ENFit FAQs

Frequently Asked Questions

Enteral-Specific (ISO 80369-3)

The following frequently asked questions are intended to be used for understanding the ENFit patient safety initiative, which involves safer medical connectors for enteral applications. The better this initiative is understood, the easier it will be for everyone involved to generate awareness, prepare for the transition, and adopt the new connectors.

What is a small-bore connector?

A small-bore connector is a medical connector with an inner diameter of less than 8.5mm that is used to link or join medical devices, components, and accessories for the purposes of delivering fluids or gases. A Luer connector is a classic type of a small-bore connector used commonly in the healthcare setting. The current universal design of the Luer connector allows for medical misconnections between unrelated delivery systems that have different intended uses (e.g., vascular, enteral, respiratory, epidural, and intrathecal).

What is being done to address medical misconnections?

To address medical misconnections, the ISO 80369 series of standards was developed through global collaboration among clinicians, regulators (e.g., FDA), manufacturers, and standard bodies like AAMI and ISO. These standards assign unique, mechanically incompatible connectors for each clinical application. GEDSA’s Stay Connected initiative helps raise awareness and support adoption.

Why are you introducing a new enteral connector?

To reduce the risk of misconnections, the ENFit connector is part of ISO 80369-3. It ensures compatibility only with other ENFit enteral devices.

Who developed the proposed enteral ISO standard connector design?

The design was a group effort. AAMI/ISO assembled the ISO 80369–3 Project Group (PG-3). This group was a global representation of clinicians, practice experts, regulators, and industry participants. Through this open forum, any company interested in the ISO 80369 standard was allowed to participate. The PG-3 group identified, validated, and aligned to a global introduction of the new standard connector to systematically replace all prior enteral nutrition connector systems.

How long has ENFit been on the market, and what is the global status of the conversion?

ENFit® connectors have been on the market since 2016 as part of a global patient safety initiative to prevent misconnections between enteral devices and other small-bore connectors. Since their introduction, ENFit adoption has steadily increased across various regions.  In the United States, many hospitals, homecare organizations, and device manufacturers have either completed or are actively working toward conversion. The United Kingdom, Europe, and Australia were among the early adopters and have achieved widespread implementation. Other regions, including parts of Latin America, the Middle East, and Asia, are in various stages of progress depending on local regulations, supply availability, and clinical engagement.  Adoption timelines may differ by country or facility, but overall, there is growing global momentum as awareness and access to ENFit-compatible products continue to expand.  You can view a map of the current global conversion status here: https://stayconnected.org/global-conversion/

What guidance has the FDA provided on the adoption of these new standards?

The FDA’s guidance: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications provides recommendations to manufacturers, FDA reviewers, and others involved in manufacturing devices that use small-bore connectors for enteral feeding. This guidance also provides direction for those submitting or reviewing premarket notification submissions [510(k)] for these types of devices.

The FDA’s guidance recommends:

Devices with connectors that are part of, or form connections to, enteral feeding tubes conform to AAMI/CN3:2014 (PS) Part 3. However, conformance to the standard is not a requirement.

Manufacturers design and test enteral connectors based upon AAMI/CN3:2014 (PS) and AAMI/CN20:2014 (PS) to ensure that each proposed enteral connector is physically incompatible with non-enteral devices.

Manufacturers of enteral connectors that do not meet AAMI/CN3:2014 (PS), also known as proprietary connectors or transition connectors, continue to design and test the devices based upon the AAMI/American National Standards Institute (ANSI)/International Organization for Standardization (ISO) 80369-1 standard “Small-bore connectors for liquids and gases in health care applications”— Part 1: General requirements.

Why should we adopt the ENFit connector?

The ENFit connector provides a simple way to reduce the risk of enteral misconnections and improve patient safety. The ENFit connector addresses “patient side” connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. ENFit connectors passed a rigorous validation process including computer aided design (CAD), human factors, and usability testing as part of the pathway to ISO standards.

What makes the ENFit connector different from legacy systems?

