Government announces review into potential bias in design and use of medical devices

A review has been launched by the Department of Health and Social Care (DHSC) into the impact of potential bias in the design and use of medical devices.

Assistive devices can be classed as medical devices, but it depends on the claims made by the manufacturer as to the product’s intended use. Otherwise, assistive devices can be classed as an aid to daily living, which is not a medical device.

Medical devices can include assistive products like wheelchairs, mobility scooters, and prosthetics, as well as products like oximeters and MRI scanners.

DHSC says there are concerns that the way medical devices are designed and used could mean a patient’s diagnosis and treatment is affected by their gender or ethnic background, exacerbating existing inequalities in healthcare.

Current UK regulations do not include provisions to ensure that medical devices are equally effective regardless of demographic factors, such as ethnicity.

The independent review will look at devices to identify potential discrepancies in how they work for different ethnic groups. As part of this, the review will consider whether existing regulations mean there is a systemic bias inherent in medical devices.

Existing research on this has highlighted the need for this issue to be further examined, the UK Government says, as these devices are critical for monitoring and deciding if treatment is needed for diseases, such as COVID-19, where every minute counts and accurate data is vital.

The review will examine medical devices currently on the market to identify areas of concerns in these products and aims to:

• take forward work on identifying where systematic bias and risk exist with existing approved devices
• make recommendations on how these issues should be tackled in the creation of a medical device from design to use, including potentially via regulation
• be future-focused and consider the enhanced risk of bias in the emerging range of algorithmic based data / artificial intelligence tools

All medical devices will be covered by the review. Details of who will be leading the review are to be confirmed in the near future.

It is hoped initial findings can be completed and presented by the end of January 2022.