Point-of-care measurement of blood oxygen saturation is commonly performed using pulse oximetry-based methods, yet clinical evidence indicates that these devices may exhibit racial disparities in accuracy. We are working to develop tissue-mimicking phantoms for performance comparison and standardization of pulse oximeters. In this study, we have evaluated the use of standard silicone modified by reducing curing agent content to reduce material hardness to biologically relevant levels. A new silicone formulation was identified which provides low hardness without modification. Measurements of compliance – channel diameter as a function of fluid pressure – indicate that both materials have potential for use in pulse oximeter testing.
Recent articles reporting racial bias in pulse oximeter performance in clinical studies have highlighted the need for well-validated, objective approaches for assessing skin pigmentation. Highly effective objective measurements of skin color will require not only the use of well-validated melanometers, but also optimized methods for implementation. Therefore, we identify Best Practices for melanometer use that can be widely applied in pulse oximeter clinical studies. Additionally, given the variety of acquisition, processing approaches and metrics currently employed in melanometers, we discuss standardization of device performance and outputs as well as use of pigmented tissue mimicking phantoms for performance evaluation.
While pulse oximeters have traditionally been utilized for measuring arterial saturation (SpO2), the widespread adoption of pulse oximetry has led to its expanded applications, including diagnostic uses like detecting hypoxemia during the COVID-19 epidemic. Recent research has identified unexpected errors in off-label applications, with discrepancies in diagnostic efficacy based on race or skin pigmentation. The positive bias in SpO2 measurements, particularly in the critical SpO2 range of 85-90%, poses a significant concern for devices intended for SpO2 measurement. This study employs Monte Carlo simulations to model transmittance mode pulse oximetry to investigate whether documented racial and pigmentation-based biases can be attributed to epidermal melanin. The research aims to elucidate key mechanisms that may guide the improvement of technology. Specifically, the study explores sensitivity to the epidermal region under conditions with and without surface reflection, shedding light on pulse oximeter function in diverse device designs. Results demonstrate a 26% increase in the total detected signal from the epidermis when transitioning from low to high surface reflection at 660 nm, and a 22% increase in the total sensitivity of the system to the epidermis at 940 nm with surface reflection. These findings suggest that heightened sensitivity to the epidermis region leads to more pronounced spectral effects, especially with reflective sensors, potentially due to reflected photons re-entering the tissue through the epidermis.
Pulse oximetry represents the universal application of optics in modern medicine. However, recent studies have raised concerns regarding the potential impact of confounding factors like variable skin pigmentation and blood content on blood oxygen saturation measurement accuracy. Tissue-mimicking phantom testing offers a low-cost solution for characterizing device performance and potential error sources. Phantom manufacturing literature for pulse oximetry on the human finger was reviewed. Studies were categorized, and relevant optical and mechanical properties were summarized and implemented toward a preliminary phantom for optimal biological relevance using molding and 3D printing. Gaps, recommendations, and strategies were presented for continued phantom development.
Recent controversial studies reporting racial bias in pulse oximetry measurements have highlighted the need for well-validated, objective techniques for assessing skin pigmentation. To address the increased interest in classification of skin using visible to near infrared reflectance measurements, we provide a thorough critical review of melanometers – devices that estimate melanin content – and skin colorimeters. This review focuses on working mechanisms and assessing the degree to which scientific data supports the use of these devices. Additionally, we describe approaches for standardization and relevant emerging optical techniques.
Conference Committee Involvement (1)
Design and Quality for Biomedical Technologies XVIII
25 January 2025 | San Francisco, California, United States
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