Devices

FDA Warning Letters to 3 Scope Makers

FDA has issued Warning Letters (see below) to all three duodenoscope manufacturers for failing to comply with a 2015 agency order to conduct postmarket surveillance studies to evaluate the effectiveness of reprocessing the devices. The order, which was part of agency actions to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes, required Olympus, Fujifilm and Pentax to each conduct a postmarket surveillance study to determine whether healthcare facilities were able to properly clean and disinfect the devices.

“To date, Olympus has failed to commence data collection, and Pentax and Fujifilm have failed to provide sufficient data, as required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use,” an agency notice says. “Olympus and Pentax also have not complied with requirements for their respective human factors studies to assess how well hospital staff are following reprocessing instructions; Fujifilm has been meeting its requirements for its human factors study... FDA expects that Olympus, Fujifilm and Pentax will submit a plan by 3/24 that outlines how study milestones will be achieved.”

Warning Letters:

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