Devices

Update on Drager Neonatal Incubators

FDA is updating an ongoing safety alert about reports of elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals from neonatal incubators. The agency says it has determined that new neonatal incubators by Drager (also known as Draeger) do not need to be run for a week before clinical use. “Testing on Drager’s newly manufactured neonatal incubators did not demonstrate concerning levels of airborne chemicals,” the update says. In addition to the Drager neonatal incubators, certain GE Healthcare neonatal incubators do not need to run prior to use, it adds.

Last year, FDA said it was evaluating published literature about suspected volatile chemicals from neonatal incubators. An agency letter to healthcare providers said the potential sources of the airborne chemicals include materials used to make the incubators as well as natural and human-made sources external to them.

The alert recommended that healthcare providers and facilities continue to use neonatal incubators while being aware of the FDA evaluation and having a plan for proper air ventilation in neonatal settings.

FDA previously said it was working with incubator manufacturers to collect and evaluate data from their products to determine whether the airborne chemicals are released and if so, the amount of exposure and the potential health risk, if any, from such exposure for newborns and others such as healthcare providers.

“Currently, FDA is not aware of any reported adverse events related to the use of neonatal incubators and exposure to these airborne chemicals,” the post said.

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