Speciality needles - an update
Joanna Ford and Pete Phillips
22 June 2015
Historically, spinal needles have been used for a wide range of non-spinal procedures where regular hypodermic needles are not long enough. However, changes to the connectors on spinal needles in the near future mean that this will no longer be possible. This paper aims to explain the background and rationale for the proposed changes as well as presenting the current options for health care professionals who must find alternatives to spinal needles for non-spinal procedures.
For many years, the luer connector has been used on a wide range of different types of medical devices. One of the reasons for this is that it makes a safe and reliable connection between devices and is familiar to health care workers. However, the disadvantage of a universal connector such as the luer is the potential to connect the wrong devices together possibly resulting in grave medical error, patient suffering and even death. An example of this is the accidental injection of chemotherapy drugs directly into the spinal canal.
As a result of these concerns, CEN (the European standards organisation) started looking at alternative connectors to Luers after the CHeF report (PD CR 13825:2000 Luer connectors. A report to CEN CHeF from the CEN forum task group 'Luer fittings') in 1999/2000. This included recommendations of non-Luer connectors for the prevention of wrong-route administration. The National Patient Safety Agency (NPSA) picked up this issue again in 2009 as standards work seemed to have stalled.
As a result of these concerns, a range of new connectors are to be produced for different types of devices which will eventually be specified in a new ISO 80369 standard. The aim is to make different groups of devices incompatible with each other so that they are less likely to be connected in error. A new design of neuraxial connector for spinal procedures is proposed as part of this process. See below for the parts of the new ISO standard affecting different types of devices:
- Part 2: Respiratory connectors
- Part 3: Enteral connectors
- Part 5: NIBP (blood pressure cuffs)
- Part 6: Neuraxial
- Part 7: Luer
There is a Welsh Government sponsored working group (the WNCRG) specifically dedicated to the neuraxial connector project in Wales. The new design of neuraxial connector has undergone a series of rigorous tests which include usability studies, misconnection testing via computer modelling and leak testing in the laboratory. The importance of thoroughly evaluating neuraxial connectors before their introduction has been emphasised (Cook 2012). Some parts of the UK have started using a proprietary design of non-Luer neuraxial connector, in particular for spinal chemotherapy, but it is anticipated that the UK will all move to a single neuraxial connector in 2017 which is compliant with ISO 80369-6. At the time of writing the new neuraxial connector standard is awaiting publication.
Implications for off-label use
Many non-spinal/epidural procedures are undertaken by clinicians using spinal needles as the long needle design helps them access difficult to reach spaces. This is sometimes called 'off-label usage'. Once neuraxial-specific connectors are introduced into the NHS, health professionals will no longer be able to use spinal needles for non-spinal procedures as the connector will not connect with standard Luer . A (non-exhaustive) list of the types of procedures this relates to are shown in the table below:
|Name of procedure||What long needle used for|
|Ascite paracentesis||fluid aspiration|
|Soft tissue biopsy||removal of soft tissue|
|Bone infiltration||aspiration of bone marrow|
|Central line insertion||guidewire placement|
|Facet joint injection||injection|
|Gall bladder procedures||soft tissue biopsy|
|Harvesting skin grafts||harvesting columns of tissue|
|Hickman line insertion||guidewire placement|
|Joint aspirations||fluid aspiration/biopsy|
|Local anaesthetic infiltration||injection|
|Bone location||needle bone biopsy|
|Suprascapular nerve block||injection|
|Vocal cord injection||injection|
|Amniocentesis needles||fluid aspiration|
As a result of these proposed changes, it is in the interest of the relevant manufacturers to ensure that other appropriate needles with luer connectors are available for these types of off-label procedures once the spinal needle manufacturers adopt the ISO-80369-6 non-luer connectors. We contacted two of the major manufacturers of spinal needles to ask them what action (if any) they would take as a result of these changes. Their responses are shown in the table below:
Table of Manufacturer responses
|Manufacturer||Current status regarding speciality needles|
They already produce 'speciality needles' with luer connectors up to 180 mm in length. They will continue to do this when spinal needles adopt non-luer connectors.
BD intend to maintain long needles with spinal tip and Luer connector
Cook T. Non-Luer connectors: are we nearly there yet?. Anaesthesia 2012; 67: 784-792