Concerned about errors in the treatment of coronary patients – NRK Norway – Overview of news from different parts of the country
This article is one month old and may contain outdated advice from the authorities regarding coronary heart disease.
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A widely used medical device that is to be detected in oxygen levels, works poorly on dark skin, one shows study from researchers at the University of Michigan.
British health authorities have this year warning that the device, called a pulse oximeter, can show too high an oxygen level in people with darker skin tones.
Important corona tool
These devices have been used more frequently during the corona pandemic, both in hospitals and privately.
Oxygen saturation in corona patients can drop to dangerous levels without being noticed – a condition known as silent hypoxia.
Here, the oxygen meters have become an important tool. They can detect low levels so that patients receive the right treatment.
People all over the world have used pulse oximeters for coronary heart disease. In Norway, sales multiplied for home use in the first months of the pandemic.
Concerned Minister of Health
In the UK, there is now a call for the use of such oxygen meters with reservations.
The device works by sending light down to the underlying tissue to measure the oxygen in the blood. No report from the British Public Health Service, NHS, published in March claims that skin color can affect how light is absorbed.
The NHS has advised patients from ethnic minority groups to continue using pulse oximeters, but to consult with health professionals.
The British Minister of Health Sajid Javid is concerned that corona patients may have received poor medical treatment. When asked by the BBC in November whether he thought patients might have died of covid-19 due to errors in pulse oximeters, he replied:
– I think possibly, yes. I do not have all the facts.
Javid requires an independent review of whether medical equipment is effective regardless of the patient’s ethnicity.
The question is whether this and other medical equipment is calibrated for patients who are fair-skinned, and that it is therefore not necessary to give the correct value to everyone.
Not known in Norway
The Norwegian Medicines Agency, which is the supervisory authority for medical equipment in Norway, has not received any concerns about such devices.
– The Norwegian Medicines Agency is not aware that there have been any incidents related to this problem when using a pulse oximeter in Norway, writes senior adviser Ole Benny Østby to NRK.
He explains that the regulations for medical equipment set requirements for diagnostic equipment and equipment with a measuring function must be designed and manufactured so that it is sufficiently accurate for precise and stable use. Remaining risk must be informed.
– The technology in pulse oximeters is based on the equipment sending light to different wavelengths through the skin and measuring the difference in light absorption between blood with and without oxygen. It is known that certain medical conditions and physical conditions can affect this type of measurements and manufacturers must warn and inform about any limits and precautions in the instructions for use, writes Østby, who says they will look at this further.
– We have close European cooperation and the Norwegian Medicines Agency will investigate the issue with authorities in other EU / EEA countries to hear whether other countries have more information or specific cases.