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  5. Impact of Skin Pigmentation On The Performance of Biomedical Optics Devices
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2023 FDA Science Forum

Impact of Skin Pigmentation On The Performance of Biomedical Optics Devices

Authors:
Poster Author(s)
Josh Pfefer, FDA/CDRH; Isaac Lin FDA/CDRH; William Vogt, FDA/CDRH; Jianting Wang, FDA/CDRH; Sandy Weininger, FDA/CDRH; Chris Scully, FDA/CDRH; and Andrew Fales FDA/CDRH
Center:
Contributing Office
Center for Devices and Radiological Health

Abstract

Poster Abstract

Melanin has long been recognized as a major absorber of light in the skin. The same optical characteristics that make melanin a key factor in determining skin color can significantly impact signals detected by medical devices. While clinical studies of pulse oximetry have garnered much attention in recent years for presenting evidence of racial disparities in performance, other biomedical optics technologies can be affected by skin pigmentation as well. We present preliminary results from a review of literature of the impact of skin pigmentation on optical diagnostic technologies including photoplethysmography-based wearables, cerebral oximeters, bilirubinometers, photoacoustic imagers, hyperspectral imaging systems, and Raman spectroscopy devices. Optical characteristics of melanin including absorption, scattering, fluorescence are discussed, as well as approaches used to optimize device robustness to variations in skin pigmentation. Increased awareness to the mechanisms and effects of epidermal melanin on detected optical signals can help both device developers and regulatory review staff institute practices to avoid racial disparities in medical devices.


Poster Image
Impact of Skin Pigmentation On The Performance of Biomedical Optics Devices

Download the Poster (PDF; 1.25 MB)

 
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