Ethnic Bias in Medical Devices: UK Government’s 18 Recommendations

An independent review by the UK government has highlighted ethnic biases in medical devices. Some medical devices used widely by the NHS were shown to be less accurate for people with darker skin tones. The review by Professor Dame Margaret Whitehead and specialist advisors calls for urgent redesign of medical devices to be equitable and makes 18 recommendations for improvement.

The importance of unbiased medical devices

Biases in medical devices can lead to poorer health outcomes for ethnic minorities, underscoring the need for diverse testing and calibration. The UK government says system-wide action is needed to ensure medical devices and healthcare technologies are fair and effective for all communities.

From the report

Pulse Oximeters

Recommendations 1 to 3 specifically target pulse oximeters. They aim to:

• Implement immediate actions to ensure current pulse oximeters work well for all patients, preventing significant health disparities.
• Enhance global standards for approving new pulse oximeter models.
• Develop advanced devices for measuring blood oxygen levels that work effectively for diverse skin tones.

Do you sell medical devices in the UK? Medical Devices manufacturers require a UK Authorised Representative to sell in the UK.

AI Medical Devices

Recommendations 8 to 14 have the aim of enabling the development of safe and equitable AI medical devices. It includes:

Recommendation 11:

Stakeholders across the device lifecycle should work together to ensure that
best practice guidance, assurance and governance processes are co-ordinated
and followed in support of a clear focus on reducing bias, with end-to-end
accountability. This should include…

The report goes on to mention Good Machine Learning Practice (GMLP) which is a guide for manufacturers on the development of unbiased AI-enabled medical devices.

Resource

Official UK Government Report