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UMDNS Device Terms
Syringes, Plunger, Enteral Feeding-Specific Connector 
Tubes, Gastrostomy, Decompression/Duodenal Feeding 
Tubes, Gastrostomy, Decompression/Jejunal Feeding 
Tubes, Gastrostomy, Feeding 
- Cross-connection of enteral tubing has led to serious consequences (e.g., feeding solution in lungs and veins).
- To help reduce the risk of cross-connections, Global Enteral Device Supplier Association (GEDSA) member manufacturers will phase out legacy (non-ENFit) devices starting July 1, 2020.
- Failure to transition could lead to delays in treatment while restocking with available products.
Manufacturer's Corrective Action/Recommendations
- FDA recommendations (letter available
- Medical 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, because 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.
- To avoid accidental misconnections, route tubes and catheters that have different purposes in unique and standardized directions.
- Patients and caregivers:
- Use available resources to learn more about the risk of misconnections and why enteral device connecters have changed. Visit the StayConnected and
Feeding Tube Awareness Foundation websites for more information.
- Ask your retail pharmacist (i.e., community pharmacist), healthcare professional, or home medical equipment supplier about ENFit and recommendations for a successful transition.
- Patients can access more information through their respective enteral device suppliers.
Hospital purchasing departments and distributors:
- Create a plan for your organization to complete a full conversion to ENFit connectors. Visit GEDSA's YouTube channel to watch the success of other organizations who have implemented ENFit.
- Educate your patients and all relevant healthcare personnel about the changes in enteral connectors.
- Communicate the ENFit conversion with the broader healthcare community in your area. E-mail
email@example.com for more information about scheduling an ENFit regional summit in your area.
- Visit the StayConnected website for free resources to aid in your ENFit adoption process.
- Identify all the enteral devices being used in your facility, determine supply needs, and develop a transition plan.
- Contact your enteral device supplier to understand the conversion process and obtain more information.
- Following the FDA's recommendations, purchase enteral devices that comply with the new ISO 80369-1 or ISO 80369-3 series standards.
- Ensure that an adequate inventory of the new devices is available to purchasers.
- Identify all enteral supplies including tubes, bags, administration sets, and syringes still using legacy feeding connectors.
Replace all legacy enteral feeding supplies when your current inventory is depleted.
- It is likely that these devices are from multiple suppliers.
- Conducting team meetings to ascertain all involved departments and patients is essential.
- Some tubing may remain in use for an extended period and require procedures to exchange. The next exchange should be made with consideration for ENFit compatibility. Some examples are:
- Percutaneous endoscopic gastronomy (PEG-Tube)
- Gastronomy (G-Tube)
- GastroJujenostomy (G-J Tube)
- Jujenostomy (J-Tube)
- Adapters may be needed to connect legacy devices to newer ENFit components; however, the extra connections that are required increase the risk of misconnection and crossover.
- Adapters to connect legacy devices to ENFit will no longer be manufactured after January 2021.
- FDA recognizes the hazards posed by cross-connections and has issued guidance
- FDA has mandated that all new products comply with ISO 80369-3 (ENFit) or a proprietary standard incompatible with other small bore tubing.
- GEDSA estimates that hospitals in North America are about 30% converted after 2 years, based on member input and anecdotal evidence. In comparison to the European Union, this has been slower than anticipated; however, several large and prestigious hospitals or groups have converted in the summer of 2019. GEDSA expects to see an acceleration in adoption rates going into 2020 as a consequence of these large and influential institutions converting to ENFit.
- GEDSA published a plan for member suppliers to phase out legacy products.
For related information, see ECRI Institute's 2018 Top 10 Health Technology Hazards article.
- July 1, 2020, legacy feeding tubes and cross-application adapters will no longer be manufactured.
- January 1, 2021, transition sets and adapters sold separately from other devices will no longer be manufactured.
- Many enteral feeding sets are shipped with transition adapters.
Figure 1. A. Legacy feeding tubes and cross-application adapters (manufacture end on July 1, 2020). B. Transition sets and adapters (manufacture end on January 1, 2021).
- United States. Food and Drug Administration. Reducing Risks through Standards Development for Medical Device Connectors [online]. 2018 Sep 6 [cited 2020 Feb 18]. Available from Internet:
- Global Enteral Device Supplier Association (GEDSA): ENFit connector conversion letter. ENFit connector conversion schedule for the U.S. [cited 2020 Feb 20].