Review launched to study the effects of biases in the design and usage of medical devices

A comprehensive review is currently underway to assess the impact of biases on the design and use of medical devices.

There are concerns that the way in which medical technology and devices are developed and used could mean that a patient’s diagnosis and treatment are affected by their gender or ethnic background, thereby causing more inequities within healthcare.

The coronavirus (COVID-19) pandemic has exposed health disparities across the United States as the virus had a greater impact on those whose health was less good and deaths rates were higher among people from ethnic minorities.

Although the UK regulations are clear about their requirements, they don’t currently provide any guidelines to ensure that medical devices are used equally regardless of ethnicity.

Independent review will investigate devices like oximeters, which are used to determine oxygen levels, and to determine the differences in their performance between different ethnic groups. As part of this review, the review will look at whether the existing regulations suggest there is a systemic bias inherent in medical devices.

For instance certain studies have concluded that those with darker skin tones who need to be hospitalised are at a higher risk of inaccurate results from oximeters due to the tendency of this group to show higher levels of oxygen in their blood.

Research on this subject has highlighted the necessity for this issue to be studied further, since these devices are crucial in determining if treatment is needed for diseases like COVID-19. every minute counts and accurate data is vital.

All devices will be covered by the review. A further example is MRI scanners that are currently not recommended for use for pregnant or nursing mothers, and further research is required to determine how to broaden the scope of equipment’s use that this review aims to do.

Patients can rest assured that the NHS is an expert in providing the best possible treatment using the technology currently in use, and the review is designed to accelerate the process of improving the quality and availability of the devices to the diverse communities.

The specifics of who will conduct the review will be laid out in due course.

Current UK regulations offer clear expectations but there is a rising risk of inequalities , as devices are developed at pace and focus on large patient groups.

Being able to stay outside of EU regulations allows the UK to increase its focus on making sure that devices are properly developed and tested to ensure that they are able to serve the full variety of our diverse communities.

The review will analyze medical devices currently on the market to find areas of concern in these products. The review aims to:

  • Continue to work on identifying areas where there is systematic risk or bias in existing approved devices

  • Provide suggestions on how to address these issues when creating of a medical product from conception to use, and possibly via regulation.

  • Be forward-looking and take into consideration the higher risk of bias with the new variety of data analysis algorithms/ artificial intelligence tools

It is hoped that the first findings will be published in January 2022.

Content Source:

Gemma Wilson

Gemma is a journalism graduate with keen interest in covering business news – specifically startups. She has as a keen eye for technologies and has predicted quite a few successful startups over the last couple of years.

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