Devices

Healthcare Staff Can Misinterpret Sterilization Indicators: FDA

FDA says it has become aware of the potential for healthcare facility staff that reprocess and sterilize medical devices to misinterpret the indicators used to validate the sterilization of the devices because there is no standard color to indicate a sterilized device. An agency online notice says that the 3M Comply Hydrogen Peroxide Chemical Indicator 1248 uses blue to indicate an unprocessed device and pink to mark a sterilized device. Conversely, the Aesculap MD334 process indicator card uses pink/magenta to indicate an unprocessed device and blue to indicate a sterilized device.

FDA says it has not received reports of injuries associated with using the indicators.

The notice says that FDA recommends that healthcare facilities and reprocessing staff review the manufacturer's instructions and know the significance of the indicator colors. It also says that staff training on the indicators for all sterilization systems used in a facility should be enhanced and reinforced with prominently displayed visual reminders.

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