The Food and Drug Administration (FDA) has yet to issue new guidelines aimed at correcting racial disparities in the accuracy of pulse oximeters, despite initial announcements that new rules would be released by September 30. This delay follows revelations nearly four years ago that these devices, which measure blood oxygen levels, frequently fail to detect low oxygen levels in patients with darker skin. Such inaccuracies can have dire consequences, including a decreased likelihood of receiving essential treatments like supplemental oxygen during critical situations such as the Covid-19 pandemic, potentially leading to fatalities and organ failure.
The extended timeline for action has stirred frustration among medical professionals who rely on these devices to manage critically ill patients, noting that the inaccuracies disproportionately affect Black and Hispanic populations. Dr. Theodore J. Iwashyna, a co-author of a pivotal December 2020 study in the New England Journal of Medicine that brought significant attention to this issue, expressed urgent concern over the need for improved devices.
The FDA’s spokesperson, Carly Kempler, explained that while updating the guidance for pulse oximeters is a priority, numerous bureaucratic steps often prolong the process. Despite this, the lack of speedy resolution continues to draw criticism, especially from those advocating for health equity, noting a pattern of slow responses to issues predominantly affecting people of color.
The principle behind the discrepancy lies in the way the devices operate. Pulse oximeters use light absorption to measure oxygen levels in the blood, but melanin present in darker skin can interfere with this process, leading to less accurate readings. Despite being a known issue among researchers for decades, awareness and urgency to correct it have been surprisingly sparse among clinicians and device manufacturers.
The problem’s persistence is highlighted by the insufficient testing standards for these devices. Current guidelines only require testing on 10 patients, which includes merely two with “darkly pigmented” skin, a practice criticized for its limited scope given the device’s widespread use. Experts like Dr. Valley, another co-author of the 2020 study, call for more concrete FDA guidance and better-designed devices that consider a broader range of skin tones during testing.
In addition to individual physicians calling for change, collective pressure has also come from a group of 25 attorneys general who, in November last year, urged the FDA to act urgently to mitigate these racial disparities. This correspondence underscored the entrenched bias not just in human interactions but also within the very tools and devices used in medical settings.
The FDA has indeed taken some actions, such as funding research and convening advisory panels to discuss and document the problem. In 2021, the FDA acknowledged the inconsistencies and risks of inaccuracies related to skin tone in a safety communication. Subsequent advisory panel meetings have led to calls for clearer labeling and more stringent testing requirements, yet noticeable improvements in regulations or device designs have lagged.
Those advocating for faster and more comprehensive reforms argue that real progress is hindered by manufacturers’ reluctance to acknowledge the scope of the problem, as echoed by Dr. Iwashyna’s criticism of the industry’s defensive stance against the demonstrated clinical harm caused by current devices. With the ongoing delay in rolling out new FDA rules, physicians and health equity advocates remain critical, calling for immediate actions such as issuing black box warnings and implementing stricter testing protocols to ensure device accuracy across diverse populations.
This ongoing controversy not only highlights the technical challenges in medical device functionality but also underscores a broader issue of equity and justice in healthcare, advocating for systemic changes to ensure all patients receive accurate and fair medical treatment.
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