 The ENFit connector has a unique enteral-specific design that does not allow connectivity with any other connector for any other clinical use. ENFit provides a threaded coupling design that signals the appropriate connection and stays in place. ENFit features administration sets and syringes that have female connector ends that fit into a male patient-access feeding tube port.

If we use enteral administration sets from one manufacturer and feeding tubes from another manufacturer, how will we know if the products will work together?

 Most enteral device manufacturers are complying with the ISO standards to help ensure compatibility between feeding tubes and feeding/administration sets. Manufacturers have worked together to develop an enteral-specific plan including transition connectors to allow cross-compatibility for the introduction period and to synchronize the transition to the ENFit connector system.

Do we have to transition to the ENFit connector?

Adoption is called for under California’s Health and Safety Code Section 1279.9. While not federally mandated in other United States, the FDA has recognized ISO 80369-3 and supports its adoption. Globally, manufacturers and suppliers have aligned with the new standard to reduce the risk of misconnections and improve patient safety. Many regions have now completed the transition. 

What is the significance of transition connectors?

Transition connectors enabled compatibility between legacy connectors and the ENFit system during the transition period. As the transition is now largely complete in many regions, many manufacturers have phased these adaptors out in those regions. However, they played a critical role in minimizing clinical disruptions during the conversion process.

How long will it take to be fully converted to the ENFit connector? 

Globally, the conversion to ENFit connectors in enteral feeding systems is well underway, but with varying rates of adoption across different regions, conversion timeframes depend on facility inventory turnover, supplier readiness, regulatory clearances, and regional mandates.

When will legacy administration sets, feeding tubes, and syringes be discontinued?

Discontinuation is at the discretion of manufacturers. However, many have already phased out products with legacy connectors, especially in regions where the ENFit connector is the standard of care. Check with your supplier representative for details.

Will there be different item numbers or SKUs for the ENFit sets, feeding tubes, and enteral-specific syringes?

Generally speaking, yes. Most manufacturers have introduced dedicated SKUs for ENFit-compatible items and have retired legacy product codes. However, this is at the discretion of each manufacturer, so product availability and labeling practices may vary. It’s best to contact your supplier directly for the most current product numbers. 

Will the ENFit Transition Connectors be available as a standalone item?

Yes, they were made available. However, with the widespread adoption of ENFit, many manufacturers have discontinued or significantly reduced the availability of transition connectors.

How can I get more information on the pricing of ENFit products?

Pricing is at the sole discretion of each device manufacturer. You should work directly with your supplier to determine pricing.

Will distributors have inventory of both the legacy system and the ENFit system?

During transition, distributors will likely have both legacy and ENFit systems in stock until inventories of the older items are depleted. Members of GEDSA (Global Engineered Device Suppler Association) have been working diligently to establish support transitions and shift customers from the legacy systems to the ENFit technology.

Will there be a standard color for the ENFit connector?

Color coding is not included in the 80369 standards. The standards will only address the ENFit connector’s design and performance criteria. These engineering design controls (forcing functions) make it highly unlikely to bring two unintended connectors together.  This solves the root cause of misconnections without relying on a color scheme that can easily be circumvented (as seen with legacy systems). While you might see the market align to consistent color usage, like purple, for ENFit connectors, it is not a requirement.

What is the role of GEDSA?

The Global Engineered Device Supplier Association (GEDSA) is a federal tax-exempt non-profit trade association established in part to help introduce the ISO 80369 connector standards and facilitate adoption of the safer connectors with the healthcare community. GEDSA, which is composed of leading manufacturers and distributors of enteral feeding devices, is united by a shared desire to increase patient safety. GEDSA speaks as a singular industry voice to communicate with the governing agencies, associations, and member suppliers, regarding issues that face device manufacturers, suppliers, and distributors. GEDSA leads a joint communication effort on behalf of the industry to ensure consistency and avoid any confusion as safer connectors are introduced globally.

Will non-enteral medical tubing connectors have distinct names?

Connector naming will most likely not be included in the ISO 80369 standards. However, to establish conformity many supplier companies are encouraged to use a common trademarked name for 80639 connectors as long as their product meets standards. Other delivery system working groups will align on a common name for the established standard connector, such as NRFit^® for neuraxial connectors.

