FDA grants first EUA for blood purification device for COVID-19 patients

Regulatory NewsRegulatory News | 10 April 2020 |  By 

The US Food and Drug Administration (FDA) on Friday granted its first emergency use authorization (EUA) for a blood purification system to treat patients at risk for respiratory failure due to coronavirus disease (COVID-19).
The EUA was granted to Terumo BCT Inc. and Marker Therapeutics authorizing the use of their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices to filter cytokines and other inflammatory proteins from patients’ blood.
“The proteins that are removed are typically elevated during infections and can be associated with a ‘cytokine storm’ that occurs in some COVID-19 patients, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death,” FDA said.
The EUA limits the use of the device to patients 18 or older that are admitted to an intensive care unit with confirmed or imminent respiratory failure. Specifically, the EUA specifies that the devices should only be used for patients with early acute lung injury, early acute respiratory distress syndrome or other specific severe or life-threatening symptoms or conditions.
“With today’s authorization of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease,” said FDA Commissioner Stephen Hahn.
MHRA Advisory
The EUA comes the same day as the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warns of serious risks involving off-label uses of hemofiltration systems to treat patients with COVID-19.
In its advisory, MHRA urges healthcare professionals to follow all manufacturer instructions for setting up the devices, noting that device maker Baxter Healthcare has issued two urgent field safety notices related to off-label modifications to its hemofiltration devices, including the use of extension sets and connectors.
MHRA also advises healthcare workers to check that the filters used with the devices are appropriate for the planned treatment and are stored properly to reduce the risk of the wrong filter being used.


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