Update on ISO 80369 series of Small Bore Connectors in medical devices.
This supersedes all previous information
A group including Pete Phillips (Chair of the Welsh Non-Luer Connectors Reference Group), Paul Sharpe (Chair of the NHS Improvement Neuraxial Oversight Group), and Matthew Alderman (NWSSP Procurement and member of the WNCRG) has issued a comprehensive FAQ for the UK NHS about the neuraxial (ISO 80369-6) connector changeover. It contains detailed information including specific information relating to the devolved administrations of the various nation states.
NHS England has now created an online resource containing comprehensive and up to date information about safe introduction of the new small bore connectors into clinical practice.
Drs Mike Kinsella and Paul Sharpe performed an OAA-approved survey on the use of non-Luer equipment for specialised procedures. The results are available here
(survey number 168).
Clinicians can download a case study of local practice of implementation of new neuraxial connectors. The document has been reviewed by the NHS Small Bore Connector Clinical Advisory Group, who agreed that the information could be useful for other Trusts embarking upon this.
There has been significant progress made towards the launch of the ‘80369’ connector series.
This will provide clinicians with a single connector standard applied across all manufacturers, making transition to non-Luer equipment easier.
The 80369 connectors are a series of six connector standards, labelled 80369-2 to -7 (80369-1 is an explanatory document for the subsequent connector standards).
The six connector standards are as follows:
80369-2 Respiratory devices
80369-3 Enteral devices
80369-4 Urinary devices
80369-5 Limb inflation devices
80369-7 Intravenous needles (the old Luer standard, but defines key dimensions to prevent cross connections with other connectors in the series).
80369-3 (ENFit) enteral connector
- September 2015 saw the commencement of the -3 enteral connector launch. This connector is labelled as ENFit for commercial sales. Despite UK clinical groups lobbying for a single roll out process, it was decided globally that there would be a two-phase deployment. Phase one being the feeding giving sets. Phase 2 will see the enteral syringes and feeding tubes being replaced with the new connectors, likely to be mid 2016. This necessitates transitional adaptors whilst patients existing systems are changed over.
- The system, like the current enteral connectors in use in the UK since 2007, utilises a reverse male-female sequence. This system has always had a potential to cause drug delivery inaccuracies with ultra low dose administration because of displacement of excess drug from the female syringe tip in to the male tube connector. This was re-discovered with designs for the new -3 system, and due to the larger size of the ENFit connector can result in a slightly higher displacement of any drug (overdose). Concern has been raised regarding the use of this connector, particularly in neonatal use, where the inaccuracy could become clinically significant. A low-dose version of the ENFit syringe has been designed and is being assessed at present. If the results are acceptable, the standard ENFit and low-dose ENFit syringes and feeding tubes will be launched in early Summer. The low dose syringe will require specific training to ensure it performs accurately.
- There has been report of the transition connectors allowing connection of the -3 system to PICC lines. This is not a new phenomenon, as it was possible with the current reverse safety system and the MHRA opinion is that caution should be maintained, as previously.
80369-6 (NRFit) neuraxial connector
- The -6 neuraxial connector, likely to be marketed under the name NRFit, will cover intrathecal, epidural, regional block needles and wound infusion catheters, delivery devices for these and all the required peripheral devices such as manometers etc. It is likely, in the near future at least, that low sales volume or niche devices such as implanted drug delivery systems and spinal drainage systems will not change to the new connectors, and may need to be managed through local risk registers.
- NHS England, with support from the devolved administrations of the UK, have engaged in comprehensive talks with industry to orchestrate a safe, sustained and single release date for essential neuraxial equipment, allowing hospitals to change their equipment in one process. The engaged parties are working towards a release date at the beginning of April 2017 at the time of writing this article.
- Wales have funded a surveillance system for the 80369-6 device changeover, and baseline data is now being recorded. The intention is to have the surveillance system running post-changeover, so that any changes in clinical incident rates due to the connectors can be detected rapidly.
The Small Bore Connector Clinical Advisory Group intends to focus on raising awareness amongst Medical Royal Colleges and Hospital Trusts as well as provide practical guides for Trusts that have currently not embarked upon transition to non-Luer equipment. The Group suggested developing a central portal where updates and information can be accessed. As the patient safety domain at NHS England is being transferred to NHS Improvement in April 2016, it is currently being explored with them to see if this central portal can be created to be accessed through the NHS Improvement website.·
- Documents supporting the deployment of the new connectors can be found here
- Information on test requirements for neuraxial syringes can be found here
- An archive of older documentation relating to this topic can be found here (OAA pages) and here and here (AAGBI pages)
On behalf of NHS England: Small Bore Connector Advisory Group
Chair of the Welsh Non-Luer Connectors Reference Group (WNCRG) for advice on ENfit connector system and Welsh Surveillance plan
Secretary NHS England Small Bore Connector Advisory Group
Patient Safety Lead (medial devices) NHS England