The Health Divide: FDA under fire for lack of action on pulse oximeters for dark skin

Published on
February 12, 2024

Doctors urge action to ensure effective blood oxygen monitoring for all

A Food and Drug Administration advisory panel met Feb. 2 to discuss the problems that pulse oximeters pose for patients with dark skin, including Black and Hispanic individuals. Advocates and experts said urgent action is needed, but change has not been forthcoming.

Studies as far back as 2005 show that the medical devices, which measure blood oxygen levels at the fingertip, often overestimate the number in people with dark skin. Melanin, the pigment in skin, absorbs the light the devices rely on for readings. 

Pandemic-era research, indicating the devices missed low oxygen levels in some Black patients and delayed or impeded care, helped bring the issue to the fore. 

“The lack of swift action by the FDA has been frustrating to many health equity advocates, consumer advocates, and a group of state attorneys general,” writes Usha Lee McFarling at STAT. The latter group sent the FDA a letter in November, stating, “It is imperative that the FDA act now to prevent additional severe illness and mortalities among darker skinned people.”

Panelists heard from experts who said that some devices on the market today fail to meet current standards. Engineers are working on devices that would provide more accurate results for all skin types, reports Cassandra Willyard at MIT Technology Review. 

Speakers also testified that many physicians and consumers still aren’t aware of the problem. 

“As someone who’s intimately aware of this issue, I still don’t know what to do for my patients,” Dr. Tom Valley of the University of Michigan told STAT. “These are devices used every day, all the time, that continue to place Black patients at risk of harm.”

Patients told the committee about receiving puzzling, inconsistent readings that made it difficult to manage health conditions.

FDA scientists proposed new rules that would raise the number of individuals manufacturers must test the devices in from 10 to 24, and to ensure subjects’ coloration spans the 10-shade Monk Skin Tone Scale.

Some advisory committee members weren’t convinced that 24 subjects was sufficient, reports Max Kozlov at Nature, and other scientists are still testing whether the Monk Skin Tone Scale is the most appropriate measure. 

The FDA will now consider the panel’s advice, but hasn’t released a deadline for the new rules.

“The longer these changes aren’t made, the longer that patients are put at risk,” Dr. Michael Sjoding of the University of Michigan told Nature.

New series shines light on Black mental health 

Word in Black, a news collaborative focused on Black people, put the spotlight on mental health in early February with a series of articles addressing happiness and the challenges and opportunities for help and treatment.

Recent data from the Pew Research Center indicate that more than 80% of Black adults are somewhat or very happy. But income makes a significant difference, reports Bria Overs

More than half of Black adults in the upper-income category — those earning more than $143,400 a year — reported being very or extremely happy. But just a quarter of lower-income Black adults, making $47,800 or less, said the same.

For those seeking mental health help, it can be hard to find a therapist who understands the experiences of people of color, writes Marlene F. Watson, director of training for therapists at the Ackerman Institute for the Family in New York.

Recent news provides an example: A new study reports that Black people are more likely than others to report sleep loss in the months after police killings of unarmed Black individuals. 

Just 4% of therapists are Black, Watson notes, even though Black people account for nearly 13% of the U.S. population. Some white therapists have told Watson they avoid the race issue, which doesn’t serve their clients.

And though Black children are at growing risk of hate crimes, homicide and suicide, advocates say states aren’t putting up sufficient funds to help them, reports Joseph Williams

The American Foundation of Suicide Prevention just launched a new program focused on mental health in Black communities, called L.E.T.S. Save Lives for Listening, Empathy, Trust, and Support. The initiative is a free presentation, meant to engender discussions and highlight resources, that will be available through the Foundation’s chapters, media partners, historically Black colleges and universities, and virtually, reports Anissa Durham.  

Black people are more likely to seek counsel from religious leaders than mental health professionals, and frequently deny problems such as depression or anxiety, Vic Armstrong, vice president for health equity at the American Foundation of Suicide Prevention, told Durham.

In Black women, that mode of thinking can manifest in the “superwoman schema,” report ABC News and Good Morning America, in which women feel they must suppress their emotions and vulnerabilities to focus on taking care of others, but this can cause stress.

Black women think, “Everything that comes my way, I should be able to handle it,” said Zoeann Finzi-Adams, a psychologist at Howard University. “That’s exhausting, because no one is able to do everything.”

Survey finds growing health care inequities for transgender Americans

While most transgender individuals are healthy, nearly half have had negative experiences with health care providers, according to the preliminary results of the 2022 U.S. Trans Survey

Of respondents who had transitioned, 94% said doing so improved life satisfaction.

The survey, which included more than 92,000 transgender people in the United States, was conducted by the National Center for Transgender Equality, an advocacy organization in Washington, D.C., and its partners.

It’s one of few efforts to spotlight the trans experience, report Orion Rummler and Kate Sosin at The 19th

The U.S. Census Bureau didn’t ask Americans about gender identity until 2021.

It’s important to collect data from transgender people themselves, because it’s often cisgender individuals who are shaping public thinking, Sandy James, the lead researcher on the survey, said in a press call.

“At best, we’re working in a vacuum,” added Rodrigo Heng-Lehtinen, executive director of the National Center for Transgender Equality. “At worst, we’re combating dangerous misinformation being spread by anti-trans extremists.”

Topline health results from the survey highlight issues transgender Americans face with providers and insurance companies. 

Of those survey respondents who’d seen a health care provider in the past year, 48% reported problems including being spoken to harshly, misgendered, physically abused or refused care. That’s up from 33% in the previous survey in 2015.

In addition, 26% of those surveyed said they’d experienced insurance problems such as denial of coverage for routine or gender-affirming care. The number was 25% in 2015.

Economic factors can also impact health; the number of respondents living in poverty rose from 29% in 2015 to 34% in 2022.

And 10% of people who took the new survey said they’d moved to a new region to avoid discrimination, with 5% crossing state lines over legislation cutting access to bathrooms, sports or health care.

“A steady condition, environment, has been created in which people are not able to thrive,” the lead researcher James said in a New York Times article by Azeen Ghorayshi.

More data and a more in-depth report will be released in the future.

“Advocates say the updated survey is overdue and direly needed as anti-transgender bills flood state legislatures,” write The 19th’s Sosin and Rummler.

From the Center for Health Journalism

April 10 is the deadline to apply for our National Fellowship, which includes an intensive training week (June 24–28), reporting grants of $2,000–10,000, and professional mentorship that supports fellows to report a major enterprise health or social well-being project. More info here.

April 11 is the deadline to apply for the Domestic Violence Symposium and Impact Reporting Fund, starting in May 2024, which includes reporting grants of $2,000–$10,000 and professional mentorship to provide reporters with a roadmap to cover the topic with nuance and sensitivity. More info here.

What we’re reading

  • “Extreme heat, wildfire smoke harm low-income and nonwhite communities the most, study finds,” by Dorothy Pineda, AP News
  • “When algorithms and AI perpetuate medical racism, who’s responsible?” by Margo Snipe, Capital B News
  • “The hidden racial bias in U.S. lung cancer screening policy,” by Melba Newsome, Undark
  • “Halfway through ‘unwinding,’ Medicaid enrollment is down about 10 million,” by Phil Galewitz, KFF Health News
  • “The Census Bureau is dropping a controversial proposal to change disability statistics,” by Hansi Lo Wang, NPR
  • “CDC anti-smoking campaign takes aim at menthol cigarettes,” by Mira Cheng, CNN

“Medical schools are not preparing us to care for autistic individuals,” by Reeda Iqbal and Sherab Tsheringia, MedPage Today