Devices

Murray Asks Olympus for Duodenoscope Info

Senate HELP Committee ranking member Sen. Patty Murray (D-WA) says data recently released by FDA shows “alarmingly high rates of contamination in certain duodenoscopes, even after the device is cleaned.” In a 5/9 letter to OIympus, she says the data “raise serious questions about your company’s ability to ensure the health and safety of patients who undergo procedures using Olympus-manufactured closed-channel duodenoscopes.”

Murray asks for this information:

a copy of each medical device report Olympus has submitted to FDA related to contamination of a closed-channel duodenoscope between 1/2017 and 5/9;
the rate of contamination for both high concern organisms and low to moderate concern organisms identified in interim results from FDA-ordered sampling studies;
when Olympus projects it will complete both FDA-ordered postmarket surveillance studies;
any analysis the company has conducted on interim findings from the surveillance studies;
how Olympus plans to address the findings of the surveillance studies and what the company’s position is on whether closed-channel duodenoscopes remain safe for patient use;
what feedback Olympus has received from users of its closed-channel duodenoscopes concerning the cleaning and reprocessing instructions or any issues related to device maintenance; and
whether Olympus has engaged in any effort to redesign or modify the closed-channel duodenoscope to address concern about its ability to be properly cleaned.

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