Medical Devices
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Additional Resources
This page provides links to resources on tubing and Luer misconnections, including education & training materials, webcasts, and guidance and standards. These resources include content from the FDA and outside organizations.
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Adverse Events Reporting Databases
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Standards and Guidance
Draft Guidance for Industry and Food and Drug Administration Staff - Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications Association for the Advancement of Medical Instrumentation (AAMI). ISO/IEC small bore connector standard 80369-1: 2010.
- 2010 Letter from FDA to manufacturers of enteral feeding tubes (PDF - 27KB)
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Articles on the Prevention of Misconnections
Enteral Feeding Misconnections: A Consortium Position Statement
Institute for Safe Medication Practices Articles on Catheter Misconnections
WHO Collaborating Centre for Patient Safety Solutions. Patient Safety Solutions. Avoiding Catheter and Tubing Misconnections.
ECRI Institute. Health Devices: Preventing Misconnection Risks in the Hospital. Volume 35, Number 3. March 2006.
The Joint Commission Sentinel Event Alert. Tubing Misconnections—A Persistent and Potentially Deadly Occurrence. April 3, 2006, Issue 36.
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