Will gastrostomy tube (G-tube) skin-level devices be changed in any way? If so, how?

No. Connectors on skin-level (button style) feeding devices are out of scope of the ISO 80369-3 design standard, so those specific device connectors will not change. At the point that extension sets attach to these devices the connection will likely remain the same since those connection points are not affected by the standard. However, the other end of the extension set (often called the proximal end) that connects to administration sets and syringes will have the ENFit male connector.

Will using a transition connector on a bolus extension set make the hole in the bolus extension–syringe connection smaller?

The hole will likely be smaller than that of legacy catheter-tip syringes. However, it won’t be smaller than the end of the extension set that connects to a low-profile device. As long as the end of the extension set remains the smallest hole in the system, the flow rate properties are expected to be consistent with the legacy configuration.

Will the ENFit connectors allow for venting?

Yes, for most tube sizes, venting will work in the same manner as legacy systems. However, for very large tubes (≥20Fr) differences in venting performance may be seen among some patients.

When using ENFit, will it be possible to hydrate with a catheter-tip or an oral-tip syringe?

No. Hydration through a feeding tube with an ENFit connector will require the use of a syringe with an ENFit connector. Catheter-tip and oral-tip syringes will not couple with the ENFit connector. The connector was designed specifically to prevent the use of catheter-tip syringes in order to reduce the risks associated with possible misconnection among other medical delivery systems. 

Will thicker formulas and blenderized foods pass through the ENFit connector?

The ISO 80369-3 enteral feeding design standard was developed with current practice in mind and specific requirements to avoid any disruption of therapy. The bore size (or hole) in the ENFit connector was designed to be consistent with the current connector (commonly called “Christmas tree” or “stepped adapter”). Therefore, feeding through devices with the ENFit connector is intended to be consistent with current practice. For more information, contact the manufacturer of the enteral device directly.

Why should the old legacy system become obsolete?

The goal of establishing an enteral connector design standard is to improve patient safety by reducing the risk of a tubing misconnection, which is rare but dangerous and can even be fatal. The most effective way to comprehensively reduce the risk of misconnections and enhance patient safety is to ensure that connectors of different delivery systems (i.e., enteral and IV) are not compatible. Leaving the legacy connectors in place means the possibility of misconnections would still exist. Today patients are typically quite mobile, moving between hospital, post-acute facilities, and home. If each channel has enteral feeding devices with different connectors, then there is a strong likelihood of disruption of therapy due to incompatibility as well as the potential for a misconnection among the legacy systems.

Will bolus syringes used for feeding blenderized diets be available with ENFit connectors?

 Yes. All syringes intended for use through the enteral feeding tube are available with ENFit.

Will the smaller size of the hole leaving the syringe impact the ability to feed?

 Enteral-specific syringes with the ENFit connector will likely have a smaller hole than legacy catheter-tip syringes. However, the hole will not likely be smaller than the patient access end of the (bolus) extension set opening on most low-profile devices. As long as the end of the extension set remains the smallest hole in the system, the flow rate properties remain similar to legacy systems.

Will there be color-coded enteral syringes available to manage medication administration?

There are no color-coding requirements in the ISO standards. Therefore, syringe manufacturers may offer enteral-specific ENFit syringes in one or more colors. Check with your manufacturer or distributor of syringes for additional details.

Do pharmacies stock ENFit enteral syringes?

Distributors and pharmacies are becoming more and more aware of this need.  Ultimately it is up to the pharmacy to decide to carry these items. Check with either your local pharmacy or your home medical equipment company for the availability of ENFit syringes.

Once syringes are specifically enteral, will there be greater insurance coverage?

GEDSA is not in a position to address issues related to insurance coverage or reimbursement. Check with your insurance provider for their specific policy.

Will there be adaptors for different kinds of syringes?

During the transition period, ENFit Transition Connectors were available to help bridge compatibility between ENFit syringes and legacy feeding ports. In many areas, now that the transition is largely complete, these adaptors are no longer widely needed or available. To ensure compatibility, you must use enteral-specific ENFit syringes with ENFit feeding tubes and devices. Catheter-tip or oral-tip syringes will not fit the ENFit connector as its design was created to prevent misconnections with non-enteral systems.

