SMTL, working with Welsh clinicians and clinicians from Bath, Bristol and Leicester, have recently completed a test programme looking at the usability of neuraxial and epidural non-Luer connectors for the International Standards Organisation.
Numerous publications have reported severe harm and death when medical devices and their associated connecting tubing were inadvertently connected to devices intended to deliver medication via a different route. The risk of a misconnection of this kind is increased when devices involved are fitted with the ‘universal’ Luer connector. Examples include the mistaken administration of medicines intrathecally (into the spinal canal) which are intended to be administered intravenously, and the unintended intravenous delivery of enteral feed. In the UK, one of the most high profile cases was that of Wayne Jowett who died of a wrong route injection in 2001, when Vincristine intended for IV administration was inadvertently injected into his spine.
To reduce the risk of further tragedies, the International Organization for Standardization (ISO) has developed the multi-part ISO 80369 standard, which includes specifications for a series of small-bore connectors designed to reduce the risk of making inadvertent misconnection between the various types of connectors. The connectors have been designed with the intention of ensuring that dissimilar ones are non-interconnectable, thus minimizing cross-connection risks.
38 doctors and 17 nurses in four different centres in the United Kingdom took part in the usability study. SMTL used a series of manikins in simulated environments and doctors and nurses undertook these simulated procedures whilst being vido-taped. Undertaking a simulation study meant that patients were not subjected to these new devices before they were demonstrated to be acceptable in a non-clinical environment.
The healthcare staff also carried out cross-connection tests, attempting to connect male and female ISO 80369-6 lock
connectors with various connectors on other medical devices.
The report was submitted to ISO in November 2014, and has now been published as ISO report "ISO/TC 210/JWG 4 N 288".
We are presently working with the various key clinicians on papers to submit to anaesthetic journals. A poster has already been accepted for a US nursing conference (Infusion Nurses Society Annual Conventions and Industrial Exhibition, Kentucky, May 2015) and an abstract for a UK anaesthetic conference (Anaesthetic Research Society meeting to be held at the Royal College of Anaesthetists in London 21 and 22 April).