scholarly journals HEARTS in the Americas Regulatory Pathway to the Exclusive Use of Validated Blood Pressure Measuring Devices

2021 ◽  

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.

2020 ◽  

La hipertension es el principal factor de riesgo modificable de algunas enfermedades graves como las enfermedades cardiovasculares (accidentes cerebrovasculares y cardiopatías isquémicas), la preeclampsia y la eclampsia (una causa muy importante de muerte en las embarazadas, así como de retraso del crecimiento fetal y mortinatos) y la enfermedad renal crónica. A nivel mundial, más de mil millones de personas tienen hipertensión, y la prevalencia es mayor en los países de ingresos bajos y medianos. La medición exacta de la presión arterial es esencial para detectar y tratar adecuadamente a las personas con hipertensión, un trastorno que constituye un asesino silencioso que causa pocos síntomas. La falta de acceso a dispositivos de determinación de la presión arterial exactos y asequibles constituye un obstáculo importante para una atención médica adecuada, en particular en los entornos de recursos escasos. La medición manual está siendo reemplazada gradualmente por la medición automatizada debido a los problemas ambientales derivados del mercurio, la falta de calibración y las mediciones incorrectas de los dispositivos aneroides en la práctica clínica, así como por la exactitud uniforme superior que ofrecen los dispositivos automáticos validados. Sin embargo, con frecuencia existe cierta preocupación respecto a la exactitud de los dispositivos automatizados que no se han validado. Este documento actualiza la orientación de la OMS sobre dispositivos de medición de la presión arterial del 2005. También responde a la preocupación existente por la carencia de dispositivos exactos y de buena calidad, especialmente en los países de ingresos bajos y medianos mediante una consulta técnica y examen de expertos. Versión oficial en español de la obra original en inglés: WHO technical specifications for automated non-invasive blood pressure measuring devices with cuff. © World Health Organization, 2020 ISBN 978-92-4-000266-1 (print version)


Hypertension ◽  
2021 ◽  
Vol 77 (3) ◽  
pp. 806-812
Author(s):  
Oommen John ◽  
Norm R.C. Campbell ◽  
Tammy M. Brady ◽  
Margret Farrell ◽  
Cherian Varghese ◽  
...  

High systolic blood pressure (BP) is the single leading modifiable risk factor for death worldwide. Accurate BP measurement is the cornerstone for screening, diagnosis, and management of hypertension. Inaccurate BP measurement is a leading patient safety challenge. A recent World Health Organization report has outlined the technical specifications for automated noninvasive clinical BP measurement with cuff. The report is applicable to ambulatory, home, and office devices used for clinical purposes. The report recommends that for routine clinical purposes, (1) automated devices be used, (2) an upper arm cuff be used, and (3) that only automated devices that have passed accepted international accuracy standards (eg, the International Organization for Standardization 81060-2; 2018 protocol) be used. Accurate measurement also depends on standardized patient preparation and measurement technique and a quiet, comfortable setting. The World Health Organization report provides steps for governments, manufacturers, health care providers, and their organizations that need to be taken to implement the report recommendations and to ensure accurate BP measurement for clinical purposes. Although, health and scientific organizations have had similar recommendations for many years, the World Health Organization as the leading governmental health organization globally provides a potentially synergistic nongovernment government opportunity to enhance the accuracy of clinical BP assessment.


2021 ◽  
pp. 101053952110260
Author(s):  
Mairead Connolly ◽  
Laura Phung ◽  
Elise Farrington ◽  
Michelle J. L. Scoullar ◽  
Alyce N. Wilson ◽  
...  

Preterm birth and stillbirth are important global perinatal health indicators. Definitions of these indicators can differ between countries, affecting comparability of preterm birth and stillbirth rates across countries. This study aimed to document national-level adherence to World Health Organization (WHO) definitions of preterm birth and stillbirth in the WHO Western Pacific region. A systematic search of government health websites and 4 electronic databases was conducted. Any official report or published study describing the national definition of preterm birth or stillbirth published between 2000 and 2020 was eligible for inclusion. A total of 58 data sources from 21 countries were identified. There was considerable variation in how preterm birth and stillbirth was defined across the region. The most frequently used lower gestational age threshold for viability of preterm birth was 28 weeks gestation (range 20-28 weeks), and stillbirth was most frequently classified from 20 weeks gestation (range 12-28 weeks). High-income countries more frequently used earlier gestational ages for preterm birth and stillbirth compared with low- to middle-income countries. The findings highlight the importance of clear, standardized, internationally comparable definitions for perinatal indicators. Further research is needed to determine the impact on regional preterm birth and stillbirth rates.


