False oxygen readings delay COVID care for black and Hispanic patients: study

Why it matters: Readings affect patient care.

Pulse oximeter readings are used routinely and help inform physicians in shaping medical care for any number of ailments, including heart failure, sleep apnea, and respiratory conditions. A normal reading for a healthy patient should be a blood oxygen saturation level of about 95 percent or higher. If the readings are falsely high, patients may look healthy on paper — but they may not get the level of care they need.

The patients in the study, published Thursday in JAMA Network Open, were the ones the researchers expected to do best: Their doctors saw the need to take a more accurate measurement of their blood oxygen levels. (Most patients’ finger reading is not double-checked with a blood draw.)

Patients whose pulse oximeter reading is 94 percent or greater but whose blood tests show lower levels are considered to have an unrecognized need for COVID treatment. It turns out that black patients are nearly 50 percent more likely than white patients to go undetected. Hispanic patients were 18 percent more likely than white patients to have unrecognized needs.

Patients with unrecognized needs, regardless of race, experienced delays of about an hour resulting in a 10% increased risk of delayed COVID treatment. They were also twice as likely to be hospitalized.

The new study did not include patients whose oxygen levels may have mistakenly appeared normal via a pulse oximeter but who did not have a follow-up blood test, and who may have been sent home even though they may have been in serious condition.

“This is the number of patients that we’re really concerned about,” said Dr. Ashraf Fawzy, study author, assistant professor at Johns Hopkins University and an intensive care physician.

BACKGROUND: Imperfections can lead to significant health disparities.

The Food and Drug Administration approves the type of pulse oximeter used in hospitals and sold by prescription. The agency issued a Safety contacts about the defects in early 2021. A hearing was held in the fall before a panel of experts, where researchers identified studies suggesting the role the device might play in deepening health disparities in darker-skinned patients.

The agency approved those devices through its so-called 510(k) program, which scans for devices that are similar to existing ones — with some extra audit. The program has come under criticism over the years because the standards for device removal are usually lower than those for the agency’s approval of new drugs.

During a hearing in November, the FDA noted that over-the-counter pulse oximeters are subject to less oversight, prompting the agency’s advisors to call for a warning to consumers who use the devices to measure their respiratory health.

What’s next: The Food and Drug Administration promises more review.

The US Food and Drug Administration has not declared A Big change on how it oversees pulse oximeters, but said on Thursday it plans to publish a discussion paper to seek feedback on the issue and hold another meeting with experts to discuss potential approaches.

“It is a top priority for the agency to ensure that pulse oximetry performance is fair and accurate for all American patients,” the agency said in a statement.

I also started some business to Better design pulse oximeter.

However, for now, Dr. Fawzi said, doctors should trust their general impression of a patient’s condition when taking the oximeter reading into account.

“It is important for us to realize that this device may lead to inaccurate clinical decisions, or that we may not engage with some people or appreciate their needs,” he said.