FDA: Class I recall of Abiomed Impella Left Sided Blood Pumps
Editor's Note The Food and Drug Administration (FDA), on July 27, identified the recall by Abiomed of all Impella Left Sided Blood Pumps as Class I, the most serious. Abiomed is recalling the pumps because the instructions for use do not adequately address precautions to take when treating transcatheter aortic…
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…
Applications for Eisenberg Patient Safety and Quality Awards due August 7
Editor's Note The Joint Commission, on July 19, announced that it and the National Quality Forum (NQF) are accepting applications for the 2023 John M. Eisenberg Patient Safety and Quality Awards through August 7. The awards, which recognize major achievements by individuals and organizations in their use of innovative approaches…
The Joint Commission updates requirements for medication compounding
Editor's Note The Joint Commission, on July 19, announced that it has revised its Medication Compounding (MC) chapter for home care organizations and the Medication Compounding Certification (MDC) program, which is available to accredited hospitals, critical access hospitals, and home care pharmacy organizations. Among the revisions: Revising the requirements to…
Navigating challenges of connecting recalls to patients, inventory
Healthcare facilities face challenges in the recall process of tissue, non-biologic implants, and medical devices because of their time-sensitive nature and inherent risks to patient safety and compliance. Hospitals often use secondary sources for recall notifications. These lists, however, do not include two critical pieces—the identification of affected patient cases…
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…
Complications, safety of simultaneous bilateral TKAs
Editor's Note In this study, researchers at the Keck School of Medicine of USC Los Angeles, find that patients having simultaneous bilateral total knee arthroplasties (TKAs) are at increased risk of several types of complications, compared with patients having unilateral TKAs. A total of 21,044 patients having simultaneous bilateral TKAs…
FDA: Class I recall of Megadyne’s Mega 2000, Mega Soft reusable patient return electrodes
Editor's Note The Food and Drug Administration (FDA), on July 11, identified the recall by Megadyne of its Mega 2000 and Mega Soft reusable patient return electrodes as Class I, the most serious. The recall was initiated after Megadyne received reports of pediatric and adult patients receiving burn injuries during…
Risk factors, rate of postoperative urinary retention following inguinal hernia repair
Editor's Note A global study led by researchers at the Royal College of Surgeons in Dublin, Ireland, finds older male patients are at greater risk of developing postoperative urinary retention (POUR) following elective inguinal hernia repair. The cohort study included 4,151 patients (3882 male and 269 female) recruited between March…
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