Safety Considerations Related To Misconnections Between Medical Devices

Safety Considerations To Mitigate The Risks Of Misconnections With Small-Bore Connectors Intended For Enteral Applications

Small-bore connectors provide a mechanism for the connection between a variety of medical devices including those with enteral and non-enteral (e.g., intravenous) applications. Small-bore Luer connectors can freely connect to many different medical devices.

Connectors can be used for the following device types:

• Intravascular Devices

• Breathing Systems And Driving

• Urethral/Urinary Devices

• Hypodermic Applications

• Limb Cuff Inflation Devices

The use of common connector designs, such as Luer connectors, has led to unintended connections between devices that have different intended uses and has resulted in serious and sometimes fatal consequences to patients.

Following are few Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications

• Misconnections can occur when a connector on a medical device performing a specific function is unintentionally or intentionally attached to a connector from another medical device that performs a completely different function.

• Human factor errors coupled with widespread use of Luer connectors may promote misconnections of enteral to nonenteral devices.

• Regarding testing, to demonstrate non-inter-connectable characteristics, the proposed connector should not provide a secure connection with a non-enteral connector when assembled with moderate force. Threaded connectors should be tested clockwise and counter clockwise.

• Color-coding, labeling, and tagging or imprinting (e.g., “feeding only,” “medication only”) on the device, by themselves, are not sufficient to mitigate health concerns from enteral misconnection. For connectors for which noninter-connectability has been demonstrated, color-coding, labeling, and tagging or imprinting on the connector could also be incorporated into the product design.

• Side port connectors that are used for flushing and/or drug administration be tested similarly to the enteral connectors.

• The Enteral labeling, including the instructions for use, should not include the terms “enteral-only” and “Non-IV.”

• In addition, for the connectors for which noninterconnectability is demonstrated, labeling and tagging or imprinting (e.g., “feeding only,” “medication only”) on the connector could be incorporated into the product design.

• Information regarding the potential to misconnect with other device applications should be included as a warning in the instructions for use.

(Ref: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
TubingandLuerMisconnections/)

Back | Next