As of June 17th, 2016 the FDA has granted FDA 510(k) clearance to at least two manufacturers submissions for the ENFit Low Dose Tip Syringe. Other manufacturers are currently in the process of gaining FDA 510(k) clearance for their ENFit LDT syringes.
Performance testing of syringes with the LDT was performed by an accredited third part lab to quantify the accuracy of the syringe within the enteral system (i.e. accuracy of dose when delivered through an enteral catheter). Legacy products were also tested by this lab to establish a baseline for existing products. The results indicated that the ENFit LDT Syringes provided equivalent to or better performance results as compared to other connectors used worldwide. Results from the Performance Testing, Usability Testing and Misconnection Risk Analysis were submitted and thoroughly reviewed by the FDA. As of 06/17/2016 at least two manufacturers have received FDA 510(k) clearance for their ENFit Low Dose Tip syringes. Other manufacturers are currently in the process of gaining FDA 510(k) clearance for their ENFit LDT syringes.
The LDT was tested to determine if it misconnected with other devices. A few potential connections existed which, after complete assessment, were determined to have a very low risk level. The risk assessment methodology followed the same methodology utilized by ISO TC 210 JWG4 when evaluating all of the small bore connectors included within the ISO 80369 series. It is important to note that there is not a single connector included within the ISO 80369 series that is entirely free of misconnection potential. Each connector has been accepted on the basis that the benefits significantly outweigh the risks.
Yes. All ENFit connectors, including the ENFit Low Dose Tip (LDT) design, have been validated through a misconnection risk analysis as required by the general standard ISO 80369-1 on small-bore connectors. The (LDT) syringe has been reviewed and gained FDA 510(k) clearance for at least two manufacturers. Other manufacturers are currently in the process of gaining FDA 5110(k) clearance for their ENFit LDT syringes.
No. ISO 80369-3 defines the geometry, material characteristics and functional performances of a standard connector pair made of one male half and one female half.
Yes. The Low Dose Tip (LDT) syringe design has been validated through rigorous performance testing, usability, human factors testing and misconnection risk analysis. The ENFit LDT Syringe has been thoroughly reviewed and received FDA 510(k) clearance for at least two manufacturers. Other manufacturers are currently in the process of gaining FDA 510(k) clearance for their ENFit LDT syringes.
The orientation in not defined in ISO 80369-3, however it is currently included in the approved committee draft of ISO 20695 enteral device standard.
Yes, the ENFit Low Dose Tip (LDT) syringe has been thoroughly reviewed and recieved FDA 510(k) clearance for at least two manufacturers. Other manufacturers are currently in the process of gaining 510(k) clearance for their ENFit LDT syringes. The LDT syringe is designed specifically to deliver a high degree of dose accuracy while meeting the requirements of ISO 80369-3.
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 Tip 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.
ISO 80369-3 defines the geometry, material characteristics and functional performance of a standard connector pair made of 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 design that complies 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).
Patients are mobile and have the ability to travel between healthcare setting 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 compliant connector but the specific orientation (direction of flow) as outlined in the ENFit System (and as proposed in the ISO 20695 enteral device standard). This ensures compatibility between components, avoids the need for adapter’s long term, and drives continuity and portability of care for patients.
Therefore, it is possible to have ISO compliant ISO 80369-3 connector, which is not compatible/compliant with ENFit. However, it is strongly encouraged that there be a single global solution.
Color coding is not included in the ISO 80369-3 standard. The standard will only address the ENFit connector’s shape and size. These newly developed engineering controls (forcing functions) make it highly unlikely to bring two unintended connectors together, a development that seems more secure as opposed to relying on memorization of a specific color scheme. While you might see a consistent color used for enteral connectors, it is not a requirement.
As devices with the ENFit connector are introduced in the market, distributors will have both the current and ENFit systems in stock. The transition plan that manufacturers and suppliers are developing will take into account inventory on hand for manufacturers, distributors, and end users. The plan does assume that it will take time to work through remaining inventory of the current products with the current connectors on them and then offer a flow-through of products with the new connector.
