Category: Press Releases

The press release issued by the Department of Health and Social Care on 11 March 2024.

Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices.

• Plan comes in response to independent report identifying the extent and impact of ethnic and other biases in the design and use of medical devices
• It is part of ongoing work to tackle disparities within the healthcare system, which includes addressing issues from the design stage and extra funding for applications for new devices that work without bias

The government has today announced action to tackle potential bias in the design and use of medical devices, as it accepts recommendations from a UK-first independent review into equity in medical devices.

The Department of Health and Social Care commissioned senior health experts to identify potential biases in these devices and recommend how to tackle them.

The government fully accepted the report’s conclusions and has made a series of commitments, including ensuring that pulse oximeter devices used in the NHS can be used safely across a range of skin tones, and removing racial bias from data sets used in clinical studies.

Minister of State, Andrew Stephenson, said:

I am hugely grateful to Professor Dame Margaret Whitehead for carrying out this important review.

Making sure the healthcare system works for everyone, regardless of ethnicity, is paramount to our values as a nation. It supports our wider work to create a fairer and simpler NHS.

Ministers agree that unless appropriate action is taken, ethnic and other unfair biases can occur throughout the medical device life cycle, from research, development and testing, to approval, deployment and post-market monitoring, as well as in the use of devices once deployed.

As a result, significant action is already being taken to overcome potential disparities in the performance of medical devices. This includes:

• the Medicines and Healthcare products Regulatory Agency (MHRA) now requests that approval applications for new medical devices describe how they will address bias
• NHS guidance has been updated to highlight potential limitations of pulse oximeter devices on patients with darker skin tone
• the National Institute for Health and Care Research (NIHR) is currently accepting funding applications for research into smarter oximeters

The government will also:

• work with MHRA to ensure regulations for medical devices are safe for patients, regardless of their background, while allowing more innovative products to be placed on the UK market. This includes a commitment to ensure pulse oximeters are safe and effective for all patients, with work underway to mitigate any inaccuracy in the devices
• drive forward work to remove racial bias in datasets, including ensuring diverse skin tones are included in data used by researchers for clinical studies
• support ongoing work with NHS England to upskill clinical professionals on issues including health equity
• work with partners to improve transparency of data used in the development of medical devices using artificial intelligence (AI), as well as AI products which influence clinical decisions

The government appointed Professor Dame Margaret Whitehead, professor of public health at the University of Liverpool, to lead the review. Professor Whitehead has vast experience in tackling health inequalities, and for many years has led the work of the World Health Organization’s Collaborating Centre for Policy Research on the Determinants of Health Equity.

The review followed concerns that pulse oximeters – widely used during the COVID-19 pandemic to monitor blood oxygen levels – were not as accurate for patients with darker skin tones, which could have led to delays in treatment if dangerously low oxygen levels in patients with darker skin tone were missed. However, the review found no evidence from studies in the NHS of this differential performance affecting care.

The medical devices review focused on 3 areas – optical devices such as pulse oximeters, AI-enabled devices and polygenic risk scores (PRS) in genomics.

Professor Dame Margaret Whitehead, chair of the review, said:

The advance of AI in medical devices could bring great benefits, but it could also bring harm through inherent bias against certain groups in the population, notably women, people from ethnic minorities and disadvantaged socio-economic groups.

Our review reveals how existing biases and injustices in society can unwittingly be incorporated at every stage of the lifecycle of AI-enabled medical devices, and then magnified in algorithm development and machine learning.

Our recommendations therefore call for system-wide action, requiring full government support. The UK would take the lead internationally if it incorporated equity in AI-enabled medical devices into its global AI safety initiatives.

The review also recommended ways of developing bias-free medical devices in the future and to improve standards globally.

Dr June Raine, MHRA chief executive, said:

MHRA acknowledges that inequities can exist within medical devices and we therefore welcome the publication of Dame Whitehead’s independent review.

We are highly committed to ensuring equitable access to safe, effective and high-quality medical devices for all individuals, and the recommendations set out in this report will support and strengthen the impact of our ongoing work in this area.

We are committed to working collaboratively with government, regulatory bodies, healthcare professionals and stakeholders to address these issues effectively.

Professor Bola Owolabi, NHS England’s director of healthcare inequalities, said:

Ensuring all patients get equitable access to high-quality healthcare remains crucial to reducing health inequalities and a priority for the NHS.