Is ENFit for all patient populations?

Yes. ENFit connectors are designed for use across all patient populations, including neonatal, pediatric, and adult patients. This ensures consistency and safety in enteral feeding for every age group and care setting, including the NICU.

What is the orientation of the ENFit system, and why is it important?

For ENFit, the ISO 80369-3 female connector is on the administration or giving side of the system and the ISO 80369-3 male connector is on the patient access or receiving side of the system.

This orientation choice was agreed to after advice from the UK’s National Patient Safety Agency during development of the ISO standard, based on the UK experience of using the reverse orientation for enteral devices since NPSA Alert 19 (http://tinyurl.com/ht4hf9o) in 2007 to reduce the risk of delivering oral and enteral medicines via the wrong route.

To ensure compatibility between components of an ISO 80369-3 compliant system, ENFit has a specified orientation. In an ENFit system, all administration sets (pump sets, gravity sets, bolus feeding devices) and ENFit Syringes have an ISO 80369-3 female connector that mates to the ISO 80369-3 male connector on the feeding tube (NG Tube, G-Tube, PEG, J-Tube).

GEDSA members have aligned to the ENFit orientation so that all components, regardless of supplier, will fit together without the long term use of adapters.

What is the advantage of having only one system in use?

This is a worldwide effort where patient portability is best addressed with one system, in order to maintain continuity of care, reduce patient risks, and ensure ease of use for the caregiver.

Can a syringe that is NOT ENFit be an ISO syringe/an ISO solution?

Yes. ISO 80369-3 defines the geometry, material characteristics, and functional performance of a connector pair (one male half and one female half). The standard does not define the orientation of the connectors within the enteral feeding system. The term “ENFit” implicitly means a connector that is compatible with ISO 80369-3 while also defining the orientation of the connectors within the enteral feeding system (female on the administration device and male on the receiving device).

If another component can be ISO compliant, why would I want to use only one design (e.g. ENFit) for my hospital and patients?

Patients are mobile and have the ability to travel between healthcare settings and implementing a single design is strongly encouraged by GEDSA, supporting organizations including ASPEN, ISMP, EPSG, ASHP and other clinical practice organizations. This is a global standard directed to drive standardization for caregivers, manufacturers, and clinician’s world-wide. GEDSA strongly encourages the standardization of not only the ISO 80369-3 compatible connectors but the specific orientation (direction of flow from female to male) as outlined in the ISO 20695 enteral device standard. This ensures compatibility between components, avoids the need for adapters in the long term, and drives continuity and portability of care for the patients.

Therefore, it is possible to have an ISO compliant ISO 80369-3 connector, which is not compatible with ENFit. However, it is strongly encouraged that there be a single global solution.

Does ISO 80369-3 allow manufacturers to choose from multiple designs?

No. ISO 80369-3 defines the geometry, material characteristics, and functional performances of a critical interface between a standard connector pair made of one male half and one female half. The standard does allow for some flexibility in design characteristics; however, the intention is that all ISO 80369-3 connector pairs will be compatible with each other.

Is the connector orientation specified in ISO 80369-3 or in any other ISO standard?

Orientation is not defined in ISO 80369-3; however, it is specified in the ISO 20695 enteral device standard.

What was the reason for the ENFit Low Dose Tip Syringe design?

Concerns were raised regarding dose accuracy of low volume medications, when delivered with standard ENFit syringes (ISO 80369-3 female tip). A technical team of industry experts worked collaboratively to select and vet a solution to address small volume dose accuracy. This solution is known as the ENFit Low Dose Tip (LDT) Syringe and, when used as instructed, performs similarly to other male oriented enteral/oral slip tip legacy syringes. Additionally, the ENFit Low Dose Tip design has better accuracy than existing female oriented syringes. For more information regarding dose accuracy, please review the ENFit LDT Research Poster at https://stayconnected.org/gedsa-enfit-ldt-research-poster/.

