Microlife VSA Blood Pressure Monitor

Vance Chang
Medical Device Practitioner’s note
6 min readApr 15, 2023

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This is one of Microlife’s several representative products. Because of its potential outstanding contribution to human beings, it is not only listed as a collection by the British Science Museum, but also listed as one of 30 high-impact of innovation to save the life, by , an international organization dedicated to health equity.

中文版

Product origin

Every day, approximately 810 women die from preventable causes related to pregnancy and childbirth. 94% of maternal deaths occur in low- and middle-income countries. The major complications that account for almost 75% of maternal deaths are: hemorrhage (severe bleeding mostly after childbirth); sepsis (usually from infections after childbirth); and hypertensive disorders (high blood pressure during pregnancy known as pre-eclampsia, which can lead to seizures and/or stroke). Each of these conditions is associated with abnormal vital signs (blood pressure — BP and heart rate — HR), and can be prevented in most cases through timely and affordable interventions. However, in low-income, resource-poor settings, abnormal vital signs often go unnoticed due to a lack of functional and accurate equipment and insufficient training of frontline staff.

To address these challenges, a team from King’s College London collaborated with the Taiwanese blood pressure monitor company Microlife to develop the CRADLE VSA [1]product, which enables accurate measurement of vital signs in pregnant women in low-income environments.

Challenges and importance of pregnancy blood pressure measurement

The accuracy of general blood pressure measurements is usually tested and validated on participants in normal physiological circumstances. However, for pregnant women, their bodies undergo various physiological changes during pregnancy, including changes in blood volume, heart rate, and vascular tone, which can affect blood pressure.

As it is unclear whether these physiological changes could cause differences in blood pressure measurements using general blood pressure monitors, it is important to validate blood pressure monitors specifically designed for pregnant women to ensure accurate readings during these physiological changes.

Product Overview

This is a semi-automatic blood pressure monitor that uses a manual pump to inflate the cuff. The machine will indicate to the user when the appropriate pressure has been reached and then begin to measure blood pressure after releasing the pressure. This blood pressure monitor can also be used with a stethoscope for traditional auscultation blood pressure measurement.

The blood pressure monitor comes with a rechargeable battery that can be charged using a regular phone charging device.

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This design is primarily intended for middle and low-income countries where batteries are not easily accessible. In addition, automatic blood pressure monitors consume a lot of power due to their motors, resulting in shorter charging intervals. By using a semi-automatic manual pressure method, these issues are avoided.

Furthermore, considering the inadequate training of frontline workers, the simpler the measurement method, the better. After the user applies pressure to a certain level, they will hear a beep, and the upward arrow will disappear, indicating that the pressure is suitable for measurement. The machine will then automatically release the pressure to start measuring blood pressure.

In addition to measuring blood pressure, this device also provides a shock index. The shock index is the ratio of heart rate to systolic blood pressure. A high ratio usually indicates low blood pressure and a high heart rate. This is a useful diagnostic tool in some areas, such as Uganda, where malaria is prevalent.

Most importantly, this blood pressure monitor has been clinically proven by a team at King’s College London to be capable of measuring blood pressure in pregnant women.

The following is the protocol.

https://vancechang.net/microlife-vsa-blood-pressure-meter/#:~:text=https%3A//cradletrial.org/wp%2Dcontent/uploads/2015/11/Clinic%2DPoster.png

The entire operation is simple and intuitive for reading information, making it suitable for frontline workers with limited training.

Purpose in low-developed countries:

(1) Pre-eclampsia

The CRADLE Expansion Project aims to promote the CRADLE Vital Signs Alert (VSA) in collaboration with the Ministry of Health throughout the nation, providing opportunities for pregnant and postpartum women in the Republic of Sierra Leone (the country with the highest maternal mortality rate in the world) to receive vital signs monitoring in health facilities, applicable to all government health facilities. So far, 636 healthcare providers have been trained, and equipment has been delivered to 74 healthcare facilities in two out of 14 districts. The team hopes to reach six districts out of the 14 by March 2021.

