Highlighted articles include:
Huber Needles: Risk of Coring - Recall
Coring may lead to infection, damage or death of tissue, swelling, or other serious adverse health consequences...
Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens
FDA and CDC have noted a progressive increase in the reports of bloodborne infection transmission over the past 10 to 15 years, resulting from the shared use of fingerstick and point-of-care (POC) blood testing devices...
INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow
There is a potential for failure of a pressure switch which may have an impact on the administration of INOMAX for inhalation to patients...
6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub
Devices in the affected batches have the potential for separation of the shaft (sheath) from the hub or for a break in the hub assembly...
Positive Displacement Needleless Connectors and Bloodstream Infections: Initial Communication
Several peer-reviewed clinical studies report an increase in bloodstream infections following the introduction and use of positive displacement needleless connectors in healthcare facilities...
Safety Investigation of Suspected Counterfeit Combat Application Tourniquets (C-A-T): Initial Communication
The suspected counterfeit tourniquets have subtle differences in stitching, printing of the logo and molding of plastic parts...
Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient's risk for PE subsides...
Staff Empowerment to "Stop the Line" Reduces Patient Identification Errors
Patient misidentification continues to be a quality and safety issue, with minimal data describing interventions to reduce identification band error rates...
Safe Sharps Handling
Two of the most common causes of needle sticks are re-capping needles and improper disposal of needles...
Updated Guideline for Using Interferon Gamma Release Assays to Detect Mycobacterium Tuberculosis Infection
This report provides guidance to U.S. public health officials, health-care providers, and laboratory workers for use of FDA-approved IGRAs in the diagnosis of M. tuberculosis infection in adults and children...
Clostridium Difficile: Navigating the Testing Options for Diagnosis
The choice for an individual laboratory should be based on careful evaluation of a selected test in your unique setting...
Guide Wire Fracture During Percutaneous Transluminal Coronary Angioplasty: Possible Causes and Management
The HeartNet team is highlighting a recently published article in Interactive Cardiovascular and Thoracic Surgery which presents the possible causes and management for guide wire fractures during percutaneous transluminal coronary angioplasty...
Well at Home Monitor - Class II Recall
The Well@Home Monitor by Patient Care technologies is intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility, the touch panel on affected devices may become unresponsive...
Baby Matters Recalls Nap Nanny Recliners Due to Entrapment, Suffocation and Fall Hazards
Voluntary recall of 30,000 Nap Nanny portable baby recliners...
Preventing Catheter/Tubing Misconnections: Much Needed Help is on the Way
Luer connector systems, common to many healthcare catheters, tubes, administration sets, extension sets, and syringes, have been at the heart of many catheter/tubing misconnections...
NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter
FDA notified healthcare professionals of a recall of two lots of NeoProfen (ibuprofen lysine) Injection because the product failed to meet a visible particulate quality requirement...
Webcast: Medical Device Event Reporting in Ophthalmic Settings
Please visit the Educational Materials page for a newly posted webcast sponsored by SightNet and presented in June...
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