Clinical validation supports our product quality

The US Blood Pressure Validated Device Listing (VDL™)

Accurate measurement of blood pressure is essential for the diagnosis and management of hypertension. That’s why the American Medical Association (AMA) convened subject matter experts to develop criteria to help identify blood pressure monitors that have been tested and validated for clinical accuracy. Then, the National Opinion Research Center (NORC) at the University of Chicago was asked to manage an independent committee comprised of physician experts to review clinical evidence and determine whether blood pressure monitors meet the criteria for clinical accuracy. After review, blood pressure monitors that meet the criteria are published on a formal list called the US Blood Pressure Validated Device Listing (VDL) and are available at validatebp.org.

OMRON Healthcare, Inc., is 1 of the first 3 manufacturers with blood pressure monitors that meet the criteria upon review. Below are the OMRON blood pressure monitors included on the VDL:

• Convened subject matter experts to develop criteria to help identify BP monitors that have been tested and validated for clinical accuracy.

• Engaged the National Opinion Research Center at the University of Chicago (NORC) to manage an independent committee comprised of physician experts to review clinical evidence and determine whether BP monitors meet the criteria for clinical accuracy.

• Published criteria-meeting, reviewed on a formal list called the US Blood Pressure Validated Device Listing (VDL) and available at validatebp.org.

OMRON Healthcare, Inc., is one of the first three manufacturers with BP monitors that meet the criteria upon review. Below are the OMRON BP monitors included on the VDL:

• 3 Series® Upper Arm Blood Pressure Monitor (BP7100)

• 3 Series® Upper Arm Blood Pressure Monitor (BP7150)

• 5 Series® Upper Arm Blood Pressure Monitor (BP7200)

• 5 Series® Wireless Upper Arm Blood Pressure Monitor (BP7250)

• 5 Series® Upper Arm Blood Pressure Monitor (BP7255)

• 7 Series® Wireless Upper Arm Blood Pressure Monitor (BP7350)

• 10 Series® Wireless Upper Arm Blood Pressure Monitor (BP7450)

• Evolv® Wireless Upper Arm Blood Pressure Monitor (BP7000)

• Complete™ Wireless Upper Arm Blood Pressure Monitor + EKG (BP7900)

• Iron Upper Arm Blood Pressure Monitor (BP5000)

• Bronze Upper Arm Blood Pressure Monitor (BP5100)

• Bronze Upper Arm Blood Pressure Monitor (BP5150)

• Silver Wireless Upper Arm Blood Pressure Monitor (BP5250)

• Silver Wireless Upper Arm Blood Pressure Monitor (BP5255)

• Gold Wireless Upper Arm Blood Pressure Monitor (BP5350)

• Platinum Wireless Upper Arm Blood Pressure Monitor (BP5450)

• 3 Series® Wrist Blood Pressure Monitor (BP6100)

• 7 Series® Wireless Wrist Blood Pressure Monitor BP6350)

• Gold Wireless Wrist Blood Pressure Monitor (BP4350)

• HeartGuide™ Wearable Blood Pressure Monitor – Medium (BP8000-M)

• Telehealth Blood Pressure Monitor (HEM-9200T)

• Telehealth Automatic Upper Arm Blood Pressure Monitor (HEM-9210T)

• Telehealth Automatic Upper Arm Blood Pressure Monitor (BP9310T)

• Telehealth Automatic Upper Arm Blood Pressure Monitor (BP9300T)

Recognized Testing Protocols

There are several internationally recognized testing protocols from major standards organizations: The Association for the Advancement of Medical Instruments (AAMI), the European Society of Hypertension (ESH), and the British Hypertension Society (BHS). The table below lists the testing conducted for each model.

These validations offer peace of mind not just for our customers but for physicians as well, who can rest assured that their patients are monitoring their health with the same reliability as the medical devices used in their examination rooms.

References

1. Topouchian J, Agnoletti D, Blacher J, Youssef A, Ibanez I, Khabouth J, Khawaja S, Beaino L, Asmar R. Validation of four automatic devices for selfmeasurement of blood pressure according to the international protocol of the European Society of Hypertension. Vascular Health and Risk Management 2011:7;709-717.

2. Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the OMRON M6 (HEM-7001-E) and the OMRON R7 (HEM 637-IT). Blood Press Monit 2006;11:165-171.

3. Takahashi H, Yoshika M, Yokoi T. Validation of OMRON RS8, RS6, and RS3 home blood pressure monitoring devices, in accordance with the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2013;9:265-72.

4. Takahashi H. Validation of the OMRON M6W upper arm blood pressure monitor, in oscillometry mode, for self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2012 Mar 01. 4 p.

5. Takahashi H. Validation of the OMRON M3W upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2012 Mar 01. 4 p.

6. Takahashi H, Yokoi T, Yoshika M. Validation of the OMRON M6 AC (HEM-7322-E) upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2014 Jan 22. 4 p.

7. Topouchian J, Agnoletti D, Blacher J, Youssef A, Chahine MN, Ibanez I, Assemani N, Asmar R. Validation of four devices: OMRON M6 Comfort, OMRON HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol. Vasc Health Risk Manag. 2014 Jan 16;10:33-44.

