What is Clinical Validation for a Blood Pressure Monitor?
One of the most common questions we hear is “What does clinical validation mean?”. When you see a "Clinically Validated for Accuracy" symbol on an A&D product, it means that the product has been thoroughly tested and has stood up to the medical industry's world-class protocols.
In recent years, physicians have come to see the value of monitoring blood pressure at home to compliment treatment of their hypertensive patients. One of the most important considerations when home monitoring is recommended is the patient having access to accurate devices with validations performed under strict protocols.
The clinical validation tests verify the accuracy of the device according to certain criteria, like whether they have high, low, or normal blood pressure, and pre-existing diseases. Essentially, this means that the blood pressure monitor has been confirmed to give accurate and reliable results.
This helps give physicians, healthcare professionals, and people taking their measurements at home confidence that they’re using a reliable device – no matter if it’s used in a healthcare facility or the comfort of your living room.
What are the different protocols?
The most common validation protocols you’ll often see are the British and Irish Hypertension Society (BIHS, formerly British Hypertension Society), the European Society of Hypertension International Protocol (ESH-IP), and the Association for the Advancement of Medical Instrumentation (AAMI).
In order to be approved for sale in the United States, the Food and Drug Administration (FDA) requires that medical devices that measure blood pressure pass the ISO 81060-2:2013 protocol, based on the ESH-IP protocol.
While each of the protocols have many similarities, there are some differences in their testing requirements. In many cases, however, a product that passes one protocol may also satisfy the criteria of other protocols as well. In fact, there is a movement to create a universal standard for clinical validation.
Some of the basic requirements are that the validation is performed by an independent party, using one of the established protocols (ex. BHS Protocol – revised 1993, or ESH International Protocol 2010) by persons meeting certain requirements, such as formal training. Often, the full report is published in a peer-reviewed journal. Publication in a peer-reviewed journal, because of their rigorous review processes, ensures that the information contained in the report meets standard practices within the field.
Grades are derived from percentages of readings within 5, 10, and 15 mmHg. To achieve a grade, all three percentages must be equal to or greater than the tabulated values. BHS grades are formatted with two grades (ex. A/A): one for the systolic reading and the other for the diastolic reading.
The ESH International Protocol and ISO Standard use a Pass/Fail grading system.
See Our Range Of Blood Pressure Monitors Here: https://www.hiberniamedical.ie/product-category/blood-pressure-monitors/bp-monitors/