Devices

FDA Working to Cut Ethylene Oxide Emissions

CDRH director Jeffrey Shuren says that with the Environmental Protection Agency poised to propose an air pollution rule later this year to address emissions of ethylene oxide (EtO) at commercial sterilizers, FDA is working with the industry on steps to reduce emissions and also to maintain sufficient sterilizing capacity. In a statement, Shuren says FDA “shares concerns about the release of ethylene oxide at unsafe levels into the environment. We have been proactively working with medical device sterilizers to reduce the amount of EtO they use while still effectively sterilizing products to help ensure they meet the EPA’s standards for ethylene oxide emissions levels. In addition, we have been working with companies on the development of novel sterilization methods to replace the use of ethylene oxide.”

Shuren’s post discusses the EtO Sterilization Master File Pilot Program for PMA holders of high-risk devices that enables certain changes between sterilization processes and facilities that reduces the amount of ethylene oxide concentrations used to sterilize medical devices without compromising safety and effectiveness. It also references Innovation Challenges that he says have shown encouraging progress with new strategies to reduce EtO emissions.

“Collectively, these programs encourage new ways to sterilize medical devices that reduce the potential impact of ethylene oxide on the environment and public health,” Shuren concludes, “and we are committed to continuing to prioritize these efforts.”

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