NPSA Safer Spinal Needles

National Patient Safety Agency Alert NPSA/2009/PSA004A&B - “Safer spinal (intrathecal), epidural and regional devices”

Currently it is possible to inject drugs intended for intravenous administration into the spinal or epidural space and conversely to inject drugs intended for spinal, epidural or regional nerve block via the intravenous route. This has occasionally resulted in fatalities and continues to feature in patient safety incident reports.

The NPSA require NHS organisations to change to equipment with non-Luer connections over the next few years; spinal equipment by 1st April 2012 and epidural and regional equipment by April 2013. From April 2012 “all spinal (intrathecal) bolus doses and lumbar puncture samples are performed using syringes, needles and other devices with safer connectors that will not connect with intravenous Luer connectors”.

 Safer spinal (intrathecal), epidural and regional devices - Part A: update
(31 January 2011) - 574 KB

Safer spinal (intrathecal), epidural and regional devices - Part A and Part B: Supporting information
(January 2011) - 240 KB

Safer spinal (intrathecal), epidural and regional devices - Part B
(24 November 2009)- 201 KB 

Frequently Asked Questions

How are our professional bodies involved?

Representatives from the RCoA, AAGBI, OAA, and APA are on the External Reference Group who have advised the NPSA from the drafting stage. The Safe Anaesthesia Liaison Group (SALG) of the RCoA with representatives from the AAGBI and NPSA ensure communication at a committee level between the organisations. The OAA and SALG are coordinating the reporting of clinical evaluations of spinal equipment.  The OAA are performing monitoring of adverse outcomes during spinal anaesthesia for caesarean section.

What is their latest guidance?

The AAGBI together with the other organisations have issued a position statement (25 October 2011)

Response to the Joint Statement - from Professor Brian Toft and Professor David Cousins

The NPSA advises independent usability testing performed for all equipment.  This was going to be performed by the Welsh NHS.  The process was paused in early 2012 - see the SMTL Website for the reasons and the current status of the process.

In the absence of this information, it is advised that clinical evaluations are performed in a structured fashion - see section above.

See also guidance from NHS Pharmaceutical Aseptic Services Group.

Do clinical evaluations require Ethics Committee approval?

The NPSA and the SW3 LREC have stated that this does not need ethical committee approval as it counts as service evaluation. If clinicians think that this should be clarified locally, then they should contact the relevant body in their own hospital.

 

Will there be one new standard spinal and epidural connector? If not, why not?

The ISO has been considering this topic for a number of years but is not close to a solution. The change to non-Luer is being introduced by the NPSA in the interests of patient safety, but the NPSA cannot stipulate that only one design will be used. There are currently around five different connector types.  

 

 

Who is being consulted in the hospital?

There are no standard plans in the NHS (except Wales: the Welsh NHS are approaching this in a formalised country-wide manner). Each hospital or group of hospitals will have to form an implementation group. The composition of these groups may consist of representatives from the following: executive director, procurement, medical devices manager, governance / patient safety representatives, anaesthesia, paediatrics, oncology, paediatric oncology, medicine, neurology, neurosurgery, chronic pain, radiology, ITU, pharmacy production / parenteral services.

 

 

How will the change be introduced in my hospital?

Equipment will have to be introduced bearing in mind factors including:

• Availability from the supplier
• Results from the NPSA non-clinical testing
• Clinical evaluation within the hospital
• In anaesthesia, spinal and epidural compatibility issues See article

 

Can we change epidural and spinal equipment at the same time?

Many units that have not already changed are planning to implement Part A and B together.

 

What will happen with CSEs if the spinal and epidural equipment does not change together?

There are two options:

1. The spinal needle will be non-Luer and the epidural will be Luer
2. A ‘CSE pack’ may have a Luer spinal and epidural needle. If so, this should be on the risk register

 

What do we do with the risk register?

See the Alert implementation checklist item 11: “Add to the organisation’s risk register any use of non-compliant devices after the required implementation dates. Introduce additional local safeguards and seek to purchase compliant devices as soon as they become available.”

 

Click to view NPSA newsletters:

 

 

FAQs in Issue 1:

1.1     I work in a NHS hospital and I am not clear who is responsible for managing the introduction of safer devices in my organisation?

