Cytokine adsorption devices for treating respiratory failure in people with COVID-19

Regulatory information

D2000 adsorption cartridge is a CE-marked class IIb medical devices. The CE mark states the device can be used for any condition that requires a reduction of metabolic waste products or inflammatory cytokines.

CytoSorb is a CE-marked class IIb medical device. The CE mark for the adsorption cartridges states the devices are approved for the removal of cytokines, bilirubin and myoglobin from blood.

HA330 and HA380 haemoperfusion adsorption cartridges are both CE‑marked class IIb medical devices. The CE mark for the adsorption cartridges states the device's adsorption cartridges are approved for the removal of endogenous and exogenous pathogenic substances in patients' blood, including cytokines, bilirubin and immune mediators.

Spectra Optia Apheresis System is a CE-marked class IIb medical device. The CE mark states the device is approved for therapeutic plasma exchange as well as a range of other cell processing protocols such as, red blood cell exchange and bone marrow transplant.

The manufacturer of CytoSorb sent their customers a Field Safety Notice in 2015. This has advice about a potential incompatibility between the device and nitrous oxide, an inhaled anaesthetic gas. It states that CytoSorb should not be used with nitrous oxide under any circumstances. The Medicines and Healthcare products Regulatory Agency (MHRA) have not issued a Medical Device Alert for this device.

The manufacturer of Spectra Optia Apheresis System sent their customers a Field Safety Notice in 2019. An MHRA Medical Device Alert was issued describing inadequate breakages in the 'frangible' connector (an element of the device that needs to be snapped before use). Failing to break the frangible connector may lead to clotting and inadequate therapy. Healthcare professionals are advised to follow the Spectra Optia Apheresis System instructions for use and quick reference guide.