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.