InnoScot Health is urging the medical device industry to take advantage of a UK government consultation to air views on potential health inequalities around device design, development, evaluation, and use

The Department of Health and Social Care has opened its independent review, entitled ‘Equity in medical devices.’ It lasts for eight weeks and closes on Thursday 6 October 2022 with the option for submissions to be made anonymously.

The UK government says that one of its priorities is to tackle health inequalities after the COVID-19 pandemic exposed health disparities, with the virus having a greater impact on those whose underlying health was poorer and death rates higher among people from ethnic minority communities.

Former Secretary of State for Health and Social Care, Sajid Javid, commissioned the review with that issue specifically in mind.

It aims to establish “where and how potential ethnic and other unfair biases may arise in the entire lifecycle of medical devices, and the extent and impact of these, and to make recommendations for more equitable solutions.”

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell believes the consultation is an important opportunity to offer vital evidence, reduce biases, and help shape a more equal future through the design, development, and use of medical devices.

She said: “The pandemic has led to concerns that the way medical devices and technologies are designed and used could mean a patient’s diagnosis and treatment is affected by their gender or ethnic background, in turn exacerbating existing inequalities in healthcare.

“This consultation is therefore a vital chance to submit data and evidence related to ethnic and unfair biases which could affect the effectiveness or safety of medical devices for different populations. It’s also a way of helping to identify solutions and drive forward new international standards for improving equity in the development or use of medical devices.”

The government has launched the call for evidence in order to collect existing data and evidence as well as information on ongoing data collection and research or evaluation projects. It is thought to be particularly relevant to those who engage in any way in the design, development, evaluation and use of medical devices.

Patients and members of the general public can also use the call to share their views and insights.

The review focusses on all types of medical device including for example:

• devices employing infrared light or imaging that may perform differently depending on skin pigmentation of the patient
• artificial intelligence (AI) enabled applications used in diagnostics and for making decisions about healthcare, which might have problems with the clinical algorithms built into them
• polygenic risk scores used for personalised medicine

A webinar will take place on Wednesday 7 September, and offer the opportunity to ask questions on the review, and set out how you can be involved.