Why Buy A Clinically Validated Blood Pressure Monitor?

The sales team at PMS often get asked the same questions from customers wanting to purchase a blood pressure monitor. Questions like which one would you recommend and which is the best one we sell will depend on the features a user is looking for and their budget.

One question we are always happy to answer is “What does clinical validation mean?”

Many customers are familiar with the CE mark on consumer electrical items.

Medical devices like blood pressure monitors must also have a CE mark by law. The CE mark means that, provided you use it correctly, the device will work properly and is safe but doesn’t mean it will necessarily give accurate readings or that it is clinically validated.

Whether you are going to record your blood pressure at home or in a clinical setting surely accuracy is the whole point of buying a monitor in the first place!

When a manufacturer like Meditech or A&D Medical state their product is “clinically validated” it means an independent validation of the device has been performed by a professional group

The most common validation protocols 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).

While each of the protocols may 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. Recently, the AAMI, ESH, and ISO experts agreed to develop a single universally acceptable standard (AAMI/ESH/ISO), which will replace all previous protocols.

Often, the clinical validation report is published in a peer-reviewed journal like Blood Pressure Monitoring.  Publication in a peer-reviewed journal is essential because of the rigorous review processes a clinical validation must go through to make sure there are no protocol violations and the chosen validation protocol has been adhered to.

The time and conditions demanded by the various protocols are extremely difficult to fulfil as a large number of subjects have to be recruited, a wide range of blood pressures are required and it can be difficult to recruit skilled staff . They can also be expensive.

There is a great overview of the detailed process involved from the Working Group on Blood Pressure Monitoring of the European Society of Hypertension here.

For these reasons not every blood pressure manufacturer will conduct a clinical validation.

PMS Instruments only distribute blood pressure monitors from manufacturers that do. Clinical validation provides so much more than a CE mark!

Whether you are a healthcare professional, or someone looking to keep a check on their blood pressure at home a clinically validated blood pressure monitor from Meditech or A&D Medical gives you the confidence to know you’re using a reliable, accurate device to make a clinical decision.

A&D Medical clinical validation studies

Validation of the A&D UM-211 device for office blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010
Fania, Claudio; Albertini, Federica; Palatini, Paolo
Blood Pressure Monitoring, October 2017,22(5):302-305

Validation of the A&D UM-201 device for office blood pressure measurement according to the European Society of Hypertension International Protocol Revision 2010
Fania, Claudio; Albertini, Federica; Palatini, Paolo
Blood Pressure Monitoring, August 2017,22(4):234-237

Validation of the fully automated A&D TM-2656 blood pressure monitor according to the British Hypertension Society Protocol (equivalent to TM-2657P)
Zeng, Wei-Fang; Liu, Ming; Kang, Yuan-Yuan; Li, Yan; Wang, Ji-Guang
Blood Pressure Monitoring, August 2013,18(4):223-226

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
Benetti, Elisabetta; Fania, Claudio; Palatini, Paolo
Blood Pressure Monitoring, June 2015,20(3):164-167

Validation of the A&D BP UA-651 device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010
Benetti, Elisabetta; Fania, Claudio; Palatini, Paolo
Blood Pressure Monitoring, February 2014,19(1):50-53

Validation of the A&D UA-1020 upper-arm blood pressure monitor with six different-shaped or different-sized cuffs according to the British Hypertension Society protocol
Zeng, Wei-Fang; Kang, Yuan-Yuan; Liu, Ming; Li, Yan; Wang, Ji-Guang
Blood Pressure Monitoring, October 2013,18(5):272-277

Validation of the A&D UA-1020 upper-arm blood pressure monitor for home blood pressure monitoring according to the British Hypertension Society Protocol
Zeng, Wei-Fang; Kang, Yuan-Yuan; Liu, Ming; Li, Yan; Wang, Ji-Guang
Blood Pressure Monitoring, June 2013,18(3):177-181

