Rédaction Africa Links 24 with Usha Lee McFarling
Published on 2024-02-02 23:28:59
The Food and Drug Administration (FDA) has come under scrutiny for its slow response to the issues surrounding pulse oximeters, which have been found to have inaccuracies, particularly in patients with darker skin. During a public meeting held virtually by an advisory panel, patients, researchers, and consumer advocates testified about the need for the FDA to take swift action to ensure that pulse oximeters are effective in all patients and that clinicians are better informed about the devices’ limitations and potential shortcomings in patients with darker skin tones.
The concern about the accuracy of pulse oximeters in patients with darker skin was triggered by a study published during the Covid-19 pandemic, which found that the devices were not detecting low oxygen levels in some individuals with darker skin. This has led to delayed or no treatment for Black patients with severe cases of Covid. Despite these findings, the FDA’s response has been slow, leading to frustration among health equity advocates, consumer advocates, and a group of state attorneys general, who sent a letter to the FDA urging action.
Physicians and researchers have also expressed frustration, with many devices on the market not meeting the current standard for clearance as per the FDA. A study conducted at Johns Hopkins University found that pulse oximeters were far less accurate in Black patients, leading to their needs for Covid therapy not being recognized. The lack of awareness about the limitations of pulse oximeters among the clinical community has been raised as a major concern, with panelists and individuals testifying about the inconsistencies in readings, particularly in patients with darker skin.
The slow progress in addressing these issues has caused distress and panic among patients relying on pulse oximeters for monitoring their blood oxygen levels. Inaccurate readings have led to confusion and unnecessary panic attacks, with some individuals unsure whether to use their rescue inhalers or call emergency medical services. Additionally, the devices’ inconsistencies have resulted in financial burdens for some patients, who have had to continuously replace probes at their own expense.
There was also concern about the lack of awareness among average consumers about the limitations of pulse oximeters, particularly when used at home. The line between medical needs and wellness in direct-to-consumer devices has become blurred, calling for clear guidance and standards for all devices used for medical decision-making, regardless of where they are sold.
FDA’s efforts to address the issue have included public meetings and releases of discussion papers, with the suggestion of using the Monk skin tone scale as an improvement to measure skin pigment in research studies. The FDA has also proposed increasing the number of patients with darker skin included in studies and is discussing what level of error can be allowed for the devices to be approved. However, the advisory panel’s views will be considered as the FDA works on new regulations for pulse oximeters, and there is no set date for when the rules will be issued.
While there has been frustration over the slow progress, both FDA officials and panelists have expressed their commitment to making pulse oximeters more equitable. The need for careful and deliberate action to ensure that any changes made to the devices solve the problem without introducing additional harms or reducing access has been highlighted.
The lack of data on how the devices perform, especially on actual patients, has caused frustration among panelists, who emphasized the importance of understanding the causes of errors and why they do not occur in all dark-skinned patients. Overall, there is a push for more transparency, accuracy, and inclusivity in the testing and approval processes for pulse oximeters.
