New safer ‘non-standardised’ small bore (non-Luer) connectors are now being introduced across the NHS to minimise the risk of wrong route errors when administrating medication via oral/enteral and neuraxial routes.
These new connectors prevent the risk of mistakenly connecting the wrong devices and harm being caused when medication is delivered to a patient via the wrong route. For example, as they both used the same type of Luer connector, incidents have occurred where a device intended for intravenous medication had been mistakenly connected to a device that delivered the medicine intrathecally.
The introduction of the new safer connectors will help minimise the risk of cross connections of devices intended for different clinical applications by making connections to the different devices incompatible. It will also harmonise the UK's ISO connectors with those used in other countries.
To prevent further risks to patient safety,
these new ISO connector designs must be introduced to the NHS in a co-ordinated
manner. Risks may arise from healthcare organisations, professionals, patients
and carers not being fully aware of the connector design change, and
implication on clinical use. New risks include the supply and attempted use of
incompatible devices and ancillary products, incorrect use of the new
connectors and device shortages.
The supporting information for the August 2017 Patient Safety Alert 'Resources to support safe transition from the Luer connector to NRFit™ for intrathecal and epidural procedures, and delivery of regional blocks' can be found at the bottom of this page.
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This document describes the six key safeguards that should ideally be in place before devices with new small bore connectors for a specified clinical application are introduced into the NHS.
The International Standards Organisation (ISO)
The International Standards Organisation (ISO) and healthcare industry have been working on a series of new International Standards for small bore connectors in a range of medical devices. ISO 80369 (under the general title Small-bore connectors for liquids and gases in healthcare applications) consists of the following parts:
- Part 1: General requirements
- Part 2: Connectors for breathing systems and driving gases applications
- Part 3: Connectors for enteral applications
- Part 4: Connectors for urethral and urinary applications
- Part 5: Connectors for limb cuff inflation applications
- Part 6: Connectors for neuraxial applications
- Part 7: Connectors for intravascular or hypodermic applications
Some ISO standards are nearing completion and industry are planning to manufacture devices incorporating new ISO design small bore connectors and place these on the market in the UK, with the intention of these products replacing similar devices with Luer and ‘non-standardised’ connectors.
Patient Safety Alert and supporting information ‘Introduction of NRFit™ devices for intrathecal and epidural procedures, and delivery of regional blocks’
To support the safe transition from the Luer connector to NRFit™ for intrathecal and epidural procedures, and delivery of regional blocks, NHS Improvement have issued a Resource Patient Safety Alert. The alert signposts providers to the supporting information below to help them recognise the risks to patients during the transition and to manage the process as safely as possible.
Position statement on the adoption of medical devices for use in neuraxial procedures fitted with (non-luer) ISO 80369-6 compliant connectors
The statement outlines the NHS requirements for a prompt and safe roll out for the new ISO compliant connectors for neuraxial applications.