Devices

Fluid Warmers Can Leach Aluminum: FDA

FDA is reminding healthcare providers about the potential for aluminum leaching and exposing patients to high levels of aluminum as a result of using certain fluid warmers. An agency statement says information reviewed by FDA indicates that aluminum leaching may occur when the fluid warmer is designed with an aluminum heating element where the element is in direct contact with the fluids or blood products being administered to a patient.

The notice lists devices identified by FDA as having the type of design described. It says Eight Medical International, Smisson-Cartledge Biomedical, and Smiths Medical have provided revised instructions for using their devices, a type of voluntary recall action, while Vyaire Medical removed its product from the market.

Meanwhile, FDA says the Smith Medical 8/6 recall of 520,163 Normoflo irrigation fluid warmers in the U.S. is Class 1. An agency notice says the warmers were manufactured between 1/1994 and 7/2021 and distributed between 1/1994 and the present. The recall involves providing new instructions for use to minimize the potential for aluminum leaching. The company says there have been no complaints, injuries, or reports of death for this issue.

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

Read more

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