8. Takahashi H, Yokoi T, Yoshika M. Validation of the OMRON M6 Comfort (HEM-7321-E) upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2014 Jan 22. 4 p.

9. Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vascular Health and Risk Management 2007;3(4):389-400.

10. El Assad M, Topouchian J, Asmar R. Evaluation of two devices for self-measurement of blood pressure according to the international protocol: the OMRON M5-I and the OMRON 705IT. Blood Press Monit 2003;8(3):127-133.

11. Stergiou GS, Yiannes NG, Rarra VC. Validation of the OMRON 705 IT oscillometric device for home blood pressure measurement in children and adolescents: The Arsakion School Study. Blood Pressure Monitoring 2006;11:229-234.

12. White WB, Anwar YA. Evaluation of the overall efficacy of the OMRON office digital blood pressure HEM-907 monitor in adults. Blood Press Monit 2001;6:107-110.

13. Omboni S, Riva I, Giglio I, Caldara G, Groppelli A, Parati G. Validation of the OMRON M5-I, R5-I and HEM-907 automated blood pressure monitors in elderly individuals according to the International Protocol of the European Society of Hypertension. Blood Pressure Monitoring 2007;12:233-242.

14. Coleman A, Steel S, Freeman P, de Greeff A, Shennan A. Validation of the OMRON M7 (HEM-780-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit 2008;13:49-54.

15. Takahashi H, Yokoi T, Yoshika M. Validation of the OMRON HBP-1300 upper arm blood pressure monitor, in oscillometry mode, for clinic use in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2014 May 22. 4 p.

16. Coleman A, Freeman P, Steel S, Shennan A. Validation of the OMRON 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit 2006;11:27-32.OMRON

17. Asmar R, Khabouth J, Topouchian J, El Feghali R, Mattar J. Validation of three automatic devices for self-measurement of blood pressure according to the International Protocol: The OMRON M3 Intellisense (HEM-7051-E), the OMRON M2 Compact (HEM 7102-E), and the OMRON R3-I Plus (HEM 6022-E). Blood Press Monit 2010;15(1):49-54.

18. El Assaad MA, Topouchian JA, Darne BM, Asmar RG. Validation of the OMRON HEM-907 device for blood pressure measurement. Blood Press Monit 2002;7:237-241.OMRON

19. Takahashi H. Validation of the OMRON EVOLV (HEM-7600T-E) upper arm blood pressure monitor, in oscillometry mode, for self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dabl Educational Trust; 2016 November 28.

20. Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of two watch-type wearable blood pressure monitors according to the ANSI/AAMI/ ISO81060-2:2013 guidelines: OMRON HEM-6410T-ZM and HEM-6410T-ZL. J Clin Hypertens. 2019;00:1–6.

21. Takahashi H, Yoshika M, Yokoi T. Validation of two automatic devices for the self-measurement of blood pressure according to the ANSI/AAMI/ISO81060-2:2009 guidelines: the OMRON BP765 (HEM-7311-ZSA) and the OMRON BP760N (HEM-7320-Z). Vasc Health Risk Manag. 2015 Jan 9;11:49-53.

22. Saito K, Hishiki Y, Takahashi H.　Validation of two automatic devices, OMRON HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010.　Vasc Health Risk Manag. 2019 Mar 6;15:47-55.

23. Bekker M, Franx A, Lely AT, Van Den Heuvel J.　Validation of the iHealth Track and OMRON HEM-9210T automated blood pressure devices for use in pregnancy.　Pregnancy Hypertension: An International Journal of Women’s Cardiovascular Health, 2019-01-01, Volume 15, Pages 37-41

24. Alpert BS. Validation of the Omron HEM-9210T by the ANSI/AAMI/ISO 81060-2: 2013 with two novel cuffs: wide-range and extra-large. Blood Press Monit. 2017 Jun;22(3):166-168.

25. Peprah, Y.A., Lee, J.Y. & Persell, S.D. Validation testing of five home blood pressure monitoring devices for the upper arm according to the ISO 81060-2:2018/AMD 1:2020 protocol. J Hum Hypertens 37, 134–140 (2023).

26. Takahashi H, Saito K, Hishiki Y. Validation of Omron HEM-7600T, a wearable device for monitoring blood pressure, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol in the general population without arrhythmias. Blood Press Monit. 2021 Apr 1;26(2):156-159.

27. Elliott WJ, Young PE, DeVivo L, Feldstein J, Black HR. A comparison of two sphygmomanometers that may replace the traditional mercury column in the healthcare workplace. Blood Press Monit. 2007 Feb;12(1):23-8. doi: 10.1097/MBP.0b013e3280858dcf. PMID: 17303984.

28. Ostchega Y, Nwankwo T, Sorlie PD, Wolz M, Zipf G. Assessing the validity of the Omron HEM-907XL oscillometric blood pressure measurement device in a National Survey environment. J Clin Hypertens (Greenwich). 2010 Jan;12(1):22-8. doi: 10.1111/j.1751-7176.2009.00199.x. PMID: 20047626; PMCID: PMC8673034.