Insulin administration: New research questions bias in safety device selection

MindMetre Research became aware of anecdotal evidence that, in some instances, the use of passive safety devices may be linked to mis-dosage and non-delivery of insulin. The company decided to investigate further through research among NHS Trusts in England and Wales, under the terms of the United Kingdom’s Freedom of Information Act. In this article, Paul Lindsell, Managing Director, MindMetre Research, first examines current legislation and guidance on safety engineered devices before evaluating the outcomes of their Freedom of Information (FOI) enquiry and its implications for diabetes care.

Safety-engineered devices:
Legislation and guidance

In 2010, the EU Directive on Sharps Safety was adopted after much debate throughout Europe [1]. The legislation was transposed into national law in all applicable countries by May 2013. While the legislation is mandatory, requiring safety devices to be used “wherever is reasonably practical” [2], there is no advice on the type of safety device that should be used.

As guidance from the Royal College of Nursing notes: “Devices can be passive or active. For example, passive devices have an automatic safety mechanism that is activated after use…. An active device needs to be manually activated by the member of staff.” [3]

Procedural standards such as the BS EN ISO 23908:2013 on Sharps Injury Prevention likewise makes allowances for the use of passive or active devices. The standard lists methods for evaluating the performance of sharps safety equipment, covering both active and passive designs of medical devices containing single-use needles. Further, guidance documents from healthcare authorities such as the Swansea Bay University Health Board [4] highlight that “…the legislation does not require organisations to specifically provide a passive device rather than an active device.”

Safety Engineered Device (SED)

A device that has a built-in mechanism to protect from sharps injury, such as attached sheath covering the needle or scalpel after use or needles that retract after use. SEDs protect the user from exposure to bloodborne pathogens or chemical hazards.

A widespread preference for passive devices

Despite the freedom to choose between active or passive delivery mechanisms, an apparent bias has emerged towards the use of passive devices in all contexts. NHS Scotland says, for example, “devices requiring no additional action to trigger the safety mechanism (i.e. passive devices) are preferable, as the safety mechanism is triggered automatically through ‘normal’ use of the device.”[5] Frequently, in the field of diabetes administration we find best practice groups making statements such as, “Where possible safety-engineered devices with passive activation should be used”.[6] Yet a recent clinical study conducted in Poland concluded that, “Surprisingly there were no significant differences between the risk of injuries with active and passive safety needles”.[7]

This kind of overarching advice on passive products may be misleading in some significant healthcare settings. Our research underlines that in some situations, an active device may be preferable and should at least be considered. Evidence from the diabetes field illustrates one significant instance where blanket use of passive devices is not always in the patient’s best interest and can even lead to harmful outcomes.

Evidence from diabetes specialist nurses

The FOI enquiry by MindMetre research was prompted by this bias towards the use of passive safety devices, alongside anecdotal evidence we received from diabetes specialist nurses, who reported two phenomena occurring at their NHS Trust. The first was insulin pooling on the skin of patients after using passive devices – which suggests the dosage has been under-delivered or not delivered at all. The second was instances of diabetics experiencing an adverse event related to mis-dosage, while still in the Unit or Trust premises.

An examination of official records found that there was a distinct lack of precise data relating to insulin pooling or the adverse events that could have followed insulin administration specifically with a passive device. Our FOI requests therefore went out to all NHS Trusts in England and Wales to gain a clearer picture of how common these issues might be. The goal was to gain some initial evidence to help determine whether diabetes specialist units might need to assess – or re-assess – which type of safety-engineered delivery device is most appropriate for insulin administration.

With this in mind, we asked the Trusts:
– if they had experienced insulin pooling when using a passive delivery device
– and if diabetic patients had experienced adverse events following insulin administration with a passive device, as a result of suspected misdosage.

Our research findings

1. Insulin pooling

On the issue of insulin pooling on the surface of the skin:
• 36.4 % of Trusts confirmed they had experienced this problem when using passive devices to administer insulin.
• 11.4% of Trusts were unable to answer the question.
• 56.8% of Trusts responded that they had not experienced pooling of insulin when using passive devices. However, just over half of these respondents gave indirect answers such as, “With the appropriate training put in place following introduction we have no evidence of insulin pooling” or “From the data that was searched, no records matching the specific criteria of the question were found”. The question simply required asking the specialist diabetes unit in the Trust whether they had experienced this issue, so these vague answers certainly raise further questions.

2. Mis-dosage

On the issue of mis-dosage when using a passive device, evidenced by an adverse, related patient event on-premises:
• 25% of respondents reported they had experience of this occurring
• 56.8% reported that they had no knowledge of such events
• 18.2% said they were unable to answer the question.

Again, as with the pooling issue, close to half of the negative answers were somewhat vague.

Stories of device switching

Additional comments from some Trusts also reveal how experience of one or both of the issues had led to staff becoming concerned for patients’ welfare, resulting in a change of device. One Trust in the North of England noted: “Inaccurate insulin dosage was seen as a result of passive safety needles, due to this [we] moved to active safety needles.” They added, “pooling of insulin was observed when using passive safety needles… again [we] moved to active safety needles for this reason.”

Other Trusts also established policies due to similar issues with one stating: “We stopped using passive safety needles more than 5 years ago (approx. 2016) because we had previously experienced these problems…” Likewise, one further Trust explained: “We have had occasional near misses where it was unknown if the insulin had been given from a passive safety needle… if the needle retracted before the insulin was fully administered, this was noted. This was one of the reasons to remove it from our local formulary… therefore the Quality and Safety team at the hospital decided to remove these and we moved to an alternative [active] device.”

A case for reassessment

Our research shows that while passive devices seem to be almost universally adopted in clinical and care contexts, this may in some cases be undermining patient well-being. Following our research, we recommend that diabetes units are supported by their NHS Trusts to determine whether there have been incidents of insulin pooling and adverse incidents from possible mis-dosage. This is partly due to the vague or indefinite answers we received in response to our FOI enquiry on the subject.

If Trusts find evidence of either of these issues taking place,  it may be sensible to revisit delivery device policies. It might be worth considering whether the balance between healthcare worker safety and patient well-being is best served by continuing to use passive devices or whether a switch to an active device should be considered – as some Trusts have already chosen to do.

Read the full report on MindMetre’s Freedom Of Information request into the use of passive and active safety devices in diabetes administration here:

Paul Lindsell

1. Official Journal of the European Union. (2010). COUNCIL DIRECTIVE 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU.
1. Reflected in individual NHS Trust guidance, such as: Yeovil Hospital (2016). Sharps Safety Policy.
1. Royal College of Nursing. (2017). Essential Practice for Infection Prevention and Control.
1. Swansea Bay University Health Board. (2020). Safer Medical Sharps Policy.
1. Elder, S. NHS Lanarkshire. (2005). Safer Sharps Devices An Evaluation of Utility in NHS Scotland.
1. FIT UK & FIT Ireland Forum for Injection Technique. (2020). The UK & IRE Injection Infusion Technique Recommendations 5th Edition II December 2020. UK_Recommendations_2020_AW.pdf
1. Garus-Pakowska et al. Department of Nutrition and Epidemiology Medical University of Lodz. (2022). Non-Safety and Safety Device Sharp Injuries—Risk of Incidents, SEDs Availability, Attitudes and Perceptions of Nurses According to Cross-Sectional Survey in Poland.