The Government has committed to taking action to remove ethnic and other biases in medical devices. The Department for Health and Social Care (DHSC) response on 11 March 2024 to the report on Equity in Medical Devices, “fully accepts” that bias can occur throughout the medical device lifecycle. 

The DHSC commissioned the Whitehead report in 2022 to examine health inequalities, including concerns in the pandemic that pulse oximeters used to determine oxygen levels did not give accurate readings across different skin tones, leading to negative health impacts for those with darker skin.

The report indicated the potential for racial and ethnic bias in the design and use of various medical devices used in the NHS, meaning  some ethnic groups were at risk of receiving worse treatment. 

The report reviewed three types of devices that may be particularly prone to bias:  

• Optical medical devices, including pulse oximeters – the review found that the light used to monitor oxygen levels reacts differently across different skin tones and this can adversely affect the treatment received by patients with darker skin. 
• Artificial Intelligence (AI)-assisted medical devices – due to the reliance on the data sets used to “train” AI-systems, any bias in that data risks being translated into a bias inherent in the relevant medical device. It was found that the prevalence of data focusing on white, male patients may lead to inaccuracies which negatively impact non-white ethnicities and women. 
• Polygenic Risk Scores – these devices calculate genetic risk factors for common diseases. However, for patients of non-European background these tests don’t predict risk as accurately due to the development and manufacturing of these devices being based on genetic data from European decent. 

The report flagged that bias can arise during any point of a medical device’s lifecycle, from the design and development process to the testing and monitoring in clinical use. The report made 18 recommendations to address these concerns:

• 1 to 3 on pulse oximeters, including immediate mitigation measures to ensure devices can perform to a high standard for all patient groups, improvements in international standards for approval of new models and the development of smarter devices that are equally effective across a wide range of skin tones.
• 4 to 7 on improved detection of bias in optical devices as a whole, better research and testing tools, more robust monitoring and auditing, and refreshed education of health professionals.
• 8 to 14 on the development of safe and equitable AI-assisted medical devices.
• 15 on the need to plan for the impact of AI-enabled medical devices.
• 16 to 18 on the societal challenges of genetic tests to assess the risk of diseases.

The Government response to the report accepts the main finding of the report and responds to each of the 18 recommendations, noting that action is already being taken in several areas to address the concerns. The response highlights that:  

• The Medicines and Healthcare products Regulatory Agency (MHRA) now requests that approval applications for new medical devices describe how they will address bias. This step is intended to ensure that manufacturers consider potential disparities during the design and development phase. Moving forward, the Government will work with the MHRA to ensure that regulations are safe for all patients while allowing innovative products to enter the market. 
• The Government will support ongoing work with NHS England to upskill clinical professionals on issues including health equity. NHS guidance has recently been updated to highlight potential limitations of pulse oximeters on patients with darker skin tone. 
• The National Institute for Health and Care Research is currently accepting funding applications for research into smarter oximeters, with the aim to improve the effectiveness and accuracy of these devices for all patients. 

The response comes amid wide-ranging reform of the medical device regulatory regime in the UK. You can read about these changes in our previous posts Key regulatory changes for Health Tech developers and MHRA reveals timeline for new medical device regulations.  

If you have any questions about the above or medical device regulation, please contact our Healthcare Team.

This article was written by Rory Trust and Chloe Francis.