Innovative technology to eliminate the racial bias in non-invasive, point-of-care (POC) haemoglobin and pulse oximetry measurements

Gokhale, Sanjay G.; Daggubati, Vinoop S; Alexandrakis, Georgios

doi:10.1136/bmjinnov-2022-001018

Cited by 9 publications

(5 citation statements)

References 25 publications

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“…Pulse oximeter technology developers should focus attention on developing accurate devices across all skin tones. Areas under research include capability to automatically recognize skin pigmentation or built-in user-optional adjustments that allow operator selection (34, 35). Such advances could permit setting individualized baselines for each wearer, enhancing accuracy and safety.…”

Section: Future Directionsmentioning

confidence: 99%

Discrimination by Design: Is It Time to Recalibrate Interpretation of Pulse Oximetry?*

Barreto

Moynihan²

2023

Pediatric Critical Care Medicine

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balanced representation of populations, and the role of disaggregation for calibration needs to be thoughtfully considered (44). Finally, race categories are inappropriate when what we are measuring is a color-tone scale rather than a social construct. In this research, investigators should endeavor to use objective measures of skin pigmentation over subjective definitions of race and ethnicity (45). CONCLUSIONSDespite being considered an objective measure, robust to implicit biases, pulse oximeters add to a mounting list of chronic racial biases in medicine that may inadvertently promote inequitable outcomes. As structural racism is pervasive, we must seek to critically evaluate all factors that potentially contribute to healthcare disparities. The simple pulse oximeter has numerous limitations. A multitiered approach to improving device accuracy is crucial to advancing healthcare for all but is especially important in improving care of patients who already experience significant health disparities due to their race and/or ethnicity.

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Section: Future Directionsmentioning

confidence: 99%

Discrimination by Design: Is It Time to Recalibrate Interpretation of Pulse Oximetry?*

Barreto

Moynihan²

2023

Pediatric Critical Care Medicine

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“…To overcome this limitation, we have developed a novel technology to estimate Hb and tissue oxygenation. The scientific basis, details, and underlying technology of the device are published elsewhere [ 7 ]. In brief, the Shani device (SH1) measures reflectance of light from the skin by a pair of light-emitting diodes (LEDs), displayed as the reflectance ratio from LED1 (E1) and LED2 (E2) and as the sum of the ratios (E; E1+E2).…”

Section: Introductionmentioning

confidence: 99%

“…In brief, the Shani device (SH1) measures reflectance of light from the skin by a pair of light-emitting diodes (LEDs), displayed as the reflectance ratio from LED1 (E1) and LED2 (E2) and as the sum of the ratios (E; E1+E2). The method of measurement is described in our previous report [ 7 ]. The light is shone on the wrist and only the reflected light is picked up by the sensors.…”

Section: Introductionmentioning

confidence: 99%

Validation of a Novel Noninvasive Technology to Estimate Blood Oxygen Saturation Using Green Light: Observational Study

