Following the EU Directive 2010/32/EU, Prevention from sharps injuries in the hospital and healthcare sector, which came into force in 2010, legislation was rolled out relating to the use of safety sharps when administering insulin to patients with diabetes (European Agency for Health and Safety at Work, 2010). Safety devices use a mechanism with either a passive or active activation that covers the needle and helps reduce the risk of needlestick injuries (NSIs). However, the EU Directive did not state a preference for which type of safety pen needle to use in the clinical space. Thus, the choice is left to medical institutions.
Active and passive devices
Both active and passive devices are designed to help improve the patient experience and be intuitive to use. However, the two devices have some fundamental differences and benefits.
The key difference is that, along with an automated safety mechanism, passive devices typically cover the needle before and after the injection process, which protects against NSIs but can make it difficult to see the needle and requires the user to use a different injection technique from standard pen needles. Crucially, the passive mechanism requires consistent pressure on the skin to function properly and, if this pressure is lost, the safety feature activates. If this happens prematurely, the administration is interrupted, and medication can remain undelivered – often confirmed with visible pooling of the insulin on the patient's skin and undelivered medication remaining in the passive device.
With active devices, the needle is visible until the safety mechanism is activated. As well as using a similar injection technique to standard pen needles, these devices require the user to manually activate the safety mechanism, eliminating the risk of accidental activation and interrupted insulin delivery.
Patient harm
Recently, NHS England's National Patient Safety Team (NPST) reviewed insulin safety pen needles, shedding critical light on the real-world impact of incorrect administration of insulin with observed insulin pooling (Jennings, 2023). This investigation was instigated following a case of diabetic ketoacidosis (DKA) triggered in a type 1 diabetes patient. When too many ketones are produced too fast, they can build up to dangerous levels in the body. In this instance within the review findings, no other precipitating factors were identified other than the potential incorrect dosage of insulin – as observed with passive devices (Jennings, 2023).
In the review of reports of harm associated with insulin delivery by safety pen needles from 2019 to 2022, the NPST identified a common theme of incidents detailing observation of pooled insulin during administration and associated consequences such as additional blood glucose monitoring to ensure patient safety. In severe cases, some reports noted unexpectedly high blood glucose levels and the unexpected presence of DKA. These reports suggested that the use of passive devices and unnoticed pooling of insulin were key factors in the outcome (Jennings, 2023). The underdosing of insulin can have serious consequences not just for people with diabetes but also for hospital resources and health professionals. Patients who experience a DKA require additional time within hospital, adding pressure to an already overstretched health service.
A national survey, carried out in 2014 within the UK, uncovered that the average cost for an episode of DKA was £2064 per patient (Dhatariya, 2017)
Training
Due to the many demands on healthcare services, there is often little time available to administer adequate training on a medical device – a common theme which was identified within the NPST report. This training issue was reflected in a survey carried out by the Royal College of Nursing (RCN) in 2020 concerning ‘blood and body fluid exposures’. In the UK, the 2013 sharps regulations requires that all staff be trained in the safe use of sharps (Health and Safety Executive, 2013). Thus, it was of concern that 25% of staff had not received training on safer sharps use, and only 38% of staff had received training in all safer sharps they needed to use (RCN, 2021).
These issues are not specific to the UK. Overworked, understaffed healthcare providers are facing these issues globally. A survey conducted by the Italian Association of Prevention and Protection Services Managers in the Healthcare Environment in 2002 and 2004 found that around 40% of all injuries to hospital personnel were due to exposure to biological risk and 70-80% of these injuries were due to injuries with needles and other sharps. This data was discussed in an article in the Italian Journal of Medicine, concluding that:
‘The improvements in staff safety previously achieved concerning proper use of insulin pens, must be maintained by continuous training of newly hired staff.’
This would help mitigate improper use of the pen needle. Given the overstretched nature of healthcare services, it raises the question of how much training can realistically be provided.
