Devices

FDA Updates Safety Notice on Heater-Cooler Devices

FDA has updated a 10/2015 safety communication calling attention to infections associated with heater-cooler devices and steps that healthcare providers and facilities can take to mitigate patient risk. Over the past few months, the agency says it has continued to evaluate contamination and infection-related issues associated with these device, and 3/28 it decided to launch a Web page specific to heater-cooler devices.

The Web page says that heater-cooler devices used during cardiothoracic surgeries and other procedures to warm or cool a patient include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although there is no direct patient contact with the water, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air through the device’s exhaust vent, it says.

Analysis of adverse event reports, medical literature, and information from national and international public health agencies indicates that the use of heater-cooler devices has been associated with nontuberculous mycobacteria infections, FDA says, primarily in patients undergoing cardiothoracic procedures.

FDA says that between 1/2010 and 8/2015, it received 32 medical device reports of patient infections associated with heater-cooler devices or bacterial heater-cooler contamination. Some 25 of the 32 reports were received in 2015. The agency says it is possible that some cases have not been reported since it is challenging for healthcare professionals and facilities to recognize that infections, particularly nontuberculous mycobacteria infections, may be associated with the use of or exposure to a particular medical device.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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