Pan American Health Organization 
HEARTS in the Americas [PDF ebook] 
Regulatory Pathway to the Exclusive Use of Validated Blood Pressure Measuring Devices

Cardiovascular disease (CVD) is the leading cause of disease burden globally. According to the 2017 Global Burden of Disease estimates, there were 14 million new cases of CVD, 80 million people living with this condition, and nearly 1 million deaths attributed to CVD in the Americas. Hypertension is the major risk factor for CVD, causing half of the cases, and is highly prevalent, affecting one in four adults, including 40% of those over age 25 years. To appropriately detect hypertension, accurate measurement of blood pressure is critical, and inaccurate measurement of BP has important consequences for policies to address hypertension, as well as for patient safety and quality of care. The Fourth World Health Organization (WHO) Global Forum on Medical Devices identified several critical issues related to medical devices. Among those issues were recommendations for increased regulation of medical devices in low- and middle-income countries and development of technical specifications to optimize procurement of priority medical devices. World Health Assembly Resolution 67.20 (Regulatory system strengthening for medical products) stresses the importance of regulation of medical devices for better public health outcomes and to increase access to safe, effective, and quality medical products. This publication seeks to contribute to meeting these recommendations by providing a practical tool for governments to improve their national regulatory frameworks to improve accuracy of blood pressure measuring devices (BPMDs), in turn contributing to the exclusive use of accuracy validated automated BPMDs in primary health care (PHC) facilities by 2025. This publication can also guide the development of procurement mechanisms that will ensure exclusive availability of BPMDs in PHC facilities. Specifically, this publication will provide a brief background on the importance of using validated BPMDs and highlight key elements of regulations related to pre-market approvals to promote accurate BPMDs.