The FDA has issued new guidance to help expand the availability of devices used in
extracorporeal membrane oxygenation (ECMO) therapy to treat COVID-19 patients.
Extracorporeal circuits and accessories for long-term respiratory/cardiopulmonary failure, including
devices used for ECMO therapy, provide assisted extracorporeal circulation and physiologic gas exchange of a patient’s blood for more than 6 hours.
The guidance is limited to certain that are intended to pump blood or oxygenate blood by:
- Moving the blood to a component that pumps/oxygenates the blood.
- Controlling pump speed.
- Controlling or monitoring gas flow for the circuit.
- Controlling the temperature of the blood.
This guidance does not apply to devices intended only for extracorporeal carbon dioxide removal
because such devices may not oxygenate the blood at clinically meaningful levels, according to the agency. Manufacturers of such devices may consider requesting an emergency use authorization.
You can read the guidance here.