Clinical Validation
Get Clinically Accurate Readings Even at Home with OMRON Blood Pressure Monitors
Why is Clinical Validation Important?
It’s not enough to just say we’re accurate. We have to prove it. Which is why we make sure that every model of our OMRON blood pressure monitors meets the highest standards of precision and reliability. Clinical validation offers peace of mind not just to our customers, but to physicians as well. They can rest assured that their patients are monitoring their health with the same reliability as the medical devices used in their examination rooms.
At OMRON Healthcare it’s our promise to minimize the impact of people’s health conditions and enable them to live a more fulfilling life with the products we offer. OMRON Healthcare devices extend their accuracy on specific patient groups in diabetic population, obese population, and pregnant women.
Validation Issuing Bodies of OMRON Blood Pressure Monitors
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European Society of Hypertension
ESH is one of the world's most respected societies for hypertension. Their aim is to provide a stable and organised platform for scientific discourse on hypertension on the European continent. Their standards of precision and reliability are among the highest in the industry and are a strict guideline for us in the design of our devices.
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Advancing Safety in Health Technology
The Association for the Advancement of Medical Instrumentation® sets consensus-based international standards for medical device manufacturers. More than 10,000 professionals work in the organisation to make medical technology safer and more efficient. Their validations provide reassurance to both customers and physicians that OMRON’s devices are well suited for monitoring health accurately and reliably.
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British and Irish Hypertension Society
BIHS is the largest forum for hypertension and cardiovascular disease professionals in the UK and Ireland. Their multidisciplinary team of clinical experts and scientists provide internationally recognised guidelines for the advanced and effective management of hypertension. When designing OMRON's blood pressure monitors, we place great emphasis on meeting these stringent standards as well as gaining the validation of the organization.
Importance of Clinically Validated Medical Devices
Some patients have specific health conditions that affect the accuracy of blood pressure measurement, such as arterial stiffness for diabetes patients, cuff size for obese patients and hemodynamic changes during pregnancy. Clinical validation certifies the accuracy of blood pressure measurements by thorough testing across these patient groups. At OMRON, we ensure all blood pressure monitors are clinically validated for accuracy. This helps healthcare professionals, and their patients take (home) measurements with confidence.²
Stride BP: an international initiative for accurate blood pressure measurement¹
The diagnosis and management of hypertension is dependent upon accurate blood pressure (BP) measurement. Despite intense efforts over several decades by the international medical community worldwide, the use of inaccurate devices has resulted in the misdiagnosis
and poor management of hypertension, which remains a largely unresolved public health problem. STRIDE BP (www.stridebp.org) is an international, non profit organization. Their mission is to improve the accuracy of BP measurement and diagnosis of hypertension.
A validation model for the medical devices industry²
Manufacturers must take an integrated approach to design, development and validation. Good design practice encourages this integrated approach while ensuring fitness for purpose within commercial reality. This paper proposes a practical approach aimed at making devices easier and more economic to validate.
Clinical accuracy of the Omron M3 Comfort® and the Omron Evolv® for self-blood pressure measurements in pregnancy and preeclampsia – validation according to the Universal Standard Protocol³
Medical devices for blood pressure (BP) measurements need to go through independent clinical validation as recommended by different authorities, both in general and in special populations such as pregnancy. After careful evaluation this paper found that both devices, Evolv and M3 Comfort fulfil the validation protocol criteria in pregnancy and pre-eclampsia. Consequently, these two devices can be recommended for home BP measurements in this specific population.
Validation of the Omron RS7 in Obese Population⁴
In obese patients with large arm circumference, wrist BP measurement has been suggested as one of the possible solutions. The purpose of this study is to assess the accuracy of the OMRON RS7® (HEM-6232T-E) device, which allows automatic oscillometer BP determination at the wrist level according to the criteria of the modified ESH-IP validation protocol in patents with large arm circumference ≥ 32 cm or obesity.
Main Takeaways
Clinically validation
The diagnosis and management of hypertension is dependent upon accurate blood pressure (BP) measurement.¹
Clinical validation certifies the accuracy of blood pressure measurements by thorough testing across these patient groups.¹
At OMRON, we ensure all blood pressure monitors are clinically validated for accuracy.³ ⁴
References
1. Stergiou, George S et al. “STRIDE BP: an international initiative for accurate blood pressure measurement.” Journal of hypertension vol. 38,3 (2020): 395-399. doi:10.1097/HJH.0000000000002289
2. Alexander, Karen, and P. John Clarkson. "A validation model for the medical devices industry." Journal of Engineering Design 13.3 (2002): 197-204.
3. Topouchian, Jirar, et al. "clinical accuracy of the Omron M3 comfortR and the Omron evolvR for self-blood pressure measurements in pregnancy and preeclampsia– validation according to the universal standard protocol." Vascular health and risk management 14 (2018): 189.
4. ASMAR, Pr Roland, and Roland Asmar. "Validation of the OMRON RS7R(HEM-6232T-E) in Patients with arm circumference≥ 32 cm according to the European Society of Hypertension International Protocol (ESH-IP)." (2018).