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A pulse oximeter probe applied to a person's finger. A pulse oximeter is a medical device that indirectly monitors the oxygen saturation of a patient's blood (as opposed to measuring oxygen saturation directly through a blood sample) and changes in blood volume in the skin, producing a photoplethysmogram that may be further processed into other measurements. [4]
The Medical Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) recently met to review the reported inaccuracy of pulse oximetry in patients with darker skin. The meeting ...
The longstanding problem of pulse oximeters providing less-accurate readings for people with dark skin tones got another look Friday from a panel of experts for the US Food and Drug Administration.
If the pulse oximeter is attached without compressing the skin, a pressure pulse can also be seen from the venous plexus, as a small secondary peak. The change in volume caused by the pressure pulse is detected by illuminating the skin with the light from a light-emitting diode (LED) and then measuring the amount of light either transmitted or ...
Inaccurate pulse oximeter readings are more common in Black patients than non-Black ones. It was a problem that could be ignored — until COVID-19 hit. An essential medical device fails people of ...
The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10] In the 1970s, Congress responded to the public's desire for additional oversight over medical devices by passing the Medical Device Amendments of 1976 (MDA) to the FD&C.
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