FDA: Safety Alert on transmission risk of SARS-CoV-2 virus in fecal microbiota
Editor's Note The Food & Drug Administration on March 23 issued a Safety Alert to inform healthcare providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT), and that the agency has determined that additional safety protections are needed.…
ASCA releases guidance on necessary surgeries for ASCs during COVID-19 pandemic
Editor's Note In consultation with clinical experts and in response to government guidance that hospitals and ambulatory surgery centers (ASCs) postpone elective surgical procedures during the COVID-19 pandemic, the Ambulatory Surgery Center Association (ASCA) released a statement March 18 on how and when facilities should proceed with cases that should…
FDA: Class I recall of Alaris Infusion Pump System and Modules
Editor's Note The Food and Drug Administration (FDA) on March 6 identified the recall by Becton Dickinson (BD)/CareFusion 303 of its Alaris System Infusion Pumps and Modules as Class I, the most serious. The recall was initiated because of multiple system errors, software errors, and use-related errors. The errors can…
FDA, CDC increase access to respirators during COVID-19 outbreak
Editor's Note The Food & Drug Administration (FDA) on March 2 announced that it had joined with the Centers for Disease Control and Prevention (CDC) to make more respirators, including certain N95s, available to healthcare personnel during the coronavirus (COVID-19) outbreak. Currently, the majority of respirators are used in industrial…
FDA: Class I recall of King Systems’ video laryngoscope adapter
Editor's Note The Food & Drug Administration (FDA) on February 27 identified the recall by King Systems of its King Vision Video Laryngoscope Adapter (size ½) as Class I, the most serious. The recall was initiated because all devices from the affected lots show a reversed image on the display,…
FDA: Class I recall of Tytek Medical TM-317 PneumoDart-Pneumothorax Needle
Editor's Note The Food & Drug Administration on February 25 identified the recall of Tytek Medical’s TM-317 PneumoDart-Pneumothorax Needle as Class I, the most serious. The recall was initiated because of the risk of blockage in the needles caused by the presence of adhesive from the assembly process. The company…
FDA: Class I recall of Abbott coronary dilatation catheters
Editor's Note The Food & Drug Administration on February 19 identified the recall by Abbott Vascular of its NC Trek RX and NC Traveler RX Coronary Dilatation Catheters (diameter 4.0 mm, 4.5 mm, and 5.00 mm) as Class I, the most serious. The recall was initiated because of failure of…
Latest sterilization packaging guideline backed by evidence
In October 2019, AORN released its updated Guideline for Sterilization Packaging, which is based on evidence from peer-reviewed literature. This article includes recommendations from that guideline and addresses common misconceptions about sterilization packaging. Other resources for proper use of sterilization packaging include the Association for the Advancement of Medical Instrumentation…
FDA monitoring coronavirus and its effect on supply chain
Editor's Note The Food & Drug Administration on February 14 announced that it is an active partner in the coronavirus (COVID-19) response. It is working closely with the Department of Health and Human Services and international counterparts to help diagnose, treat, and prevent the disease as well as surveil the…
FDA: Coronavirus hasn’t led to drug, device shortages, but situation fluid
Editor's Note The Food & Drug Administration (FDA) Commissioner Stephen Hahn says there have been no drug or medical device shortages reported in the US so far amid the coronavirus outbreak, but the situation remains fluid, the February 7 Politico reports. The FDA has pulled its inspectors from China, and…
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