Tag: manufacturing issue

$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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APIC calls for improved medical device reprocessing instructions, guidelines

Editor’s Note The Association for Professionals in Infection Control and Epidemiology (APIC) is advocating for clearer reprocessing instructions for medical devices to improve patient safety and efficiency, Outpatient Surgery Magazine August 19 reports. Many current instructions for use (IFUs) are considered overly complex, outdated, and difficult to interpret, especially for…

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By: Tarsilla Moura
September 4, 2024
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Some FDA-recalled medical devices remain in use while manufacturers implement corrections

Editor's Note A 2016 recall issued for the Abbott MitraClip cardiac device highlighted potential safety concerns, but instead of removing the product from the market, Abbott and the Food and Drug Administration (FDA) allowed continued use with revised instructions and additional training for doctors. This approach reflects a broader trend…

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By: Tarsilla Moura
August 27, 2024
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FDA updates warning about plastic syringes made in China

Editor's Note An ongoing US Food and Drug Administration (FDA) evaluation of plastic syringes made in China reveals that quality problems are more widespread than initially believed, the agency reported on March 19. The update to an original November 23 safety notice recommends the following action to alleviate potential quality…

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By: Matt Danford
March 20, 2024
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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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