Not long ago, during the peak of COVID, many people lost their lives. The situation was miserable as the resources were burning out, medical stores were short on supplies, and the cherry on the top was the bias in medical devices. At such times, some articles came up suggesting that people from brown ethnicities were more prone to develop severe COVID-19 infection. One such study was that brown people were twice as likely to contract the virus. It further stated that people of Asian heritage were 1.5 times more prone to get infected than their white counterparts. But, the reason for this discrimination was not fully understood and required further study.

Bias In Medical Devices

Recently, the UK health secretary, Sajid Javid, declared a review on systemic bias and racism in medical devices. He announced the review bias and declared it unacceptable at any level. According to him, the pandemic highlighted the health disparities among race and gender. He added that one-third of admissions in intensive care during the pandemic's peak was a black and ethnic minority. That was more than double of their population.

This Sunday, the anchor Andrew Marr invited the UK health and social care secretary on his show. He asked Javid about his views on the deaths of people as oxygen-measuring devices didn't work well on people with dark skin. At which he replied, "I think possibly yes, yes. I don't have the full facts."

In Sunday times, Javid wrote, It is easy to assume that everyone's having the same experience from the machine. "But technologies are developed and created by people, and so bias, however inadvertent, can be a problem here too."

Oximeters

Let's start from a mere example of oximeters, a device that gained popularity during the COVID. It estimates the amount of oxygen in a patient's blood by sending an infrared light. The portable device has a significant role in determining the need for hospitalization. People with dangerously low levels of oxygen in the blood (hypoxemia) often need immediate hospitalization. 

However, there are some concerns that oximeters may give different readings on different people, especially those who belong to ethnic minorities. Experts believe the inaccuracies in readings could be the reason behind the higher death rates among minority ethnic people.

Back then, in July, NHS England and the medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said, "pulse oximeters may sometimes overestimate oxygen levels." 

Concerning this, the NHS England issued updated guidance, advising patients from ethnic minority groups such as Asians and black to seek advice from a healthcare professional regarding pulse oximeters. 

In addition, Javid revealed that the devices were intended for Caucasians in his statement to Guardian last month. He further added, "Therefore, you were less likely to end up on oxygen if you were black or brown because the reading was just wrong."

Probability Of Fluctuation In Readings

What could be the reason that the same oximeter gives different readings on different skin colors? According to the experts, the light passes through the skin to reach the blood to record the blood oxygen level. However, skin pigmentation can affect the absorption of light, hence the reading of the oximeter.

Earlier this year FDA, in his safety communication regarding the safety and limitations of a pulse oximeter, referred to the research of the University of Michigan Medical School. In the retrospective study, Michael W. Sjoding and his team observed that hypoxemia in black people was three times more frequently than their white counterparts when detected by blood gas measurements. The results suggest reliance on oximeter and supplemental oxygen can increase the risk for hypoxemia in people with darker skin. However, apart from race and ethnicity, there were other factors as well. Therefore, their findings highlight a need to learn more about clinical bias. The Food and Drug Authority also agreed to evaluate the association between skin color and the efficacy of an oximeter.

Respiratory Masks

Moving forward, respiratory masks, the essential part of Personal Protective Equipment (PPE), are also suspected to be biased. The mask must fit perfectly on the face to provide efficient protection against the viral particles filtering, and that's where the problem arises. Since people from different races have different facial indexes, it seems pretty impossible to have one or two sizes for all. 

Some reviews that have been published recently are also supporting the fact. One published last year stated that initial fit pass rates could vary from 40% to 90%, and these rates are low in females and Asians. The other one that was published this year throws light on the design of respiratory masks. According to it, most are suitable for Caucasians and single ethnic populations. However, the people from Balck, Asian, and Minority Ethnic (BAME) remained underrated. The primary reason, according to the study, is the different facial dimensions (FD). The study itself stated that BAME people have different facial dimensions to Caucasians. Hence, the respirators need to accurately fit the wearer's face to provide sufficient protection against the viral particles.

Spirometer

Another medical device that has been used widely in COVID times is the Spirometer. Its role is to measure lung capacity, which helps rule out several pathological conditions ranging from obstructive to restrictive lung disorders and many more. But, the question that arises here is, do people from all races and ethnicities share the same lung capacity? If they do not, then what should be the parameter to assess lung function?

Although not many studies are available to date, researchers from different fields are stepping forward to understand clinical bias. Similarly, Dr. Achuta Kadambi, a computer scientist and electrical engineer at the University of California, Los Angeles, believes that Asian or Black ethnicities have lower lung capacity than white people.

To rule out the possibility of any error, the factor of "correction" applies to interpret the data of a spirometer. The practice is not that common as lung capacity also depends on several other conditions and lifestyles. However, the ethnic adjustment suggests 10% to 15% smaller lung capacity for Black people and 4% to 6% smaller lung capacity for Asians compared to their White counterparts. These ethnic adjustments in medical devices have their drawbacks as well as they can exacerbate racial disparities in recovery from COVID-19.

Plethysmograph 

Another point that Kadambi raised was wrong or misinterpreted pulse readings in people with higher melanin concentrations. Plethysmography, a non-invasive method, measures the blood volume and pulse in different body parts by observing the skin changes. The findings of plethysmography are dependent on many factors such as lightning or skin color. Such visual cues can differ because of the melanin deposition, a pigment that gives the skin its color.

Artificial Intelligence 

With the advancement in Artificial Intelligence (AI) in medicine, it has become easier to get an accurate diagnosis without unnecessary testing and undue expenditure. Several medical devices help to suggest the diagnosis based on their imaging skills and AI. Some interpret skin conditions that can vary from minor issues to lethal diseases such as skin carcinomas. As we know, people with different skin colors can present with different appearances of lesions. However, only a handful of images in the databases belong to individuals with dark skin color. Concerning this, there could be the chance that the AI system can miss it and lead to misdiagnosis. Especially in cases of skin cancer and diabetic retinopathy.

Measures To Solve The Issue

UK health and social secretary Javid also acknowledged the issue. In his statement, he said that if we feed our Artificial Intelligence with the data from white patients, it can't help our population as a whole. We need to have data that is representative of our nation. Not only this, but he also announced the funding to support the development of AI. It will make sure the databases for AI are inclusive or diverse so that no one deprives it because of his race. This support plan will tackle racial inequalities and level up healthcare.

According to the health and social secretary of the UK, he was committed to removing the barrier. So that everyone, no matter the background, can live healthier, longer lives.

Conclusion

To conclude, medical devices can also be subjected to clinical bias. Since different people belong to different ethnicities, there is always a chance of fluctuation in the readings of medical devices. The health secretary Javid accepted that oxygen measuring devices do not work well on darker skin tones. He further clarified that people create technologies, and inadvertently can be an issue.

Whether it is an oximeter or a Spirometer, the probability of different readings in people of other races is always there. Even the same-sized respiratory mask doesn't work for all because of a difference in facial dimensions. In addition, people with higher melanin deposition can also face a wrong reading. Whether it is plethysmography or AI detecting skin cancer, there are chances of missing the crucial information. Most probably because of limited datasets. To overcome this, the NHS has announced funding to level up healthcare and to eradicate racial inequality.