The technical meeting on "Regulatory Framework and Validation of Automatic Blood Pressure " organized by the Pan American Health Organization, as part of the technical activities of the HEARTS Initiative, highlighted the need for a regulatory framework that progressively promotes and reinforces the availability of these devices, especially in primary care services, and training of personnel in the correct measurement of blood pressure and in the use of validated devices.
OVERVIEW
The correct measurement of blood pressure (BP) is one of the most common clinical exams. HEARTS in the Americas recognizes that a crucial factor for the diagnosis and management of hypertension is the correct measurement of BP. Appropriate patient preparation, correct measurement technique, the accuracy and precision of the devices being used, and a suitable measurement environment are key. The first exploratory studies in the countries that are implementing HEARTS in the Americas are indicating that most of them lack an appropriate regulatory framework that ensures the availability of BP devices validated for clinical use and that in the health services of the first level of care there is a shortage of validated BP devices.
HEARTS in the Americas has identified that the issue of the accuracy of BP measurement is critical to ensuring the Initiative's progress, and that lack of recently trained and certified personnel and the measurement of BP with non-validated equipment is a serious quality of health services and patient safety issue. On the other hand, the development of a regulatory framework that progressively promotes and reinforces improved availability and use of validated BP devices used by appropriately trained personnel will be a significant contribution to the control of hypertension and consequently reduce the burden attributable to cardiovascular diseases, especially due to strokes, ischemic heart disease and chronic kidney disease.
During the meeting, approximately 40 technical representatives from regulatory and clinical areas of the governments of the 12 countries of the Region that are currently implementing the HEARTS (see list of participants) were provided technical sessions to train the working groups on how to carry out validation studies of electronic blood pressure devices independently. Further, mechanisms for establishing regulatory and procurement environments for validated devices were discussed, and guidance was provided on the PAHO Strategic Fund as an alternative mechanism to improve the accessibility and quality of validated electronic blood pressure devices.
Participating in the opening ceremony of the Technical Meeting were Dr. Gina Watson, Representative of PAHO / WHO in Ecuador; Mr. Fernando Jácome, National Director of International Cooperation; and Dr. Pedro Orduñez, PAHO Regional Advisor for Noncommunicable Diseases and in charge of the Initiative at the Regional level.
See webnote
Objectives
To achieve consensus on a strategy for the adoption of regulatory frameworks that progressively facilitate the availability of validated equipment for the accurate measurement of BP and appropriately trained personnel in primary health care.
Contribute to HEARTS countries creating local and lasting capacities so that they can independently carry out validation studies of automated BP devices that meet the quality standards required..
Contribute to HEARTS countries creating local and lasting capacities to train and certify health care professionals and others in accurate blood pressure measurement.
PRESENTATIONS
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Hypertension: magnitude of the problem and key actions for its diagnosis and control
Dr. Norm Campbell, Professor Emeritus, University of Calgary
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Accuracy of blood pressure measurement: a matter of quality of health services and patient safety
Dr. James Sharman, Deputy Director of the Menzies Institute for Medical Research, University of Tasmania
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Validation of electronic blood pressure measuring devices: what are validation studies and why are they important
Dr. Raj Padwal, Professor of Medicine and Co-Director of the Hypertension Dyslipidemia Clinic, University of Alberta
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PAHO/WHO policies on medical devices towards access and Universal Health Coverage
Alexandre Lemgruber, Regional Advisor, Health Technologies, PAHO
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Importance of the regulation of electronic blood pressure measuring devices and examples of best practices
Dr. James Sharman, Deputy Director of the Menzies Institute for Medical Research, University of Tasmania
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Regulatory environments and situation in primary health care in HEARTS countries: Results of the PAHO review
Dr. Cintia Lombardi, HEARTS Consultant, PAHO
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Lists of validated blood pressure measuring devices
Dr. Raj Padwal, Professor of Medicine and Co-Director of the Hypertension Dyslipidemia Clinic, University of Alberta
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WHO’s technical specifications for blood pressure measuring devices (pending WHO publication)
Dr. Norm Campbell, Professor Emeritus, University of Calgary