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Enhancing patient safety
ENFit - The NEW international design standard for medical devices tubing connectors is being launched in March 2016 as part of a phased initiative called ‘Stay Connected’.
Stay Connected is led by an international
group of clinicians, manufacturers, and
regulators, which together developed ISO
80369-3. This standard establishes
requirements for small-bore connectors
for liquids and gases, making it difficult, if
not impossible, for unrelated delivery
systems to be connected.
The introduction of this standard will mark a new milestone in the global effort to improve patient safety, starting with enteral feeding systems. In an interim step toward enhancing patient safety during the ISO process, UK manufacturers met the customer demand for a safer connector with a reverse Luer system. However, since
The introduction of this standard will mark a new milestone in the global effort to improve patient safety, starting with enteral feeding systems. In an interim step toward enhancing patient safety during the ISO process, UK manufacturers met the customer demand for a safer connector with a reverse Luer system. However, since
Reverse luer lock connections are specific to the
UK, with increasing patient mobility and
portability, a single global solution is
required to ensure patient safety and
prevent either a misconnection or no
connection.
The new ISO standard connector system—called ENFit—will replace the reverse Luer connector systems in the UK, to ensure one global enteral connector. The ENFit connector will look very similar to the existing connector, however the bore size is slightly larger.
The new ISO standard connector system—called ENFit—will replace the reverse Luer connector systems in the UK, to ensure one global enteral connector. The ENFit connector will look very similar to the existing connector, however the bore size is slightly larger.
Why we are introducing a new enteral 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 nutrition formula connector that will be utilized by all enteral equipment and universally adopted into practice.
Why you should adopt the new standard connector?
The new ISO 80369-3 standard connector provides a simple way to reduce the risk of enteral tube feeding misconnections and improve patient safety.
The new connector:
• Addresses “patient side” connections between feeding tubes,
administration sets, medication, flush, and bolus feeding syringes
and other enteral devices.
• Passes 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 new standard connector different from the current system?
The new standard connector has a unique enteral-specific design that:
• Does not allow connectivity with any other connector for any other clinical use.
• Provides a locking feature that signals the appropriate connection and
stays in place.
• Has a female connector end for any administration sets and syringes
that fit into a male patient-access feeding tube port.
If you use enteral administration sets and feeding tubes from different manufacturers, will they work together?
All major enteral device manufacturers are expected to comply with the 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 crosscompatibility for the introduction period and to synchronize the introduction of the new connector system.
