Tag: Safety Communication

FDA issues Class I alert for Abiomed Impella heart device over cybersecurity risks

Editor's Note The Food and Drug Administration (FDA) on October 10 classified a cybersecurity correction involving Abiomed’s Automated Impella Controller as a Class I recall, the most serious type, according to the FDA Medical Device Recalls and Early Alerts database. While devices are not being removed from clinical settings, the…

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By: Tarsilla Moura
October 10, 2025
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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 issues early alerts on multiple high-risk device recalls from J&J, Medtronic, Baxter, Boston Scientific

Editor's Note The Food and Drug Administration (FDA) has issued a series of early alerts this month regarding high-risk recalls from several leading medical device makers, citing patient safety risks ranging from pump failures to vascular complications. These alerts highlight issues with products from Johnson & Johnson’s (J&J’s) Abiomed unit,…

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By: Tarsilla Moura
August 28, 2025
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Nurse-led safety forums strengthen escalation of care protocols

Editor's Note A recent article from Cleveland Clinic details the use of confidential staff forums to address barriers to escalating patient care concerns, resulting in greater caregiver engagement and targeted improvements. Published July 25, the article describes how nursing leaders collaborated with the Cleveland Clinic Alliance for Patient and Caregiver…

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By: Matt Danford
August 1, 2025
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Consistent staff engagement helps ASCs prevent lawsuits, spot deeper issues early

Editor's Note Regular check-ins and visible leadership can help ambulatory surgery centers (ASCs) head off legal trouble before it starts. That is the central message from employment attorney Salvatore Puccio on a recent episode of the Advancing Surgical Care Podcast, Ambulatory Surgery Center News July 23 reports. Puccio, a partner…

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By: Tarsilla Moura
July 30, 2025
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FDA issues early alert for microbore extension sets

Editor's Note B Braun Medical is recommending certain microbore extension sets—single use, disposable, add-ons for infusion, injection, or aspiration—be removed from anywhere they are used or sold, according to a July 17 announcement from the US Food and Drug Administration (FDA). According to FDA’s early alert, the recall was motivated…

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By: Matt Danford
July 18, 2025
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Hidden head injury hazards expose cracks in OR safety culture

One of the most sobering moments in the career of anesthesiologist Cornelius Sullivan, MD, occurred not as a caretaker in the OR, but as a patient in the emergency department. Having been knocked out cold by a low-hanging monitor during a surgical procedure at Boston Children’s Hospital, he had to…

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By: Matt Danford
July 1, 2025
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FDA designates Class 1 recalls for intraoperative positioning guidewires, infusion pumps, dialysate

Editor's Note Centerline Biomedical’s recall of IOPS Guidewire ATW-2,  Zyno Medical’s recall of Z-800 series infusion pumps, and Nipro’s recall of MedicaLyte Liquid Bycarbonate Concentrate have been designated by the US Food and Drug Administration (FDA) as Class 1, the most serious designation indicating risk of severe injury or death.…

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By: Matt Danford
June 17, 2025
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