Clinical studies must now include 25 percent of patients with darker skin tones<\/p>\n<\/h3>\n
By Physician\u2019s Briefing Staff HealthDay Reporter<\/b>
\n<\/b><\/p>\n
TUESDAY, Jan. 7, 2025 (HealthDay News) — The U.S. Food and Drug Administration released draft guidelines on Jan. 6 proposing that manufacturers conduct larger, more inclusive studies to ensure pulse oximeters work for people with darker skin.<\/p>\n
Among the key changes, the new recommendations call for enrolling at least 150 patients with diverse skin tones in clinical studies; increasing representation of patients with darker skin to at least 25 percent in each study, up from 15 percent; and using multiple methods to evaluate skin pigmentation, including scientific measurements of melanin.<\/p>\n
The proposal applies only to professional pulse oximeters used in medical settings, such as hospitals and clinics. Over-the-counter oximeters, often marketed as “general wellness” devices, are not affected.<\/p>\n
The FDA recommendations come after studies, including one from 2021<\/a>, revealed that pulse oximeters often overestimate oxygen levels in Black patients, potentially delaying treatment and increasing health risks, a news release states.<\/p>\n Existing devices already on the market will not need to meet these new standards unless manufacturers request updates or modifications.<\/p>\n The FDA will accept public comments<\/a> on the draft proposal for 60 days before finalizing the guidelines.<\/p>\n