A physician in California is pursuing a lawsuit against 12 companies over their continued sale of devices that researchers say inaccurately measure blood-oxygen levels in people of colour. Studies — some decades old — have established that the devices, called pulse oximeters, can overestimate the amount of oxygen in the blood of people with dark skin, which could lead health professionals to delay or decide against treatment.
The suit — filed by the Roots Community Health Center in Oakland, California, which is led by physician and researcher Noha Aboelata — is the first to take aim at the manufacturers of the devices. It asks for an injunction prohibiting further sales of the devices in California until they provide accurate readings for people of colour, or until warning labels are attached to note their inaccuracies.
High amounts of a type of melanin pigment in dark skin can interfere with the devices’ performance. During the COVID-19 pandemic, in which people infected with the SARS-CoV-2 coronavirus sometimes had abnormally low oxygen levels, physicians put a spotlight on the problem. It was noticed that Black people were three times as likely as white people to receive pulse oximeter readings in a ‘safe’ range when, in fact, their blood-oxygen levels were dangerously low.
But researchers expressed disappointment at the slow pace of response from the medical-device industry and the US government. Legal experts say that this lawsuit offers an avenue to address the controversial devices that hasn’t been explored before. And even though the suit was filed in a California county court, it could have ripple effects because of how large the state’s medical-device market is.
PS: In several covid threads I mentioned these inaccuracies of the pulse oximeters, specially the low cost ones. These el-cheapos are notoriously inaccurate with dark skinned people. I have a Masimo MightSAT which is hospital grade and the manufacturer claims accurate. But clinicians say that Masimo tests were alright with healthy people in a lab setting, while inaccuracies can still result with sick coloured people in a clinical setting.
The suit — filed by the Roots Community Health Center in Oakland, California, which is led by physician and researcher Noha Aboelata — is the first to take aim at the manufacturers of the devices. It asks for an injunction prohibiting further sales of the devices in California until they provide accurate readings for people of colour, or until warning labels are attached to note their inaccuracies.
High amounts of a type of melanin pigment in dark skin can interfere with the devices’ performance. During the COVID-19 pandemic, in which people infected with the SARS-CoV-2 coronavirus sometimes had abnormally low oxygen levels, physicians put a spotlight on the problem. It was noticed that Black people were three times as likely as white people to receive pulse oximeter readings in a ‘safe’ range when, in fact, their blood-oxygen levels were dangerously low.
But researchers expressed disappointment at the slow pace of response from the medical-device industry and the US government. Legal experts say that this lawsuit offers an avenue to address the controversial devices that hasn’t been explored before. And even though the suit was filed in a California county court, it could have ripple effects because of how large the state’s medical-device market is.
PS: In several covid threads I mentioned these inaccuracies of the pulse oximeters, specially the low cost ones. These el-cheapos are notoriously inaccurate with dark skinned people. I have a Masimo MightSAT which is hospital grade and the manufacturer claims accurate. But clinicians say that Masimo tests were alright with healthy people in a lab setting, while inaccuracies can still result with sick coloured people in a clinical setting.
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