Study Finds Black and Hispanic Patients Experienced Delayed Covid Care Due to Inaccurate Oxygen Readings

The Significance: How Readings Impact Patient Care

Pulse oximeter readings, which are commonly used in medical settings, play a crucial role in shaping the care provided to patients with various illnesses, including heart failure, sleep apnea, and respiratory conditions. In a healthy individual, a normal reading should indicate an oxygen saturation level in the blood of 95 percent or higher. However, if these readings are falsely elevated, patients may appear fine on paper but may not receive the necessary level of care.

The patients involved in the study published in JAMA Network Open were those for whom doctors recognized the need to obtain more precise measurements of blood oxygen levels. This is because most patients’ fingertip readings are not verified with a blood draw. Surprisingly, patients who had fingertip pulse oximeter readings of 94 percent or higher, but had lower levels in their blood tests, were found to have an undetected requirement for Covid therapy. It was discovered that Black patients were nearly 50 percent more likely than white patients to have their condition go unnoticed, while Hispanic patients had an 18 percent higher likelihood compared to white patients.

Patients with unrecognized needs, regardless of their race, experienced delays of approximately an hour, resulting in a 10 percent increased risk of delayed Covid treatment. Moreover, they were over twice as likely to be readmitted to the hospital.

It is important to note that the study did not include patients whose oxygen levels may have falsely appeared normal on the pulse oximeter and did not undergo follow-up blood tests, potentially leading to seriously ill individuals being discharged.

Dr. Ashraf Fawzy, an assistant professor and intensive care physician at Johns Hopkins, expresses concern about this particular patient population.

The Context: Flaws and Health Disparities

The type of fingertip pulse oximeter used in hospitals, which is also sold via prescription, is approved by the Food and Drug Administration (FDA). Earlier this year, the FDA issued a safety communication highlighting the flaws associated with these devices. During a hearing in the fall, expert panelists and researchers emphasized the device’s role in exacerbating health disparities, particularly for patients with darker skin tones.

The FDA approves such devices through the 510(k) program, which applies less stringent scrutiny to devices that are similar to existing ones. Over the years, this program has faced criticism for its lower standards compared to the FDA’s approval process for new drugs.

At the November hearing, the FDA acknowledged that over-the-counter pulse oximeters face even less oversight, leading advisory panel members to advocate for warnings to consumers who utilize these devices to assess their own respiratory health.

What Lies Ahead: Further Evaluation by the FDA

While the FDA has not yet announced any significant changes in its oversight of pulse oximeters, it has stated its intention to release a discussion paper to gather feedback on the issue. Additionally, the agency plans to convene another meeting with experts to explore potential approaches.

The FDA emphasizes that ensuring equitable and accurate performance of oximetry devices for all patients in the United States is a top priority.

Efforts are already underway to design an improved pulse oximeter that addresses these concerns. In the meantime, Dr. Fawzy advises doctors to consider the overall impression of a patient’s condition, in addition to pulse oximeter readings.

He emphasizes the importance of recognizing that this device may lead to inaccurate clinical decisions, resulting in undertreatment or failure to recognize the needs of certain individuals.