WASHINGTON (AP) — Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work for patients of color, under a new federal proposal released Monday.
The Food and Drug Administration's recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen. The FDA said it wants companies to conduct larger studies and include more patients from different racial groups.
By snapping a device onto a finger and then sending two wavelengths of light into the skin, the oximeter measures how much of the light is absorbed and estimates how much oxygen is flowing through the blood.
Oximeters were a critical part of emergency care for patients with COVID-19 during the pandemic. But several studies have suggested that darker skin pigmentation can sometimes throw off the accuracy of readings. In 2021, the FDA warned doctors about potential inaccuracies with oximeters after a study found the devices tended to overestimate Black patients’ oxygen levels, which could lead to delays in getting treatment and increased risks of death.
The issue has become a prominent example of the potential racial biases of medical technology, leading to multiple meetings and studies by FDA regulators since 2022.
The FDA’s draft recommendations, which are not binding, would make several changes to how companies are expected to test their devices, including:
— Enrolling at least 150 patients of different skin tones in clinical studies;
— Including at least 25% of patients with darker skin complexion in each study, up from 15% previously;
— Evaluating pigmentation of every study participant using at least two different methods, one based on a researcher's evaluation and another based on scientific, light-based measurement of melanin levels in the skin.
The FDA recommendations apply to only professional oximeters used in hospitals, doctor’s offices and other medical settings. The government doesn't regulate the vast majority of over-the-counter oximeters, most of which are considered “general wellness” devices by the agency.
The guidelines wouldn’t eliminate older devices currently used by doctors. But the FDA makes clear it expects to see new diversity data from manufacturers when requesting changes or updates to older oximeters.
Monday’s announcement is only a draft. The FDA said it will take public comments on its proposal for 60 days before beginning work on a final version.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
FILE - A health worker uses a pulse oximeter to check the oxygen saturation level of another after administering COVID-19 vaccine at a hospital in Gauhati, India, Jan. 21, 2021. (AP Photo/Anupam Nath, File)
WASHINGTON (AP) — The Supreme Court on Thursday said the Trump administration must facilitate the return of a Maryland man who was mistakenly deported to prison in El Salvador, rejecting the administration’s emergency appeal.
The court acted in the case of Kilmar Abrego Garcia, a Salvadoran citizen who had an immigration court order preventing his deportation to his native country over fears he would face persecution from local gangs.
U.S. District Judge Paula Xinis had ordered Abrego Garcia, now being held in a notorious Salvadoran prison, returned to the United States by midnight Monday.
“The order properly requires the Government to ‘facilitate’ Abrego Garcia’s release from custody in El Salvador and to ensure that his case is handled as it would have been had he not been improperly sent to El Salvador,” the court said in an unsigned order with no noted dissents.
Chief Justice John Roberts had already pushed back Xinis' deadline, and the justices said that her order must now be clarified to make sure it doesn’t intrude into executive branch power over foreign affairs, since Abrego Garcia is being held abroad. The court said the Trump administration should also be prepared to share what steps it has taken to try and get him back — and what more it could potentially do.
The administration claims Abrego Garcia is a member of the MS-13 gang, though he has never been charged with or convicted of a crime. His attorneys said there is no evidence he was in MS-13.
The administration has conceded that it made a mistake in sending him to El Salvador, but argued that it no longer could do anything about it.
The court’s liberal justices said the administration should have hastened to correct “its egregious error” and was “plainly wrong” to suggest it could not bring him home.
“The Government’s argument, moreover, implies that it could deport and incarcerate any person, including U. S. citizens, without legal consequence, so long as it does so before a court can intervene,” Justice Sonia Sotomayor wrote, joined by her two colleagues.
In the district court, Xinis wrote that the decision to arrest Abrego Garcia and send him to El Salvador appears to be “wholly lawless.” There is little to no evidence to support a “vague, uncorroborated” allegation that Kilmar Abrego Garcia was once in the MS-13 street gang, Xinis wrote.
Abrego Garcia, 29, was detained by immigration agents and deported last month.
He had a permit from the Homeland Security Department to legally work in the U.S. and was a sheet metal apprentice pursuing a journeyman license, his attorney said. His wife is a U.S. citizen.
In 2019, an immigration judge barred the U.S. from deporting Abrego Garcia to El Salvador, finding that he faced likely persecution by local gangs.
A Justice Department lawyer conceded in a court hearing that Abrego Garcia should not have been deported. Attorney General Pam Bondi later removed the lawyer, Erez Reuveni, from the case and placed him on leave.
Associated Press writer Lindsay Whitehurst contributed to this report.
Jennifer Vasquez Sura, the wife of Kilmar Abrego Garcia of Maryland, who was mistakenly deported to El Salvador, speaks during a news conference at CASA's Multicultural Center in Hyattsville, Md., Friday, April 4, 2025. (AP Photo/Jose Luis Magana)