I welcome the report’s findings and the NHS will work alongside government and MHRA to implement them and ensure NHS staff have the resources and training they need to tackle racial bias.

There is ongoing work to ensure healthcare is equitable. In recent years, the government has created schemes providing targeted support for the cost of living and the COVID-19 pandemic and established the Office for Health Improvement and Disparities (OHID), a government unit dedicated to reducing negative health disparities across the country.

We have:

• commissioned work like Core20Plus5, a national NHS England approach to inform action to reduce healthcare inequalities
• established the Maternity Disparities Taskforce
• invested £50 million in health inequalities research for local authorities

The press release issued by the Department of Health and Social on 10 March 2024.

The investment will be provided over the next 3 years to ensure maternity services listen to and act on women’s experiences.

• £35 million investment to fund specialist training for staff and additional midwives to improve maternity services
• £9 million dedicated to prevent avoidable brain injuries in childbirth
• women’s voices and experiences to be prioritised with funding allocated to improve care

Almost £35 million will be invested to improve maternity safety across England with the recruitment of additional midwives and the expansion of specialist training to thousands of extra healthcare workers.

The investment, which was announced as part of the Spring Budget 2024, will be provided over the next 3 years to ensure maternity services listen to and act on women’s experiences to improve care.

The funding includes:

• £9 million for the rollout of the reducing brain injury programme across maternity units in England, to provide healthcare workers with the tools and training to reduce avoidable brain injuries in childbirth
• investment in training to ensure the NHS workforce has the skills needed to provide ever safer maternity care. An additional 6,000 clinical staff will be trained in neonatal resuscitation and we will almost double the number of clinical staff receiving specialist training in obstetric medicine in England
• increasing the number of midwives by funding 160 new posts over 3 years to support the growth of the maternity and neonatal workforce
• funding to support the rollout of maternity and neonatal voice partnerships to improve how women’s experiences and views are listened to and acted on to improve care

Ahead of Mother’s Day, the Health and Social Care Secretary visited Cambridge University Hospital. She spoke with health experts from the hospital and microbiology faculty about a range of women’s health issues, including maternity care and breast cancer.

Health and Social Care Secretary Victoria Atkins said:

I want every mother to feel safe when giving birth to their baby.

Improving maternity care is a key cornerstone of our Women’s Health Strategy and with this investment we are delivering on that priority – more midwives, specialist training in obstetric medicine and pushing to improve how women are listened to in our healthcare system.

£35 million is going directly to improving the safety and care in our maternity wards and will move us closer to our goal of making healthcare faster, simpler and fairer for all.

This investment follows a recent announcement of a new set of Women’s Health Strategy priorities for 2024, which include:

• better care for menstrual and gynaecological conditions
• expanding women’s health hubs to improve women’s access to care
• tackling disparities and improving support for vulnerable women including victims of sexual abuse and violence
• bolstering maternity care before, during and after pregnancy by continuing to deliver on NHS England’s 3-year delivery plan for maternity and neonatal services and focusing on preconception and postnatal care for women, raising awareness of pregnancy sickness and actioning the recommendations set out in the Pregnancy Loss Review
• investment into more research in women’s health and improving how women are represented in medical research

Minister for the Women’s Health Strategy, Maria Caulfield, said:

This extra funding will help clinicians deliver the best care for expecting mothers and improve maternity safety.

I especially welcome the expansion of posts for midwives, who play a crucial role in delivering babies safely and caring for expectant mother pre- and postnatally.

Crucially, as part of this investment, we’re also rolling out a training programme to prevent avoidable brain injuries in childbirth.

As part of the government’s  commitment to action the recommendation of the Pregnancy Loss Review, the baby loss certificate service launched last month to allow parents who experienced a pregnancy loss before 24 weeks to apply for a certificate to acknowledge their loss. Since the launch of the service, as of 4 March 2024, the total number of completed requests was 37,268.

Chief Midwifery Officer for England, Kate Brintworth, said:

We are focused on ensuring that women receive the safest high-quality care before, during and after their pregnancy.

The rollout of maternity and neonatal voice partnerships is an important step in improving care by listening to women’s views and experiences and acting upon them.

Our workforce must also have the right skills for improving maternity safety and this investment helps ensure all those working in maternity services in England have the tools and training to reduce avoidable brain injuries in childbirth.

We will continue our plans to grow the midwifery workforce and nearly double the number of staff who have received specialist training in obstetric medicine in England.