Prolonged timescales for the introduction of safety-critical new medical technologies may be inevitable
Jacqui Wise’s report1 of the House of Commons Health Committee’s
Report on Patient Safety2 mentions the alarm expressed by MPs regarding
the time taken for the introduction of luer-incompatible spinal needles,
to help avoid fatal ‘wrong-route’ injections into the spine.
In 2001, I commented that, due to perceived resistance to change from
within the medical device industry, financial and political support would
be needed to effect such a change3. The Chief Medical Officer responded to
expert recommendations on the development of non-luer spinal systems4, 5
by establishing a multi-disciplinary group, involving several governmental
and non-governmental agencies, clinicians and academics. In April 2002, an
‘Invitation to Supply’ was placed in the Official Journal of the European
Communities6 by the NHS Purchasing and Supply Agency, asking manufacturers
to supply luer-incompatible spinal needles and associated devices.
A comprehensive series of evaluations of the several systems
submitted subsequently took place. A prospective analysis of potential
hazards rising from the introduction of non-luer spinal systems was also
carried out7. The selected design was modified in response to feedback
from clinical and simulator tests which were funded by the Department of
Health (DoH).
Further testing then took place across a range of clinical
disciplines, including anaesthetists, haematologists, paediatric
oncologists and pharmacists. The results8 prompted further refinements and
the preparation of design proposals for an international standard.
This step-wise approach was predicated by the potential for creating
new hazards: The introduction of a luer-incompatible system without a
simultaneous and rigorous system for training and informing all potential
users of the change. Whilst at least one range of non-luer spinal and
epidural products is now available, the engagement of the diverse NHS
professional organisations has yet to be achieved.
The Neurax® connector design9, now incorporated into a range of
medical devices and evaluated on behalf on the DoH, was developed by NHS-
employed innovators - not by any company within the established medical
device industry. The reasons for this will have to be answered by the
industry’s representative organisations.
This has inevitably meant that progress with the development has been
slower, than if this initiative had been backed by the resources available
to a multi-national enterprise, of which there are several in the field.
The expansion of the design brief to include a means to prevent deaths
from epidural medication misconnection, as occurred in Swindon in 200410,
introduced further delay.
Implied criticism of the NHS by the Health Committee is thus
premature and misdirected. A safe introduction of a new non-luer system
requires a co-ordinated support from Government, Royal Colleges, NHS
organisations including the Supply Chain and medical device manufacturers.
The Medicines and Healthcare Products Regulatory Agency, The National
Patient Safety Agency, and DoH Patient Safety Team would seem to be best-
placed to coordinate this.
I am confident that, given the extent of the work done so far, if
this initiative is now supported at the appropriate level in all relevant
areas, the introduction of this safety technology to eliminate wrong-route
spinal injections can be achievable within a far shorter time-frame than
has elapsed since this issue first arose.
(Competing interests: Philip J Bickford Smith is Director of B-Link
(UK) Ltd, a private company developing small-bore medical connectors,
including the Neurax system).
Philip J Bickford Smith
Consultant Anaesthetist, Bradford Teaching Hospitals NHS Foundation Trust
& UK Expert Member of the ISO/IEC Joint Working Group 4/ Project Group
6 on small-bore medical connectors for neuraxial applications.
References
1. Wise J MPs attack NHS for putting targets ahead of patient safety
BMJ 2009;339:b2706
2. The House of Commons Health Committee Patient Safety- Sixth Report
of Sessions 2008-09 London: The Stationery Office, 3rd July 2009
3: Bickford Smith PJ Designing safer medical devices requires
financial and political support BMJ2001, 322:548
4.Department of Health. External Inquiry into the averse incident
that occurred at the Queen’s Medical Centre, Nottingham, 4th January 2001
by Prof. Brian Toft London: Stationery Office, 2001
5. Department of Health. The Prevention of Intrathecal Medication
Errors – A Report to the Chief Medical Officer. Professor Kent Woods.
London: Department of Health 2001
6. Official Journal of the European Communities - Supply contracts -
Restricted procedure UK- Chester: spinal connectors 2002/S 66-051750. http://www.ojec.com
Competing interests:
Philip J Bickford Smith is Director of B-Link (UK) Ltd, a private company developing small-bore medical connectors, including the Neurax system mentioned here
Competing interests:
No competing interests
13 July 2009
Philip J Bickford Smith
Consultant Anaesthetist
Bradford Teaching Hospitals NHS Foundation Trust,, West Yorkshire BD9 6RJ
Rapid Response:
Prolonged timescales for the introduction of safety-critical new medical technologies may be inevitable
Jacqui Wise’s report1 of the House of Commons Health Committee’s
Report on Patient Safety2 mentions the alarm expressed by MPs regarding
the time taken for the introduction of luer-incompatible spinal needles,
to help avoid fatal ‘wrong-route’ injections into the spine.
