Supply Chain/Technology
Machine learning model uses data from wearable devices to detect COVID-19 in HCWs
Editor's Note Researchers at the Icahn School of Medicine, Mount Sinai, New York City, have developed a machine learning model that uses physiological metrics collected from wearable devices that can detect and predict COVID-19 in healthcare workers (HCWs). A total of 407 HCWs from 7 hospitals were enrolled in the…
FDA: Class I recall of one lot of Draeger SafeStar 55 Breathing System Filters
Editor's Note The Food and Drug Administration (FDA) on June 21 identified the recall by Draeger, Inc, of one lot (LT2103) of its SafeStar 55 Breathing System Filters as Class I, the most serious. The Breathing System Filter is used as part of a ventilator when a patient is under…
The Joint Commission seeking comments on EM surge management plan
Editor's Note The Joint Commission announced on June 15 that it is seeking comments on proposed Emergency Management (EM) chapter requirements related to surge management for its hospital and critical access hospital accreditation programs. Since approval of the new, revised EM standards, which are effective July 1, experts in the…
FDA: Class I recall of Woodside Acquisitions’ Oral Rapid and Joysbio SARS-CoV-2 Antigen Rapid Test Kits
Editor's Note The Food and Drug Administration (FDA) on June 9 updated the Class I recall by Woodside Acquisitions Inc of its Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) that are not authorized, cleared, or approved by the FDA. The FDA…
ASRA Pain Medicine issues recommendations in light of contrast shortage
Editor's Note The American Society of Regional Anesthesia and Pain Medicine (ASRA Pain Medicine) developed and published on May 23 recommendations clinicians should take during the current shortage of the iodinated contrast medium (ICM) iohexol. Contrast medium, according to ASRA Pain Medicine, is used to confirm accurate needle placement and…
Contamination during reuse of N95 masks
Editor's Note This simulation study, led by researchers at the Louis Stokes Cleveland VA Medical Center, Cleveland, finds that reuse of N95 masks can result in contamination of those wearing the masks and the environment, even when correct technique is used. A total of 12 healthcare workers (HCWs) performed 3…
FDA: Class I recall of Medtronic HVAD Pump Implant Kit
Editor's Note The Food and Drug Administration (FDA) on June 8 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit as Class I, the most serious. The HVAD System is used as a bridge to cardiac transplants. The Kit was recalled because of a…
FDA: Class I recall of Philips Respironics V60, V60 Plus Ventilators
Editor's Note The Food and Drug Administration on June 3 identified the recall by Philips Respironics of all V60 and V60 Plus Ventilators as Class I, the most serious. The recall was initiated because an internal power fluctuation may cause the ventilator to shut down unintentionally with or without any…
FDA: Class I recall of Atrium Medical’s iCast Covered Stent
Editor's Note The Food and Drug Administration (FDA) on June 2 identified the recall by Atrium Medical Corporation of its iCast Covered Stent System as Class I, the most serious. The recall was initiated because of increased complaints about the separation of the balloon or catheter hub from the delivery…
FDA: Class I recall of Arjo Sara Plus lift
Editor's Note The Food and Drug Administration (FDA) on May 27 identified the recall of the ArjoHuntleigh Polska Sara Plus floor lift as Class I, the most serious. The recall was initiated because of the risk of smoke or fire if the lift is used when the battery is low.…
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