Devices

Foreign Bug Outbreak Linked to Olympus Scope: LA Times

Recent medical device reports are linking a superbug outbreak at a foreign health facility to a duodenoscope that Olympus modified last year in an move to reduce its risk of spreading bacteria between patients, according to a article by LA Times investigative reporter Melody Petersen. Five patients treated with the modified device tested positive for the same potentially deadly bacteria, according to a report filed with FDA, the article says. One patient died, but the report blamed it on the person’s pre-existing condition rather than the infection. “American hospitals are currently using about 4,400 of the devices that Olympus voluntarily recalled last year to replace a small mechanism linked to deadly outbreaks around the world,” it says.

Last year, FDA cleared an Olympus 510(k) for the TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections (see story). The company decided to recall its original model currently being used in health care facilities and make the needed repair, an agency news release said at the time. The clearance follows a 2014 request from FDA for Olympus to obtain 510(k) clearance for its “closed” elevator channel model, which had never been cleared for marketing. In a letter sent to Olympus, the agency stated that design changes to this model from previous models, which resulted in a “closed” elevator channel rather than an “open” elevator channel, were significant and impacted the safe use of the device.

FDA spokeswoman Deborah Kotz told Petersen that the agency was “was aware of these reports and continues to investigate adverse events associated with duodenoscopes as appropriate.”

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