FDA knew of, but didn’t act on little devices’ deadly racial problems

pulseoximeter-150x150Until the coronavirus pandemic struck, few regular folks knew about pulse oximeters, much less had one on hand for urgent use. The devices, which fit over a finger, are supposed to give fast readings on the levels of oxygen in patients’ blood — a key measure of their respiratory wellness.

But the devices, whether in relatively inexpensive consumer versions or in medical-grade units used in doctor’s offices, clinics, and hospitals, are far from perfect. They suffer major inaccuracies when used by those with darker skin.

Federal regulators have known about this flaw for years. But at a time when patients, families, doctors, and hospitals relied on the devices routinely to make critical treatment decisions affecting those struggling with likely coronavirus infections, an information chasm opened. Doctors urged people to pop by drug stores and other retailers to pick up the devices, saying that they could be helpful in letting them know when their oxygen levels were dipping in concerning enough fashion that they should seek emergency treatment.

The public, though, wasn’t told in timely fashion about pulse oximeters’ inaccuracies. And those with darker skins suffered serious consequences with delayed or denied care, explaining in part why the pandemic took its terrible, inequitable toll on black Americans and communities of color, experts have told the federal Food and Drug Administration, the New York Times reported:

“Dr. Amal Jubran, a pulmonary critical care doctor at Loyola Medicine in Chicago, one of the first physicians to identify the problem in 1990, testified … that flawed readings were ‘hazardous’ during the height of the pandemic. They ‘most likely contributed to the several-fold greater number of deaths in Covid-19 in ethnic minority patients than in white patients,’ Dr. Jubran told the panel.”

News organizations — notably the science and medical site Stat, and its Pulitzer Prize-winning reporter Usha Lee McFarling — have reported for months on the pulse oximeter mess. It became the focus of a session in which the FDA’s own, independent, expert advisors assailed the agency for its handling of the devices.

The situation with pulse oximeters, critics say, illustrates many of the wrongs in how the FDA is supposed to but fails to safeguard the public from harms with medical devices.

The devices, for example, have gotten widely onto markets — in consumer and medical-grade versions — with relative ease. That’s because they were “grandfathered in,” under FDA rules that allow devices relatively similar to products already in use to, basically, get waved ahead, according to testimony received by the agency for its pulse oximeter meeting.

Further, the tests and research that has been done on these medical devices and their effectiveness lacked rigor — to say the least. The FDA heard experts say that pulse oximeters mostly have been studied on healthy, younger, white men, and only small samples of them. Then the agency also heard from critics of the devices and their accuracy, the New York Times reported:

“Doctors who appeared before the [FDA] panel cited a series of studies that showed how inaccurate readings from the devices used in hospitals affected people with darker skin during the pandemic and were associated with inadequate medical care. One University of Michigan study found that the devices that squeeze the finger gave elevated readings in black people when a blood test showed a lower rate, suggesting ‘hidden’ hypoxemia, or significantly low blood oxygen. The discrepancy was found in nearly 12% of black people and in nearly 4% of white people. Dr. Ian Wong, a Duke University researcher, confirmed elevated levels of hidden hypoxemia in black and Hispanic patients. He also told the panel that he found that all patients who had hidden hypoxemia had a risk of in-hospital death that was 70% higher than those with accurate readings. Doctors at the Johns Hopkins University School of Medicine confirmed the disparity again and noted the result: Black and Hispanic patients were 29% and 23% less likely to be recognized as candidates for Covid treatments.”

The FDA in 2021 flagged the problems but, mostly, shrugged. The agency and makers, for example, said that consumer versions of the pulse oximeter weren’t within regulatory purview, especially because they were described as for “recreational” use.

What?

The FDA, after a 10-hour session, took no action on the devices, suggesting, though, that makers may need to issue more detailed information and cautions for users. The agency also said it would consider whether future versions of the devices may need to be subjected to tougher standards. The inaction infuriated critics, the New York Times reported:

“Veverly Edwards, a community representative and the only African American on the panel of mainly white male doctors, called for manufacturers to be held accountable. She said black people should have a sustained voice on the matter that also affects people of many ethnicities with dark skin. ‘I guess my fear is that historically that the disparity in health care is like it never stops,’ said Ms. Edwards, who is an assistant professor at the University of Memphis. ‘When you lump African Americans in with everyone else, we end up on the short end — because this started 30 years ago and here we are today addressing it.’”

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the injuries that can be wreaked on them by dangerous drugs and defective and dangerous products, notably by medical devices. Patients are staggered by the costs of medical devices, and they deserve greater protection from their harms.

Lawmakers need to stop heeding the “poor me” or hurry-hurry innovation claims of medical device makers and to push the FDA to safeguard the public, not advance industry interests.

The agency and others in the sprawling U.S. health system also must have heightened awareness of disparities that inflict damage on non-majority patients. The pandemic and racial unrest related to multiple cases of police misbehavior have reminded the nation that we have serious work to do to ensure our country is fair, just, and equitable to all Americans, especially black people who have suffered historic and continuing wrongs, including shabby treatment in health care.

We have much work to do to ensure that health care is a right for all and not a privilege in the wealthiest nation in the world. We can and must offer safe, affordable, accessible, efficient, and excellent medical services to everyone we can, especially without regard to their age, sex, race, national origin, sexual orientation, economic standing — and more.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information