Why is this action required?
In 2010, a new international safety standard for small bore connectors (ISO 80369) was developed by an international group of experts from 31 countries. This included a dedicated connector for neuraxial (spinal) applications (NRFit™ ISO 80369-6) defined as “those for administering medications to neuraxial sites, wound infiltration anaesthesia delivery and other regional anaesthesia procedures, or to monitor or remove cerebrospinal fluid for therapeutic or diagnostic purposes” (2).
The ISO 80369 series was specifically designed to prevent dangerous wrong-route connections by making connectors for different organ systems intentionally incompatible. NRFit™ connectors eliminate the possibility of misconnecting neuraxial devices with intravenous or enteral systems — an error that could otherwise prove fatal.
While access to a full portfolio of NRFit™ devices and supply chain fragility has delayed its full implementation in Ireland and internationally, industry throughout Ireland has now adopted NRFit™ and has made it available.
Internationally this transition has progressed in countries such as England, Northern Ireland, Scotland, Wales and Japan. This HSE NPSA was drafted based on the alert from the NHS UK issued in 2024 (3) and was adapted for the healthcare system in Ireland.
What evidence supports the issuing of this HSE NPSA?
A literature review published in 2020, described 133 cases from 1999 to 2019 of neuraxial to intravenous (or vice versa) misconnection events leading to wrong-route medication errors causing the deaths of 26 patients, and serious injury such as paraplegia, spinal cord injury, and seizures in 20 patients (4).
- On reviewing HSE national incident data it was identified that 20 incidents were reported between January 2023 to June 2024 where a drug was connected to the wrong access. Seven incidents may have been prevented with NRFit™ connectors. Fortunately, none of these have led to serious harm however the risk for serious harm does exist.
What stakeholders were involved in issuing this HSE National Patient Safety Alert?
This alert has been developed collaboratively by the following groups:
- Health Service Executive (HSE)
- National Cancer Control Programme
- National Clinical Programme for Anaesthesia
- National Medication Safety Programme
- National Patient Safety Alerts Committee
- Procurement
- National Quality and Patient Safety
- Office of the Nursing and Midwifery Services Director
- The College of Anaesthesiologists of Ireland
- Health Products Regulatory Authority (HPRA)
Issues and risks of not changing to NRFit™
- The risk of a neuraxial or regional wrong route medication error leading to severe harm or death.
- The risk of inadvertent intravenous injection or infusion of wrong drug to neuraxial route. Internationally, fatal events have occurred from IV medications given intrathecally (e.g. vincristine).
- Preventable patient harm can lead to litigation and loss of public trust.
- Increased cost and complexity in managing two different systems of connectors and potential inconsistent practice across Irish hospitals and services.
National Change
In preparation for this HSE National Patient Safety Alert the HSE engaged with manufacturers to notify them of this change and assess whether or not there would be any demand and supply issues and to consider any medical device issues. The major suppliers of neuraxial and regional block medical device consumables have confirmed that they can supply the full range of NRFit™ compatible medical device consumables to all the HSE hospitals in Ireland. Having several suppliers available will ensure supply chain in Ireland. This change may result in a slightly higher cost to the purchaser initially as the HSE transition to the currently less commonly used devices with NRFit™. It should be noted that as demand and production increases for NRFit™ products, this higher cost is expected to reduce.
While all major manufacturers are producing enough NRFit™ products to meet current demand, it is critical that transitioning hospitals accurately forecast their NRFit™ requirements well in advance of actual switch over, as it is not possible to use/connect any Luer products with any NRFit™ products. Some hospitals operate a lean stockholding policy, it is recommended that while transitioning to NRFit™ they should hold a sufficient buffer stock of the full suite of NRFit™ products to meet their requirements and to protect against any delays in the supply chain. It will be important for local procurement to support the service with accurate forecast requirements as supply will be demand led. This must be communicated with the manufacturers in advance of go-live date to help prepare for the change. For customer and vendor enquiries please contact Procurement.Helpdesk@hse.ie; for support when registering or accessing the PACE system, contact Register to access PACE.
When accessing PACE, please find the information on the relevant NRFit products under these catalogue references:
- HSE 27385 - National DPS Qualification for NRFit Consumable Products (Approved Supplier List)
- HSE 19833 - National Contract for PCA Infusion Pumps
While it is noted that some Irish hospitals have already made or commenced this transition to NRFitTM a national approach to this change project will promote patient safety and leverage on the 'economies of scale'. For any hospital to do this independently would be more challenging and costly.
In summary, there may be an initial cost implication, which is expected will ultimately reduce, and accurate forecasting (with buffer stock) of NRFit™ product requirements will be critical.
Where can I get further information?
References
- https://www.england.nhs.uk/wp-content/uploads/2024/01/NRFit-NatPSA-FINAL-v1.pdf
- Guidance on the Safe Use of Intrathecal Chemotherapy in the Treatment of Cancer
- https://www.england.nhs.uk/2024/01/transition-to-nrfit-connectors-for-intrathecal-and-epidural-procedures-and-delivery-of-regional-blocks/
- Viscusi et al (2020) Neuraxial and peripheral misconnection events leading to wrong-route medication errors: a comprehensive literature review Thomas Jefferson University, Philadelphia, Pennsylvania, USA
- Narayanan, S.M. (2025) Improving safety in regional anaesthesia – adopting the NRFitTM System, Ir Med J; May 2025; Vol 118; No. 5; P69
Appendix 1: Comparison: NRFit™ Connector vs Luer Connector
NRFit™ Connector (ISO 80369-6)
Feature:
- Compatibility: Dedicated to neuraxial & regional anaesthesia; cannot connect to IV/enteral
- Safety Risk: Low - incompatible with non-neuraxial devices
- Uses: Spinal anaesthesia, epidurals, regional blocks, intrathecal drug delivery
- Appearance: Slightly longer, smaller bore, often yellow-coded
- Standard: ISO 80369-6 (global safety standard)
Luer Connector
Feature:
- Compatibility: Universal, fits across many devices (IV, enteral, neuraxial, etc.)
- Safety Risk: High — allows misconnections (IV ↔ enteral ↔ neuraxial)
- Uses: IV infusions, enteral feeding, general syringes
- Appearance: Standard male/female taper
- Standard: Legacy, widely used
Source (5): Narayanan, S.M. (2025) Improving safety in regional anaesthesia – adopting the NRFitTM System, Ir Med J; May 2025; Vol 118; No. 5; P69