Supply Chain/Technology
FDA: BD recalls certain lots of ChloraPrep
Editor's Note The Food & Drug Administration announced on April 20 that Becton, Dickinson and Company (BD) was recalling certain lots of its ChloraPrep Hi-Lite Orange 26 mL Applicator. ChloraPrep is used as an antiseptic to prepare a patient’s skin before surgery. The recall was initiated because the Applicator, which…
Hospira recalls one lot each of 0.5% Bupivacaine and 1% Lidocaine because of mislabeling
Editor's Note Hospira Inc, a Pfizer company, announced May 4 that it is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCL Injection, USP 30 mL because of mislabeling. A portion of each lot was incorrectly labeled as the other product.…
FDA: Class I recall of Alaris Infusion Pump Module 8100
Editor's Note The Food and Drug Administration, on April 30, identified the recall of the Alaris Infusion Pump Module 8100 as Class I, the most serious. The Pacific Medical Group (DBA Avante Health Solutions) is recalling the infusion pump because the front bezel components may crack or separate, leading to…
FDA: Class I recall of Cordis Precise PRO Rx US Carotid System
Editor's Note The Food and Drug Administration (FDA), on April 26, identified the recall by Cordis Corporation of its Precise PRO Rx US Carotid System as Class I, the most serious. The Carotid System is being recalled due to a risk of separation of the atraumatic distal tip of the…
FDA: Class I recall of Medtronic’s Extracorporeal Blood Pumping Console
Editor's Note The Food and Drug Administration (FDA), on April 20, identified the recall of Medtronic’s Bio-Console 560 Extracorporeal Blood Pumping Console as Class I, the most serious. The Console is used during heart surgery to pump and return blood to a patient during cardiopulmonary bypass. The recall was initiated…
Effect of indoor air changes on COVID-19 transmission
Editor's Note In this JAMA Insights article, researchers from the Harvard School of Public Health, Boston, and University of Michigan, Ann Arbor, conclude that increasing air changes per hour and air filtration are simple concepts that could be used to help reduce within-room, far-field (ie, within-room but beyond 6 feet)…
FDA issues Class I recall of certain Medtronic ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA), on April 12, identified the recall of Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. The recall was initiated because of an unexpected and rapid…
Studies assess use of Mako System in joint arthroplasty
Editor’s Note. This article presents value-based analyses on the use of Mako robotic technology in total knee, partial knee, and total hip arthroplasty. The authors are with Stryker Orthopaedics in Mahwah, New Jersey. Joint arthroplasty is an effective procedure to treat advanced osteoarthritis of the hips and knees. It…
HHS report finds US hospitals in crisis
Editor's report A new report released by the Department of Health and Human Services (HHS) Office of Inspector General (OIG) on March 23 details how the COVID-19 pandemic has created new problems and worsened existing issues at US hospitals, leaving staff frustrated, exhausted, and burned out. Among the problems outlined…
FDA: Class I recall of Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface
Editor's Note The Food and Drug Administration (FDA), on March 24, identified the recall by Medtronic of its Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface as Class I, the most serious. The recall was issued because of potentially elevated levels of harmful bacterial endotoxins. Use of a device…
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