Enteral Plastic Safety Group (Statement)

Issued September 2016

ISO 80369-3: IMPORTANT UPDATE – ENFit Implementation

As part of a carefully planned 2–stage process, ENFit implementation commenced towards the end of 2015 throughout the UK. ENFit is the global enteral feeding device connector design that complies with the new International Standard (ISO 80369-3).

The first stage of the process, introduction of transition giving sets is now complete, with the majority of patients already using these alongside their existing enteral feeding tubes.

The second stage of the plan is to introduce ENFit enteral feeding tubes and all related ancillary items (including NG tubes, PEG’s, jejunal tubes, button gastrostomy tubes, and enteral syringes), in order to complete the implementation process.

As a result of further testing that was required on ENFit low dose enteral syringes during the first half of 2016, the introduction of ENFit enteral feeding tubes and related ancillary items was delayed. This second stage is now underway and the vast majority of these products are already available.

To support the completion of the process, it has been agreed by members that transition giving sets will now be available until the end of December 2016, to ensure full compliance with the ENFit system. From then, loose adaptors will remain available separately for any remaining patients not yet transitioned to the ENFit system. It is recommended that health professionals liaise directly with their homecare service provider(s) to facilitate ordering the appropriate adapters for their community patients.

Note: All companies supplying adapters offer guidance around their appropriate use in practice available on their website, or on request.

Full details regarding this statement, the International Standard and the introduction of ENFit are available from all EPSG members as listed below.

*The EPSG (Enteral Plastic Safety Group) represents all leading UK enteral feeding devices suppliers, with clinical representation from the PENG of the BDA, NNNG and supported by PINNT, BAPEN and BPNG. The aim of this forum is to discuss enteral feeding device safety from both a clinical and manufacturing perspective. The term ‘enteral feeding device’ refers to any type of feeding tube that is placed into the gastro-intestinal tract i.e. naso-gastric (NG), naso-jejunal (NJ), gastrostomy (Button, PEG/RIG) or jejunostomy (JEJ), as well as giving/extension sets, syringes and enteral feeding pumps. The following companies are members of the EPSG: Abbott; Corpak; Covidien; Fresenius Kabi; GBUK Enteral (Enteral UK); Intervene; Medicina; Nutricia; Vygon. **Devices that will have the new connector include: enteral giving sets, enteral syringes, all enteral feeding tubes, all enteral accessories.

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