Devices

FDA Raises Infection Risk for Reprocessed Urological Endoscopes

FDA says it wants to be sure that healthcare providers, including those who work in healthcare facility reprocessing units, are aware of the risk of infections associated with reprocessed urological endoscopes, including cystoscopes, ureteroscopes, and cystourethroscopes. A 4/1 letter to healthcare providers says the agency has received numerous medical device reports describing patient infections post-procedure or other possible contamination issues associated with reprocessing the devices.

The letter says FDA is investigating the potential causes and contributing factors associated with the reported infections and contamination issues. “While some reports indicate possible inadequate reprocessing or maintenance issues … as a potential cause,” it says, “FDA is also evaluating other potential issues including reprocessing instructions in the labeling and device design.”

The agency emphasizes the importance of following the manufacturer’s labeling and reprocessing instructions for the devices, including accessory components, for cleaning and subsequent processing to minimize the risk of infection.

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