F.A.Q The new ISO Standard for neuraxial applications: ISO 80369-6
NRFit
1. What is ISO 80369? A patient may be connected to several simultaneous medication/infusion delivery systems, via, for example: intravenous, enteral and epidural routes. The ISO 80369 series of Standards aims to avoid misconnections between these unrelated delivery systems which can cause patient injury and death. To do so, ISO 80369 is the creation of a unique international standard design for connectors for every clinical application (Intravenous, Respiratory, Enteral, Urology…), which are non-interconnectable.
ISO 80369 Part 1 General requirements
Part 2 Connectors for Respiratory
Part 3 Connectors for Enteral
Part 4 Connectors for Urology
Part 20 Test methods
Part 5 Connectors for Limb cuff inflation
Part 6 Connectors for Neuraxial
Part 7 Connectors for Intravascular
(Luer)
2. What is ISO 80369-6? ISO 80369-6 is part 6 of the ISO 80369 series, which is dedicated to neuraxial applications. Part 6 details all the dimensions, performances, materials, and drawings of the new neuraxial standard connector.
3. What is “NRFit”?
NRFit is the trade name of the new neuraxial standard connector compliant with ISO 80369-6.
4. What are the differences between Luer and NRFit connectors? The change from Luer to NRFit devices only affects the connector and does not affect any other part of the product specification. The difference between Luer and NRFit connectors may not be immediately noticeable upon visual inspection. The bore size of an NRFit connector is approximately 20% smaller than Luer and there is a collar on the male slip syringe-tip.
Luer connection
NRFit connection
5. Why should you use ISO 80369-6 compliant devices? By having a dedicated connector for neuraxial applications, the ISO 80369-6 system prevents the misconnection between neuraxial devices and any other device designed for non-neuraxial applications. Indeed, there have been fatalities where intravenous medicines have been administered via the spinal route and epidural medicines administered by the intravenous route.
6. What is neurafitTM ? neurafitTM is the brand name of Vygon’s range of devices with NRFit connectors.
7. Which devices will become ISO 80369-6 compliant? The scope of the ISO 80369-6 standard includes all devices which connect to the neuraxial route in the following applications: - spinal anesthesia. - epidural anesthesia. - combined spinal-epidural anesthesia. - cerebro-spinal fluid (CSF) pressure monitoring and lumbar puncture. - peripheral nerve blocks. - wound infiltration.
8. Who designed the NRFit connector? The new design was developed via collaboration between ISO member manufacturers, clinical end-users, regulatory and testing organizations.
9. When and where will the NRFit connectors be available? Vygon is expecting to launch neurafitTM which is neuraxial range of devices with NRFit connector from Q1 2018. For detailed information regarding availability in your country, please contact Vygon local representative.
10. Will it become compulsory to use NRFit connector? No, an ISO standard is not a law, but an international recommendation. “The important distinction between standards and legislation is that standards are voluntary, whereas legislation is mandatory. When regulatory authorities use standards as a basis for legislation, only then do they become mandatory, and then only within the jurisdiction covered by the legislation. […]”(1) Therefore, this will depend on local law.
11. Will Luer neuraxial connectors still be available? The Luer connection will become the ISO 80369-7 standard and will continue to have applications in intravascular and hypodermic access. Considering the safety advantages of ISO 80369-6 devices, it is likely that the supply of Luer connection neuraxial devices will decline over time.
(1) http://www.iso.org/sites/ConsumersStandards/1_standards.html
Vygon’s solution for neuraxial applications
neurafitTM
• Spinal anesthesia Quincke needle Whitacre needle
• Lumbar puncture • Peripheral nerve blocks Locoplex Echoplex Visioplex Silverstim Techniplex
• Epidural anesthesia Tuohy needle LOR syringe Catheter connector Epidural filter
Manometer Quincke needle Whitacre needle
•C ombined spinal-epidural anesthesia Whitacre needle Tuohy needle with back-eye LOR syringe Catheter connector Epidural filter
With following accessories: • Syringes • Drawing-up device • Extension line • 3-way tap • Blood patch kit • Syringe cap
12/2017 - DB AIGU 16 344 E
ANAESTHESIA & EMERGENCY For further information, please contact: questions@vygon.com The specifications shown in this leaflet are for information only and are not, under any circumstances, of a contractual nature.
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