In a recent safety communication by the U.S. Senator asking the agency to review the accuracy of pulse oximeters, the FDA reviewed the agency’s accuracy because of concerns about possible ethnic differences in pulse oximeter measurements.
As people have sought ways to monitor their respiratory status at home based on the threat posed by the coronavirus pandemic, pulse oximeters that can be purchased as prescription drugs and over-the-counter products are increasingly being used. For a long time, this trend has heightened concerns about the relationship between skin pigmentation and oximeter results.
The FDA responded to these concerns by informing patients and healthcare providers of the limitations of the device. The agency encourages people to track changes in their oxygen levels over time, and to take other evidence other than oximeter data into consideration when making decisions.
At the beginning of the COVID-19 pandemic, interest in pulse oximeters surged. The device shines a beam of light on the fingertips to estimate the oxygen saturation in the blood. Consumers look for these devices to obtain a way to assess the impact of the coronavirus on the respiratory system in their homes and to obtain data points to provide a basis for decision-making when to seek medical services. The discovery that some people with low oxygen levels barely breathe, which adds to the potential value of the data.
Some pulse oximeters are sold as general health products, sporting goods or aviation products in the form of OTC. The OTC oximeter is not suitable for medical use and has not been reviewed by the FDA. Other pulse oximeters can be cleared through the 510(k) pathway and can be provided with the prescription. Consumers who monitor their oxygen levels usually use OTC oximeters.
Concerns about the effect of skin pigmentation on the accuracy of pulse oximeters can be traced back to at least the 1980s. In the 1990s, researchers published studies of emergency department and intensive care patients and found no link between skin pigmentation and pulse oximetry results. However, early and later studies produced conflicting data.
COVID-19 and a recent messenger published in the New England Journal of Medicine have brought this topic back into focus. A letter from NEJM reports an analysis that found that “black patients have almost three times the frequency of occult hypoxemia in white patients, and pulse oximeters cannot detect this frequency.” including Elizabeth Waugh Senators including Elizabeth Warren (D-Mass.) cited NEJM data in a letter last month asking the FDA to review the link between skin pigmentation and pulse oximeter results.
In a safety notice on Friday, the FDA stated that it is evaluating the literature on the accuracy of pulse oximeters, and “focuses on evaluating the literature on whether people with darker skin have poor product accuracy.” The FDA is also analyzing pre-market data and working with manufacturers to evaluate other evidence. This process may lead to revised guidelines on the subject. Existing guidelines recommend that at least two dark pigmented participants be included in clinical trials of pulse oximeters.
So far, the FDA’s actions have been limited to statements regarding the proper use of pulse oximeters. The FDA safety newsletter describes how to obtain and interpret readings. Generally, pulse oximeters are less accurate at low blood oxygen levels. The FDA stated that a 90% reading may reflect actual numbers as low as 86% and as high as 94%. The accuracy range of OTC pulse oximeters that have not been reviewed by the FDA may be wider.
Dozens of companies compete in the prescription pulse oximeter market. In recent years, many Chinese companies have obtained 510(k) licenses to join other medical technologies on the market, such as Masimo and Smiths Medical.
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Diabetes patients Dexcom and Insulet both predicted this year’s business growth and market expansion in their speeches.
With the resurrection of the coronavirus and the emergence of more contagious strains, the challenges and opportunities faced by COVID-19 are in front of medical device and diagnostic companies.
Post time: Mar-15-2021