Devices

Issues at Italy’s Steril Milano Sterilization Facility

FDA says it is aware of sterility issues with medical devices processed at the Steri Milano SRL Reggiolo and Monza ethylene oxide sterilization facilities in Italy. “FDA became aware that Steril Milano falsified graphs and parameters of sterilization certificates for a variety of FDA regulated products, dating back to 2016,” an agency notice says.

The notice says FDA is working with medical device manufacturers, international partners, and U.S. federal partners to investigate the scope of medical devices that may be affected and intends to contact potentially affected firms that are known to have contracted medical device sterilization services with the Steril Milano facilities.

“FDA believes that 97 medical device manufacturers may be affected,” the notice says. “The types of medical devices that may be affected include biopsy needles, catheters, intravascular administration sets, arthroscopes, syringes, and other medical devices. The … facilities were closed 3/2021 and are no longer sterilizing medical devices.”

As of 6/1, FDA says, 10 firms have recalled their affected medical devices.

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