Transitioning from Getinge Cardiosave and Cardiohelp Systems: ECRI's Recommendations

The FDA has recommended that healthcare facilities transition away from Getinge Cardiosave balloon pump and Cardiohelp extracorporeal cardiopulmonary support systems due to continuing safety and quality concerns. The FDA's letter to healthcare facilities does not contain recommendations on alternative products. To help facilities select suitable options for adult patients, ECRI is providing recommendations and information on alternative devices.

Alternative products:

Only one FDA-cleared alternative to the Cardiosave is available, sold by Teleflex; various alternatives to the Cardiohelp system are available. We provide general specifications and pricing for the Teleflex device and several Cardiohelp alternative products in the following resources.

Resources for download:

• Transitioning from Getinge Cardiosave and Cardiohelp Systems: ECRI's Recommendations for Alternative Products
• Technology Report: Extracorporeal Pumps and IABP Systems

Recommendations:

ECRI recommends facilities with affected Getinge devices comply with the FDA’s recommendations, plus take the following actions:

• Assign device replacement planning to an appropriate facility committee, such as medical device, product evaluation, or value analysis.
• If necessary, assign supervision of Getinge Cardiosave and Cardiohelp system use to an appropriate facility committee, such as perfusion, patient safety, or risk management.
• For facilities with established adult ventricular assist device (VAD) programs, consider using a percutaneous VAD in suitable patients for short-term circulatory support instead of a balloon pump.

Background: What do these devices do?

An intra-aortic balloon pump (IABP) is a mechanical device that helps the heart pump blood. IABP are used to treat patients that need emergency, short-term circulatory assistance. ECMO systems are life-sustaining systems used to treat patients that need short-term cardiopulmonary support.