Health disparities in medical devices have long been a concern, but the issue gained more attention in 2022 when Noha Aboelata, the CEO of a health clinic in Oakland, California, noticed the racial biases in pulse oximeters that were impacting her predominantly Black and brown patients. These devices were found to overestimate blood oxygen levels in individuals with darker skin tones, leading to inaccurate readings and potentially harmful consequences for patients.
To address this issue, Aboelata took action by suing 12 pulse oximeter manufacturers and distributors, aiming to push for more equitable devices. The lawsuit, filed nearly a year ago, has already seen some progress, with companies like Medtronic settling and taking steps to educate physicians about the limitations of their devices. These efforts include providing QR codes on devices that link to educational information on pulse oximetry and opening a lab to test future devices on a more diverse range of skin tones.
Despite these developments, experts like Sara Gerke from the University of Illinois College of Law emphasize that more needs to be done to design products that work effectively for everyone. Pulse oximeters, which measure blood oxygen levels by shining light through the skin, have been known to be less accurate in darker skin tones, leading to challenges in assessing the severity of conditions like Covid-19, especially in Black patients.
While the lawsuit is a step in the right direction, it alone cannot solve the problems with pulse oximeters. Several senators have urged the FDA to address the issue, and the agency has held public meetings calling for clearer labeling and more rigorous testing of these devices. However, delays in updating guidelines and addressing the concerns have left healthcare professionals frustrated, with many calling for urgent action to prevent further harm to patients.
Roots Community Health, Aboelata’s clinic, has reached settlements with several companies, including Veridian Healthcare, Gurin Products, and Zewa. Medtronic, a major player in the pulse oximeter market, has also settled in the lawsuit and committed to prioritizing patient safety through educational efforts and partnerships. However, other companies have yet to settle, leaving room for continued advocacy and pressure for change.
Looking ahead, experts are waiting for updated FDA guidance that could lead to the development of devices that work effectively across all skin tones. A shift towards more inclusive and accurate medical devices is crucial to addressing health disparities and ensuring equitable healthcare for all individuals. While progress has been made, there is still much work to be done to fix the underlying issues with pulse oximeters and other medical technologies.
As the healthcare industry continues to grapple with racial biases and disparities, initiatives like Aboelata’s lawsuit and advocacy efforts from healthcare professionals and experts play a vital role in driving change and promoting health equity for all patients.
The issue of racial bias in medical devices has recently come to light, with Medtronic adding a QR code to its devices that leads to educational materials on pulse oximeters. While this is a step in the right direction, many believe that it is just a small piece of the puzzle.
One individual commented, “It really is just a small piece of it. I do hope it’s a catalyst. I do hope it helps raise more awareness across the board, but I think we’re still a really long way from any justice on this issue.” This sentiment reflects the larger conversation surrounding racial bias in healthcare and the need for systemic change.
The addition of the QR code by Medtronic is a positive step towards educating healthcare professionals and patients about the limitations of pulse oximeters in accurately measuring oxygen levels in individuals with darker skin tones. This awareness is crucial in ensuring that all patients receive the same standard of care, regardless of their race.
However, many believe that more needs to be done to address the underlying issues of racial bias in medical devices. This includes diversifying clinical trials to ensure that medical devices are effective for all populations, as well as increasing education and training on cultural competency for healthcare professionals.
The conversation around racial bias in healthcare is complex and multifaceted, requiring a comprehensive approach to address the systemic issues at play. While the addition of a QR code to Medtronic’s devices is a step in the right direction, it is clear that there is still a long way to go in achieving justice on this issue.
Overall, the hope is that this small step will serve as a catalyst for larger change in the healthcare industry, leading to increased awareness and action to address racial bias in medical devices. It is through these collective efforts that true progress can be made towards achieving justice and equality in healthcare for all individuals, regardless of their race.