(2) Shock index Uganda

Malaria is the leading cause of death and illness in Uganda, accounting for nearly a quarter of all deaths. Community health workers need to identify severe malaria at low cost to confirm diagnosis and begin treatment quickly. The CRADLE project aims to evaluate CRADLE VSA to help community health workers screen for malaria. Patients with an elevated shock index (indicated by a yellow flashing light and downward arrow on the CRADLE VSA) are 11 times more likely to have severe malaria than patients with a normal shock index. The CRADLE VSA may represent a low-cost and easy-to-use tool to help detect severe malaria early.

Pregnancy anemia and shock index in India

In rural India, up to 90% of pregnant women suffer from anemia, which increases the risk of stillbirth, neonatal death, and low birth weight. The CRADLE project conducted a study on 638 pregnant women who participated in prenatal checks in the southwestern Indian state of Karnataka and found that CRADLE VSA can be used to detect women who may have anemia, indicating that it can be a simple and inexpensive screening tool for women in need of iron supplementation.

Others

Uganda has housed 1.4 million refugees in 13 coordinated sites run by the United Nations High Commissioner for Refugees (UNHCR), including Bidibidi, the world’s second-largest refugee settlement covering 230 square kilometers and housing 270,000 refugees, mainly from South Sudan. There are not enough healthcare workers to provide basic healthcare, and the country is heavily reliant on community health workers without medical training to provide care. Since April 2018, the CRADLE project has provided CRADLE VSA equipment and training to over 1,000 community and healthcare workers in three refugee settlements in Uganda: Bidibidi, Nakivale, and Kyangwali.

Up to a quarter of Ugandans have hypertension, and most are unaware of its long-term consequences. Activities are needed to support the prevention, early detection, and early treatment of non-communicable diseases, aiming to reduce the burden of hypertension and improve the overall health of the population.

Current achievements:

So far, more than 10,000 CRADLE VSA devices have been used in clinical settings in Africa, Asia, and the Caribbean, and they are the first accurate pregnancy blood pressure device in most clinics and hospitals. It has reduced maternal mortality and morbidity rates. For example, during the CRADLE 3 trial, after introducing the CRADLE VSA into primary healthcare facilities in the Republic of Zambia, maternal mortality rates decreased by 60% and the incidence of pre-eclampsia decreased by 40%.

Countries involved in the CRADLE project:

https://cradletrial.org/ongoing-work/

The simple technology of CRADLE VSA can make a significant contribution to United Nations Sustainable Development Goal 3, which aims to reduce global maternal mortality to less than 70 deaths per 100,000 live births by 2030.

CRADLE VSA is one of the first blood pressure devices proven to be accurate during pregnancy. The device has been validated to detect abnormal low blood pressure associated with high blood pressure and rapid heart rate, which is critical in detecting shock secondary to infection or bleeding. It is also accurate in non-pregnant adults, increasing its potential for widespread use in rural populations.

This is why the organization PATH, which is dedicated to health equity, has listed CRADLE VSA as one of 30 high-impact innovations for saving lives.

https://media.path.org/documents/APP_ic2030_fs.pdf?_gl=1mpwqnf_gaNzY4MDM2MDY3LjE2ODEzMDQwNjI._ga_YBSE7ZKDQM*MTY4MTMwNDA2Mi4xLjAuMTY4MTMwNDA2Ni4wLjAuMA..

Note

No matter how technology proceeds nowadays. Limited progress in reducing health inequality was noticed. I am proud of serving this company. Also, it is also highly honored to collaborate with CRADLE team.

[1]: CRADLE (Community blood pressure monitoring in Rural Africa & Asia: Detection of underLying pre-Eclampsia and shock)

VSA (Vital Signs Alert)

Reference:

https://cradletrial.org/

MICROLIFE CRADLE VSA SAVES MOTHERS

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Vance Chang
Medical Device Practitioner’s note

Over 25 years experience in medical & biotechnology industry involving RD, product management, business development, and regulatory affair/quality management.