In 2001, I commented that, due to perceived resistance to change from
within the medical device industry, financial and political support would
be needed to effect such a change3. The Chief Medical Officer responded to
expert recommendations on the development of non-luer spinal systems4, 5
by establishing a multi-disciplinary group, involving several governmental
and non-governmental agencies, clinicians and academics. In April 2002, an
‘Invitation to Supply’ was placed in the Official Journal of the European
Communities6 by the NHS Purchasing and Supply Agency, asking manufacturers
to supply luer-incompatible spinal needles and associated devices.
A comprehensive series of evaluations of the several systems
submitted subsequently took place. A prospective analysis of potential
hazards rising from the introduction of non-luer spinal systems was also
carried out7. The selected design was modified in response to feedback
from clinical and simulator tests which were funded by the Department of
Health (DoH).
Further testing then took place across a range of clinical
disciplines, including anaesthetists, haematologists, paediatric
oncologists and pharmacists. The results8 prompted further refinements and
the preparation of design proposals for an international standard.
This step-wise approach was predicated by the potential for creating
new hazards: The introduction of a luer-incompatible system without a
simultaneous and rigorous system for training and informing all potential
users of the change. Whilst at least one range of non-luer spinal and
epidural products is now available, the engagement of the diverse NHS
professional organisations has yet to be achieved.
The Neurax® connector design9, now incorporated into a range of
medical devices and evaluated on behalf on the DoH, was developed by NHS-
employed innovators - not by any company within the established medical
device industry. The reasons for this will have to be answered by the
industry’s representative organisations.
This has inevitably meant that progress with the development has been
slower, than if this initiative had been backed by the resources available
to a multi-national enterprise, of which there are several in the field.
The expansion of the design brief to include a means to prevent deaths
from epidural medication misconnection, as occurred in Swindon in 200410,
introduced further delay.
Implied criticism of the NHS by the Health Committee is thus
premature and misdirected. A safe introduction of a new non-luer system
requires a co-ordinated support from Government, Royal Colleges, NHS
organisations including the Supply Chain and medical device manufacturers.
The Medicines and Healthcare Products Regulatory Agency, The National
Patient Safety Agency, and DoH Patient Safety Team would seem to be best-
placed to coordinate this.
I am confident that, given the extent of the work done so far, if
this initiative is now supported at the appropriate level in all relevant
areas, the introduction of this safety technology to eliminate wrong-route
spinal injections can be achievable within a far shorter time-frame than
has elapsed since this issue first arose.
(Competing interests: Philip J Bickford Smith is Director of B-Link
(UK) Ltd, a private company developing small-bore medical connectors,
including the Neurax system).
Philip J Bickford Smith
Consultant Anaesthetist, Bradford Teaching Hospitals NHS Foundation Trust
& UK Expert Member of the ISO/IEC Joint Working Group 4/ Project Group
6 on small-bore medical connectors for neuraxial applications.
References
1. Wise J MPs attack NHS for putting targets ahead of patient safety
BMJ 2009;339:b2706
2. The House of Commons Health Committee Patient Safety- Sixth Report
of Sessions 2008-09 London: The Stationery Office, 3rd July 2009
3: Bickford Smith PJ Designing safer medical devices requires
financial and political support BMJ2001, 322:548
4.Department of Health. External Inquiry into the averse incident
that occurred at the Queen’s Medical Centre, Nottingham, 4th January 2001
by Prof. Brian Toft London: Stationery Office, 2001
5. Department of Health. The Prevention of Intrathecal Medication
Errors – A Report to the Chief Medical Officer. Professor Kent Woods.
London: Department of Health 2001
6. Official Journal of the European Communities - Supply contracts -
Restricted procedure UK- Chester: spinal connectors 2002/S 66-051750.
http://www.ojec.com
7. PS/038 - A prospective hazard analysis and pre-implementation
evaluation of non-Luer spinal connectors.
http://www.pcpoh.bham.ac.uk/publichealth/psrp/PS038_Project_Summary.shtml
8. PS/049 Pre-Implementation Evaluation of Non-Luer Compatible Spinal
Equipment
http://www.pcpoh.bham.ac.uk/publichealth/psrp/PS049_Project_Summary.shtml
9. http://www.neurax.co.uk
10.
http://www.timesonline.co.uk/tol/life_and_style/health/article3314183.ece
Competing interests:
Philip J Bickford Smith is Director of B-Link (UK) Ltd, a private company developing small-bore medical connectors, including the Neurax system mentioned here
Competing interests: No competing interests