Every clinical device must be a measure in itself for accuracy and precision. It is a vital link in the entire disease management chain, hence room for error is unthinkable. A blood pressure monitor is no different. Therefore standard clinical validation tests are done with blood pressure monitors to verify its accuracy and reliability. These tests are run by established international institutes namely AHA, ESH, BIHS, and ISO. The test result of this clinical validation determines whether or not the blood pressure device is ready for general use. Having said that, here are few of the standard practices in the BP monitor validation process.
- Basic Validation: This is a primary clinical validation test performed with a sample group. Generally the participants of a sample group do not have any pre-existing medical conditions. Thus, basic validation allows BP devices to be used by the general public. It is also done as a mandate, since every blood pressure monitor must undergo this primary validation test to verify the accuracy of blood pressure readings before being sold in the market.
- Special Patient Group Validation: A blood pressure monitor that is validated in “regular subjects” may not give accurate readings when used by pregnant women, children, elderly or diabetics. Patients like these, who do not fall under the category of general public are part of the Special Patient Group and require special validation. Some of the patients that fall under the Special Patient Group are:
- Pregnant/ Pre-eclampsia patients: Pre-eclampsia is a new type of hypertension seen amongst pregnant women after 20 weeks of gestation. Due to the unpredictable nature of pre-eclampsia, these patients need to monitor their blood pressure often. Most blood pressure monitors underestimate blood pressure in pre-eclampsia and therefore must be specifically validated for this distinct patient group.
- For End-Stage Renal Disease (ESRD): ESRD, also known as Kidney Failure, often does not show any symptoms and is mainly detected in patients through their blood pressure readings. ESRD also results in the arteries becoming stiff and calcified which is why special tests are required to accurately measure blood pressure for these patients.
- Diabetes Mellitus type 1 and 2: Patients who are diagnosed with Diabetes tend to develop stiff arteries, which affects their BP readings. Circa 120/80 BP monitors have been specially validated to accurately measure BP readings for those diagnosed with Diabetes.
- For children above 12 years: Due to the high respiration rate and smaller cuff size for children’s arm size, BP monitors require an advanced algorithm to accurately measure the blood pressure of children aged 12 – 18 years. Circa 120/80 monitors are well equipped with superior technology which is validated to give accurate BP readings for children in this age group.
- Cuff validation: With the increase of obese users of blood pressure machines, validating cuff sizes play a vital role in the accuracy of BP readings. Microlife thus developed an XL sized cuff which has been validated to accurately measure the blood pressure of patients with a large upper arm circumference. For instance, using a smaller sized cuff on large sized upper arm will lead to an uncomfortable fit which will result in a higher BP reading than it actually is. It is recommended to opt for BP monitors like Circa 120/80 blood pressure monitors which have undertaken cuff validation.
Basic validation is a necessity for all BP monitors, but BP monitors which go to the extent of validating their BP machines with Special Patient Groups, undertake Cuff validation, along with additional validations to verify their new and advanced technologies are the ones which are recommended. Protocols of home blood pressure monitors recommended by leading global bodies AHA, ESH, BIHS have been incorporated in Circa 120/80. So the next time you are purchasing a home blood pressure monitor, do check the extent of its clinical validation.