Vital to COVID-19 response Smartphone pulse oximeters can measure oxygen saturation and heart rate to
FDA Standard says new study. Researchers say some smartphones could also be a future telemedicine
solution for other illnesses such as the flu and tuberculosis
Thursday February 18, 2021 (San Diego, U.S.)—Research from the University of California released in MedRxiv demonstrates for the first time pulse oximeters found in some mobile phones (Samsung Smartphone 9 and S10) meet full FDA clearance Standards and can be used to gauge the severity of COVID-19 infection and identify patients with low oxygen saturation (SpO2) at risk of poor outcomes. Specialists in Global Health (SiGH) provided support for this research.
The combination of lockdowns, self-isolation and shortage of hospital beds brought to bear by the COVID-19 pandemic has highlighted the need for accurate home-based pulse oximetry but this is faced with challenges:
- Inequity in the distribution of accurate oximetry devices globally has been well documented by the WHO
- FDA/ISO cleared pulse oximeter devices cost hundreds of dollars
- At home pulse oximeters currently in use, including those dispensed by large healthcare systems, are inexpensive devices that may be associated with wide variability in accuracy
The authors of the study, Accuracy of Integrated Pulse Oximetry in the Samsung 9/9+ Smartphone performed detailed human hypoxia testing on 12 healthy people who inspired mixed gases to reach stable arterial oxygen saturations between 70% and 100%. Over 257 arterial blood samples were analysed for oxygen saturation and compared to measurements obtained by the smartphone pulse oximeter. Readings from the smartphone were well within the standards required for FDA/ISO clearance for use as a clinical pulse oximeter. This is the first report of smartphone derived pulse oximetry measurements that meets full FDA/ISO accuracy certification requirements.
“Smartphones with sensors and apps could significantly enhance remote monitoring due to their ubiquity, and don’t require patients to have additional expensive gadgets,” said Sara H. Browne, MD, professor of clinical medicine in the UC San Diego School of Medicine and an infectious disease specialist.”
According to the Authors both S9 and S10 Samsung Galaxy smartphones contain the same dedicated pulse oximetry indicating there are over a 100 million smartphones currently in circulation that could be used to take accurate pulse oximetry measurements. The Authors conclude by urging Industry to pursue Emergency Use Authorization clearance with the FDA to support the expanded need for accurate at home pulse oximetry during the current pandemic.
Specialists in Global Health also supported a peer-reviewed study recently published in the journal CHEST on the accuracy and precision of smartphone pulse oximetry by Researchers from the University of California, San Diego. Using a smartphone with similar embedded hardware to the Samsung smartphone, researchers analysed over 2200 readings taken simultaneously from smartphone pulse oximetry and in-hospital Welch-Allyn instruments in a wide range of persons and found equivalent measurement accuracy and precision.
Accurate smartphone pulse oximetry over multiple geographical locations on demand is of immense practical medical importance globally, particularly in LMICs. During respiratory viral pandemics accurate pulse oximetry is used by medical practitioners in triage, initial clinical management.
The researchers state that with this kind of accuracy S9 and S10 pulse oximetry could be used during virtual telemedicine visits to provide data Healthcare providers need in their assessments. As this technology is smartphone based, during pandemics willing patients could allow their data to be connected to regional hospitals and national data hubs, enabling large-scale regional data analysis in near-real time to estimate resource requirements.
The authors suggest smartphone pulse oximetry may empower patients by storing at home readings to present to hospital triage or medical practitioners.
“Post pandemic this capability has wide global utility with relevance to acute and chronic cardiopulmonary diseases, including influenza and TB, and postoperative follow-up care,” concluded Browne.
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Notes to Editors
Specialists in Global Health (SiGH) serves as a granting body with a two-fold purpose—First, we provide the connection and means for educating and supporting medical specialist training in developing countries. Second, we provide the access and tools to introduce mobile health technologies into low resource settings. We want to build the infrastructure in developing countries and support the education and training needed for medical professionals to become skilled specialists. Through this process the medical professionals can be with their families while they work to improve health and build strength in their own communities. Ultimately, we want them to become the top specialists in their countries with the knowledge to train other doctors in their communities.