Prompted by a report of fatal medical tubing misconnection errors and ‘wrong-route’ drug administration, both the European Commission and the UK's Department of Health established groups of technical and clinical experts during the 1990’s to explore technical solutions, to help eliminate these incidents.
In 2000, the European standards organisation, CEN, published a report which recommended the development of a series of new connectors, which could be fitted to relevant medical devices such as equipment tubing, syringes and needles, to help avoid misconnections.
The design of each connector type in the series would ensure that it could not be connected to any of the others, except to its own male/female 'pair'. The new connectors would also need to be incompatible with the 'luer' connector, since the ‘luer’ will still be widely-used.
Each new connector was to be assigned to a specific medical device 'function' e.g. ‘respiratory’, ‘enteral’, ‘vascular’, ‘urinary’, ‘blood-pressure cuffs’.
One 'function', not mentioned in the CEN report, but since picked up by the UK's Department of Health, was the need for a dedicated connector for use with equipment used for making 'neuraxial' injections (Neuraxial = around the nerves of the central nervous system).
The focus on this application arose from reports of 14 deaths in the UK, over a 10-year period, arising from injections of chemotherapy drugs, intended for intravenous administration, into patients’ spinal fluid. Recommendations for action, contained within two reports to the UK’s Chief Medical Officer, prompted the development of the Neurax® connector system.
The Neurax® NRFitTM System
The Neurax® system is based around a specialised small-bore connector system, moulded from hard plastic, which is either permanently-fitted or moulded onto specific small-diameter tubular medical devices, typically needles, syringes, microbial filters, drug containers and flexible fluid-conducting tubes.
Neurax® connectors enhance the safety aspects of these products, which are designed to be used to sample spinal fluid or deliver drugs, including local anaesthetics and cancer chemotherapy, into the spaces surrounding the nerves in the central nervous system.
The safety enhancement is achieved by making the connectors dimensionally and mechanically incompatible with the standard ISO 'luer' connector. Luer connectors are fitted to medical devices, such as hypodermic needles, IV cannulae and syringes, which are intended either to be inserted into blood vessels or gain access to the blood, directly or indirectly.
Drugs contained in equipment fitted with Neurax® connectors cannot be injected into a blood vessel via a ‘luer’ connector. Likewise, drugs intended to be given into the bloodstream via a normal ‘luer’ syringe cannot be injected into the spinal fluid or epidural space if a Neurax®-fitted device is used. The Neurax® connector also cannot be connected to luer-compatible needle-free access ports commonly fitted to intravenous lines.
Whilst the Neurax® system components are fully-compatible with each other, attempts to make a connection between a Neurax® connector and either a 'luer', or any larger medical connector, will result in an incomplete seal, thwarting attempts at establishing a fluid-tight pathway.