MedSun: LabNet
LabNet
These subnetworks are designed to collect and share information about actual and potential adverse events from specific clinical areas of MedSun facilities using high-risk products.
For related information, see the latest device approvals that may be relevant to your specific clinical area.
The following is the latest content from the LabNet Subnetwork:
LabNet
Focuses on promoting awareness of medical devices in hospital laboratories and reporting identified problems to FDA’s Office of In Vitro Diagnostics. To see recently submitted MedSun Laboratory Device Reports, see Laboratory/In Vitro Diagnostic Devices.
Sodium Azide Safety Tip (OIVD) |
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FDA MedWatch Safety Alert
FDA has received an increasing number of reports of explosions involving solutions containing sodium azide used in clinical facilities. This communication is to remind laboratories and hospitals about the danger posed by long-term accumulation of sodium azide solutions, and to recommend steps to prevent such incidents. This safety tip provides recommendations on proper handling, storage, and disposal of sodium azide.
Additional Information:
FDA Office of In-Vitro Diagnostics (OIVD) website. Sodium Azide Solutions: Potential for Explosions from Improper Handling and Disposal. October 9, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm186147.htm
Higher Standards on the Way for Glucose Meters? |
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AACC Clinical Laboratory News
The FDA will consider tightening standards for strip-based blood glucose meters, echoing the concerns of many in the clinical lab field who have warned for a decade that the meters are not reliable. FDA also acknowledged an issue that has been a growing concern among laboratorians—that poor outcomes in recent tight glucose control (TGC) trials might be, in part, due to the use of error-prone meters instead of more accurate point-of-care instruments.
Additional Information:
Higher Standards on the Way for Glucose Meters? AACC Clinical Laboratory News. September 2009.
http://www.aacc.org/publications/cln/2009/september/Pages/inside0909.aspx
Lab Safety: Evaluating Training |
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Lab Manager Magazine
With a research facility's typical mix of research laboratories, instrument rooms, chemical storage, waste handling and busy receiving/loading docks, a wide array of hazards is always present. Every day, employees must deal with these hazards while hopefully avoiding accidents and injuries. The article lists ways to evaluate lab training programs and tips on preventing accidents and injuries.
Additional Information:
Lab Safety: Evaluating Training. Lab Manager Magazine. September 3, 2009.
http://www.labmanager.com/articles.asp?ID=341
All LabNet Content to Date
- (November 2009) Sodium Azide Safety Tip (OIVD)
- (November 2009) Higher Standards on the Way for Glucose Meters?
- (November 2009) Lab Safety: Evaluating Training
- (October 2009) Interim Guidance for the Detection of Novel Influenza A Virus Using Rapid Influenza Diagnostic Tests
- (October 2009) H1N1 Resources from FDA and CDC
- (September 2009) Novel Influenza A (H1N1) Virus Infections Among Health-Care Personnel
- (September 2009) Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases
- (September 2009) GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology
- (August 2009) Ethics Code Changes for Diagnostics Manufacturers, Clinical Laboratory News Why Should Laboratories take Notice
- (July 2009) Roche Diagnostics notifies customers of the potential for ACCU-CHEK Softclix 10 and/or 17 count lancets to be uncapped which may lead to an accidental needle stick
- (July 2009) Detection of Novel Influenza A (H1N1) Virus by Laboratory Testing
- (July 2009) False Positive Results with a Commercially Available West Nile Virus Immunoglobulin M Assay
- (May 2009) MRSA Screening Used to Decrease SSIs
- (May 2009) Update Regarding the Availability of Rapid Influenza Tests and Viral Transport Media
- (April 2009) Revelations in In Vitro Diagnostic (IVD) Device Labeling - Proactive Prevention of Adverse Events by Informed Decision Making
- (April 2009) Factitious Biochemical Measurements Resulting from Hematologic Conditions
- (March 2009) ISO Accreditation Comes to America: Are Labs Ready to Embrace an International Quality Management System?
- (March 2009) Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis
- (February 2009) Falsely Elevated Glucose Readings from Maltose-Containing Drugs
- (January 2009) Reducing Errors in the Clinical Laboratory: A Lean Production System Approach
- (January 2009) New Device Approval - COBAS TaqMan HCV Test For Use With the COBAS AmpliPrep Instrument and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer - P060030
- (December 2008) 2009 National Patient Safety Goals: Laboratory Services Program
- (December 2008) October 2008 Clinical Laboratory News: Guidelines Have an Impact but Face Tough Challenges
- (December 2008) Patient Safety Focus: Pre-analytic Labeling Errors
- (November 2008) Problems with Medical Devices Used in Point-of-Care Testing
- (November 2008) FDA Clears New CDC Test to Detect Human Influenza
- (October 2008) FDA Approves DNA Test to Measure Hepatitis B Virus Levels
- (October 2008) ROC Curves: Uncovering the Pearls and Avoiding the Pitfalls
- (September 2008) FDA Approves New Genetic Test for Patients with Breast Cancer
- (July 2008) Point-of-Care Testing
- (June 2008) Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product
- (June 2008) Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations
- (June 2008) 2008 National Patient Safety Goals Laboratory Services Program
- (June 2008) Recognizing the Sources of Interference with Immunoassays
- (May 2008) Of Special Interest to Laboratorians/LabNet
- (April 2008) Of Special Interest to Laboratorians/LabNet
- (February 2008) Of Special Interest to Laboratorians/LabNet
- (December 2007) Of Special Interest to Laboratorians/LabNet
- (November 2007) Of Special Interest to Laboratorians/LabNet
Updated November 23, 2009