According to a study released on Thursday, pulse oximeters consistently underestimated oxygen levels in the blood of darker-skinned Covid patients, resulting to treatment delays and hospital readmissions.
Study participants were hospitalised coronavirus patients in the early years of the epidemic. Blood-oxygen levels were an important element in prioritising patients for scarce hospital resources.
Blood-oxygen levels were first recorded using a pulse oximeter at the fingertip, and then the researchers from Baylor College, Johns Hopkins University, and HCA Healthcare evaluated the cases of over 24,500 individuals.
These investigators and other specialists have voiced worry that the fingertip readings from pulse oximeters are inaccurate for individuals of colour. Federal officials have already begun reviewing the situation and are working to find ways to create more reliable readings.
Medical professionals commonly utilise pulse oximeter data to guide treatment decisions for a wide range of ailments, including heart failure, sleep apnea, and respiratory issues. For a healthy individual, the oxygen saturation value in their blood should be at least 95%. Patients may seem to be doing great on paper if the readings are inflated, but they may not get the necessary treatment.
Researchers predicted the greatest outcomes from the participants in the study published Thursday in JAMA Network Open. Their physicians realised they needed to monitor their oxygen levels more precisely.
If a patient’s blood oxygen saturation levels were lower than what was indicated by a fingertip pulse oximeter reading of 94% or above, they were classified as having an unmet need for Covid treatment. Nearly half as many black patients as white patients had their disease misdiagnosed. Unmet medical needs were 18 percent more common among Hispanic patients than among white patients.
There was a 10% greater chance of delayed Covid administration for patients of any race whose requirements were unrecognised, and the delays averaged around an hour. They had about a twofold higher risk of being readmitted to the hospital.
Patients whose oxygen levels may have incorrectly looked normal on the pulse oximeter but who did not have a follow-up blood test were excluded from the current research.
The fingertip pulse oximeters offered on prescription in hospitals have been approved by the FDA. In early 2021, the agency published a safety statement warning of the problems. In the autumn, a hearing was conducted before a panel of experts to discuss the device and the potential impact it may play in worsening health inequalities for patients of colour.
The FDA gave its OK for the gadgets under its 510(k) programme, which gives the green light to items that are functionally equivalent to already-approved devices. Over time, the programme has been panned since device clearance criteria are often lower than those for the approval of new medications by the FDA.
Advisors to the F.D.A. called for warnings to consumers who use the devices to measure their own respiratory health during a hearing in November after the agency observed that pulse oximeters sold over the counter are subject to even less monitoring.
Although the F.D.A. has not yet declared a significant shift in its regulation of pulse oximeters, it stated on Thursday that it will publish a discussion paper seeking public comment on the topic and would hold another meeting with experts to examine various ways.
However, Dr. Fawzy advised that clinicians should trust their gut when considering a pulse oximeter measurement for the time being.