Supply Chain/Technology
FDA: Class I recall of GE Healthcare’s CARESCAPE R860 Ventilator
Editor's Note The Food and Drug Administration (FDA) on June 28 identified the recall by GE Healthcare of its CARESCAPE R860 Ventilator as Class I, the most serious. The recall was initiated because the ventilator backup batteries, including replacement backup batteries, may run out before they are expected to do…
Contrast media shortage reveals cracks in supply chain
May 2022 saw a critical shortage of the iodinated contrast medium (ICM) iohexol that extended well into June because of a COVID-19-related shutdown of a GE Healthcare plant in Shanghai, China, that interrupted the manufacture of ICM. According to the American College of Radiology, contrast media were added to the…
Hospitals can still be better prepared for natural disasters
When a natural disaster strikes—whether flood, tornado, hurricane, or wildfire—nearly every aspect of a healthcare system’s operations are impacted. There is an influx of patients in crisis and a spike in calls for emergency services. There are logistical problems—impassable roads, power outages, and communication and internet breakdowns. Supply chain disruptions…
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…
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