Editor's Note The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has initiated a pilot program to improve the speed of public notifications regarding high-risk medical device recalls. According to a November 21 announcement, this initiative aims to minimize the time between the FDA's awareness…

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Editor's Note The Centers for Medicare & Medicaid Services (CMS) published 2023 survey data for ambulatory surgery centers (ASCs), highlighting top citations, ASC Focus June 7 reports. Due to system migrations, public data updates halted since May 2022, but CMS staff provided data to ASCA on May 30, 2024. The…

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Editor's Note The FDA has issued a warning regarding fraudulent, duplicated and otherwise unreliable data coming from third party test labs that produce data for medical device companies, including many based in India and China. Issued February 20, the alert warns medical device manufacturers that they are responsible for confirming the…

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Editor's Note: Equinoxe Shoulder System joint replacement devices manufactured by Exactech between 2004 and 2021 are at risk of premature wearing or failure due to defective packaging, according to a January 16 safety alert from the US Food and Drug Administration (FDA). The bags used to package the devices were…

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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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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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Editor's Note The American Hospital Association (AHA) November 6 is alerting healthcare institutions to a new ransomware known as BlackSuit, which is likely to pose a serious threat to the healthcare and public health sectors.  According to AHA: BlackSuit is very similar to the Royal ransomware family, which followed the…

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Editor's Note Cisco has released an update that fixes a critical vulnerability in their Emergency Responder communications platform, a system used throughout the health sector, an October 6 HC3: Sector Alert from the Department of Health and Human Services (HHS) Office of Information Security reports. The HHS recommends that healthcare systems…

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Editor's Note On June 29, the Cybersecurity & Infrastructure Security Agency (CISA) issued a medical advisory alert "warning of a significant, high-risk vulnerability in Medtronic’s Paceart Optima System, which is used to compile and manage patients’ cardiac device data," the American Hospital Association (AHA) July 6 reports. According to CISA,…

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Editor's Note ECRI, on May 18, announced the winners of its annual 2023 Alerts Impact Award. The Award is given to members of ECRI’s Alerts Workflow system for excellence in recall management. The system’s software is used by supply chain, clinical engineering, IT, pharmacy, lab, clinical departments, and ancillary-care points…

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