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 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…
Breathe easier with the right respiratory protection
The COVID-19 pandemic has underscored the importance of respiratory protection in healthcare settings and in the community. Healthcare workers at high risk of infection need the most effective respiratory protection, and not all surgical masks and respirators are alike. Checking for proper fit, donning and doffing correctly, and following manufacturers’…
Systematic review of N95 respirator reprocessing
Editor's Note This systematic review by researchers from the University of California, Los Angeles, of five decontamination processes for N95 respirators finds ultraviolet germicidal irradiation, moist heat, and microwave generated steam reprocessing to be effective and simple to implement. A total of 42 studies were reviewed. Ultraviolet germicidal irradiation, moist heat,…
FDA calls on 25 firms to stop displaying misleading certificates
Editor's Note The Food and Drug Administration (FDA) announced March 3 that it has asked 25 firms to stop producing and issuing misleading “FDA registration certificates” and FDA logos that create the impression the FDA has approved or authorized their products. The firms include mask, respirator, face shield, and other…
FDA: Class I recall of Medtronic's HVAD Pump Implant Kits
Editor's Note The Food and Drug Administration (FDA) on March 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits as Class I, the most serious. The kit is part of the HeartWare HVAD System, which is used to help the heart pump blood…
