Devices

FDA, Others Issue Duodenoscope Sampling Protocols

FDA, the Centers for Disease Control and Prevention, and the American Society for Microbiology have announced the availability of voluntary, standardized duodenoscope surveillance sampling and culturing protocols to help reduce the risk of infection and increase the safety of the medical devices. The protocols are an update to an interim duodenoscope surveillance protocol released by CDC 3/2015. FDA says microbiological sampling and culturing of duodenoscopes involves sampling their channels and distal ends, then culturing those samples to bacterial contamination that may be present after reprocessing.

Duodenoscopes undergo a multi-step cleaning and high-level disinfection procedure (reprocessing) so that they can be reused with patients. However, their design makes it difficult to remove contaminants compared to other types of endoscopes. “If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient,” an FDA notice says.

The groups have scheduled a 3/22 Webinar to review the sampling and culturing protocols.

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