NRFit™ and ISO 80369 standard compliance – Adoption and evolution

Introduction

In hospitals and clinics, patients are often examined and attended to by staff belonging to different departments. Moving between the different departments and healthcare providers often means that multiple Luer devices are used on the patient. There are opportunities for misconnection because universal Luer connections are used for multiple applications. This is particularly so when they are used by staff with varying skillsets. There have been reports of patient death or injury arising from misconnections that resulted in the inappropriate delivery of enteral solutions, intrathecal medication or compressed gases.1

The ISO 80369 series of standards

In 2000, the European Committee for Standardization (CEN) conducted a study to analyse the risk caused by misconnections in Luer devices. Consequently, SIST EN 15546-1 “Small-bore connectors for liquids and gas in healthcare applications — Part 1: General requirements” 1 was published in 2008. The publication of this European standard led to an increased focus on this important issue internationally. It resulted in the establishment of an international joint working group of ISO/TC 210 and IEC/SC 62D to work on this issue and led to the development of the ISO 80369 series of standards.2

The primary aim of this set of standards is the prevention of misconnections through safe design. The standards require that connectors for one application will not physically connect with those for another application. The 80369 series also specifies the general requirements for small-bore connectors carrying fluids or gases in applications of medical care and includes the methodology to ensure non–interconnectability.2 In addition to general standards (Part 1), specific ones have been developed for respiratory (Part 2), enteral (Part 3), urology (Part 4), limb cuff (Part 5), neuraxial (Part 6) and intravascular connectors (Part 7).

BD’s involvement

BD has actively supported this initiative and is specifically involved with parts 3, 6, and 7. The standards for Part 6, named ISO 80369-6, specifically require that connectors used for neuraxial applications like spinal or epidural anaesthesia must be incompatible with small-bore connectors used for other applications. This type of design is referred to as a forced function innovation and is the most reliable form of error-prevention. Devices using forced function innovations following the ISO 80369-6 standards are called NRFit™ devices.