In a letter to manufacturers, healthcare professionals and purchasers, the U.S. Food and Drug Administration (FDA) warned of possible misconnections with enteral devices. The letter states that since 2011, 2 deaths, 24 serious injuries, and 32 device malfunctions related to these misconnections have occurred.
If proper procedure is not followed, these tubes can mistakenly be connected to the wrong medical device and prove fatal. The FDA recommends that healthcare professionals:
- Use enteral devices that meet the ISO standards and are intended to reduce the risk of misconnection.
- Check the labeling or check with the distributor or manufacturer to determine whether your connectors meet the ISO standards.
- Organize a plan for your organization to implement the use of these new devices.
- Do not modify or adapt devices since that may defeat their safety system.
- Minimize the use of transition adapters (a device component that forms an intermediary connection between two incompatible medical devices).
- Do not use cross-application connectors.
- Trace all lines back to their origin when reconnecting devices.
- Route tubes and catheters that have different purposes in unique and standardized directions, to avoid accidental misconnections.
Recommendations for hospital purchasing departments and distributors:
- Purchase enteral devices that comply with the new ISO 80369-1 or ISO 80369-3 series standards to reduce the risk of misconnection.
- Ensure that an adequate inventory of the new devices is available to purchasers.