Considerations Related To Misconnections Between Medical Devices
Safety Considerations To Mitigate
The Risks Of Misconnections With Small-Bore Connectors Intended For Enteral
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:
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.