So what is supposed to be happening now in my hospital?

1.2     How should the new devices be introduced into clinical practice in my hospital?

1.3     What degree of training is necessary before clinicians start using Alert-compliant devices?

1.4     Can’t this work be undertaken nationally or regionally?

1.5     What is the status of combined and epidural kits (CSE)? Are they covered by NPSA Part A or Part B guidance?

1.6     What is the status of Loss of Resistance Syringes (LOR) are they covered by Part A or Part B guidance?

1.7     What if non-Luer 10 ml and 20 ml syringes are not available by April 2011?

1.8     I understand that the International Standards Organisation (ISO) is developing an international standard for neuraxial connectors, how will this affect the NPSA guidance?

 

 

FAQs in Issue 2:

 

2.1     External-ventricular drains are silastric tubes that enter the ventricles of the brain to treat hydrocephalus and to give intrathecal drugs (usually antibiotics). Are these devices covered in the NSPA Alert?

2.2     Are Ommaya reservoirs covered by NPSA guidance?

2.3     Neuro-endoscopes have Luer connectors for connection directly to giving sets so saline can be irrigated into the ventricles during the operation. Guidance please?

2.4     The NPSA Alert stated ‘eliminate the use of three-way taps and adaptors with Luer connectors, which enable connection of specified devices to intravenous devices’. Please clarify exactly what is meant by this guidance?

2.5     Is sub-tenon anaesthesia covered by the alert, and if so which part of the alert covers it?

2.6     How should the epidural blood patch technique be undertaken with safer neuraxial devices in the future?

2.7     Are Bier’s Blocks covered by the Alert?

2.8     What are the definitions for regional and local anaesthesia used by the NPSA?

2.9     The NPSA Alert states that neuroaxial devices with safer connectors should not connect with intravenous Luers. Does this include all possible cross connections?

2.10   Should safer connectors, used in neuroaxial devices, connect with needle free connectors and bi-connectors used in intravenous devices?

2.11   Should syringes and needles used to administer local anaesthetics into the skin have safer connectors?

There is some confusion over the product range required to implement NPSA Alert Part A guidance, i.e. a recommended product range available for information?

 

 

 

Read the NPSA's Rapid Response Report of 28 November 2011

FAQs in Issue 3

3.1     Are spinal catheters covered in part A or B of the NPSA Alert?

3.2     Are winged needle infusion (Butterfly) devices with non-luer connectors necessary to achieve compliance with the NPSA alert? 

3.3     In my orthopaedic practice, I use a spinal needle to aspirate the knee joint. What do I need to do in April 2012? 

3.4     Is local anaesthetic wound infusion devices covered by Part B, or is it outside the NPSA alert?

3.5     Which suppliers are supplying short spinal needles with safer connectors suitable for use with children? 

3.6    Is there a requirement for tamper evident syringe caps to meet the NPSA Alert requirements?

 

 

 

FAQs in Issue 4

4.1     Are winged needle infusion (Butterfly) devices with non-Luer connectors necessary to achieve compliance with the NPSA alert?

4.2     Are 1 ml, 10 ml, and 20 ml syringes required for Part A recommendations? 
 

 

Further information and documents

Evaluations of non-Luer spinal equipment:

Neurax/ B-Link (UK) Ltd and Spinalok/InterVene Ltd See: article and accompanying editorial

Neurax/ B-Link (UK) Ltd

BD UniVia-6

Pajunk/ Bluebox Polymedic/ Sarstedt/ Smiths



Statements:

Safer spinal (intrathecal), epidural and regional devices - Part A
(24 November 2009) - 199 KB


Safer spinal (intrathecal), epidural and regional devices supporting information
(November 2009) - 103 KB 

Film “Just another day” (World Health Organisation video - 'Learning from Error')

Letter (16 August 2010) to Professor David Cousins from Presidents of AAGBI, OAA, RCoA and APAGBI

Response (1 September 2010) from Professor David Cousins, Head of Patient Safety - Medication and Medical Devices, NPSA

Statement (18 August 2010) from the President of the RCoA