. 223-226.
AAMI Pass, Recommended dabl Educational Trust
BHS A/A, Recommended dabl Educational Trust
UM-211 ESH Pass Fania, C., et. al. (2017). Validation of the A&D UM-211 Device for Office Blood Pressure Measurement According to the European Society of Hypertension International Protocol Revision 2010.  Blood Pressure Monitoring (Vol. 00), pp. 1-4.
ESH Pass, Recommended dabl Educational Trust, At rest cuff sizes of 16-24, 22-32 and 31-45cm.
Highest International Standards (available prior to their most recent updates) Silver Hypertension Canada
TM-2440/TM-2441 ISO Pass Kario, K., et. al. (2018). Validation of the TM-2441 Ambulatory Blood Pressure Measurement Device According to the ISO 81060-2:2013 standard. Blood Pressure Monitoring (Vol. 00), pp. 1-4.
AAMI Pass, Recommended dabl Educational Trust
Highest and most current international standards Gold Hypertension Canada