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UK government to tackle ethnic and other biases in medical devices

Significant action is being taken to overcome potential disparities in the performance of medical devices, ministers have said

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The UK government has announced action to tackle potential bias in the design and use of medical devices after an independent review raised concerns over AI devices and pulse oximeters used in the NHS.

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 said it fully accepted the report’s conclusions and made a series of commitments, including making sure 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 agreed 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.

They said “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 appointed Professor Dame Margaret Whitehead, professor of public health at the University of Liverpool, to lead the review.

The review followed concerns that pulse oximeters – widely used during the 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, it found no evidence from studies in the NHS of this differential performance affecting care.

The medical devices review focused on three 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, Whitehead said, 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, added: “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.”

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UK reviews surrogacy firm over rejected insurance claims

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The UK government is reviewing a surrogacy firm after complaints that medical insurance claims involving surrogates in Mexico were rejected.

The Department of Health and Social Care (DHSC) is considering whether UK-based provider My Surrogacy Journey should remain listed on gov.uk as one of four domestic surrogacy agencies available to intended parents.

The review follows allegations concerning its Mexican sister company, where surrogates are based.

Health minister Diana Johnson said: “The department is looking into the allegations about My Surrogacy Journey.

“As part of that assessment, the department will consider whether it is appropriate for that company to remain on the gov.uk list of agencies.”

Emails sent by My Surrogacy Journey chief executive Michael Johnson-Ellis and seen by the Guardian suggest multiple surrogate women in Mexico had their insurance claims rejected.

The emails also suggest 300 couples using the company were moved to a new insurance provider because of the increased risk of claims being rejected.

Commercial surrogacy is banned in the UK, where only altruistic arrangements are permitted.

My Surrogacy Journey operates a not-for-profit UK branch alongside for-profit sister companies in Mexico and the US. All three companies have the same owners and chief executives.

The reported insurance issues relate to surrogacy arrangements in Mexico.

One couple told the Guardian they paid tens of thousands of pounds to cover medical costs after their surrogate had a hysterectomy during childbirth and an insurance claim was refused.

The Guardian said it understood that at least five sets of parents said they had to cover medical costs after insurance claims were rejected.

In an email to the couple whose surrogate underwent a hysterectomy, Johnson-Ellis wrote: “We have already told you that the insurance companies have been declining some of the claims and we are actively working with the broker to get this issue resolved but you should also consider that they may not be paid out and there is nothing we are able to do to change this …

“We appreciate this is not an insignificant sum but this genuinely is out of our control.”

Johnson-Ellis also said the company had switched insurance providers, writing: “We’re also managing this for 300 other journeys, which is a complex position to be in.”

Lawyers acting for My Surrogacy Journey said the company did not comment on individual cases, but that existing insurance policies were in place and claims continued to be accepted and processed.

They said the company understood that a small number of claims had been rejected and was supporting people seeking to resolve those claims with an insurer.

Under the surrogacy arrangements, intended parents are understood to be contractually required to cover medical costs not paid by an insurer.

The couple said they had been recommended the company’s Mexico option. Its website advertises that intended parents using the route can have a baby in “under 18 months”.

They said they were told the UK route could take up to five years and that the US option was much more expensive.

Lawyers for My Surrogacy Journey said prospective parents are given information about typical timelines, costs, legal frameworks and practical considerations, and that the 18-month timeframe is indicative only.

The couple said their surrogate developed placenta accreta, a serious condition in which the placenta attaches to the wall of the uterus.

Emails from Johnson-Ellis acknowledged that the insurance provider investigated the birth after the surrogate experienced health complications.

The parents are considering legal action, while the Guardian said it understood at least four other couples were reviewing their options.

Phil Brickell, MP for Bolton West, raised concerns in parliament about a separate couple who had used My Surrogacy Journey.

He said: “Two of my constituents recently travelled to Mexico, where their children were born by surrogacy.

“Those births were facilitated by a company called My Surrogacy Journey, which is listed on gov.uk.

“While in Mexico, they had repeated traumatic experiences with the company relating to issues including insurance for their children, accusations of bullying towards staff and repeated efforts to silence any constructive criticism.

“I understand that other members of this house have received similar complaints.”

Brickell called for My Surrogacy Journey to be removed from gov.uk pending a review by the Human Fertilisation and Embryology Authority.

Lawyers acting for My Surrogacy Journey said the company was communicating with DHSC and was confident any issues could be resolved.

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‘Limited scientific evidence’ for most menopause supplements, expert says

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Many menopause supplements contain ingredients with limited evidence for symptom relief, while formulations and prices vary widely, a study has found.

Researchers analysed 201 products sold by nine major UK retailers, comparing their ingredients, doses and monthly costs.

