{"id":26381,"date":"2021-07-05T22:37:01","date_gmt":"2021-07-05T22:37:01","guid":{"rendered":"https:\/\/medical.andonline.com\/?p=26381"},"modified":"2023-06-13T12:19:05","modified_gmt":"2023-06-13T12:19:05","slug":"special-healthcare-provider-report-ensuring-home-blood-pressure-monitors-are-accurate-for-in-home-patient-use-part-i-clinical-validation","status":"publish","type":"post","link":"https:\/\/medical.andonline.com\/special-healthcare-provider-report-ensuring-home-blood-pressure-monitors-are-accurate-for-in-home-patient-use-part-i-clinical-validation\/?lang=ce","title":{"rendered":"Special Healthcare Provider Report Ensuring Home Blood Pressure Monitors are Accurate for In-home Patient Use, Part I: Clinical Validation"},"content":{"rendered":"<div class=\"flex_column av_one_full  flex_column_div av-zero-column-padding first  avia-builder-el-0  el_before_av_one_full  avia-builder-el-first  \" style='border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><h3><span style=\"font-weight: 400;\">Special Healthcare Provider Report<br \/>\nEnsuring Home Blood Pressure Monitors are Accurate for In-home Patient Use, Part I: Clinical Validation<\/span><\/h3>\n<\/div><\/section><br \/>\n<section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><p><em>With excerpts from an interview with Jerry Wang, Director of Engineering, A&#038;D Medical\u00a0<\/em><\/p>\n<\/div><\/section><br \/>\n<section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><p>Volume I, Issue VI<\/p>\n<\/div><\/section><\/p><\/div>\n<div class=\"flex_column av_one_full  flex_column_div av-zero-column-padding first  avia-builder-el-4  el_after_av_one_full  el_before_av_one_full  column-top-margin\" style='border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><p>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<ul>\n<li><strong><span style=\"color: 0066b3;\">Shortages<\/span><\/strong>\u00a0of trained healthcare practitioners;<\/li>\n<li>An ever-growing population of patients with\u00a0<strong><span style=\"color: 0066b3;\">chronic disease<\/span><\/strong>; and<\/li>\n<li>Consumers demanding to utilize\u00a0<strong><span style=\"color: 0066b3;\">technology<\/span><\/strong>\u00a0to manage healthcare on their own.<\/li>\n<\/ul>\n<p>As a result, the home blood pressure monitor has become a critical tool for long-term health management. 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. In this blog post, we\u2019ll look at the term \u201c<a href=\"\/clinical-validation\/?lang=ce\">clinical 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><\/div><div class=\"flex_column av_one_full  flex_column_div av-zero-column-padding first  avia-builder-el-6  el_after_av_one_full  el_before_av_one_full  column-top-margin\" style='border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><h3><strong><span style=\"color: ef7f20;\">Clinical Validation: The Gold Standard?<\/span><\/strong><\/h3>\n<p>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<p>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<p>Patients need to understand all the aspects of the clinical validation process in order to assess manufacturer claims.<\/p>\n<p>\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&#038;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><\/div><\/p>\n<div class=\"flex_column av_one_full  flex_column_div av-zero-column-padding first  avia-builder-el-8  el_after_av_one_full  avia-builder-el-last  column-top-margin\" style='border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><h3><strong><span style=\"color: ef7f20;\">Other Factors that Can Impact Blood Pressure Monitor Accuracy<\/span><\/strong><\/h3>\n<p><strong><em><span style=\"color: 0066b3;\">Each Product Must Be Validated<\/span><\/em><\/strong><\/p>\n<p>\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<p>As such, each new product and its peripheral components (such as cuffs) need to pass the standard clinical validation process.<\/p>\n<p><strong><em><span style=\"color: 0066b3;\">Assurance of Mass Production Accuracy<\/span><\/em><\/strong><\/p>\n<p>\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<ul>\n<li><strong><span style=\"color: 0066b3;\">Design Control<\/span><\/strong>: the design, exactly as it is, is the one that needs to enter the production process.<\/li>\n<li><strong><span style=\"color: 0066b3;\">Production Control<\/span><\/strong>: From end-to-end, the product resourcing, testing, manufacture, sampling and packaging, should be in control of the manufacturer. Without that level of precise control, manufacturers have no way of knowing if design or production has resulted in the tweaking of the design in a way that would negate accuracy results.<\/li>\n<li><strong><span style=\"color: 0066b3;\">Consistency<\/span><\/strong>: The above manufacturing process as defined above needs to be tested for accuracy as well, to ensure long-term consistency in the production process.<\/li>\n<\/ul>\n<p>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<p>In our\u00a0<a href=\"\/blog\/ensuring-home-blood-pressure-monitors-are-accurate-for-in-home-patient-use-part-2\/?lang=ce\">next blog post<\/a>\u00a0as part of this special series, we\u2019ll look at educating patients on the right way to take blood pressure \u2013 and how you can do a simple in-office test with their home equipment to judge its accuracy.<\/p>\n<p><a class=\"button\" href=\"\/sites\/default\/files\/documents\/Medical_Clinical%20Validation%20Whitepaper.pdf\">Download the Whitepaper<\/a><\/p>\n<\/div><\/section><\/div>\n","protected":false},"excerpt":{"rendered":"<p>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","protected":false},"author":20,"featured_media":24298,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1070],"tags":[],"table_tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.4 (Yoast SEO v21.4) - 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