The Food and Drug Administration (FDA) has released long-awaited guidance on how pulse oximeters should be tested and labeled to ensure accuracy in people with darker skin tones. The document recommends testing the devices on a larger and more diverse population, with clearer guidelines on the makeup of populations and skin tones to be included in testing.
Previous guidelines required 200 data points for testing, but the new guidance suggests submitting 3,000 data points and increasing the sample size for studies to 150 or more participants. The FDA recommends using the Monk Skin Tone scale and the individual typology angle (ITA) scale to assess skin tones, with at least 25% of subjects in each of the light, medium, and dark skin tone groups.
The guidance also addresses the issue of racial bias in pulse oximeters, which has been a concern for decades. Studies have shown that these devices are less accurate in patients with darker skin, leading to potential misdiagnoses and inadequate treatment. The FDA’s new guidelines aim to ensure that pulse oximeters perform comparably across all skin tones.
The release of this guidance follows a 2021 safety communication from the FDA, advisory board meetings, and extensive studies conducted by the agency. While the guidelines are not legally enforceable, they provide recommendations for manufacturers seeking approval to market pulse oximeters. The FDA is seeking public comment on the guidelines before finalizing them.
Experts and healthcare professionals have welcomed the new guidance as a step in the right direction, but some believe that more needs to be done to address the issue effectively. ICU physician Tom Valley emphasized the importance of testing pulse oximeters on the patients for whom they are intended, particularly those with darker skin tones who may be most affected by inaccuracies.
The FDA also addressed concerns about previously approved devices that may not work equally on all skin tones. Manufacturers are encouraged to gather clinical data showing the efficacy of these devices on all skin tones and submit new labels for review under the 510(k) submission pathway.
Overall, the FDA’s new guidance on pulse oximeters represents a significant effort to address racial disparities in healthcare technology and ensure that all patients receive accurate and appropriate care, regardless of their skin tone. The FDA has announced plans to maintain a list of devices that have been proven to work equally well on all skin tones on its website, in an effort to promote transparency within the medical device industry. This move is seen as a positive step towards ensuring that medical devices are inclusive and effective for all patients, regardless of their skin color.
Carmel Shachar, an assistant professor of clinical law at Harvard School of Law, believes that the public website listing will serve as a motivational tool for manufacturers to ensure their devices are not biased. By providing a clear label stating that a device is not biased, manufacturers can attract healthcare providers who are looking for inclusive devices. This information will also be valuable for physicians who want to make informed decisions about the devices they use on a daily basis.
The guidelines set by the FDA apply to devices used in hospitals and doctor’s offices, but do not extend to devices sold directly to consumers for wellness or athletic purposes. However, some experts, like Gerke, believe that these over-the-counter devices should also be subject to the same requirements to ensure they work equally well for all users, especially since they are often used for medical reasons.
Lawmakers have been pushing the FDA to address this issue since 2021, and some manufacturers, like Medtronic, have already taken steps to address the issue. Medtronic has settled a lawsuit brought against them by a clinic in California that serves a large Black population and has committed to testing devices using the Monk Skin Tone scale to ensure equity. They plan to provide feedback to the FDA on this matter.
Despite these efforts, many individuals who rely on these devices remain frustrated with the FDA’s slow progress on the issue. Some doubt that voluntary guidelines will be enough to prompt manufacturers to improve the accuracy of their devices without enforcement. Theodore Iwashyna, a critical care physician and professor at Johns Hopkins University, has expressed skepticism about the effectiveness of the proposed guidelines without strict enforcement and compliance measures.
In conclusion, the FDA’s decision to maintain a list of devices that work equally well on all skin tones is a positive step towards promoting inclusivity in the medical device industry. However, there is still work to be done to ensure that manufacturers comply with these guidelines and that all patients receive equitable care. Continued pressure from lawmakers, healthcare providers, and patients will be essential to drive further progress in this area.