Devices

Murray Asks Olympus to Confirm Scope Safety

Following reports of a new outbreak of antibiotic-resistant infections associated with duodenoscopes, Sen. Patty Murray (D-WA) is asking Olympus Corp. officials to confirm that its “repaired” closed-channel duodenoscopes are safe for use. Murray says the scopes in question were reportedly rebuilt under an agreement between Olympus and FDA following her 2015 investigation that linked the devices to 25 outbreaks. The latest reported outbreak occurred at a hospital outside the U.S.

“This tragic incident is particularly alarming because your company recalled and reportedly fixed the devices in question after an investigation by my staff revealed a dangerous flaw in the design of Olympus duodenoscopes,” Murray wrote. “I write to you today to request information in order to assess whether repaired Olympus closed-channel duodenoscopes are safe, and to understand whether the federal oversight of medical device safety in the United States is operating as it should.”

Murray’s 4/3 letter asks for:

unredacted copies of all medical device reports or adverse event reports sent by Olympus to FDA about its closed-channel duodenoscope models from 2/1/16 until the present;
copies of all documents from 2/1/16 until the present that reference antibiotic-resistant infections and any duodenoscope; and
validation data demonstrating that the repaired scopes can be reprocessed effectively.

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