Tag: FDA

FDA warns of chemical exposure from compressor, ventilator combos

Editor's Note:  General Electric (GE) EVair and EVair 03 (Jun-air) air compressors can release dangerous levels of formaldehyde when paired with Carescape R860 and Engström Carestation/Pro ventilators, the U.S. Food and Drug Administration (FDA) warned January 9. Designed to supply the respective ventilators when wall air is not available, the…

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By: Matt Danford
January 12, 2024
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Superpotency concerns spur recall of IV bags for vancomycin, phenylephrine, and fentanyl

Editor's Note:  Englewood, Colo,-based Leiters Health is voluntarily recalling 33 lots of vancomycin, phenylephrine, and fentanyl IV bags due to concerns that they may contain twice the labeled amount of drug, according to a January 8 safety alert from the US Food and Drug Administration (FDA). “The semi-automated IV bag…

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By: Matt Danford
January 11, 2024
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FDA issues statements on VHP sterilization; hip surgery device safety

Editor's Note Recent announcements from The US Food and Drug Administration (FDA) validate vaporized hydrogen peroxide (VHP) as an established device sterilization method and warn against the use of the Synovo Total Hip Replacement system. Issued January 8, the announcement about VHP is part of the agency’s multi-pronged approach to…

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By: Matt Danford
January 9, 2024
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Investigation reveals medical device safety testing concerns

Editor's Note Published December 21, a year-long investigation by KFF Health News into medical device malfunctions found that the FDA allows the sale of most medical devices, including many implants, without requiring tests for safety or effectiveness. Instead, manufacturers need to show only that they have “substantial equivalence” to an…

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By: Brita Belli
January 8, 2024
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First hospital joins FDA’s medical device information sharing and analysis initiative

Editor’s Note Charlotte, North Carolina-based Atrium Health is the first hospital to join the Medical Device Information Analysis and Sharing (MDIAS) public-private partnership (PPP) between the Food and Drug Administration (FDA) and private sector stakeholders. The news was announced December 12 by Mitre, a nonprofit research organization and the independent…

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By: Brita Belli
December 13, 2023
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FDA issues safety notice for syringes made in China

Editor's Note The US Food and Drug Administration (FDA) issued a safety notice on November 30 regarding quality concerns related to several Chinese manufacturers of syringes. The FDA is evaluating these devices for potential problems, including leaks, breakages, and the presence of particles in the syringes.  According to the safety…

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By: Brita Belli
December 5, 2023
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FDA encourages new cybersecurity standards on medical device manufacturing

Editor's Note The US Food and Drug Administration (FDA) has recognized the latest guidance on medical device cybersecurity from the Association for the Advancement of Medical Instrumentation (AAMI), an AAMI November 14 press release reports. This latest cybersecurity recognition is encouraging its use across the medical device manufacturing industry to…

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By: Brita Belli
November 15, 2023
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Steven Rosenberg, pioneer in immunotherapy, awarded National Medal of Technology and Innovation

Editor's Note Steven Rosenberg, MD, PhD, chief of the Surgery Branch at the Center for Cancer Research at the National Cancer Institute, part of the National Institutes of Health (NIH), and a pioneer in the development of immunotherapy to fight cancer, was awarded the National Medal of Technology and Innovation.…

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By: Brita Belli
October 25, 2023
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AI brain implants allow paralyzed man to regain use of arms, hands, fingers

Editor's Note In a first of its kind surgical procedure, doctors have installed artificial intelligence (AI) implants in the brain of a 46-year-old man who was paralyzed from a fall on the ice, CNN September 27 reports. The AI implant formed a "digital bridge"–an idea pioneered by the French neuroscientist…

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By: Brita Belli
September 28, 2023
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FDA: Class I recall of Mallinckrodt One-Way Valve, 22F x 22M

Editor's Note The Food and Drug Administration (FDA), on September 12, identified the recall by Mallinckrodt Manufacturing of its One-Way Valve, 22F x 22M, as Class I, the most serious. The recall was issued because the devices are not opening properly, which prevents or reduces the flow of ventilated air…

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By: Judy Mathias
September 13, 2023
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