LabNet News

LabNet News LabNet News includes excerpts from MedSun News, a monthly newsletter. The MedSun Project consists of a group of hospitals and nursing homes working collaboratively with the FDA in order to identify, understand, and share information about medical devices. In 2006 MedSun was expanded to include the collection of adverse events (whether actual or potential) occurring from the use of laboratory in vitro diagnostic devices (IVDs) in hospital laboratories and patient care areas. This segment of MedSun is known as LabNet. Reports about laboratory products are sent to the OIVD group for analysis and follow-up.

Below is a collection of articles related to IVDs.

• June 2008
  • Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product
  • Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations
  • 2008 National Patient Safety Goals Laboratory Services Program
  • Recognizing the Sources of Interference with Immunoassays
    
• May 2008
  • Of Interest to Laboratorians
• April 2008
  • FDA Reminds Healthcare Professionals About Falsely Elevated Glucose Levels
• March 2008
  • Laboratory Device Problem Reports
• February 2008
  • Problems with Glucose Meters and Continuous Glucose Monitoring Systems
  • IVD Problem Reports
• December 2007
  • New AHRQ Guide Helps Clinicians Determine Necessary Preventive Medical Tests for Patients
• November 2007
  • CLIA Waiver Granted by FDA for i-STAT® CHEM8+ Test Cartridge
  • FDA Clears Genetic Lab Test for Warfarin Sensitivity
• May 2007
  • Top-Ten Reported In Vitro Diagnostic Devices
• March 2007
  • FDA’s OIVD Begins Open Dialogue With LabNet Sites
  • More on the Breast Cancer Specific Molecular Prognostic Test
• February 2007
  • FDA Clears Breast Cancer Specific Molecular Prognostic Test
• November 2006
  • Rapid Lead Screening Test Now Available at More Facilities
• September 2006
  • FDA Seeking Comments on Use of Identifier System for Medical Devices: Identifier System Could Be Important Tool for Patient Safety
• March 2006
  • C-Reactive Protein: Differences Among Various Assays