Work continues on standard for respiratory connectors

A resolution to release ISO 80369-2 has been unanimously approved

ISO TC210/JWG4 has produced a series of standards for, what are termed, small-bore connectors which have been developed to replace the ubiquitous Luer connector on all medical devices other that those used for vascular and hypodermic applications. This project which now spans 20 + years was borne from the wish to prevent inadvertent connections between medical devices of differing applications in particular enteral, neural, respiratory and blood pressure monitoring, sadly many of which proved fatal. During this time it was realised that there was as much potential for inadvertent connections at the reservoir end of the system as bag spikes were as ubiquitous as Luer connectors with possible fatal consequences from giving the wrong drug to the wrong site. Another series of standards was then developed, the 18190 series, all of which have recently been published and cover enteral, neural, apheresis and vascular applications.

All the parts of the ISO 80369 series of standards, which includes a revised part for Luer connectors, have been published over the last 2 years with the noticeable absence of part 2 for respiratory connectors. This part 2 was held up awaiting testing to see if it met the performance requirements to validate the design and dimensions. There was also a potential misconnection, identified by the CAD analysis, between the male respiratory, low pressure connector and the new enteral female connector. After a close review of the draft standard it became apparent that the testing to validate the design had already been done and the potential misconnection mitigated.

So at last this long awaited standard could be resurrected and measures were put in place to restart this project. A resolution to release this standard was circulated to the ISO 210 Technical Committee and unanimously approved. After a compulsory new work item ballot has been completed this standard can be circulated as a DIS. Once approved, which hopefully will be a foregone conclusion, we can then release all the standards that have also been on ice awaiting its arrival. Standards such as ISO 17296 O2 therapy tubing, ISO 23368 Nasal cannulae, ISO 23372 air entrainment devices, ISO 19211 fire activated O2 shut off devices to name but a few.

Terry Longman is an independent consultant on matters relating to standards and specialises in anaesthetic and respiratory equipment. He is on several committees at national, European and international levels with over 40 years' experience in the medical equipment industry.