Validation of A&D UA-778 blood pressure monitor in children
Narogan, Marina V.; Narogan, Marina I.; Syutkina, Elena V.
Blood Pressure Monitoring, October 2009,14(5):228-231

Validation of A&D UA-85X device for blood pressure measurement
Bonso, Elisa; Ragazzo, Fabio; Palatini, Paolo
Blood Pressure Monitoring, December 2008,13(6):339-341

Validation of 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
Yip, Gabriel Wai-Kwok; So, Hung-Kwan; Li, Albert Martin; Tomlinson, Brian; Wong, Sik-Nin; Sung, Rita Yn-Tz
Blood Pressure Monitoring, April 2012,17(2):76-79

Validation of the A&D UM-101 professional hybrid device for office blood pressure measurement according to the International Protocol
Stergiou, George S.; Giovas, Periklis P.; Gkinos, Charilaos P.; Tzamouranis, Dimitris G.
Blood Pressure Monitoring, February 2008,13(1):37-42

Meditech clinical studies

Reproducibility of 24-h ambulatory blood pressure and measures of autonomic function
Morrin, Niamh M.; Stone, Mark R.; Henderson, Keiran J.
Blood Pressure Monitoring, June 2017,22(3):169-172
Brief Report

Obstructive sleep apnea increases systolic and diastolic blood pressure variability in hypertensive patients
Shi, Jing; Piao, Jingyan; Liu, Bin; Pan, Yujiao; Gong, Yongtai; Deng, Xianzhu; Sun, Weiyan; Lu, Shuang; Li, Yue
Blood Pressure Monitoring, August 2017,22(4):208-212
Clinical Methods and Pathophysiology

The influence of physical training status on postexercise hypotension in patients with hypertension: a cross-sectional study
Imazu, Alexandre A.; Goessler, Karla F.; Casonatto, Juliano; Polito, Marcos D.
Blood Pressure Monitoring, August 2017,22(4):196-201
Clinical Methods and Pathophysiology

Clinical practice of ambulatory versus home blood pressure monitoring in hypertensive patients
Paolasso, Jorge A.; Crespo, Florencia; Arias, Viviana; Moreyra, Eduardo A.; Volmaro, Ariel; Orías, Marcelo; Moreyra, Eduardo Jr
Blood Pressure Monitoring, December 2015,20(6):303-309
Clinical Methods and Pathophysiology

The association of night-time systolic blood pressure with ultrasound markers of subclinical cardiac and vascular disease
O’Flynn, Anne Marie; Ho, Emily; Dolan, Eamon; Curtin, Ronan J.; Kearney, Patricia M.
Blood Pressure Monitoring, February 2017,22(1):18-26
Clinical Methods and Pathophysiology

Myocardial ischemia during everyday life in patients with arterial hypertension: prevalence, risk factors, triggering mechanism and circadian variability
Uen, Sakir; Un, Ismail; Fimmers, Rolf; Vetter, Hans; Mengden, Thomas
Blood Pressure Monitoring, August 2006,11(4):173-182

Development of normative ambulatory blood pressure data in children: Marianne Soergel and the Arbeitsgruppe Pädiatrische Hypertonie
Blood Pressure Monitoring, June-August 1999,4(3):121-126

Making ambulatory blood pressure monitoring accessible in pharmacies
James, Kirstyn; Dolan, Eamon; O’Brien, Eoin
Blood Pressure Monitoring, June 2014,19(3):134-139

Simultaneous recording of blood pressure and ST-segment with combined, triggered ambulatory 24-h devices
Uen, Sakir; Vetter, Hans; Mengden, Thomas
Blood Pressure Monitoring, February 2003,8(1):41-44

Silent myocardial ischaemia in treated hypertensives with and without left ventricular hypertrophy
Stojanovic, Milos M.; O’Brien, Eoin; Lyons, Simon; Stanton, Alice V.
Blood Pressure Monitoring, February 2003,8(1):45-51

Author: Andrew Webb

I am the Managing Director of PMS (Instruments) Ltd a successful UK based medical distribution, service and sales company specialising in cardiovascular equipment.