ISO 80369-3: UK timelines
A new International Standard (ISO 80369-3) is being published this year, covering all connectors on enteral devices. In order to comply with this International Standard, a new global enteral feeding device connector design (named ENFit) will be introduced nationwide from September
This change will impact all enteral feeding devices** within the UK.
The ENFit introduction will be a 2-stage process, with transition giving sets and gravity sets made available from September 2015. ENFit feeding tubes and syringes will be introduced from 14th March 2016.
To facilitate the smooth transition to the ISO standard, as required by clinicians and the NHS in general, all EPSG member companies and NHS Supply Chain*** have agreed not to place any ENFit enteral feeding device** (other than transition giving sets and gravity sets) into the UK market until 14th March 2016. It is envisaged that this process will minimise disruption to the NHS, whilst maintaining patient safety at all times.
Full details regarding this statement, the International Standard and the introduction of ENFit are available from all EPSG members as listed below. Further information about the safe introduction of devices with new connectors can also be found on the NHS England website at: www.england.nhs.uk/ourwork/patientsafety/medicaldevice-
*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. *** all other distribution channels are being encouraged to follow this approach.