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Cardiac Surgery Infection Risk from Heater-Cooler Devices to be Examined by FDA Panel

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A panel of expert advisors to the FDA will meet in June to review the risk of bacterial infections from heating and cooling devices used during heart surgery, and to make recommendations to the agency about what regulatory actions may be necessary to protect consumers. 

The Circulatory System Devices advisory panel to the FDA will meet on June 2 and 3, to give evaluation cleaning and disinfection methods, and how to validate that the devices have been properly cleaned in order to prevent cardiac surgery infections. The meeting was announced in a Federal Register notice filed on April 15.

The meeting comes after a safety warning issued by the FDA in October 2015, over the risk of infections from heart surgery heater-cooler devices. At that time, the agency warned that there have been a large number of adverse events linked to the use of surgical heating and cooling devices.

No specific products were mentioned, as the FDA warning applies to all devices providing heated and/or cooled water to oxygenator heat exchangers, cardioplegia (paralysis of the heart) heat exchangers and warming/cooling blankets. These devices are used during cardiothracic surgeries and other medical procedures to warm or cool patients, and include a water tank that provides temperature-controlled water to the devices.

According to the agency, at least 32 medical device reports have been received involving patient infections or bacterial device contamination linked to surgical heater-cooler devices between January 2010 and August 2015.

About half of the cases were just reports of bacterial contamination with no known infected patients. However, 25 of those reports came from just this year. Only eight of the reports came from the U.S, associated with three events describing patient infections. The rest came from mostly western Europe.

The advisory committee’s recommendations will not be binding on the FDA, although the agency weighs the committee’s recommendations heavily when making final regulatory decisions.

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