WASHINGTON, D.C. – U.S. Senator Angus King (I-Maine) today called on the Food and Drug Administration (FDA) to explain its decision to delay for more than a year the release of a safety alert that would have notified hospitals and patients of the severe risks associated with the use of a device in heart surgeries.

The device, a Sorin 3T heater-cooler, has been used in thousands of heart surgery operations across Maine and has also been shown to put patients at risk of acquiring a dangerous mycobacterial infection. The FDA was made aware of evidence of those risks in August 2014, but neglected to release a safety alert until October 2015.

“The heater-cooler devices associated with these infections are used for heart surgeries in Maine and across the country. While no infections have yet been reported as a result of this device’s use in Maine and the risk remains low, the dozens of reported cases in the U.S. and abroad are a serious cause for concern for me and for my constituents who were exposed to the device,” Senator King wrote in his letter to the FDA. “What I find particularly troubling is that, despite evidence presented to federal regulators in August 2014 of the device’s link to these infections, the Food and Drug Administration (FDA) demurred on releasing a safety alert until more than a year later, and furthermore did not give hospitals and patients detailed recommendations to deal with the issue at hand for another year after that.”

Senator King called on the FDA to explain its decision to not alert the public and to also explain why it waited two years to provide detailed advice and recommendations to hospitals.

The complete text of the letter can be read HERE and is below:

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December 7, 2016

The Honorable Robert M. Califf, MD

Commissioner

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Dr. Califf:

I am writing today to express my deep concern about the Sorin 3T heater-cooler device, which has been used in thousands of heart surgery operations across Maine and which has also been shown to put patients at risk of acquiring a dangerous mycobacterial infection.

The heater-cooler devices associated with these infections are used for heart surgeries in Maine and across the country. While no infections have yet been reported as a result of this device’s use in Maine and the risk remains low, the dozens of reported cases in the U.S. and abroad are a serious cause for concern for me and for my constituents who were exposed to the device.

What I find particularly troubling is that, despite evidence presented to federal regulators in August 2014 of the device’s link to these infections, the Food and Drug Administration (FDA) demurred on releasing a safety alert until more than a year later, and furthermore did not give hospitals and patients detailed recommendations to deal with the issue at hand for another year after that.

I am left to ask: given the severe safety concerns associated with the device, why did the FDA choose not to alert the public of the risks associated with the device until 14 months after regulators were made aware of the infections it caused? Furthermore, why did hospitals and patients have to wait two years after the FDA was first informed of the infection risk to be given detailed advice and recommendations?

Thank you for your attention to these concerns. I look forward to your response to this letter.

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