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)
HARRISBURG, Pa. (AP) — Pennsylvania lawmakers on Tuesday returned Democratic Speaker Joanna McClinton to lead the chamber for the new session after the Republican floor leader bowed out to resolve a deadlock.
Democrats won 102 seats in November, a single-vote majority, but one of their members was absent from swearing-in day after suffering a health crisis.
"My question to each of you distinguished colleagues is, what will you be remembered for?" McClinton said after taking the oath of office.
In the initial vote for speaker, Republican Leader Jesse Topper and McClinton each garnered 101 votes. Topper removed himself from consideration and McClinton, of Philadelphia, prevailed on the second ballot on a voice vote.
Rep. Matthew Gergely had a “medical emergency over the holidays requiring hospitalization,” according to Beth Rementer, the House Democratic caucus spokesperson. She said he is not expected to return “for some time.”
Gergely’s absence, the close House margin and Republican control of the Senate could complicate first-term Democratic Gov. Josh Shapiro’s hopes of getting things done this year. Democrats had the same 102-101 majority in the last session, and other than the two annual budgets, little substantial legislation was enacted.
Democrats won chamber control two years ago and successfully defended it while several vacancies arose and were filled by special elections. In November, not one of the 203 House seats changed parties, meaning Democrats retained majority control by the slimmest of margins.
House Democratic Leader Matt Bradford of Montgomery County thanked Topper, who drew a standing ovation, as Bradford acknowledged the close margin, telling colleagues “we need to be humble and we need to be wise.”
In floor remarks, Topper wished Gergely a full and speedy recovery.
"There are very few days in this job that are not difficult," Topper said, urging members to feel gratitude for the opportunity to serve and to avoid becoming frustrated or cynical. “We see many of those who we represent not on their best day, but on their worst.”
House Republicans changed leadership since November, turning to Topper of Bedford County to be their floor leader. A former ranking member on the Education Committee, Topper succeeded Rep. Bryan Cutler, a former House speaker and caucus leader who remains in the House after being reelected in a Lancaster County district.
House Democrats meanwhile have five new members after Reps. Mike Sturla of Lancaster County and former House Speaker Mark Rozzi of Berks County retired; Reps. Patti Kim of Dauphin County and Nick Pisciottano of Allegheny County relinquished their seats to make successful runs for state Senate; and Rep. Kevin Boyle of Philadelphia lost in the spring primary.
House Republicans saw Rep. Dawn Keefer win a state Senate seat in York County and Rep. Ryan Mackenzie unseat Democratic U.S. Rep. Susan Wild.
In other GOP caucus changes, Rep. Rob Mercuri didn't seek reelection while running unsuccessfully for Congress in Allegheny County. Reps. Jim Gregory of Blair County and Mike Cabell of Luzerne County lost in the spring primary and six others didn't run again: Donna Oberlander of Clarion County, Jim Marshall of Beaver County, Aaron Kaufer of Luzerne County, George Dunbar of Westmoreland County, Paul Schemel of Franklin County and Barry Jozwiak of Berks County.
In the state Senate, Republican Joe Picozzi unseated freshman Democratic Sen. Jimmy Dillon in a Philadelphia district. Because Kim flipped a redistricted Harrisburg area seat, Republicans still control the chamber by the same margin, 28-22. But there is currently one Senate vacancy: Sen. Ryan Aument, a Lancaster Republican, resigned at the end of December to take a top staff job with incoming U.S. Sen. Dave McCormick.
Members of the Pennsylvania House of Representatives gather with family members to be sworn in, elect a speaker and begin the new two-year legislative session, Jan. 7, 2025, in Harrisburg, Pa. (AP Photo/Marc Levy)
FILE - The Pennsylvania Capitol is seen, Feb. 6, 2024, in Harrisburg, Pa. (AP Photo/Matt Rourke, File)
