On September 7, 2018, the FDA issued a letter titled “The FDA Encourages Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury.” The letter was addressed to all manufacturers of enteral feeding tubes, health care professionals, hospital purchasing departments, and distributors. Within the letter, the FDA references many incidences of enteral device misconnections and expresses the need for hospitals and clinicians to transition to safer enteral device connectors, including ENFit®, which is a significant step forward to help improve patient safety.
In the letter the FDA states, “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®.”
As healthcare facilities and professionals implement FDA recommendations, it is essential to understand the distinction between ISO 80369-1 and ISO 80369-3 (commonly identified as ENFit). Below are frequently asked questions to help you recognize the differences between ISO 80369-1 and 80369-3, and to emphasize the importance of timely adoption of ISO 80369-3 as supported by GEDSA, the Institute for Safe Medication Practices (ISMP), ASPEN, and ECRI.
What is the difference between ISO 80369-3 and ISO 80369-1?
ISO 80369-3 is the specific standard for small-bore enteral connectors. It defines the dimensions and requirements for the design and functional performance of connectors used on enteral delivery and access devices. ISO 80369-3 is the only standard that is associated with the term ENFit.
ISO 80369-1, first published in 2010, discusses general requirements for small-bore connectors for liquids and gases across multiple routes of administration. It establishes methodology to assess non-interconnectable characteristics, but it does not provide dimensional specifications for any connector. Enteral devices that claim compliance to ISO 80369-1 may not connect with other enteral devices. This standard allows for proprietary connectors that do not satisfy the requirements of ISO 80369-3.
ISO 80369-1 is NOT associated with the term ENFit.
What is ENFit®?
ENFit is a registered trademark commonly used to identify ISO 80369-3 compliant connectors. All ENFit devices (syringes, administration sets, extension sets, NG tubes, G-tubes, PEG, J-tubes, and accessories) are connectable across manufacturers because they have a standardized direction of flow. ENFit is a unique enteral-specific design that:
- Mandates a specific direction of fluid flow (female to male)
- Supports patient safety initiatives
- Mitigates the risk of misconnection with non-enteral devices
- Provides a secure, locking connection, minimizing inadvertent disconnections
Why is ENFit® the best choice for my hospital?
ENFit is the best choice for your hospital because it provides a simple way to reduce the risk of enteral tube feeding misconnections and improve patient safety. ENFit device adoption and standardization is critical for several reasons:
- To support patient safety initiatives
- To ensure compatibility across multiple ENFit manufacturers that cover the entire enteral device ecosphere
- To provide commonality and connectability for enteral devices across all patient populations (no need for proprietary connectors that are )
- To help ensure adequate and robust supply chain through multiple vendor participation
- To reduce the risk of backorders that might arise from single source proprietary connectors
- To allow for patient portability, no matter if the patient came from a facility across the street or across the world
How can a manufacturer supply a proprietary enteral connector that meets only ISO 80369-1?
Unlike ISO 80369-3, ISO 80369-1 does not define a standardized enteral specific connector design, and allows for a variety of proprietary connector designs under specific conditions. Manufacturers must ensure their proprietary enteral connector design is not connectable with devices intended for administration routes other than enteral as outlined in the standard. This requires extensive risk assessments, engineering assessments, compatibility assessments, human factors testing and regulatory agency approval/clearance (where applicable) prior to commercial distribution. Specifically, it requires the following shall be met:
- Not connectable with connectors intended for administration routes other than enteral
- Does not create an unacceptable risk for the medical device or its accessories
- Is extensively evaluated per requirements in ISO 80369-1 to mechanically verify non-interconnectable characteristics
- Connector must be made of rigid or semi-rigid material
Prior to using such a device, clinicians should verify compliance by confirming that documented objective evidence demonstrates that risks have been reduced to acceptable levels for the acceptability criteria specified ISO 80369-1 and other acceptability criteria established by the manufacturer for non-interconnectable characteristics for the medical device or accessory. (See Section 5.8 of ISO-80369-1:2010 Part 1 General Requirements).
Manufacturers promoting ISO 80369-1 products should be compelled to provide documentation that demonstrates ISO 80369-1 compliance.
Why should my hospital select NeoMed’s NeoConnect® portfolio of ENFit products?
NeoConnect is NeoMed’s branded family of ENFit products and is the ideal ENFit product portfolio for use in all care environments. NeoConnect should be selected as your hospital’s ENFit vendor of choice because:
- NeoConnect delivery and patient access devices comply with the ISO 80369-3 Standard
- NeoMed has designed a comprehensive portfolio of ENFit products, including the ENFit Low Dose Tip (LDT) Syringe, open hub feeding tubes, and many innovative filling and dosing accessories for the pharmacy
- NeoMed is an ENFit solution leader with over 250 successful ENFit transitions representing over 21 million administered feed and medication doses
- The NeoConnect with ENFit Connectors product portfolio follows guidelines and recommendations established by The Joint Commission, GEDSA, ECRI, ISMP and ASPEN
- NeoMed offers your facility ENFit transition support and assistance programs
- NeoMed’s secure supply chain ensures that your NeoConnect products/orders are committed to your facility and will not be diverted to another customer
In summary, NeoMed supports the FDA’s guidance encouraging the use of enteral device connectors that reduce the risk of misconnection and patient injury. ENFit enhances improved patient outcomes, minimizes the risk of misconnection, and provides the benefit of standardization that proprietary systems cannot offer. NeoMed encourages adoption of safer ISO 80369-3 compliant connectors and is dedicated to helping our customers with a smooth ENFit transition using the NeoConnect portfolio. Selecting NeoMed as your ENFit transition partner will ensure a secure supply chain, demand planning, and GO LIVE management.