The Food and Drug Administration (FDA) has recently released long-awaited guidance on how manufacturers should test and label pulse oximeters that measure blood oxygen levels, particularly in people with darker skin tones. This move comes after years of complaints and concerns about the accuracy of these devices on individuals with darker skin.
The new guidelines recommend testing the devices on a larger and more diverse population, with a focus on including individuals with a range of skin tones. The FDA suggests that manufacturers use the Monk Skin Tone scale and the individual typology angle (ITA) to categorize skin tones for testing. At least 25% of participants should represent each of the light, medium, and dark skin tone groups, with a specific emphasis on including individuals with very dark skin in the testing process.
If a pulse oximeter demonstrates equal performance across different skin tones, the device package insert should prominently state that the device has been evaluated to perform comparably on individuals with a wide variety of skin tones. This guidance aims to address concerns regarding racial bias in the performance of pulse oximeters.
Studies have shown that pulse oximeters may be less accurate in individuals with darker skin tones, leading to potential disparities in healthcare outcomes. For example, some patients with darker skin may not receive proper treatment, such as supplemental oxygen, in emergency situations, which could result in organ failure or death.
The new FDA guidance is a significant step towards addressing these disparities, although some experts believe that more rigorous testing is necessary. ICU physician Tom Valley expressed concerns that pulse oximeters are not often tested on the patients who need them most, such as sick individuals in hospitals. He emphasized the importance of real-world data collection to ensure the devices work effectively for all patients.
Additionally, the FDA highlighted the need for manufacturers to provide clinical data showing the efficacy of pulse oximeters on all skin tones when submitting devices for approval. This data should be included in a new 510(k) submission, which would be reviewed within 30 days.
Overall, the FDA’s new guidance on testing and labeling pulse oximeters represents a positive step towards addressing racial disparities in healthcare technology. By emphasizing the importance of inclusivity and accuracy in device testing, the FDA hopes to improve healthcare outcomes for all individuals, regardless of their skin tone. The Food and Drug Administration (FDA) has announced that it will maintain a list of devices proven to work equally well on all skin tones on its website to promote transparency. This move is seen as a positive step towards ensuring equitable healthcare access for all individuals, regardless of their skin color.
Carmel Shachar, an assistant professor of clinical law at Harvard School of Law, believes that the public website will serve as a tool for manufacturers to showcase their devices as unbiased. By labeling their devices as suitable for all skin tones, manufacturers can attract healthcare providers who prioritize diversity and inclusivity in their medical practices.
Dr. Valley, a medical professional, emphasized the importance of having access to information about devices that work effectively on all skin tones. This information will help physicians make informed decisions about the equipment they use in their daily practice.
The FDA’s draft guidelines apply to devices used in hospitals and doctor’s offices, aiming to ensure that these devices are unbiased and accurate for all patients. However, devices sold directly to consumers for wellness or athletic purposes are currently not subject to FDA review. Some experts argue that these over-the-counter devices should also meet the same standards to guarantee equal performance for all users.
Lawmakers have been pushing for FDA action on this issue since 2021, following a lawsuit against pulse oximeter manufacturers, including Medtronic, by a clinic serving a predominantly Black population in California. Medtronic has expressed its commitment to achieving equitable care and is already working on testing devices using the Monk Skin Tone scale to ensure fairness.
Despite these efforts, some individuals remain skeptical about the FDA’s voluntary guidance and believe that enforcement is necessary to drive manufacturers to improve device accuracy. Critical care physician Theodore Iwashyna, co-author of a recent study on device accuracy, expressed doubts about the effectiveness of voluntary recommendations without enforcement.
Overall, the FDA’s initiative to maintain a list of devices that work equally well on all skin tones is a positive step towards promoting health equity. By encouraging manufacturers to prioritize inclusivity and accuracy, the FDA aims to improve healthcare outcomes for all individuals, regardless of their skin color.
