which continue to disregard

WHICH? Continue to Disregard Correct Blood Pressure Monitor Validations


WHICH? Continue to Disregard Correct Blood Pressure Monitor Validation

In August 2017, Prof. Eoin O’Brien and Prof. George Stergio, two of the world’s most eminent experts and leaders in blood pressure and in blood pressure monitor validation published a critical editorial on the quest, over 35 years, for the recognition of the importance of blood pressure monitor validation and for the importance of institutions and individuals only to use a blood pressure monitor that has been validated according to a recognised protocol.¹ The salient use of “A 35-year travail”, in the title, indicates how frustratingly difficult this has been. The free-access document is available from Wiley here.

The article contains a scathing indictment of how “devices appearing on the market must fulfil stringent safety requirements but are not required to have undergone accuracy testing according to one of the [ESH-IP 2010² and ISO-81060-2:2013³] protocols”. WHICH? consumer magazine is criticised for its lack of transparency in its tests for accuracy and it cites a “Don’t Buy” recommendation for a device proven to be accurate by a proper scientific study⁴. The article acknowledges that both consumer and scientific bodies have a common goal and calls for closer collaboration between consumer and scientific bodies to eliminate differences in their processes.

As of May 2018, they present reviews of 20 blood pressure monitors. The table below compares the WHICH? reviews both to actual validations, as shown on Medaval, and to recommendations by the ESH⁶. Under the Medaval Listing, four of the devices are marked as Unverified derivative, indicating a British and Irish Hypertension Society (BIHS) status, based only on manufacturer declarations⁷ while the Unpublished validation marks a device shown as validated by the Deutsche Hochdruckliga but the results for which are not published⁸.

Note:  As no wrist devices are recommended by the European Society of Hypertension (ESH), they are excluded from this table. 

Unfortunately, WHICH? have shunned this call and continue to make recommendations that are at odds with scientifically proven validations⁵.

Blood Pressure Monitor WHICH? Recommendation Medaval Listing ESH Recommended
iHealth Feel BP5 Between Best & Don’t Buy ★★★★ Yes
iHealth Sense BP7 (KD-972) Don’t Buy ★★★★ (Wrist device)
Omron M7 (HEM-780-E) Best Buy ★★★ Yes
Withings BP-800 Between Best & Don’t Buy ★★ Yes
Braun ExactFit 5 (BP-6200) Between Best & Don’t Buy Yes
Braun Vitalscan 5 (BPW-4300) Between Best & Don’t Buy (Wrist device)
Homedics BPA-2000-EU Best Buy Unverified derivative Yes
Omron M2 Basic (HEM-7120-E) Best Buy Unverified derivative Yes
Omron Pro Logic PL100 (HEM-7101-PR) Between Best & Don’t Buy Unverified derivative Yes
Omron RS2 (HEM-6121-E) Best Buy Unverified derivative (Wrist device)
Beurer BM-40 Don’t Buy Unpublished validation No
Boots – Upper Arm Best Buy Not validated No
IBP HL868ZA Best Buy Not validated No
Omron Evolv BP-7000 (HEM-7600T-Z) Best Buy Not validated No
Kinetik BPx1 Don’t Buy Not validated No
Boots – Wrist Between Best & Don’t Buy Not validated (Wrist device)
Philips DL8765-37 Between Best & Don’t Buy Not validated (Wrist device)
Beurer BC-31 Don’t Buy Not validated (Wrist device)
IBP HL168ZA Don’t Buy Not validated (Wrist device)
Kinetik BPM3C Don’t Buy Not validated (Wrist device)

Medaval cautions all consumers, whether they be professional healthcare or individuals, on the importance of only buying Blood Pressure Monitors and Blood Glucose Monitors that have been PROVEN to be ACCURATE.

Just because it’s a Medical Device does not imply it is ACCURATE. The Industry and all review sites and ‘search engines’ cannot be relied upon to give you the consumer any scientific data to backup their claims. Medaval can however because we do not sell devices, only the scientific services that prove device accuracy.

References

  1. O’Brien E, Stergiou GS. The pursuit of accurate blood pressure measurement: A 35-year travail. J Clin Hypertens (Greenwich). 2017 Aug;19(8):746-752. doi: 10.1111/jch.13005. Epub 2017 Apr 21. PMID: 28429879.
  2. O’Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; Working Group on Blood Pressure Monitoring of the European Society of Hypertension European Society of Hypertension. International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit. 2010;15:23-38. doi: 10.1097/MBP.0b013e3283360e98. PMID: 20110786. Erratum in Blood Press Monit. 2010;15(3):171-2.
  3. Association for the Advancement of Medical Instrumentation, American National Standards Institute, International Organization for Standardization. AAMI/ANSI/ISO 81060-2:2013, Non-invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. Arlington, VA, USA: AAMI; 2013.
  4. Wang Q, Zhao H, Chen W, Li N, Wan Y. Validation of the iHealth BP7 wrist blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Feb;19(1):54-7. doi: 10.1097/MBP.0000000000000017. PMID: 24361919.
  5. Which? 20 blood pressure monitor reviews. [Internet] London, UK: Which?; 2018. https://www.which.co.uk/reviews/blood-pressure-monitors. Accessed 2018 May 21. [Registration required for full details.]
  6. Stergiou GS, Asmar R, Myers M, Palatini P, Parati G, Shennan A, Wang J, O’Brien E; European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. Improving the accuracy of blood pressure measurement: the influence of the European Society of Hypertension International Protocol (ESH-IP) for the validation of blood pressure measuring devices and future perspectives. J Hypertens. 2018 Mar;36(3):479-87. doi: 10.1097/HJH.0000000000001635. PMID: 29384984.
  7. British and Irish Hypertension Society. Validated BP Monitors for Home Use. [Internet] Leicester, UK: BIHS; 2017/2018. https://bihsoc.org/bp-monitors/for-home-use/. Accessed 2018 May 21.
  8. Deutsche Hochdruckliga eV DHL. Geprüfte Messgeräte 2001-2017. [Internet] Heidelberg, Deutschland: DHL; 2018 Apr 28. https://www.hochdruckliga.de/messgeraete-mit-pruefsiegel.html Accessed 2018 May 21.

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