Clinically validated

Microlife blood pressure monitors - measurement quality with the highest of standards.

Clinical validation - what is it?

Blood pressure monitors must be clinically validated before being sold on the market. Clinical validation verifies the measurement accuracy of the monitor and tests are performed with selected subjects who meet certain criteria (blood pressure classification, age, sex, pre-existing diseases, etc.). 

There are qualitative and quantitative differences between the various existing validation methods. Therefore, when choosing a blood pressure monitor, you should always ask to what extent it is “clinically validated”. Validation of a blood pressure monitor is a standard requirement, but what is more important is to what extent it has been validated.

Basic validations

Basic validation is performed on a group of subjects that is representative of an "average population without any diagnosed pre-existing conditions". The larger the number of subjects, the more statistically significant, thus more reliable, the validation test is. For example, basic validations can be based on the test protocols of the following institutions:

*There are differences between the test protocols of the institutions; for example in respect of the group size.

Another difference is in the blood pressure ranges examined: The blood pressure ranges in which the blood pressure monitors are checked for measuring accuracy differ depending on the protocol (see graph). The broader the range is, the better the devices are checked to be reliable at extremely low or extremely high blood pressure.

Special patient validations

Because of the technique that is used in automated oscillometric blood pressure monitors, they can be inaccurate when used in so-called special patient groups. This can lead to the fact that a blood pressure monitor that is validated in “regular subjects” may not give accurate readings when used e.g. during pregnancy or when used in children, elderly or diabetes patients. This can have serious clinical consequences. Therefore, medical standard authorities require that a blood pressure monitor may only be recommended for such a special patient group if it has been validated for this specific group. Microlife blood pressure monitors have passed several of these challenging validations so that they can now be recommended for all of the following special patient groups.

Microlife's upper arm blood pressure monitors are always a good choice. These are especially validated for:

Diabetes
Patients with Diabetes Mellitus type 1 and 2 may have stiff arteries that can affect the blood pressure measurement. A recent validation study in diabetes patients type 1 and 2 showed Microlife monitors are accurate when used in this patient group.

Pregnancy and Pre-Eclampsia
Most oscillometric blood pressure monitors underestimate blood pressure in pre-eclampsia. For this reason, oscillometric blood pressure monitors may only be recommended for use in pregnancy when specifically tested in this special patient group. Microlife allows pregnant women to measure their blood pressure at home which could reduce the number of hospital visits and may help to make motherhood safer.

End-stage renal disease
Patients with moderate to severe renal disease have a very high incidence of hypertension, paired with stiff (calcified) arteries. As automated measurements can be influenced by stiff arteries, a special validation is required before blood pressure monitors can be recommended for use among patients with end stage renal disease.

Children
As children have a high respiration rate and have difficulties in sitting still, one needs a blood pressure monitor with a high-quality algorithm that can filter out these artefacts. In addition, a wide cuff range is needed that covers very small to large arm circumferences. 
Microlife blood pressure monitors have proven to cover all these aspects and therefore can be recommended for children and adolescents aged 3 to 18 years (Microlife WatchBP Office and O3 Ambulatory) and 12 to 18 years (All Microlife automatic upper arm blood pressure monitors and WatchBP Home).

Cuff validations

Cuffs, as important as the blood pressure monitor.

Validations are generally performed with the standard cuff-size of the respective device model. However, Microlife has put extra attention to validations with all type of cuff sizes and/or types (soft cuffs, rigid cuffs, wide-range cuffs, etc.). Due to the large increase of people who are overweight, validations of XL cuffs are becoming more important. In order to ensure that correct blood pressure values are obtained in these patients Microlife has developed an XL-cuff which has been validated for accurate blood pressure measurement in patients with large arm-circumference. Microlife is the only provider for home BPM with an explicit validation for the XL cuff and comes highly recommended for overweight patients.

Click here to read more about cuff types and sizes.

All Microlife's special patient validations at a glance:

Further studies

Microlife AFIB, the atrial fibrillation detection.

In addition to the validations mentioned above, there are also studies conducted to other innovative Microlife technologies and measurement methods. They work with new technologies or measuring methods, which are used in blood pressure monitors. Well-known institutions, such as the universities of Oxford, Athens, Rome, Maastricht, Hong Kong and New York, have published clinical studies regarding the Microlife AFIB technology, which is applied exclusively in Microlife upper arm blood pressure monitors. All studies have shown that Microlife AFIB can automatically detect dangerous atrial fibrillation - the most frequent cause of a stroke - even with high precision. Microlife AFIB as of today, is worldwide the only approved technology for AF screening during blood pressure measurement. (MDD93/42/EEC, MedDEV 2.7.1., FDA)

Read more about AFIB

Microlife SmartMAM - Consecutive measurements with 1 click.

Other studies investigated the value of multiple blood pressure measurements – a technique that is also automated in the Microlife models (so-called SmartMAM technology). In these studies interval times between the individual measurements were observed in order to obtain valid measuring results at the end. A pause time of 15 seconds for oscillometric measurement was determined sufficient as a reference value, as is also the case with the MAM technology.

Read more about MAM

Click here to download this information as a pdf.