In the United Kingdom alone, the NHS is estimated to spend more than £10 billion every year on diabetes treatment. While prevention programs have been set up to help manage this rise, the charity Diabetes UK says that unless the government commits more funding to expand and improve these programs, up to one in ten adults in the UK could be living with the disease by 2030.
Now, there are several new ways to give insulin, but using a pen with a pen needle is a common method. Standard pen needles keep the sharp needle exposed during the injection and do not have a feature to shield it after use. Safety devices, on the other hand, use either a passive-automatic or active-manual mechanism to cover the needle, which lowers the risk of needlestick injuries (NSIs). In 2010, the EU Directive on Sharps Safety was introduced, requiring these devices to be used in clinical settings but not stating a preference for one type over the other.
Both active and passive safety devices are designed to protect patients and healthcare professionals, especially against bloodborne pathogens that could transmit infections through accidental NSIs. The main difference is that passive devices, with their automated safety feature, usually cover the needle both before and after the injection, which might make it hard to see the needle and could require a different way of injecting. With active devices, the needle is visible from when the safety cap is taken off until you manually trigger the safety system. Being able to see the needle during the whole injection can give more control and means the user has to play an active role in the safety process.
NSIs can create significant financial and mental health challenges for healthcare organizations, and while safety devices are meant to help prevent these issues, making sure patients get the correct dose safely is also key. Passive safety devices can make it harder to verify whether the full insulin dose has been received, since you cannot easily see the needle through the process.
In 2022, the independent research company MindMetre published findings from a UK study looking at safety device use at NHS trusts after hearing stories about incorrect insulin dosing. Diabetes specialist nurses reported cases of insulin collecting on the skin after injection (suggesting the full dose was not given) or side effects related to the wrong dose happening while the patient was still being cared for by the Trust. This often occurred when a passive device’s automatic safety feature was activated too early, which stopped the whole dose from being administered.
Both kinds of events were a concern, but a lack of data led MindMetre to submit information requests to all NHS Trusts in England and Wales under the Freedom of Information Act. Their objective was to find out how common these issues were and whether diabetes specialist units were using the best type of safety pen needles for their patients.
The results showed that 36.4% of NHS Trusts had experienced incidents where insulin pooled on the skin, and 25% reported incorrect insulin dosage, documented as an adverse event happening on their premises. Both events happened when using a passive device. Trusts could also add extra explanation to their answers. One Trust said, “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.”
Laws leave the decision between active and passive safety devices up to healthcare professionals, but the reasons for choosing passive over active remain unclear. As a company that makes both types, Owen Mumford commissioned a clinical study in 2020 to get healthcare professionals’ opinions and gather evidence on this subject. Regarding accurate dosage, 98% of those surveyed agreed they were in control of dose delivery, with 96% confident that they could deliver a full dose with no leakage when using an active safety pen needle. In contrast, with passive devices only 59% felt in control and 41% were confident about full dose delivery without leakage.
MindMetre’s research suggests that, as with many other clinical situations, the patient’s experience with injections matters just as much as that of the healthcare worker. Innovations that reduce the risk of NSIs are vital, not just because laws mandate safety devices, but because accuracy in dosage is equally important for patient health. Owen Mumford’s study found that active safety pen needles may give greater confidence in delivering the full dose, a point reinforced by Trusts that switched devices and gave feedback to MindMetre. Likewise, using a passive device may lower the risk of NSI, as long as insulin delivery issues do not come up after switching.
The main challenge is finding the right balance between safety and control to provide the best experience for both healthcare professionals and patients. This means regularly reviewing how well current devices work, making sure they meet standards, and taking corrective steps if they do not.