Devices

FDA Transcript of Heater-Cooler Device Recommendations

FDA has posted the transcripts (6/2 transcript and 6/3 transcript) from a 6/2-6/3 Circulatory System Devices Panel meeting that discussed and made recommendations about aerosolized transmission of nontuberculous mycobacteria (NTM) from contaminated water inside heater-cooler devices into the operating room environment and sterile field and ultimately into patients undergoing open chest surgical procedures. The panel was convened due to NTM infections identified in patients in Europe and the U.S. that have previously undergone open chest cardiothoracic surgeries and were exposed to heater-cooler devices during surgery.

“While FDA believes that these invasive, non-pulmonary infections are currently uncommon and that the benefits of open chest cardiac surgery with cardiopulmonary bypass outweigh the risks in appropriately selected patients,” the agency says, “the NTM infections that have been reported in the U.S. and Europe linked to prior cardiothoracic procedures have caused serious illness and in some cases have resulted in death. One of the NTM organisms identified among these patient infections associated with heater-cooler devices, Mycobacterium chimaera, is emerging as particularly pathogenic.”

The advisors made recommendations about both short-term and long-term mitigations, including (1) mitigating water contamination and biofilm formation in heater-cooler devices and the water circuit; (2) case definition and patient and provider notifications; and (3) present and future device design considerations for reducing the risk of NTM.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome