The Environmental Protection Agency today released a list of commercial medical device sterilizing facilities where lifetime risk from ethylene oxide emissions are highest to people who live nearby. In addition, the Food and Drug Administration released a statement highlighting how the agency is working to reduce ethylene oxide use and support innovation in medical device sterilization, while underscoring its concern about potential shortages that could result from disruptions in sterilizer operations. About half of medical devices are sterilized using ethylene oxide. The EPA will host an Aug. 10 webinar to update and hear from stakeholders as it prepares to propose an air pollution regulation next year to address ethylene oxide emissions. Register here to attend.

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The Food and Drug Administration has identified a Class I recall of certain convenience kits by AVID Medical that contain recalled Medline Namic Angiographic…
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The Food and Drug Administration has issued an early alert for all automated Impella controllers by Abiomed following an issue that has caused three deaths and…
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Boston Scientific, a large supplier of medical devices, said in an Aug. 26 statement posted on its website that on Aug. 25 it “identified a cybersecurity…
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The Food and Drug Administration has issued early alerts for the following products: •    Certain epidural kits by Medical Action…
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The Food and Drug Administration has identified a Class I recall of certain Medline convenience kits containing B. Braun components that have Huons Bupivacaine…
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The Food and Drug Administration Aug. 3 identified Class I recalls of two convenience kit products. Certain kits by Medline…