Temporary Expanded Indications to Address COVID-19
The United States Food and Drug Administration, on Monday, April 6, 2020, issued a guidance document to expand the availability of devices used for extracorporeal membrane oxygenation (ECMO) therapy to address the Coronavirus Disease 2019 (COVID-19) Pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary.
Cardiopulmonary devices, such as the devices listed in the table below, are technologically capable of being used for ECMO therapy for greater than 6 hours. FDA is permitting manufacturers of cardiopulmonary bypass devices to temporarily modify the Indications for Use to include ECMO therapy greater than 6 hours, without prior submission of a premarket notification to FDA.
The below devices can be used in an ECMO circuit to treat patients who are experiencing acute respiratory failure and/or acute cardiopulmonary failure. The device can be used in an ECMO circuit > 6 hours.
A Special Supplement to the product package insert will be included in the TandemLife Procedure Kit. The Special Supplement contains the temporary Indications for Use statement as well as the following information related to the product’s use in ECMO:
• Device Performance
• Summary of Durability Testing
• Summary of Animal Testing
• Summary of Clinical Testing
• Potential Risk
• Clinical Signs and Observations that suggest device change-out is required
• Use Conditions
The Special Supplement to the product package inserts can be accessed by requesting a PDF copy of the Special Supplement via the contact form below.