The FDA begins a review of how skin pigmentation affects the pulse oximeter results.

• Following a recent call by US Senators to review the accuracy of the devices, which is a cause for concern due to possible racial differences in pulse oximeter readings, the FDA issued a hazard statement regarding the accuracy of pulse oximeters in people with dark problems. Skin pigmentation.

• The use of prescription and over-the-counter pulse oximeters has increased as people seek ways to monitor their respiratory conditions at home in the face of the threat of a coronavirus pandemic. This trend has raised concerns about the long-debated relationship between skin pigmentation and oximeter results.

• The FDA responded by informing patients and healthcare professionals about the device’s limitations. The agency encourages individuals to monitor changes in oxygen levels over time and to consider tests other than oximeter data when making decisions.

Interest in pulse oximeters increased at the beginning of the COVID-19 pandemic. The devices manually send out a beam of light to determine the oxygen saturation of the blood. Consumers were looking for devices that would allow them to assess the effects of the coronavirus on their respiratory system at home and then get a data point to make decisions about when to seek medical attention. The potential value of the data was heightened by the discovery that some people on low oxygen levels have little difficulty breathing.

Some pulse oximeters are sold over the counter as aviation, sports, or general wellness products. Tabletop pulse oximeters are not intended for medical use and are not controlled by the FDA. Other pulse oximeters are cleaned via the 510 (k) route and require a prescription. Consumers who monitor their oxygen levels often have a desktop oximeter.

Concerns about the effect of skin pigmentation on the accuracy of the pulse oximeter date back to at least the 1980s. In the 1990s, researchers published studies in emergency rooms and intensive care units that found no association between skin pigmentation and pulse oximeter findings. However, earlier and later studies have generated conflicting data.

That topic brought the spotlight to COVID-19 and a recent letter to the New England Journal of Medicine. The NEJM letter reported an analysis which found that “compared to white patients, black patients were almost three times more likely to have occult hypoxemia that was not detected by pulse oximetry”. Senators, including Elizabeth Warren of Massachusetts, cited NEJM data in the letter; Last month he asked the FDA to review the relationship between skin pigmentation and pulse oximeter results.

During Friday’s safety briefing, the FDA announced that it was evaluating the precision literature for pulse oximeters, with an emphasis on the literature that evaluates whether the products may be less accurate in people with darker skin pigmentation. The FDA also reviews market data and works with manufacturers to evaluate other tests. The process can lead to changes in the guidelines on this matter. Existing guidelines recommend the inclusion of at least two darkly pigmented test subjects in clinical studies with pulse oximeters.

So far, the FDA has limited itself to making a statement on the proper use of pulse oximeters. The FDA on-site safety notice describes how the measured values are recorded and interpreted. In general, pulse oximeters are less accurate when blood oxygen levels are low. The FDA said the 90% value could reflect actual numbers of 86% and even 94%. However, the accuracy range for desk-top pulse oximeters not approved by the FTC may be wider.

Dozens of companies are competing in the prescription pulse oximeter market. In recent years, several Chinese companies have obtained 510 (k) approvals to join other medical technologies on the market, such as Masimo and Smiths Medical.