Blood pressure measurement device selection in low‐resource settings: Challenges, compromises, and routes to progress

Abstract

High blood pressure (BP) is the single leading preventable cardiovascular disease (CVD) risk factor across the world. In order to decrease the global burden of CVD, broad hypertension screening programs that facilitate early hypertension diagnosis and treatment are essential. Accurate BP devices are a key element of hypertension control programs. With the overwhelming number of devices available now on the market, most of which have not been tested for accuracy, it can be challenging to select the optimal BP measurement device for clinical settings. This review details essential factors to consider when selecting a good-quality BP device, particularly for use in low-resource settings. Barriers to the procurement and use of good-quality devices are reviewed and practical solutions proposed. | 793 BRADY et Al. | B P ME A SUREMENT DE VI CE ACCU R AC YAccurate devices are those that have been validated according to an established protocol, 8-12 provide multiple cuff sizes to ensure appropriate upper arm fit, and are maintained in good condition. Howto cite this article: Brady TM, Padwal R, Blakeman DE, et al. Blood pressure measurement device selection in lowresource settings: Challenges, compromises, and routes to progress. J Clin Hypertens. 2020;22:792-801. https://doi.

Weak and fragmented regulatory frameworks on the accuracy of blood pressure‐measuring devices pose a major impediment for the implementation of HEARTS in the Americas

“…Compared to Latin America, countries like Canada, the United States, and Australia are often perceived to more established BPMD regulatory systems. To some extent this is true, in the sense that entities like Health Canada, the US Food and Drug Administration, and Therapeutic Goods Administration in Australia have overseen regulatory approval of BPMDs for many years and because registries of validated devices exist in these countries (eg, from Hypertension Canada and the American Medical Association) 9 . However, numerous critical regulatory gaps exist in these countries as well, and they are not any more advanced in this field than most Latin American countries.…”

“…1,3,4 Fortunately, hypertension can be easily detected and effectively treated and controlled if there is a system in place adequately equipped with a skilled workforce, accurate blood pressure measurement devices (BPMDs), and a safe and effective core set of medicines, all together operating in the context of an accessible and organized health system. [3][4][5] To respond to these challenges, Global HEARTS, the World Health Organization (WHO) flagship initiative for CVD prevention and control, 6 has been implemented via the HEARTS in the Americas The specific pillar of "blood pressure measurement" focuses on correct blood pressure measurement technique, 8 use of automated BPMDs that have been validated for accuracy, 9 and strengthening of regulatory frameworks relevant to measurement accuracy. 10 This pillar is guided by the WHO policies on medical devices 11 and it promotes the progressive implementation of the WHO Technical specifications for automated non-invasive BPMDs with cuff.…”

“…The specific pillar of “blood pressure measurement” focuses on correct blood pressure measurement technique, 8 use of automated BPMDs that have been validated for accuracy, 9 and strengthening of regulatory frameworks relevant to measurement accuracy 10 . This pillar is guided by the WHO policies on medical devices 11 and it promotes the progressive implementation of the WHO Technical specifications for automated non‐invasive BPMDs with cuff 12 .…”

A simple six-step guide to National-Scale Hypertension Control Program implementation

“…Medication and BP measurement devices are an essential part of launching a hypertension program. The BP device model chosen for a new hypertension program should be externally validated as accurate, come with multiple cuff sizes, and be durable and affordable for the program [ 14 ]. Technical specifications outlined by WHO should be considered when procuring devices [ 15 ].…”

“…To replace outdated mercury devices, the WHO recommends accuracy-validated automated BP devices over the alternative of manual aneroid BP devices for measuring adult BP. This is because aneroid BP devices require frequent calibration to maintain accurate BP readings and are more prone to observer bias and terminal digit preference [ 14 , 15 ]. Validated automated digital devices, which inflate automatically and use oscillometric pulses to estimate BP, can be for home or office use, require less skill to operate, eliminate risk of observer bias and terminal digit preference, do not require re-calibration, and require less maintenance [ 14 , 15 ].…”