Devices

CDRH Backs Olympus Updated Reprocessing Instructions

A CDRH safety alert says Olympus has updated reprocessing instructions for its 160F/VF duodenoscope models to include a more rigorous protocol for pre-cleaning, manual cleaning and high-level disinfection procedures, specifically additional flushing, brushing and increased flushing volume. It also recommends a reusable brush (Model MAJ-1534) to manually clean the distal end of the scope, including the elevator recess area. “This new brush can be sterilized by autoclave following use, as outlined in the updated reprocessing manual,” it says. Olympus sent a letter dated March 14, 2016 to health care facilities and other users about the updated, validated reprocessing instructions.

The Center has been keeping a close watch on duodenoscopes following an outbreak in infections associated with the devices over the past few years. Last year, the agency ordered the three makers to conduct postmarket surveillance studies to better understand how their scopes are reprocessed in real-world settings. “The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinical setting where they are being used,” CDRH chief scientist William Maisel was quoted as saying in a news release at the time. “These studies will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA’s actions to protect the public health and help reduce the risk of infections.”

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