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 also, 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 2011 and epidural and regional equipment by April 2013. From April 2011 “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”. 
 

Introduction (NPSA)

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

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

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

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




Frequently Asked Questions

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. Therefore the change is being introduced by the NPSA in the interests of patient safety. There will potentially be a different connector type for each supplier, though there may be some design sharing leading to interchangeability between a few suppliers.

Why do we have to change our spinal connector?

Mistakes with spinal anaesthesia and lumbar puncture are very rare but as long as there are Luer spinal needles in use, these could find their way into areas where intrathecal chemotherapy occurs.

When will the new spinal needles be available?

This is not certain but is not likely to be until the end of 2010.

Will the implementation deadline be achieved?

“NHS organisations should not request further orders for non-compliant devices from 1st October 2010”. This date is not achievable, but hospitals may wish to change to the new equipment as soon as possible before April 2011.

How will the new equipment be assessed?

The NPSA plans on having independent non-clinical testing performed for all equipment.

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

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

Unlikely. Non-Luer epidural equipment can be introduced as soon as it is available before 2013, with the same constraints as for spinal equipment. However, unless epidural equipment becomes available before April 2011, a hospital would have to delay the introduction of non-Luer spinal equipment until after the mandated date (see risk register) in order to achieve a combined change over for both products.

How do we draw up drugs into the non-Luer syringe?

There will be non-Luer blunt needles, filter needles, filter straws etc.

What will happen with CSEs?

Between 2011-2013, the spinal needle will be non-Luer and the epidural will be Luer.

What will happen with blood patches?

This is not certain but it may be necessary to take the blood sample and then transfer to a non-Luer syringe.

Do we have to change?

Yes. Compliance with an NPSA alert is not a legal requirement; however if a hospital was to ignore the directive and a serious adverse clinical outcome was to occur, the chief executive would potentially be liable for any action brought in law as a result.

Do we have to change our spinal equipment by April 2011?

No. If the new non-Luer equipment has not undergone adequate a) independent non-clinical evaluation and b) clinical evaluation by the doctors within the hospital who will be using it on patients, then the current Luer equipment can be placed on the hospital’s risk register and the implementation date deferred.


What do we do with the risk register?

See PSA004A & B 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.”


How are our professional bodies involved?

The NPSA have had representatives from the RCoA, AAGBI, OAA, and APA on the External Reference Group discussing this alert from the drafting stage. The Safer Anaesthesia Liaison Group of the RCoA with representatives from the AAGBI and NPSA ensure communication at a committee level between the organisations. 
 

Further information

Link to NPSA newsletter – this will be activated ASAP




Monitoring via NOAD (National Obstetric Anaesthesia Database)
of adverse anaesthetic at caesarean section using spinal or CSE anaesthesia

We believe that it is important to collect data on adverse clinical outcomes before and after the introduction of non-Luer spinal equipment to monitor for a possible increase resulting from the change. These outcomes are general anaesthetic (GA) conversion, spinal anaesthesia failure and pain during surgery.

      Level 2 – summary data on GA conversion
      Level 3 – same, broken down into conversion related/not related to technical problems with equipment 
      Level 4 – all outcomes

After the changeover, data will be collected until there is stability in the clinical situation i.e. hospitals are using a preferred equipment type and anaesthetists are familiar with the equipment.


Units collecting data:

NPSA safer needles and NOAD  (click image below to view list)

Data summary:

(Table to follow - Baseline data, GA rates, fail/pain rates, needle types)


Needles in use:

Spinal:     BD, Pajunk, Polymedic, Smiths, Vygon
Spinal component of CSE:     BD, Pajunk, Polymedic, Smiths, Vygon