Was the ENFit Low Dose Tip Syringe assessed for potential misconnections with other devices?

Yes. The Low Dose Tip design has been validated through rigorous misconnections risk analysis and performance testing, as well as usability and human factors testing. The ENFit design, including the Low Dose Tip design, provides a solution for accurate enteral dosing while maintaining a high level of mitigation to the risk of inadvertent tubing misconnections.

Why does ISO 80369-3 not incorporate the Low Dose Tip design?

ISO 80369-3 was published on 07/01/2016 and is part of a larger initiative, the ISO 80369 series of standards. The scope of the parent standard, ISO 80369-1, is to develop a series of small bore connectors that are unable to connect to other systems, preventing misconnections. ISO 80369-3 is the standard that specifically defines the connector design for enteral applications. The standard is limited to defining the connector geometry. Specifications regarding device performance, specifically related to dose accuracy, are out of scope for ISO 80369-3. The ENFit Low Dose Tip (LDT) design was adopted to meet clinicians’ expectations regarding low volume dose accuracy. Dimensional information for the ENFit LDT can be found in Annex K of the ISO 20695 enteral device standard.

What were the results of the ENFit Low Dose Tip Syringe design testing?

Performance testing of ENFit LDT Syringes was completed by an accredited third-party lab to quantify the accuracy of the syringe within the enteral system (i.e. accuracy of dose when delivered through an enteral catheter). The ENFit LDT Syringe dose accuracy is substantially equivalent to the dose accuracy of male enteral/oral slip tip legacy syringes for low volume doses (e.g. 0.2mL dose delivered from a 1mL syringe with ± 10% accuracy) when used as instructed. Results from the performance testing, usability testing, and misconnection risk analysis were submitted and thoroughly reviewed by the FDA in the form of a Device Masterfile.

Why was there an aggregate taken of three enteral/oral slip tip legacy syringes during the ENFit Low Dose Tip Syringe testing?

 Since there are no ISO design standards for enteral/oral slip tip legacy syringes, GEDSA evaluated three of the most commonly used enteral/oral slip tip legacy syringes and took an aggregate of the results to determine a baseline for dose accuracy.

The results were aggregated for these three syringe designs to provide a baseline because they can be used interchangeably across legacy enteral systems. This provides an overall grasp at the dosing accuracy of this style of syringe when used as instructed, independent of the specific syringe chosen.

Is the dosing accuracy performance data available for review?

Yes. A summary of the dosing accuracy data can be found in the ENFit LDT Research Poster at https://stayconnected.org/gedsa-enfit-ldt-research-poster/.

How does ENFit low-dose accuracy compare to enteral/oral slip-tip legacy syringes? 

An analysis of the dose accuracy was performed to determine if any statistically significant differences were observed between ENFit Syringes, ENFit LDT Syringes, and legacy enteral/oral slip tip syringes. The syringes were tested per the manufacturer’s instructions for use. Testing indicates that the ENFit LDT Syringe performs equal to or better than legacy enteral/oral slip tip syringes.

Are there any standards that define dose accuracy requirements of enteral/oral syringes?

No, there are no standards (ISO, AAMI, ASTM, EN) for enteral/oral syringes that specify dose accuracy. Since there is not a standard that is specifically applicable to the dose accuracy of enteral/oral syringes intended to connect with other medical devices, many manufacturers refer to the performance requirements in ISO 7886-1, Sterile Hypodermic Syringes for Single Use – Part 1: Syringes for Manual Use as a proxy.

What is the ISO 7886-1 standard? 

ISO 7886-1 is a standard for manual hypodermic syringes, which includes requirements and test methods for various syringe parameters including tolerance on graduated capacity. Typically, enteral/oral syringe manufacturers apply the requirements of this standard, such as tolerance on graduated capacity, since there are no relevant standards in place for enteral/oral syringes.

Do all ENFit Low Dose Tip (LDT) Syringes comply with the tolerance on graduated capacity requirements of ISO 7886-1?

All tested ENFit Syringes and ENFit Low Dose Tip Syringes meet the requirements for tolerance on graduated capacity per ISO 7886-1.

