Health Citizens – European Research Center

Tag: Medical Devices

  • Equity in medical devices: independent review

    Equity in medical devices: independent review

    Medical devices are often assumed to work equally well for everyone, but an independent review commissioned by the UK government shows this is not always the case. The review began after concerns that pulse oximeters, which measure oxygen levels in the blood, may be less accurate for patients with darker skin. It found that these devices overestimate oxygen levels in people with darker skin tones. In US studies, this has been linked to delayed recognition of disease and to denied or delayed treatment.

    The review found similar problems in other devices. Devices that measure bilirubin through the skin may overestimate its levels in babies with darker skin. Ventilators have default settings designed for men. AI tools that help detect skin cancer may have been trained mostly on images from people with fair skin, and an X-ray dataset that underrepresented women led to lower accuracy when diagnosing them. Genetic risk scores, which estimate a person’s risk of disease, are based on data that is overwhelmingly from people of European ancestry and may not work as well for other groups.

    To address these problems, the review makes 18 recommendations to the government, regulators, the NHS and device developers, from more diverse data and clinical trials to regular checks for bias once devices are in use.

    Learn more about this review here: https://www.gov.uk/government/publications/equity-in-medical-devices-independent-review-final-report/equity-in-medical-devices-independent-review-summary-report

    Reference:

    Whitehead, M., Ali, R., Carrol, E., Holmes, C., & Kee, F. (2024). Equity in medical devices: Independent review. Final report. Department of Health and Social Care.

  • FDA proposes updated recommendations to help improve performance of pulse oximeters across skin tones

    FDA proposes updated recommendations to help improve performance of pulse oximeters across skin tones

    Pulse oximeters are small devices, usually placed on a finger, that estimate the level of oxygen in the blood. Evidence shows they may be less accurate in people with darker skin. This problem gained wider attention during the COVID-19 pandemic, when inaccurate readings led to delayed treatment for some patients with darker skin.

    In January 2025, the US Food and Drug Administration (FDA) proposed draft guidance with updated recommendations for pulse oximeters used for medical purposes, mainly in hospitals and doctors’ offices. Manufacturers should collect clinical data to assess how accurate their devices are across different skin tones. They should also include more study participants, so that studies better reflect the patients who will use the device, and use standardised methods to classify participants’ skin tone, such as the Monk Skin Tone scale.

    The FDA also recommends that labels clearly state any limitations of the device for different skin tones, and it plans a public website listing cleared pulse oximeters. The guidance does not cover devices sold for general wellness or sports. Together, these measures aim to help patients and health professionals identify devices that work reliably for everyone.

    Learn more here: https://www.fda.gov/news-events/press-announcements/fda-proposes-updated-recommendations-help-improve-performance-pulse-oximeters-across-skin-tones

    Reference:

    U.S. Food and Drug Administration. (2025, January 6). FDA proposes updated recommendations to help improve performance of pulse oximeters across skin tones [Press announcement].