For cardiac surgery heater-cooler system, FDA clears new iteration, updates safety alert
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The FDA announced it has cleared a new version of a heater-cooler system for use during cardiac surgery and updated a safety communication for a previous version of the device associated with infection risks.
An updated version of the system (Heater-Cooler System 3T, LivaNova) designed to reduce the risk for infection, including instructions on how to properly clean and disinfect the system, has been cleared, according to the updated safety communication from the FDA. The design upgrade (3T Aerosol Collection Set) was also implemented to reduce the risk for potential aerosol emissions from the system itself.
Healio previously reported that research showed the old system raised the risk for invasive Mycobacterium chimaera infection.
The original safety communication was issued in October 2018 by the FDA. At the same time, the company issued a medical device correction letter, alerting health care facilities of updated instructions to monitor hydrogen peroxide concentrations in the water circuit to limit microbial growth and how to adjust it accordingly. The company also informed facilities of an available design upgrade (3T Aerosol Collection Set) to reduce the risk for potential aerosol emissions from the system itself.
Health care providers and staff who are using the old version of the system are instructed to start using the updated labeling and to continue following instructions provided in previous letters and recommendations from 2018 and 2020, according to the safety communication.
The FDA will continue to evaluate the risk and mitigation measures associated with this system and will provide updates as appropriate, according to the safety communication.