Small Bore Connectors in the Welsh NHS - Supporting Information

ISO 80369 ("Small-bore connectors for liquids and gases in healthcare applications") is a new standard (most parts being published in 2016) which specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. The intention of the standard is to reduce the risk of wrong-route delivery of enteral solutions, intrathecal medication or compressed gases associated with medical devices which use Luer or flexible connectors,  by ensuring that none of the connectors in the series can cross-connect with any other.

The standard comprises of multiple parts which are 'application specific', giving dimensions and performance parameters for connectors to be used with enteral feeding devices, neuraxial/epidural devices, respiratory devices, blood pressure monitoring inflation cuffs, and standard Luer devices.

In 2015, the first devices devices with enteral connectors (enterel administration sets using the ISO 80369-3 'ENFit' connector) were  deployed in the UK, including the Welsh NHS.  2016 saw the completion of the ISO 80369-3 rollout in the Welsh NHS.

UPDATE Dec 2018: It was originally anticipated that industry would launch the full range of ISO 80369-6 (NRFit) compliant neuraxial devices in 2017 (spinal needles, epidural catheters) to replace their Luer connectors with ISO 80369-6 connectors, but deployment by industry was delayed. One Welsh NHS Health Board (Aneurin Bevan University Health Board) has undertaken a partial implementation during 2018 for bolus neuraxial injections. All other NHS Wales Health Boards and Trusts are waiting for industry to launch the complete range necessary to undertake both spinal bolus injections and epidural infusions.

Supporting material to help Welsh NHS organisations can be found below:

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