Influencing the introduction of safer medical devices

Academics: Professor R. Lawton and Dr P. Gardner, Faculty of Medicine and Health

Luer-locks are standard connectors are part of devices that are used to give drugs, feed and also take samples from patients. This standardisation has led to fatal mistakes in some scenarios, such as drugs that should only be injected intravenously being administered into the spine. Following the death of a young man in 2001, and 13 others in the UK over the previous 15 years, the Department of Health called for prototype non-Luer connectors to be evaluated with the aim of “reducing to zero the number of patients dying or being paralysed by maladministration of spinal injections”.

Following a competitive bid, a team from Leeds was selected to conduct the investigation. They analysed data on incidents involving Luer connectors, conducted clinician workshops to investigate new devices and tested prototypes on a spinal simulator. The team then evaluated prototype devices in four NHS Trusts to see how safe, effective and practical they were.

Enabling “design for safety”

This novel work demonstrated that a prototype (Neuraxial) connector could be used to treat patients more safely but also identified improvements that would need to be made and changes to packaging and storage that would enable safe and smooth implementation.

The findings formed the basis for National Patient Safety Agency policy alerts which introduced non-Luer spinal connectors to the NHS in 2009. Companies used the alerts to inform further development, resulting in revisions to existing non-Luer connectors and the design of new devices. The research shaped the design of the Surety system, which is currently accepted as the non-Luer connector of choice. 

Preventing fatal mistakes

Since 2009, there have been no reports of fatal or paralysing misconnection errors in the UK involving non-Luer designs. Currently 55 NHS Trusts are using non-Luer spinal connectors and adoption is continuing across the country. The Neurax connector design which has been modified based on the research is the basis for a draft ISO standard, which will influence international adoption.            

I would like to emphasise the importance of your (Leeds team’s) work in developing / testing the Neurax design, a variation of which is likely to be the new ISO standard design used globally in a few years time.

Head of Medication Safety, National Patient Safety Agency
Funder: Department of Health