![]() The panel reviewed the many reasons pulse oximeters may not work as well in sick patients, including poor circulation caused by many medical conditions. “The sample size seems concerningly small for devices that affect the health of millions of patients,” said David Sterken, a hospitalist at the University of Wisconsin who spoke before the panel, which met virtually for eight hours. Such studies, many panel members said, may be too small to determine how well the devices work in people with darker skin. No formal votes were taken the panel met to hear from researchers and physicians about the issue and to offer guidance to FDA officials who will take the panel’s recommendations into account as they update regulations.Ĭurrent FDA guidelines require studies of just 10 patients, of which two, or at least 15%, must be darkly pigmented. “There is a problem and it has clinical significance.” “I am now convinced,” said Robert Loeb, a professor emeritus of anesthesiology at the University of Florida. Panel members, even those who had initially been skeptical of the validity of those recent studies, said after reviewing the data they were persuaded that the devices were indeed less accurate on patients with darker skin and could lead to poorer health outcomes. The widely used instruments monitor blood oxygen levels and have been shown to work less well on patients with darker skin, possibly exacerbating health disparities in many racial and ethnic groups. ![]() ![]() Exclusive analysis of biotech, pharma, and the life sciences Learn MoreĪ Food and Drug Administration advisory panel suggested Tuesday that the agency improve how it regulates pulse oximeters, calling for clearer labeling and more rigorous testing of the devices.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |