WHO technical specifications for automated non-invasive blood pressure measuring devices with cuff

WHO medical devices technical series

Overview

Hypertension is the leading modifiable risk factor for serious diseases such as cardiovascular disease (stroke and ischaemic heart disease), pre-eclampsia and eclampsia (a major killer of pregnant women and a cause of poor fetal growth and stillbirth) and chronic kidney disease.

Globally, over one billion people have hypertension, with a higher prevalence in low- and middle-income countries. Accurate blood pressure measurement is essential to identify and properly manage individuals with hypertension, a silent killer with few symptoms.

Lack of access to accurate, affordable blood pressure devices is a significant barrier to proper medical care, particularly in low-resource settings. Manual blood pressure measurement is gradually being replaced by automated measurement because of environmental concerns about mercury, poor calibration and improper measurement with aneroid devices in clinical practice and the superior consistent accuracy of validated automated devices. There is, however, frequent concern about the accuracy of automated devices that have not been validated.

This document updates WHO’s 2005 guidance on blood pressure measuring devices (BPMDs). It also responds to concern about the lack of accurate, good-quality devices, especially in low-and middle-income countries (LMIC) through technical consultation and expert review. The focus of the publication is on automated non-invasive BPMDs with cuff, including characteristics, regulatory requirements and standards, calibration and maintenance. It also provides guidance on procurement, decontamination and decommissioning. Additional elements on accurate measurement of blood pressure and training for personnel are included.

WHO Team
Access to Assistive Technology and Medical Devices (ATM), Access to Medicines and Health Products (MHP), Health Product Policy and Standards (HPS), Management-Screening,  Diagnosis and Treatment (MND), Medical Devices and Diagnostics (MDD)
Editors
World Health Organization
Number of pages
72
Reference numbers
ISBN: 978 92 4 000265 4
Copyright