Equity in Medical Devices

Monday 11th March 2024 Written Statements

[The Minister for Health and Secondary Care (Andrew Stephenson)]

The NHS is committed to upholding high standards in medical device safety. In response to emerging evidence of potential ethnic and other unfair biases in the design and use of some medical devices commonly used in the NHS, an independent review was commissioned by former Secretary of State for Health and Social Care, my right hon. Friend the Member for Bromsgrove (Sajid Javid).

Today, I am pleased to publish the final report of the independent review into equity in medical devices, alongside the Government’s response.

I would like to place on record my gratitude to the review chair, Dame Margaret Whitehead, and the panel who conducted this review. They embraced a comprehensive approach, involving stakeholders, fostering collaboration with clinical experts, NHS planners and policy advisors, engaging with health professionals on the frontline, educators and crucially, patients and the public. This deliberate approach underscores the importance and impact of the panel’s findings, and their recommendations are integral to our commitment to fostering a fair and healthy future for all.

The panel made 18 recommendations, taking these recommendations in turn:

Recommendations 1 to 3 focus specifically on pulse oximeters and cover immediate mitigation measures to ensure existing devices can perform to a high standard and improvements in international standards for approval of new device models.

Recommendations 4 to 7 focus on prevention of potential for harm through improved detection of bias in optical devices, including better research and testing, more robust monitoring and auditing and refreshed education for health professionals.

Recommendations 8 to 14 focus on enabling the development of safe and equitable artificial intelligence (AI) medical devices.

Recommendation 15 underscores the urgency of preparing for the transformative impact of large language and foundation models on healthcare and regulatory systems.

Recommendations 16 to 18 address equity concerns and societal challenges related to polygenic risk scores (PRS) in genomics. They emphasise the need for regulation in response to the influx of commercial PRS tests in the UK.

The Government’s response has been published alongside the final report. The Government welcome and acknowledge the importance of the outlined recommendations, endorsing its main argument that, unless appropriate actions are taken, biases can occur throughout the entire medical device life cycle.

We are dedicated to ensuring equitable medical device practices, spanning from design through to use. The Government have already initiated substantial efforts addressing many of the essential elements of the report’s recommendations, as detailed in the Government response. As we continue to drive progress, we welcome ongoing collaboration with industry partners, which is paramount to embedding best practices and supporting the NHS in delivering optimal and equitable care for all.

Both the final report from the independent review into equity in medical devices and the Government’s response will be deposited in the Libraries of both Houses, and published on www.gov.uk.

[HCWS329]