Recent news from GEDSA: "The UK's National Health Service (NHS) has issued a National Patient Safety Alert instructing all relevant NHS-funded providers to transition to NRFit® connectors for all intrathecal and epidural procedures, and delivery of regional blocks. The transition should be completed by 31 January 2025. If not already done, leaders should make it an organizational priority to convert to NRFit devices as soon as practical."
About GEDSA: the Global Enteral Device Supplier Association (GEDSA), a nonprofit 501(c)(6) trade association formed to establish a voice for addressing issues that face device manufacturers, suppliers, and distributors, and to help introduce international patient safety standards for healthcare tubing connectors.
About National Health Service (NHS): formed in July 1948, is the publicly funded healthcare system in England, and one of the four National Health Service systems in the United Kingdom. It offers a comprehensive range of free healthcare services for citizens who are ordinarily residents of the UK.
The NHS has long used a range of medical devices with the universal Luer connector to administer medicines via different routes of administration, including the intravenous, intrathecal, and epidural routes. This commonality of connector carries a significant risk of accidental wrong route administration of medication. The potential for a fatal outcome from this, especially if medication for intravenous administration is given via the intrathecal or epidural route, is well known and previous patient safety alerts have been issued.
In 2010, a new international standard for small bore connectors (ISO 80369) was developed. This included a dedicated connector for neuraxial applications (NRFit™ ISO 80369-6) defined as “those for administering medications to neuraxial sites, wound infiltration anaesthesia delivery and other regional anaesthesia procedures, or to monitor or remove cerebrospinal fluid for therapeutic or diagnostic purposes.”
While access to a full portfolio of NRFit™ devices and supply chain fragility has delayed its full implementation in the NHS, industry throughout the UK has now adopted NRFit™.
Some organisations have already transitioned to these devices, supported by a joint statement from the Association of Anaesthetists, Royal College of Anaesthetists and the Safe Anaesthesia Liaison Group, but many have yet to do so completely.
Actions to be completed by 31 January 2025:
Prioritise the establishment of a short-life working group (SLWG) to scope out and co-ordinate the transition to NRFit™ across all relevant clinical specialties:
a. Identify a clinical lead to chair the group.
b. Ensure local procurement leads are included to identify all devices that need to transition to NRFit™.
c. Plan and risk assess the most appropriate and safe process for transition and to monitor implementation.
To ensure comprehensive transition from Luer to NRFit™ devices is managed and supply chain continuity maintained, local procurement leads must:
a. Engage with NHS Supply Chain to agree a timeline for transition to NRFit™.
b. Identify all device locations and order codes and revise stock management systems.
After completion of Action 2, the SLWG will:
a. Clearly communicate the agreed timeline and implementation plan to all relevant clinical staff.
b. Ensure all relevant policies, procedures, and educational and training resources for intrathecal, epidural, and regional block procedures are updated with reference to the use of NRFit™ devices and are fully accessible.
What is NRFit®?
NRFit® is a standard for neuraxial and regional anesthesia devices, designed to prevent misconnections with incompatible devices. This initiative follows concerns raised by the World Health Organization (WHO) about patient safety risks associated with the misconnection of small-bore connectors. By adopting NRFit®, the NHS aims to reduce the incidence of adverse events stemming from such errors.
Our Two Cents on This :
1: The transition to NRFit® aligns with global efforts to standardize medical device connectors and improve patient safety. The NHS's commitment to this change is driven by several key factors:
Patient Safety: The primary goal is to eliminate the risk of misconnection errors, which can lead to serious patient harm. NRFit® connectors are designed to be incompatible with other connector types, ensuring that neuraxial and regional anesthesia devices are only connected to appropriate medical systems.
Compliance with International Standards: The adoption of NRFit® ensures compliance with the ISO 80369-6 standard, part of a broader initiative to standardize small-bore connectors across various medical applications.
Streamlining Clinical Practice: By standardizing connectors, healthcare providers can streamline their workflows, reducing confusion and the potential for errors during medical procedures.
2:Implications for Healthcare Providers
For healthcare providers, the NRFit® Conversion Plan will necessitate several adjustments:
Training and Education: Staff will require comprehensive training to familiarize themselves with the new connectors and understand the reasons behind the change. Ongoing education will be crucial to ensure smooth implementation and adherence to new protocols.
Inventory Management: Existing stock of non-NRFit® devices will need to be phased out and replaced with compliant products. This transition will require careful inventory management to avoid disruptions in clinical practice.
Financial Considerations: While the long-term benefits of increased patient safety and standardized connectors are clear, the initial costs associated with training, purchasing new equipment, and updating protocols must be considered and budgeted.
3: Impact on Medical Device Manufacturers
Medical device manufacturers will also feel the effects of this conversion plan:
Product Redesign and Compliance: Manufacturers must ensure that their products meet the NRFit® standards, necessitating design changes and rigorous testing. Compliance with ISO 80369-6 will be a key requirement for market access.
Supply Chain Adjustments: The shift to NRFit® connectors will impact the supply chain, requiring updates to production processes, inventory management, and distribution networks. Manufacturers must work closely with healthcare providers to ensure a seamless transition.
Market Opportunities: The NRFit® Conversion Plan presents opportunities for innovation and market growth. Manufacturers who can swiftly adapt and provide compliant products will be well-positioned to meet the increased demand from healthcare providers transitioning to the new standard.
The UK's NHS NRFit® Conversion Plan is a significant step towards enhancing patient safety and standardizing medical device connectors. While the transition will pose challenges for both healthcare providers and medical device manufacturers, the long-term benefits of reduced misconnection risks and improved clinical outcomes are invaluable. As stakeholders in the healthcare industry, it is our collective responsibility to embrace this change, invest in the necessary adjustments, and prioritize patient safety above all.
This newsletter aims to provide a comprehensive overview of the NRFit® Conversion Plan and its impact on the healthcare industry. For further information and updates on the implementation process, stay connected with our communications.
About Us:
At KBMED, we are committed to advancing healthcare safety and innovation. Our range of high-quality medical devices and solutions are designed to meet the evolving needs of healthcare providers worldwide. For more information, visit our website at www.kbmed.com or contact our customer support team.
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