Heart Surgery
FDA: Class I recall of Abbott Amplatzer Steerable Delivery Sheath
Editor's Note The Food and Drug Administration (FDA), on July 26, identified the recall by Abbott of its Amplatzer Steerable Delivery Sheath as Class I, the most serious. Abbott is recalling the sheath because of an increased risk for air emboli being introduced into patients who have cardiac catheterization procedures…
Does a ‘weekend warrior’ physical activity pattern prevent cardiovascular disease?
Editor's Note This study by researches at the Massachusetts General Hospital, Boston, and the Broad Institute of MIT and Harvard, Cambridge, Massachusetts, examines whether moderate to vigorous physical activity concentrated in 1 to 2 days of the week (ie, a “weekend warrior” pattern) confers similar cardiovascular benefits as more evenly…
FDA: Class I recall of Quidel Triage Cardiac Panels
Editor's Note The Food and Drug Administration (FDA), on July 17, identified the recall by Quidel Cardiovascular Inc of its Quidel Triage Cardiac Panels as Class I, the most serious. The recall was initiated because of reports of inaccurate tests showing lower than expected troponin levels in samples. A falsely…
Discrepancies in FDA clearance, marketing of AI-, ML-enabled medical devices
Editor's Note This study from New York University and NYU Langone Health, New York City, finds discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical devices, with some devices being marketed as having capabilities not approved by the Food and Drug Administration (FDA).…
FDA: Class I recall of Medtronic implantable cardioverter, cardiac resynchronization therapy defibrillators
Editor's Note The Food and Drug Administration (FDA), on July 18, identified the recall by Medtronic of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. Medtronic is recalling all ICDs and CRT-Ds, with glassed feedthroughs that were manufactured after 2017, as…
FDA: Class I recall of Draeger Medical’s Oxylog 3000 Plus Emergency and Transport Ventilators
Editor's Note The Food and Drug Administration (FDA), on July 13, identified the recall by Draeger Medical of its Oxylog 3000 Plus Emergency and Transport Ventilators as Class I, the most serious. The recall was initiated because of reports that the ventilator may not automatically switch back to using AC…
The Joint Commission/AHA revise requirements for Advanced Certification in Heart Failure program
Editor's Note The Joint Commission, on July 12, announced that it and the American Heart Association (AHA) have revised requirements for the Advanced Certification in Heart Failure program to align with the latest clinical practice guidelines for heart failure, effective January 1, 2024. Requirements for interdisciplinary team members have been…
Vanderbilt team develops new protocol for emergency resternotomy
Editor's Note A multidisciplinary cardiovascular intensive care unit (CVICU) team at Vanderbilt University Hospital in Nashville, Tennessee, recently conducted a bedside surgery simulation of a resternotomy to develop a new protocol for the lifesaving procedure, according to the June 15 VUMC Reporter. When a cardiac surgical patient starts bleeding postoperatively…
ACS, SVS verify first four hospitals in Vascular Verification Program
Editor's Note The American College of Surgeons (ACS) and Society for Vascular Surgery (SVS) announced on June 14 that they had verified the first four hospitals as part of the recently launched Vascular Verification Program (Vascular-VP). To receive verification, these hospitals displayed a commitment to improving outcomes and delivering the…
Surgeons’ leadership style linked to team behavior in hybrid OR
Editor's Note This study, led by researchers in Belgium, finds that surgeons’ leadership style enhances surgical team behavior, especially during the most complex phases. A total of 22 endovascular procedures (47 hours of video recordings) were analyzed. Among the findings: Surgeons’ transformational leadership was positively related to the extent that…
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