{"id":17254,"date":"2021-08-31T23:16:58","date_gmt":"2021-08-31T23:16:58","guid":{"rendered":"https:\/\/ade-medical.z4pby1v9-liquidwebsites.com\/?page_id=17254"},"modified":"2023-04-27T04:59:01","modified_gmt":"2023-04-27T04:59:01","slug":"special-healthcare-provider-report-ensuring-accuracy-for-in-home-patient-use","status":"publish","type":"page","link":"https:\/\/medical.andonline.com\/professional-resources\/special-healthcare-provider-report-ensuring-accuracy-for-in-home-patient-use\/","title":{"rendered":"Special Healthcare Provider Report: Ensuring Accuracy for In-home Patient Use"},"content":{"rendered":"
With excerpts from an interview with Jerry Wang, Director of Engineering, A&D Medical Accuracy in blood pressure monitors for mass market consumption has never been more critical, due to the following factors, which have resulted in something of a perfect storm in the healthcare field:<\/p>\n As a result, the home blood pressure monitor has become a critical tool for long-term health management.<\/p>\n But as healthcare providers look to recommend blood pressure devices to their patients for accurate home use, two main factors have become clear: 1) the phrase \u201cclinically validated\u201d \u2013 once a go-to term for accurate products \u2013 has become a marketing term as opposed to a scientific one, and 2) educating patients on the correct way to take blood pressure readings remains critical.<\/p>\n In this blog post, we\u2019ll look at the term \u201cclinical validation<\/a>,\u201d and how to advise patients to research what it means \u2013 to ensure product accuracy at the on-set.<\/p>\n<\/div><\/section><\/p><\/div> Clinical Validation: The Gold Standard?<\/span><\/strong><\/p>\n Healthcare practitioners have a deep understanding of the process of clinical validation as it relates to devices like blood pressure monitors: The accuracy is determined by comparing device measurement to the measurement of a trained observer using a mercury sphygmomanometer and stethoscope.<\/p>\n But unfortunately, the phrase \u201cclinically validated\u201d has become as ubiquitous as other marketing claims because the process of clinical validation is not always followed to its fullest measure \u2013 or for each product line.<\/p>\n Patients need to understand all the aspects of the clinical validation process in order to assess manufacturer claims.<\/p>\n \u201cMost healthcare practitioners understand the three major components that comprise clinical validation, including utilization of modern protocols, independent verification of accuracy, and publication in a peer-reviewed journal,\u201d said Jerry Wang, Director of Engineering\u00a0with A&D Medical. \u201cBut what they may not be aware of is that there are other factors that can impact the accuracy of an otherwise clinically validated product. It is those factors that can have major impact on the patient\u2019s ability to assess their own health accurately, and make the healthy changes they need to make to their lifestyle.\u201d<\/p>\n<\/div><\/section><\/p><\/div> Other Factors that Can Impact Blood Pressure Monitor Accuracy<\/span><\/strong><\/p>\n Each Product Must Be Validated<\/span><\/em><\/strong><\/p>\n \u201cOccasionally, companies will claim a certain level of accuracy in their products, which have met all the clinical validation standards,\u201d said Mr. Wang. \u201cBut they will then modify the design in its next product cycle iteration in such a way that the original validation is no longer representative of the product \u2013 and not verify the new product line under the same clinical validation standards.\u201d<\/p>\n As such, each new product and its peripheral components (such as cuffs) need to pass the standard clinical validation process.<\/p>\n Assurance of Mass Production Accuracy<\/span><\/em><\/strong><\/p>\n \u201cWe will also occasionally see clinically-validated products that do not maintain the level of substantiated accuracy through the production process,\u201d said Mr. Wang. \u201cIn order to ensure final products going onto the shelves at pharmacies or online through e-commerce venues, the following controls should be put in place across production lines.\u201d<\/p>\n Walking patients through not only the clinical validation process, but also the additional components required for product accuracy will put them on the path to choosing the most accurate home blood pressure monitor.<\/p>\n
\n<\/em>Volume I, Issue VI
\n<\/em><\/p>\n<\/div><\/section>
\n\n
Clinical Validation<\/strong><\/h3>\n<\/div><\/section>
\nOther Factors<\/strong><\/h3>\n<\/div><\/section>
\n\n