Tag: manufacturing issue

FDA accelerates medical device safety alerts to reach public within days

Editor's Note The Food and Drug Administration (FDA) has expanded its early alert recall program to include all medical devices, speeding up how quickly the public learns about high-risk safety issues, Modern Healthcare October 9 reports. The initiative allows the FDA to post early alerts within days of manufacturers notifying…

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By: Tarsilla Moura
October 10, 2025
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FDA has begun requiring electronic De Novo submissions for new medical devices

Editor's Note Beginning October 1, the Food and Drug Administration (FDA) is mandating that all De Novo classification requests be submitted electronically using its eSTAR system, according to a final rule and guidance issued by the agency. As detailed in the September 30 release, the shift marks a procedural change…

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By: Tarsilla Moura
October 8, 2025
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FDA posts four device safety communications, prompting inventory, workflow checks

Editor's Note The Food and Drug Administration (FDA) has issued four medical device recalls and early alerts between September 23 and 30, covering Automated Impella Controllers, Olympus ViziShot 2 FLEX (19G) endoscopic aspiration needles, 3M Ranger blood and irrigation fluid warming systems, and BD Alaris infusion pump sets. The notices…

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By: Tarsilla Moura
September 30, 2025
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FDA inspections slow as support staff layoffs strain overseas oversight

Editor's Note Logistical staff layoffs at the US Food and Drug Administration (FDA) are hindering the agency’s ability to scrutinize drug manufacturing safety in foreign countries, according to a July 7 report in ProPublica. A spokesperson from the US Department of Health and Human Services (HHS) told ProPublica that FDA…

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By: Matt Danford
July 8, 2025
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FDA issues early alerts for intravascular catheters

Editor's Note The US Food and Drug Administration (FDA) warned of safety risks resulting from manufacturing issues with two varieties of intravascular catheter—Conavi Medical’s Novasight Hybrid line and BD’s PowerPICC intravascular devices—in separate early alerts April 18. In one reported incident, the sheath of a Novasight Hybrid catheter—a device used…

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By: Matt Danford
April 21, 2025
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Tariffs strain supply chains, split medical manufacturing community

Editor's Note President Donald Trump’s latest round of tariffs—especially steep duties on Chinese imports—has sharply divided the medical community, with device manufacturers urging exemptions while some US-based PPE producers cheer the protectionist move. CNBC reported the news April 16. The tariff rate on China is 145%, the outlet reports, while…

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By: Matt Danford
April 17, 2025
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Hospitals continue to grapple with IV fluid shortage

Editor's Note US hospitals continue to face a shortage of intravenous (IV) fluids due to Hurricane-related damage to the Baxter manufacturing facility that was responsible for 60% of the nation’s supply, MedPage Today reported December 31. Citing a report from Baxter, the article notes that the manufacturer has restored eight…

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By: Matt Danford
January 2, 2025
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$350 million invested in medical gowns for Strategic National Stockpile

Editor's Note Six US companies will manufacture approximately 250 million medical gowns as part of a government effort to shore up supplies that were subject to shortages during the COVID-19 pandemic, the Associated Press (AP) reported October 3. Led by the Administration for Strategic Preparedness and Response (ASPR), the initiative…

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By: Matt Danford
October 7, 2024
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ECRI issues guidance to address medical supply shortages caused by hurricanes, dockworkers’ strike

Editor's Note Patient safety nonprofit ECRI is offering resources to help healthcare providers mitigate potential shortages of critical medical supplies following the devastation caused by Hurricane Helene along the US southeast coast and the ongoing strike by the International Longshoremen’s Association (ILA). According to an October 1 announcement, the first…

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By: Matt Danford
October 3, 2024
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Hurricane disrupts IV fluid manufacturing as hospitals cope with chaos

Editor's Note The shuttering of a critical Baxter International manufacturing plant in North Carolina due to Hurricane Helene could put significant stress on already strained healthcare supply chain, according to an October 1 report in Axios. According to the article, the facility is a critical production center for produces intravenous…

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By: Matt Danford
October 1, 2024
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