Viewed by many as “the fifth vital sign,” pulse oximetry is an essential reading in any number of presentations to urgent care. Now new investigations are amplifying a question many have had for years, though: Does the pulse oximeter work equally well with patients of all skin tones? The Food and Drug Administration says it’s going to look more closely at the matter, but in the meantime, according to an article published by Medpage Today, numerous new studies are calling the universal accuracy of pulse ox measurements into doubt. The controversy began when the FDA Medical Devices Advisory Committee announced that an upcoming meeting would include discussion of “ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations.” Since then, according to the Medpage Today piece, “real-world studies have been published suggesting increased risk for missed diagnosis of hypoxemiavii (ie, ‘occult hypoxemia’), delays in treatment eligibility decisions and worse patient outcomes among subjects with darker skin pigmentation.” One paper noted that pulse oximeters appeared to provide less accurate readings in Asian, black, and Hispanic patients compared with results in white patients. The FDA has not declared pulse oximeters to be ineffective with nonwhite patients and, again, has expressed that further study is needed.
Use of Pulse Oximeters Is Both Common and Essential—but Could Be Plagued by an Inherent Flaw