USA – FDA Offers Expanded Use for ECMO, Cardiopulmonary Bypass and Ophthalmic Devices Amid COVID-19

The US Food and Drug Administration (FDA) on Monday issued guidance allowing for limited expanded use of extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices during the coronavirus disease (COVID-19) pandemic.

The agency also opened the door to expanded use for a range of ophthalmic assessment and monitoring devices to reduce the need for in-person visits to health care facilities during the outbreak.

ECMO and Cardiopulmonary Bypass Devices

According to FDA, long-term extracorporeal oxygenation is needed to treat some patients with COVID-19 who experience acute respiratory or cardiopulmonary failure.

FDA says it will not object to certain modifications to already cleared ECMO or cardiopulmonary bypass devices during the public health emergency without prior 510(k) notification to expand their availability and use, so long as the modifications do not pose an undue risk to patients.

While cardiopulmonary bypass devices function similarly to ECMO devices, they are regulated separately and cleared for six or fewer hours of use…