News

28/07/2015

POSITION STATEMENT ISO 80369-3

REDUCING THE RISK OF MEDICAL DEVICE TUBING MISCONNECTIONS - ENFit™

ISO 80369-3 – Reducing the risk of Medical Device Tubing Misconnections
Position Statement for Australia and New Zealand

For many years there has been an ongoing joint effort by the International Organization for Standardisation (ISO) to address the design of small-bore connectors for various clinical applications, and as part of a continuous improvement programme to prevent wrong route delivery of fluids and gases (tubing misconnections). It is expected that ISO 80369-3 (referring to enteral feeding devices) will be formally recognised as an ISO standard in mid-2015. The ISO standard has been developed by an international group of clinicians, manufacturers and regulators along with the International Organization of Standardization (ISO) and the Association for the Advancement of Medical Instrumentation (AAMI).

The International Standard ISO 80369-3 refers to enteral feeding devices specifically and this statement refers to all enteral feeding devices within Australia and New Zealand.

In order to comply with the International Standard, a new distal (patient end) enteral feeding device connector design (named ENFit™) is being introduced into Australia and New Zealand from October 2015. ENFit™ is a unique, enteral specific designed connector that does not allow connection to any other type of medical device.

This change impacts the entire enteral feeding system, including enteral feeding tubes, enteral feeding sets and  enteral feeding syringes, across all healthcare settings. Introduction of ENFit™ will impact the current connectors available, including stepped/funnel, ENLock, reverse luer and other proprietary connectors. Leading enteral device suppliers across Australia and New Zealand have worked to synchronise the introduction of ENFit™ enteral devices from the planned introduction date of October 2015 to aid a smooth transition and ensure compatibility between enteral devices.

Introduction of ENFit™ devices will commence with enteral feeding transition sets from October 2015 and following this, enteral feeding syringes. Enteral feeding tubes will transition during January to March 2016.

All enteral feeding sets will go through a ‘transition period’ estimated to last 12 months during which time the sets will be compatible with both current and new ENFit™ connections. This is to allow cross-compatibility during the introduction period and to minimise disruption to supply and clinical practice and allow distributer and facilities to work through their existing inventory. Final enteral feeding sets with the ENFit™ connection will be phased in from late 2016.

Full details about this statement and the transition can be found at www.stayconnected2015.org. If you have any specific questions related to the enteral system you currently use please contact your local company representative directly. Please find below the list of companies who have signed up to this transition timeline and plan.

ISO Partners 2