“The U.S. Food and Drug Administration (FDA) is concerned by continued reports of misconnections with enteral devices. To reduce the risk of misconnections and patient injury, the FDA recommends hospitals and clinicians use enteral devices with connectors that meet the International Organization for Standardization (ISO) 80369-1 or ISO 80369-3 standard, or that are otherwise designed to reduce the risk of misconnections. There are currently marketed enteral connectors that meet the 80369-3 standards, many of which are identified by the tradename ENFit.
Misconnections between enteral devices and other medical devices, such as tracheostomy tubes, have been associated with patient death and serious injuries. Since 2011, the FDA has received reports of 2 deaths, 24 serious injuries, and 32 device malfunctions related to enteral misconnections. The FDA is also concerned that many misconnections, including enteral misconnections, are not reported, or are reported as medication errors.
The FDA is aware that some people who rely on enteral tube-feeding at home have concerns about using the 80369-3 connectors. The 80369-3 connectors have slightly narrower openings than some connectors on the market. People who use larger diameter gravity-feeding tubes, such as 24 French, may experience longer feed times if they switch to 80369 connectors. The FDA has conducted testing of commercial pre-packaged formulai and blenderized diets through 80369-3 connectors and has concluded that flow rates may be slightly slower, but this does not pose a safety concern. Additional resources are available from the Oley Foundation and the Feeding Tube Awareness Foundation.
The FDA continues to work with standards organizations, federal partners, professional societies, patient advocacy groups, individual patients and other stakeholders. The FDA works with these groups to reduce the chance of medical device misconnections, ensure patient safety, and facilitate the availability of products that work for the multitude of patient populations, uses, and care environments.
Recommendations for health care 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.”
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