Prices ranged from £1.50 to £95 a month, while no single ingredient or category of ingredient was common across all products.

The study, carried out by University College London, found that 80 per cent of products contained herbs, 77 per cent contained vitamins and 74 per cent contained phytoestrogens, naturally occurring plant compounds found in foods including soy and flaxseed.

Vitamin B6 was the most common vitamin, while red clover and sage were the most frequently identified plant ingredients.

Researchers said more evidence was needed on the effectiveness and safety of supplements marketed for menopause symptoms.

Professor Joyce Harper, senior author of the study and professor of reproductive science at University College London, said: “The menopause supplement market is growing rapidly, despite limited scientific evidence that many of these products improve menopause symptoms.

“Some social media influencers promote these products as effective solutions, despite many claims not being supported by scientific evidence.

“This can contribute to the spread of misinformation and help drive a rapidly growing menopause supplement market, leading some women to spend substantial amounts of money on supplements in the hope of improving their symptoms and overall wellbeing.”

Half of the supplements did not contain vitamin D, while less than 24 per cent contained calcium.

The British Menopause Society and International Menopause Society have highlighted vitamin D and calcium as important for maintaining bone health and preventing osteoporosis after menopause.

Researchers also identified botanical ingredients that may carry risks, including black cohosh.

Poppy Sullivan, first author of the study, said: “Certain botanical ingredients in some menopause supplements may also have risks.

“Black cohosh, in particular, is known to carry a potential risk of liver toxicity.”

The amounts of vitamins and minerals included in different products also varied widely.

Sullivan said: “Some nutrients can have adverse effects when consumed in excess over time.

“For example, excessive vitamin D intake can theoretically lead to high calcium levels, which could cause adverse effects such as vomiting and confusion.”

The study found little empirical evidence supporting the effectiveness of even the most expensive products.

Researchers called for more high-quality research, including clinical trials, to determine whether menopause supplement ingredients are effective and safe.

They said the findings could also help healthcare professionals understand the wide variation in supplement formulations.

The researchers acknowledged that the analysis may not have included every menopause supplement available in the UK.

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Ultrasound Direct extends Trice Imaging partnership

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Ultrasound Direct has extended its Trice Imaging partnership for three years, adding a reporting tool across its 70-clinic UK network.

The private ultrasound provider will continue using the Tricefy platform for secure image storage and patient engagement, alongside TriceIQ for efficiency and productivity analytics.

It will also introduce Trice Workspace Reporting across its network. The companies say the tool will help standardise ultrasound reporting templates and workflows and reduce variation between clinics.

Ultrasound Direct carries out an estimated 120,000 patient scans each year across services including pregnancy, fertility, women’s health, men’s health and other diagnostic pathways.

Its network uses a large pool of sonographers working across different ultrasound systems and serves referral routes including self-referring patients, GPs and commercial partners.

Mike Steward, founding director at Ultrasound Direct, said: “Having worked with Trice Imaging since 2018, we first partnered to replace manual methods of providing scan images to expectant parents with Trice’s secure electronic image-sharing platform. Today, every study performed across the Ultrasound Direct Network is recorded and stored on Tricefy, while our clinical services have expanded considerably beyond pregnancy into fertility, women’s health, men’s health and other diagnostic pathways.”

He added: “To continue futureproofing our image management strategy across a network of 70 clinics, a large team of sonographers, varying ultrasound systems and a growing number of referral partners with different needs, we decided to extend with Trice Imaging. This includes the introduction of the new Trice Workspace Reporting module to help us scale and standardise our ultrasound reporting templates and workflow, reducing variability between clinics.”

The partnership began in 2018, initially focusing on replacing manual methods of sharing pregnancy scan images with expectant parents.

Johanna Wollert Melin, founder and chief executive of Trice Imaging Europe, said: “Ultrasound Direct has been a valued partner in the UK for 8 years.”

She added: “At the heart of the relationship is a willingness to explore new ideas, test new tools and the spirit to solve real challenges across a large and complex clinical network.”

Mark A. Samii, chief revenue officer at Trice Imaging, said: “We are delighted to retain and extend our relationship with Ultrasound Direct.”

He added: “The addition of Trice Workspace Reporting addresses a challenge we hear from multi-site providers globally – keeping reporting quality consistent across many users, systems, referral or payer relationships.”

Steward said Ultrasound Direct continues to see growing demand for private diagnostics alongside NHS care from self-referring patients and an increasingly diverse range of professional and commercial referral partners.

He added: “As that development continues, scalable digital infrastructure becomes increasingly important. Our focus is on ensuring that a growing national network can support consistent clinical workflows, different referral pathways and the technology requirements of the future, while continuing to provide patients with accessible diagnostic services.”

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