The Scope and Recommendations

The Review was prompted by concern that pulse oximeters, particularly important in the COVID-19 pandemic, might not be as accurate for patients with darker skin tones as for those with light skin tones. Against this backdrop, the Review was tasked with establishing the extent and impact of how potential racial, ethnic and other factors can lead to unfair biases in the design and use of medical devices.

The Review's recommendations aim to "ensure a high degree of protection for patients and the public and to strengthen the UK’s reputation for responsible and safe innovation in relation to medical devices for all who use them". The Review also highlighted that bias can be introduced at every stage of a device's lifecycle and emphasised the need for a system-wide approach in order to tackle the inequalities found in medical devices.

The Review's Findings

The Review focused on three types of medical device that may be particularly prone to unfair biases:

• Optical Medical Devices

Pulse oximeters, used to estimate oxygen levels in blood, were found to overestimate true oxygen levels in patients with darker skin tones leading to poorer performance. The COVID-19 pandemic highlighted that inaccurate readings could lead to harm if there was a delay in identifying dangerously low oxygen levels in patients with darker skin tones. 

The Review confirmed that evidence of this causing harm was found in the US healthcare system, although the Review did not find any evidence of care being affected in the NHS. However, the potential for harm was clearly present.

The Review recommended immediate mitigation measures be put in place. This included:

• issuing consolidated guidance to developers and manufacturers which addresses improving diversity in testing, investigating and development of medical devices;
• increasing skin tone diversity of medical imaging databanks and improving tools for measuring skin tone incorporated into optical devices; and
• reviewing medical education/ professional development requirements for health professionals which cover equity issues occurring in the use of medical devices.

The Review noted that for optical devices overall, they wanted "to prevent adverse impacts arising in new devices by adding an equity lens to the whole device lifecycle."

• Artificial Intelligence (AI) in Medical Devices

The Review explored the possible harm through inherent bias in AI specifically for women, ethnic minorities and those from disadvantaged socio-economic backgrounds.

Use of AI-enabled medical devices is now widespread and as AI has become incorporated into every aspect of healthcare, built-in bias has the potential to lead to poorer healthcare for the affected population groups. Going forward, the NHS would need to enable the development of bias-free AI devices. 

The Review recommended:

• incorporating the diversity of users of AI into medical devices and diagnostics;
• engaging AI as a Medical Device Change Programme; and
• researchers, developers and those deploying AI devices should ensure they are transparent about the diversity, completeness and accuracy of data through all stages of research and development.

The Review noted initiatives on equity and AI that are already underway by the MHRA, along with international collaborations. However, the Review highlighted a wider need to think and plan for potential unintended consequences arising from the AI revolution in healthcare.

• Polygenic risk scores (PRS) within genomics

PRS is used to assess risk of diseases that have multiple social, environmental and genetic causes. Although it has not yet been adopted by the NHS, PRS tests are available commercially to consumers. 

The Review noted however that data sources, upon which PRS are based, have bias against groups with non-European genetic ancestry. This could result in disruption to the efforts to tackle modifiable risk factors for disease and lead to PRS information being misinterpreted by the public, for example, it could lead to inaccurate beliefs about genetic determinism.

The Review's main action points called for:

• engaging with patients and the public so PRS studies are widened beyond genetic diversity;
• commissioning a broad programme of research and consultation to fill gaps in knowledge and understanding regarding PRS; and
• UK professional bodies should develop guidance for healthcare professionals on the equity and ethical challenges and limitations of applying PRS testing in patient care and population health programmes.

Future Work

The Review also noted that there should be an assessment of medical devices encountered during pregnancy and during neonatal care, as part of the wider investigations into bias and its impact on health outcomes for ethnic minority and poorer women and their babies.

Affirming that a core responsibility of the NHS is to maintain the highest standards of safety and effectiveness of medical devices available for all patients in its care, the Government has fully accepted the Review, agreeing "wholeheartedly" with the principle that medical technology should be unbiased and equitable. There was a determination to harness the transformative potential that MedTech has to improve patient care and efficiency. The government's commitment extends beyond solely supporting effective MedTech to fostering its equitable adoption. By doing so, "we aim to ensure that every individual across the country not only gains access to the health benefits offered by medtech, but that the tech itself plays a pivotal role in addressing health disparities". 

The MHRA have also welcomed the Review. They acknowledged that more needs to be done to address inequities in the regulation of medical devices and that they will take forward the recommendations of the Review. 

In particular, the MHRA will:

• work towards providing strengthened guidance to developers and manufacturers on improving diversity in testing, investigating and development of medical devices;
• engage in the Software and AI as a Medical Device Change Programme to ensure device regulation is fit for purpose, taking into account the diversity of users of AI and other software as a medical device and diagnostics;
• continue to strengthen their vigilance role, as specified in Baroness Cumberlege’s Independent Medicines and Medical Devices Safety review by listening to and engaging with patients and the public.

Conclusion

The specific recommendations of the Review and the wider perspectives it has put forward to tackle health disparities, should be welcomed by industry and patients alike.

The MHRA is in the process of developing new regulations for medical devices in the UK and published its regulatory roadmap in January 2024. This aimed at enhancing patient safety while ensuring the UK's ability to benefit from advances in MedTech. It will be vital for the MHRA to incorporate the work of the Review for its reform to meet its objectives. 

However, manufacturers and developers need not await the MHRA's further guidance but consider now how they can address issues of equity at every stage of the lifecycle of the medical devices they are developing.