Pricing is at the sole discretion of device manufacturers. You should work directly with your supplier to identify the best solution for your patients.
Patients will need to consult their healthcare providers to understand if and when transition to a system with ENFit connectors is recommended. GEDSA recommends that the administration sets with transition connectors be made available for a period of one year after the introduction of ENFit tip syringes. Existing devices with the current connector will continue to be available to home use patient populations which use of ENFit will not be most suitable.
Enteral feeding tubes may also have a transition period where ENFit Transition Connectors would be made available for cross-compatibility between current and the new ENFit connector. Introduction and availability of new items are at the sole discretion of manufacturers. For precise timing and availability of new item introductions, contact your supplier representative.
Yes, the ENFit Transition Connectors are anticipated to be available by manufacturers. For timing, pricing, item numbers, and other details, please contact your supplier representative.
Introduction of new items and related issues, such as new item numbers, are at the sole discretion of manufacturers. For precise answers relative to new item introductions, contact your supplier representative.
Introduction of new items and related issues such as new item numbers are at the sole discretion of manufacturers. For precise answers relative to new item introductions, contact your supplier representative.
Discontinuation of items is at the sole discretion of manufacturers. In the State of California, enteral products with current connectors that allow fitment into a connection port other than the type for which it was intended will be prohibited in hospitals and skilled nursing facilities after July 1, 2016.
The California mandate does not include home use therefore current systems may still be used in home care. Check with your healthcare professional to determine which connector system would be most appropriate for use. Several GEDSA manufacturers have indicated that in addition to supplying feeding tubes with the ENFit connector they will continue to supply feeding tubes with the current connector until further notice. For precise timing of item discontinuation, contact your supplier representative.
GEDSA recommends the introduction of new ENFit connectors in the first half of 2016 as soon as manufacturers are ready with adequate supply of feeding tubes and ENFit tip syringes including LDT syringes subject to design verification and regulatory approval in the following regions:
- North America (Group 1)
- Europe, Middle East, Africa, Australia and New Zealand (Group 2),
- It is recommended that Latin America and most of Asia begin to transition administration sets in 2016, followed by ENFit tip syringes and feeding tubes in 2017 where the transition will be completed sometime in 2018. For China and Japan, we recommend communicating these changes in 2016 with introduction of new ENFit enteral devices to be introduced starting 2017. Visit www.StayConnected.org for up to date information of ENFit timing.
- The UK (Group 3) introduction commences in June with targeted transition complete December, 2016.
- The transition for these markets is anticipated to be completed sometime in 2017.
Transition feeding/administration sets allow fitment to both current feeding tube connectors as well as ENFit connectors through the use of a dual compatible connector. Transition feeding/administration sets will minimize disruption to supply and clinical practice and allow distributors and facilities to work through existing inventory of feeding tubes and feeding/administration sets.
Within the United States, California Assembly Bill 444 makes adoption mandatory for hospitals and skilled nursing facilities in the State of California, prohibiting the use of an epidural, intravenous, or enteral feeding connector which fits into a connection port other than the type for which it was intended.
This bill does not apply to home care use and while the standard is optional in the United States, several manufacturers are planning to adopt the ENFit connector design to be compliant with the new ISO standard. These transitions are expected to be complete sometime in 2017, in the US, Canada, and Puerto Rico, Europe, Middle East, Africa, Australia & New Zealand at which point the current universal connector will no longer be in wide circulation.
The ISO 80369-3 connector standard is designed to address enteral route administration. Oral administration is not included in the scope of the standard. Work with your supplier representative to determine the best solution for oral administration of medication.
The low dose ENFit tip design has been created to address concerns with displacement of fluid in the tip and dosing accuracy. To ensure dosing accuracy with doses of ≤ 1 mL and for syringes of sizes 5 mL and less, an ENFit Low Dose Tip (LDT) syringe is recommended. In larger syringe sizes, the amount of fluid displaced maintains an acceptable dosing amount. However for smaller syringe sizes, the low dose tip design may provide a more suitable dosing amount.
