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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 accuracy of pulse oximeters for people with dark skin tones is now being reviewed. An FDA advisory panel met Friday to talk about how to make these devices more accurate for people with darker ...
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.
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 pulse may vary due to exercise, fitness level, disease, emotions, and medications. [11] The pulse also varies with age. A newborn can have a heart rate of 100–160 bpm, an infant (0–5 months old) a heart rate of 90–150 bpm, and a toddler (6–12 months old) a heart rate of 80–140 bpm. [ 12 ]
Unbeknownst to the company, the pulse oximeter was also being used to monitor oxygen deprivation in patients under anesthesia in operating rooms. [5] Reports of this application reached the company's management in late 1982, and the company began to focus time and resources in developing operating room applications to help anesthesiologists ...