Additional Resources: Medical Device Connectors
This page provides links to resources on medical device misconnections, including education & training materials, webcasts, and guidance and standards. These resources include content from the FDA and outside organizations.
Additional Resources
Webcasts
- FDA Patient Safety News (YouTube Video). More Patient Deaths from Luer Misconnections. October 2007.
Adverse Events Reporting Databases
Standards and Guidance
- Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 142KB)
- 2010 Letter from FDA to manufacturers of enteral feeding tubes (PDF - 27KB)
- ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
- ISO 80369-3:2016, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
- IEC 80369-5:2016, Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
- ISO 80369-6:2016, Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for Neuraxial Applications
- ISO/FDIS 80369-7, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
Articles on the Prevention of Misconnections
- Enteral Feeding Misconnections: A Consortium Position Statement
- Institute for Safe Medication Practices (ISMP) Article reported tubing misconnections
- WHO Collaborating Centre for Patient Safety Solutions. Patient Safety Solutions. Avoiding Catheter and Tubing Misconnections
- The Joint Commission Sentinel Event Alert. Tubing Misconnections—A Persistent and Potentially Deadly Occurrence. April 3, 2006, Issue 36