Standard connection systems means interoperability; all major enteral device manufacturers are expected to comply with the proposed new 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 introduction of the ENFit connector system.
With guidance from regulatory authorities, practice experts, and the industry, healthcare facilities and providers will be guided through a careful transition plan from the current system to the new connector. Each company will follow its own product and market launch timeline. To avoid confusion and reinforce a common enteral connection, the global industry group has aligned to:
- Develop and execute a coordinated joint communications initiative
- Identify this new connector with a common name (ENFit) to be used by manufacturers
- Introduce enteral products with the ENFit connector within the same timeframe
Yes. For accurate enteral dosing, draw up devices such as straws or fill caps may be necessary to use during filling. Additionally, to ensure dosing accuracy with doses of ≤ 1 mL and for syringes of sizes 5 mL and less, an ENFit Low Dose Tip (LDT) syringe is recommended.
A technical team of industry experts have worked collaboratively to identify a solution to address dose accuracy with a new ENFit low dose tip that has demonstrated the ability to deliver highly accurate doses while appropriately fitting into current practice. The device design solution which is ISO 80369-3 ENFit compliant is progressing through final validation and anticipated to be ready for market introduction in 2016 pending regulatory clearance.
Dead space is the volume which is leftover in the tip of a syringe which remains undelivered after the gradient marking is at zero. Dead space occurs in all syringes and there are existing standards in place for some specific applications which identify ranges for acceptable levels of dead space in some syringes.
Because there is placement of the male patient access side into the female ENFit tip syringe there is a potential for the fluid inside the tip of the syringe to be displaced. GEDSA members have established an ENFit tip syringe protocol which addresses fluid displacement in the dead space.
In addition, a technical team of industry experts have worked collaboratively to identify a new ENFit low dose tip design that has demonstrated the ability to deliver highly accurate doses while appropriately fitting into current practice. The device design which is ISO 80369-3 ENFit compliant is progressing through final validation and anticipated to be ready for market introduction in 2016 pending regulatory clearance.
The ENFit connector provides a simple way to reduce the risk of enteral tube feeding 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
- Has been tested using a rigorous validation process including performance testing, misconnections assessment, computer aided design (CAD), human factors, usability and risk analysis testing.
- Provides the added benefit of providing a connection that stays connected much like a Luer lock system for IV/hypodermic applications
The ENFit connector has a unique enteral-specific design that:
- Does not allow connectivity with connectors for any other clinical use
- Provides a locking feature for a secure, leak free connection
- Administration sets and syringes have a female connector end that fit onto or over a male patient access feeding tube port
The FDA’s final 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 final 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 ISO 80369-20:2015 (formerly AAMI/CN20(PS):2014) to ensure that each proposed enteral connector is physically incompatible with non-enteral devices.
- Manufacturers of enteral connectors that do not meet AAMI/CN3 (PS):2014 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) 80369-1:2010 standard “Small-bore connectors for liquids and gases in health care applications— Part 1: General requirements.”
In an effort to expedite the transition to safer connectors, the Association for the Advancement of Medical Instrumentation (AAMI) established a Provisional American National Standards AAMI/CN3(PS):2014 “Small-bore connectors for liquids and gases in health care applications” – Part 3: Connectors for enteral applications”. The US Food and Drug Administration (FDA) recognizes this standard and encourages all manufacturers to implement it on enteral devices.
The Final Draft International Standard ISO 80369-3 is under review and anticipated to be approved with a published and recognized standard due mid-2016. The latest draft addresses dose accuracy, improved connector usability, engineering assessments and other technical content supporting the common goal of improved patient safety.
The new design was a group effort. Developed by ISO/TC 210/JWG 4Project Group (PG-3). This group is a global representation of clinicians, practice experts, regulators, and industry participants. Through this open forum, any company, National Standard organization or health care group interested in the ISO 80369-3 standard was allowed to participate. The PG-3 group identified, validated, and aligned to a global introduction of the new standard connector.
