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…
FDA authorizes marketing of first AI guided cardiac ultrasound
Editor's Note The Food & Drug Administration (FDA) on February 7 authorized marketing of software to assist in the acquisition of cardiac ultrasound images. The software, named “Caption Guidance,” uses artificial intelligence (AI) to help capture images of a patient’s heart from different angles, which are used to diagnose various…
FDA: Class I recall of GE Healthcare CARESCAPE Respiratory Modules, Airway Gas Option
Editor's Note The Food and Drug Administration (FDA) on February 4 identified the recall by GE Healthcare of its CARESCAPE Respiratory Modules and Airway Gas Option as Class I, the most serious. The recall was initiated because of a manufacturing issue that may cause the devices to display incorrect oxygen…
Cardinal Health recalls more than 9 million surgical gowns
Editor's Note Cardinal Health is voluntarily recalling 9.1 million potentially contaminated surgical gowns, 7.7 million of which were distributed to 2,807 facilities across the country, the January 22 Becker’s Hospital Review reports. The company took the action after learning of unsanitary environmental conditions at a plant in China that manufacturers…
FDA: Quality issues with Cardinal Health surgical gowns, packs
Editor's Note The Food & Drug Administration (FDA) on January 16 announced that Cardinal Health has alerted it customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contain the gowns. Cardinal Health and the FDA recommend that customers immediately discontinue use…
FDA: Class I recall of Medfusion 4000 Syringe Pumps
Editor's Note The Food & Drug Administration (FDA) on December 19, 2019, identified the recall by Smiths Medical ASD, Inc of its Medfusion 4000 Syringe Pumps as Class I, the most serious. The recall was initiated because of malfunctioning low-battery alarms, which may lead to an interruption of therapy. The…
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