What is the difference between tolerance on graduated capacity, as defined in ISO 7886-1, and dose accuracy?

Term	Technical Definition	Translation
Tolerance on Graduated Capacity	Tolerance on Graduated Capacity (TOGC) is the allowable variability of volume of water expelled from the syringe when the plunger traverses a given scale interval(s). This defines the required precision of the scale or markings on a syringe barrel. The tolerance is specific to the syringe and not the entire system. For a full definition refer to ISO 7886-1 section 3.2.	The ability of the graduation markings to accurately measure the volume of the liquid drawn into and expelled from the syringe. TOGC is measured in an ‘unconnected’ state (not attached to another device).
Dosing Accuracy	The actual dose delivered to the patient by the syringe in relation to the intended dose within a feeding system. Dosing accuracy is concerned with the feeding system, not just the syringe. Dosing accuracy is impacted by multiple variables within the system, including tolerance on graduated capacity. Dose accuracy requirements are not defined in ISO 7886-1.	The ability of the entire system to deliver the desired dose volume when connected.

 

Non-Traditional Use of Enteral Patient Access Devices

GEDSA advises against and cannot comment on or address any off-label use. All products and product designs are the responsibility of each specific legal manufacturer, distributor or supplier. Products with these design features may be pending regulatory clearance or may not be available in a specific geography. Consult your supplier representative for product-specific use, availability, indications, contraindications, precautions, and warnings.

Additional Resources

1. ANSI/AAMI/ISO 80369-1:2010: Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements. AAMI, Arlington, VA, 2010.

2. Section 1279.7 of California’s Health and Safety Code https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC&sectionNum=1279.7

3. Guenter, P., Hicks, R., Simmons, D., Crowley, J., Croteau, R., Gosnell, C., Vanderveen, T. Enteral Feeding Misconnections: A Consortium Position Statement. The Joint Commission Journal on Quality and Patient Safety. https://pubmed.ncbi.nlm.nih.gov/18491692/

4. Making healthcare safer II: An updated critical analysis of the evidence for patient safety practices, pp.487-492, AHRQ. https://www.ahrq.gov/research/findings/evidence-based-reports/ptsafetyuptp.html Published March 2013.

5. Examples of Medical Device Misconnections https://www.fda.gov/medical-devices/medical-device-connectors/examples-medical-device-misconnections

6. Memorandum to manufacturers, healthcare professionals and hospital purchasing departments about Luer misconnections. FDA Website. https://www.fda.gov/media/78921/download Published July 9, 2010.

7. Memorandum: Luer Misconnection Adverse Events. CMS Website. https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-to-states-and-regions-items/survey-and-cert-letter-13-14 Published March 2013.

8. Sentinel Event Alert: Tubing misconnections: A persistent and potentially deadly occurrence. The Joint Commission Website. https://www.jointcommissionjournal.com/article/S1553-7250(06)32054-5/abstract Published April 2006.

9. Simmons, D., Phillips, M., Grissinger, M., Becker, S. Error-Avoidance Recommendations for Tubing Misconnections When Using Luer-Tip Connectors: A Statement by the USP Safe Medication Use Expert Committee. The Joint Commission Journal on Quality and Patient Safety. https://pubmed.ncbi.nlm.nih.gov/18491693/ Published May 2008.

10. Simmons, D., Symes, L., Guenter, P., Graves, K. Tubing Misconnections: Normalization of Deviance. Nutrition in Clinical Practice. https://pubmed.ncbi.nlm.nih.gov/21586413/ Published June 2011.

11. FDA Guidance document Safety Considerations to Mitigate Risks of Misconnections with Small bore Connectors Intended for Enteral Applications February 11, 2015 https://www.fda.gov/files/medical%20devices/published/Safety-Considerations-to-Mitigate-the-Risks-of-Misconnections-with-Small-bore-Connectors-Intended-for-Enteral-Applications—Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdf

12. Joint Commission Sentinel Event Alert Issue 53 Managing risk during transition to new ISO tubing connector standards August 20, 2014 https://www.jointcommission.org/en-us/knowledge-library/newsletters/sentinel-event-alert/issue-53