The purpose of the new connector is to help reduce the risk of enteral tube feeding misconnections and improve patient safety. The new ISO standard, ISO-80369-3, has been established for Luer connectors on the nutrition formula end and the patient-access end. There is just one standard connector that will be utilized by all feeding set manufacturers and universally adopted into practice.
The Global Enteral Device Supplier Association (GEDSA) is a federal tax-exempt non-profit trade association established in part to help introduce the new ISO standard connector and facilitate adoption of the ENFit connector with the healthcare community. GEDSA, which is comprised of leading manufacturers and distributors of enteral feeding devices, is united by a shared desire to improve patient safety and optimal delivery of enteral feeding and connectivity. GEDSA speaks in a singular industry voice to communicate with the governing agencies, associations, and member suppliers, regarding issues that face enteral device manufacturers, suppliers, and distributors. GEDSA will lead a joint communication effort on behalf of the industry to ensure consistency and avoid any confusion as new, safer connectors are introduced in market.
- Develop and execute a coordinated joint communications initiative
- Identify this connector with a common name (ENFit) to be used by all manufacturers
- Introduce enteral products with the ENFit connector within the same timeframe
To reduce the frequency of medical tubing misconnections, an international group of clinicians, manufacturers and regulators, such as the FDA, is collaborating with the International Organization of Standardization (ISO) and the Association for the Advancement of Medical Instrumentation (AAMI) to develop ISO 80369 standards.
Connectors will now have unique international standard dimensions which are designed to promote improved patient safety and help ensure that connectors for unrelated delivery systems are incompatible.
A small-bore connector is a connector with an inner diameter of less than 8.5 mm 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 tubing misconnections—connections between unrelated delivery systems that have different intended uses (e.g., vascular, enteral, respiratory, epidural, and intrathecal). The ISO 80369-3 standard deals with enteral connectors. The ISO 80360-3 connector in the reverse direction is commonly known as the trademarked name ENFit®.
Mike Cohen ISMP Newsletter Article ENFit Enteral Devices…Important Safety Considerations for Hospitals Published April 9, 2015 Read Now
FDA Guidance document Safety Considerations to Mitigate Risks of Misconnections with Small bore Connectors Intended for Enteral Applications Published February 11, 2015 Read Now
AAMI/CN3: 2014 Provisional American National Standard Small-core connectors for liquids and gases in healthcare applications-part 3: Connectors for enteral applications Published December 2, 2014
Joint Commission Sentinel Event Alert Issue 53 Managing risk during transition to new ISO tubing connector standards Published August 20, 2014 Read Now
Memorandum: Luer Misconnection Adverse Events. CMS Website. Read Now
Making healthcare safer II: An updated critical analysis of the evidence for patient safety practices, pp.487-492, AHRQ. Read Now
AB 1867 (California 2012). Read Now
Simmons, D., Symes, L., Guenter, P., Graves, K. Tubing Misconnections: Normalization of Deviance. Nutrition in Clinical Practice. Read Now. Published June 2011.
ANSI/AAMI/ISO 80369-1:2010: Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements. AAMI, Arlington, VA, 2010.
Memorandum to manufacturers, healthcare professionals and hospital purchasing departments about Luer misconnections. FDA Website. Read Now. Published July 9, 2010.
Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events. FDA-MedSun KidNet Subnetwork webcast. FDA Website. Read Now. Published November 19, 2008.
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. Read Now
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. Read Now
Sentinel Event Alert: Tubing misconnections: A persistent and potentially deadly occurrence. The Joint Commission Website. Read Now. Published April 2006.
Medical Device Safety: Examples of Tubing and Luer Misconnections. FDA Website. Read Now
The Joint Commission and World Health Organization Collaborating Centre. Case Studies: Developing new solutions for patient safety. World Health Organization Website. Read Now