2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Zheng Li ◽  
Cynthia Jones ◽  
Girum S. Ejigu ◽  
Nisha George ◽  
Amanda L. Geller ◽  
...  

Abstract Background Three months after the first reported cases, COVID-19 had spread to nearly 90% of World Health Organization (WHO) member states and only 24 countries had not reported cases as of 30 March 2020. This analysis aimed to 1) assess characteristics, capability to detect and monitor COVID-19, and disease control measures in these 24 countries, 2) understand potential factors for the reported delayed COVID-19 introduction, and 3) identify gaps and opportunities for outbreak preparedness, particularly in low and middle-income countries (LMICs). We collected and analyzed publicly available information on country characteristics, COVID-19 testing, influenza surveillance, border measures, and preparedness activities in these countries. We also assessed the association between the temporal spread of COVID-19 in all countries with reported cases with globalization indicator and geographic location. Results Temporal spreading of COVID-19 was strongly associated with countries’ globalization indicator and geographic location. Most of the 24 countries with delayed COVID-19 introduction were LMICs; 88% were small island or landlocked developing countries. As of 30 March 2020, only 38% of these countries reported in-country COVID-19 testing capability, and 71% reported conducting influenza surveillance during the past year. All had implemented two or more border measures, (e.g., travel restrictions and border closures) and multiple preparedness activities (e.g., national preparedness plans and school closing). Conclusions Limited testing capacity suggests that most of the 24 delayed countries may have lacked the capability to detect and identify cases early through sentinel and case-based surveillance. Low global connectedness, geographic isolation, and border measures were common among these countries and may have contributed to the delayed introduction of COVID-19 into these countries. This paper contributes to identifying opportunities for pandemic preparedness, such as increasing disease detection, surveillance, and international collaborations. As the global situation continues to evolve, it is essential for countries to improve and prioritize their capacities to rapidly prevent, detect, and respond, not only for COVID-19, but also for future outbreaks.


Author(s):  
Sariyamon Tiraphat ◽  
Vijj Kasemsup ◽  
Doungjai Buntup ◽  
Murallitharan Munisamy ◽  
Thang Huu Nguyen ◽  
...  

Active aging is a challenging issue to promote older population health; still, there is little clarity on research investigating the determinants of active aging in developing countries. Therefore, this research aimed to examine the factors associated with the active aging of the older populations in ASEAN’s low and middle-income countries by focusing on Malaysia, Myanmar, Vietnam, and Thailand. The study is a cross-sectional quantitative research study using multi-stage cluster sampling to randomize the sample. The sample consists of 2031 older people aged 55 years and over, including 510 Thai, 537 Malaysian, 487 Myanmar, and 497 Vietnamese. We collected a quantitative questionnaire of age-friendly environmental scale and active aging scale based on the World Health Organization (WHO) concept. The predictors of active aging include age-friendly environments, lifestyles, and socioeconomic factors; the data are analyzed by using multiple logistic regression. After adjusting for other factors, we found that older people living in a community with higher levels of age-friendly environments are 5.52 times more active than those in lower levels of age-friendly environments. Moreover, the older population with healthy lifestyles such as good dietary intake and high physical activity will be 4.93 times more active than those with unhealthy lifestyles. Additionally, older adults with partners, higher education, and aged between 55 and 64 years will be 1.70, 2.61, and 1.63 times more active than those with separate/divorce/widow, primary education, and age at 75 years or higher, respectively. Our results contribute considerable evidence for ASEAN policy-making to promote active aging in this region.