A study in the Canadian Medical Association Journal (Yu et al, 2012) spotlighted the case of a 74-year-old woman with type 2 diabetes, who was admitted to hospital multiple times due to episodes of DKA. Her condition was concluded to be secondary to suboptimal insulin dosing. The woman's long-term care facility was administering insulin using safety pen needles with a sliding sleeve encircling the needle that is activated by pressure on the injection site – a passive device. Aligned to the NPST findings (Jennings, 2023), Yu et al (2012) stated that with passive safety pen needles:
‘If incorrectly applied it is possible for the insulin to be deployed while the needle is outside the body. The automatic shield may prevent the user from seeing if the needle is subcutaneous. Thus, users must be educated on appropriate administration.’
Prevalence of DKA
Although it is not always clearly identified why DKAs have happened, when considering the prevalence of DKAs reported in studies, we can see the extent of the issue, and the need to safeguard against it, whatever the cause may be. An international review of studies of hospitalisations caused by DKA found that DKA is the leading cause of mortality among children and young adults with type 1 diabetes, accounting for 50% of all deaths in this population (Vellanki and Umpierrez, 2018). In addition to this, rates can vary greatly depending on the healthcare setting. An analysis conducted in India reported that up to 30% of hospitalised DKA cases result in inpatient death (Agarwal et al, 2016).
Further to this, a study on the trends in hospital admission for DKA in adults with type 1 and 2 diabetes in England found that the incidence rate of DKA in 2013 was 1.5 times higher (1.53%) in type 1 patients than in 1998, and it was higher still for patients with type 2 diabetes (4.2%). This demonstrates a serious increase that needs to be guarded against to prevent further hospitalisation in the future (Zhong et al, 2018).
Raising awareness of devices available
Following analysis of the reports, the NPST has shared its findings with members of the National Association of Medical Device Educators and Trainers (NAMDET) to raise awareness that both active and passive devices are available, each with their own specific set of benefits (Jennings, 2023). Crucially, the team also reinforced the importance of education and training for insulin administration with both kinds of safety pen needle; and using an active safety pen needle may be less of a risk when considering accurate and assured insulin delivery, certainly where there is limited ability to provide device training or a reliance on temporary staff (Jennings, 2023).
In line with the reinforcement of education around the types of safety pen needles, Trend Diabetes has provided updated best practice guidelines on injection technique. The guidelines include information on active devices, meaning health professionals can gather information on all the options available to them when choosing a safety pen needle (Hicks and James, 2023). This update aids the NHS focus on increased education around the topic, allowing healthcare providers to make an informed decision on what safety pen needle suits their needs.
Health professionals' preferences
Medical device manufacturer Owen Mumford has carried out a survey of the opinions of health professionals delivering insulin injections with both active and passive devices, providing evidence-based insight on the topic. The evaluation provided invaluable feedback on safety pen needle use in clinical settings. The results showed a strong preference among the participants for an active safety mechanism. 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 (Owen Mumford, Project Tarvos, unpublished data on file, 2020). Of those using a passive device, the results were far less favourable, with 59% of respondents agreeing they were in control of the dose delivery and 41% agreeing they were confident they were able to deliver the full dose of medication with no leakage.
The results relating to training also favoured active safety pen needles. For the active device, 98% of respondents stated that they found it easy to activate the safety mechanism. Ninety-two per cent of health professionals did not have to change their normal injection technique to be sure they inserted the active safety pen needle into the subcutaneous tissue. In total, 94% agreed they did not require a lot of training to use the active device correctly, and 98% agreed that it was easy to educate their patient on the use of the active device for home use. These compelling figures suggest that active devices are more intuitive to use than passive devices, a characteristic that can be beneficial when operating within a busy, under-resourced clinical environment.
The NPST noted that support is available by passive pen needle manufacturers to help mitigate the training issue if the user requires it (Jennings, 2023). The report does, however, note that there is a general lack of awareness around active pen needles as a suitable alternative. These devices may be judged less of a risk when considering the injection technique and the manual safety mechanism, which is designed to improve the confidence of the user on the accuracy of insulin dosage.
Collaboration needed
The collaboration between medical device manufacturers and healthcare institutions is essential for driving positive change in patient care. It is important to put the right device, for the right clinical scenario, into the hands of those who need them.