Gokhale,

Daggubati,

Alexandrakis

2024

JMIR Biomed Eng

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Background Pulse oximeters work within the red-infrared wavelengths. Therefore, these oximeters produce erratic results in dark-skinned subjects and in subjects with cold extremities. Pulse oximetry is routinely performed in patients with fever; however, an elevation in body temperature decreases the affinity of hemoglobin for oxygen, causing a drop in oxygen saturation or oxyhemoglobin concentrations. Objective We aimed to determine whether our new investigational device, the Shani device or SH1 (US Patent 11191460), detects a drop in oxygen saturation or a decrease in oxyhemoglobin concentrations. Methods An observational study (phase 1) was performed in two separate groups to validate measurements of hemoglobin and oxygen concentrations, including 39 participants recruited among current university students and staff aged 20-40 years. All volunteers completed baseline readings using the SH1 device and the commercially available Food and Drug Administration–approved pulse oximeter Masimo. SH1 uses two light-emitting diodes in which the emitted wavelengths match with absorption peaks of oxyhemoglobin (hemoglobin combined with oxygen) and deoxyhemoglobin (hemoglobin without oxygen or reduced hemoglobin). Total hemoglobin was calculated as the sum of oxyhemoglobin and deoxyhemoglobin. Subsequently, 16 subjects completed the “heat jacket study” and the others completed the “blood donation study.” Masimo was consistently used on the finger for comparison. The melanin level was accounted for using the von Luschan skin color scale (VLS) and a specifically designed algorithm. We here focus on the results of the heat jacket study, in which the subject wore a double-layered heated jacket and pair of trousers including a network of polythene tubules along with an inlet and outlet. Warm water was circulated to increase the body temperature by 0.5-0.8 °C above the baseline body temperature. We expected a slight drop in oxyhemoglobin concentrations in the heating phase at the tissue level. Results The mean age of the participants was 24.1 (SD 0.8) years. The skin tone varied from 12 to 36 on the VLS, representing a uniform distribution with one-third of the participants having fair skin, brown skin, and dark skin, respectively. Using a specific algorithm and software, the reflection ratio for oxyhemoglobin was displayed on the screen of the device along with direct hemoglobin values. The SH1 device picked up more minor changes in oxyhemoglobin levels after a change in body temperature compared to the pulse oximeter, with a maximum drop in oxyhemoglobin concentration detected of 6.5% and 2.54%, respectively. Conclusions Our new investigational device SH1 measures oxygen saturation at the tissue level by reflectance spectroscopy using green wavelengths. This device fared well regardless of skin color. This device can thus eliminate racial disparity in these key biomarker assessments. Moreover, since the light is shone on the wrist, SH1 can be readily miniaturized into a wearable device.

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“…There are early possibilities, such as green light oximetry, cameras, and improved algorithms. [6][7][8] However, "simple replacement" may neither be simple, cheap, nor timely. The objective of this manuscript is to describe the financial and logistical burden in replacing pulse oximeters at one health system and across the United States.…”

Section: Introductionmentioning

confidence: 99%

The High Price of Equity in Pulse Oximetry: A cost evaluation and need for interim solutions

Dempsey,

Lindsay,

Tcheng

et al. 2023

Preprint

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Importance: Disparities in pulse oximetry accuracy, disproportionately affecting patients of color, have been associated with serious clinical outcomes. Although many have called for pulse oximetry hardware replacement, the cost associated with this replacement is not known. Objective: To estimate the cost of replacing all pulse oximetry hardware throughout a hospital system. Design: Single-center survey, 2023 Setting: Single center. Participants: One academic medical center with three hospitals. Main Outcomes and Measures: Cost of fleet replacement as identified by current day prices for hardware. Results: New and used prices for 5,079/5,678 (89.5%) across three hospitals for pulse oximetry devices were found. The average equipment cost to replace pulse oximetry hardware is $15,704.12 per bed. Replacement and integration costs are estimated at $28.5-31.8 million for the entire medical system. Extrapolating these costs to 5,564 hospitals in the United States results in an estimated cost of $14.1 billion. Conclusions and Relevance: “Simply replacing” pulse oximetry hardware to address disparities may be neither simple, cheap, or timely. Solutions for addressing pulse oximetry accuracy disparities leveraging current technology may be necessary.

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Innovative technology to eliminate the racial bias in non-invasive, point-of-care (POC) haemoglobin and pulse oximetry measurements

Cited by 9 publications

References 25 publications

Discrimination by Design: Is It Time to Recalibrate Interpretation of Pulse Oximetry?*

Discrimination by Design: Is It Time to Recalibrate Interpretation of Pulse Oximetry?*

Validation of a Novel Noninvasive Technology to Estimate Blood Oxygen Saturation Using Green Light: Observational Study

The High Price of Equity in Pulse Oximetry: A cost evaluation and need for interim solutions

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