Active and passive: Safety devices and diabetes care

Tracey Sainsbury, group product manager, Owen Mumford discusses how the number of people living with diabetes is increasing.

In the UK alone, the NHS is estimated to spend over £10 billion each year on treatment. Although prevention programmes are in place to manage this increase, the charity Diabetes UK suggests that unless the government increases investment in these programmes to improve their scope and offering, up to one in 10 adults in the UK could be living with the disease by 2030. 

There are many new methods now available to administer insulin, but a common route is with a pen and pen needle. Standard pen needles have an exposed sharp throughout the injection experience, with no feature to shield the needle after use. Safety devices use a mechanism with either a passive-automatic or active-manual activation that covers the needle and helps reduce the risk of needlestick injuries (NSIs). In 2010, the EU Directive on Sharps Safety was introduced which mandated the use of these devices in clinical scenarios but did not provide a preference for either. 

Both active and passive safety devices are designed to improve safety for patients and healthcare professionals, particularly from the transmission of bloodborne pathogens that may cause infections through accidental NSI. The key difference is that along with the automated safety mechanism, passive devices typically cover the needle before and after the injection process, which may make it difficult to see the needle and need to use a different injection technique. Active devices show the needle from the moment the safety cap is removed until the safety mechanism is manually activated. Visibility of the needle throughout the injection experience can offer better control and requires the user to be actively involved in the safety process.   

NSIs can represent a significant financial and psychological issue for healthcare institutions and although safety devices are designed to mitigate this, patient safety and correct dosage is also of concern. Passive safety devices can cause issues when administering insulin, specifically because they cannot provide a clear visual indication that the full medication dose has been delivered due to the lack of a visible needle. 

In 2022, independent research company MindMetre published the results of a UK study into the use of safety devices among NHS trusts following anecdotal evidence of incorrect insulin dosage. Diabetes specialist nurses reported witnessing either insulin pooling on the skin after injecting (suggesting that the full dose had not been delivered), or adverse events related to incorrect dosage while the patient was still present and in the Trust’s care. This can often happen when the automatic safety mechanism of a passive device is activated too early and interrupts administration of the full medication dose. 

Both instances were of concern, but an absence of data on these issues led MindMetre to request information from all NHS Trusts across England and Wales under the Freedom of Information Act. The goal of obtaining this data was to understand how widespread these issues were and to assess whether diabetes specialist units were using the right kind of safety pen needles for their patients. 

The results found that 36.4% of NHS Trusts said they had experienced insulin pooling, and 25% experienced incorrect dosage of insulin evidenced by an on-premises adverse event by the patient. Both situations occurred when using a passive device. Trusts were also given the option to provide additional context to their responses – with one Trust noting that “inaccurate insulin dosage was seen as a result of passive safety needles, due to this [we] moved to active safety needles,” and “pooling of insulin was observed when using passive safety needles… again [we] moved to active safety needles for this reason.” 

Legislation leaves the choice of active or passive safety devices to healthcare professionals, but it remains unclear why passive devices are chosen over active. As a manufacturer of both types of safety device, Owen Mumford commissioned a clinical evaluation of safety pen needles in 2020 that surveyed the opinions of healthcare professionals delivering insulin injections and collated evidence-based insight on the topic. On the subject of accurate dosage, 98% of respondents agreed they were in control of the dose delivery, with 96% agreeing that they were confident they were able to deliver the full dose of medication with no leakage when using an active safety pen needle. Comparatively, there was a significant difference with 59% of respondents agreed they were in control of the dose delivery and 41% agreed they were confident they were able to deliver the full dose of medication with no leakage when using a passive device. 

MindMetre’s research suggests that, as with many other clinical scenarios, the patient’s injection experience is as crucial as that of the healthcare professional. Innovation that helps to reduce the risk of NSIs is essential, not least because of the laws in place that mandate the use of safety devices, but accurate dosage is of equal importance when it comes to patient wellbeing. Owen Mumford’s clinical evaluation suggests that an active safety pen needle can provide more confidence in full dose delivery, which is reinforced by the Trusts who provided comment to MindMetre’s enquiry and made the switch themselves. Similarly, issues surrounding increased risk of NSIs could be mitigated with a passive device – provided that no insulin delivery issues emerge following the switch. 

The key is balancing safety and control to create an injection experience that does not compromise on the needs of healthcare professionals and patients. This can be achieved by continuously evaluating the performance and success of current devices to ensure they meet standards and committing to corrective action when they do not.