Atmosphere ◽  
2021 ◽  
Vol 12 (1) ◽  
pp. 118
Author(s):  
Carlos Zafra ◽  
Joaquín Suárez ◽  
Jorge E. Pachón

This paper analyzes the PM10 concentrations and influences of atmospheric condition (AC) and land coverage (LC) on a high-pollution megacity (Bogota, Colombia) from a public health viewpoint. Information of monitoring stations equipped with measuring devices for PM10/temperature/solar-radiation/wind-speed were used. The research period lasted eight years (2007–2014). AC and LC were determined after comparing daily PM10 concentrations (DPM10) to reference limits published by the World Health Organization (WHO). ARIMA models for DPM10 were also developed. The results indicated that urban sectors with lower atmospheric instability (AI) had a 2.85% increase in daily mortality (DM) in relation to sectors with greater AI. In these sectors of lower AI, impervious LC predominated, instead of vegetated LC. An ARIMA analysis revealed that a greater extent of impervious LC around a station led to a greater effect on previous days’ DPM10 concentrations. Extreme PM10 episodes persisted for up to two days. Extreme pollution episodes were probably also preceded by low mixing-layer heights (between 722–1085 m). The findings showed a 13.0% increase in WHO standard excesses (PE) for each 10 µg/m3 increase in DPM10, and a 0.313% increase in DM for each 10% increase in PE. The observed average reduction of 14.8% in DPM10 (−0.79% in DM) was probably due to 40% restriction of the traffic at peak hours.


2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S51-S52
Author(s):  
Kajal Mehta ◽  
Nikitha Thrikutam ◽  
Kiran K Nakarmi ◽  
Paa Ekow Hoyte-Williams ◽  
Michael Peck ◽  
...  

Abstract Introduction Cooking- and cookstove-related burns (CSBs) comprise a large proportion of burn injuries globally. A cookstove is any apparatus that provides heat and is used for cooking (e.g., three-stone fire, traditional or improved cookstove). There are limited data on patterns of cooking behaviors and CSBs to inform prevention initiatives and advocacy. We aimed to describe the epidemiology, risk factors and outcomes of cooking-related burns and CSBs, specifically. Methods Patients with cooking and non-cooking related burns from 2018 to 2020 were identified in the World Health Organization (WHO) Global Burn Registry (GBR). Patient demographics, cooking arrangement, injury characteristics [mechanism, total body surface area (TBSA), revised Baux score] and outcomes were described. Differences in proportions and medians were compared. Bivariate regression was performed to identify risk factors associated with occurrence of CSB. Results GBR contained data of 6,965 burn-injured patients from 17 countries; 88% were from middle-income countries. One quarter of burn injuries (1,723 burns) were cooking-related. More than half of cooking-related burns (55%) occurred in females. Median age for cooking-related burns was 11 years (IQR 2–35). Of cooking-related burns, 22% were cookstove-related burns (CSBs; 311 burns). The most common mechanism in CSB was flame (87%), whereas the most common mechanism in other cooking burns was scald (62%). Patients with CSBs were more often female (65% vs 53%; p< 0.001) and much older than patients with other cooking burns (32 years, IQR 22–47 vs 5 years, IQR 2–30). CSBs were significantly larger in TBSA size (30%, IQR 15–45% vs 15%, IQR 10–25%; p< 0.001), had higher revised Baux scores (70, IQR 46–95 vs 28, IQR 10–25; p< 0.001) and more often resulted in death (41 vs 11%; p< 0.001) than other cooking burns (Table1). Patients with CSBs were more likely to be burned by fires (OR 4.74; 95% CI 2.99–7.54) and explosions (OR 2.91, 95% CI 2.03–4.18) than other cooking injuries. Kerosene had the highest odds of CSB than all other cooking fuels (OR 2.37, 95% CI 1.52–3.69). Conclusions Cooking-related burns are common and have different epidemiology than CSBs, specifically (e.g., more often female, older, larger burn size, higher mortality). CSBs were more likely caused by structural factors (e.g., explosion, fire) than behavioral factors (e.g., accidental movements) when compared to other cooking burns.


2018 ◽  
Vol 13 (4) ◽  
pp. 187-188 ◽  
Author(s):  
Bethany Hipple Walters ◽  
Ionela Petrea ◽  
Harry Lando

While the global smoking rate has dropped in the past 30 years (from 41.2% of men in 1980 to 31.1% in 2012 and from 10.6% of women in 1980 to 6.2% in 2012), the number of tobacco smokers has increased due to population growth (Ng et al., 2014). This tobacco use and second-hand smoke exposure continue to harm people worldwide. Those harmed are often vulnerable: children, those living in low- and middle-income countries (LMICs), those with existing diseases, etc. As noted by the World Health Organization (WHO), nearly 80% of those who smoke live in a LMIC (World Health Organization, 2017). Furthermore, it is often those who are more socio-economically disadvantaged or less educated in LMICs that are exposed to second-hand smoke at home and work (Nazar, Lee, Arora, & Millett, 2015).


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