Devices

FDA Alert on Neurosurgical Head Holders

FDA has issued a safety alert on neurosurgical head holders based on medical device reports associated with the slippage or movement of a skull clamp before or during surgical procedures, resulting in more than 700 injuries. device used to secure the patient’s head position during surgical procedures. The system may include a head holder frame that attaches to the operating table, skull clamp, neurosurgical head hold stabilization components, skull pins and other accessories.

FDA’s review of medical literature and currently available data suggest that device slippage is not specific to any manufacturer or brand of devices. “The causes of skull clamps slipping before and/or during surgical procedures are multifactorial, and may include device performance (e.g., mechanical failure of the skull clamp), device application (e.g., issues with placement of the skull clamp and/or accessories), patient specific characteristics (e.g., thickness and bone quality of the patient’s skull) and lack of maintenance,” the alert says. “Some of these risks can be mitigated through device placement considerations, proper use and proper device maintenance.”

The alert recommends that users follow the manufacturer’s recommendations for cleaning, maintenance, and replacement schedule based on device life expectancy. It also says they should inspect the neurosurgical head holder system and all accessories before and after each use.

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