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Clinical Validation

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.  

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-767F, UA-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.

UA-767 Plus Series (including UA-787EJ, UA-611, UA-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).

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.

UA-705 Series (including UA-705V, UA-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.

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.

UA-611

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-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.

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.

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.