Patient safety


Insulin administration: delivery device safety


Paul Lindsell, managing director, MindMetre Research looks at the latest evidence on the safety of delivery devices used for the administration of insulin. He highlights some concerning findings around insulin pooling and misdosage incidents, following the use of passive devices.


To protect the safety of healthcare professionals administering insulin, safety-engineered devices with built-in mechanisms to protect from sharps injury are mandatory under the EU Directive on Sharps Safety. These devices fall into two main categories: active devices that must be manually activated by healthcare professionals (HCPs) and passive devices with an automatic safety mechanism that is activated after use. MindMetre Research was recently made aware of anecdotal evidence of insulin misdosage or non-delivery with the use of passive injection devices. As a result, we decided to carry out an enquiry into these phenomena in NHS Trusts in England and Wales, under the terms of the United Kingdom’s Freedom of Information (FOI) Act.


Background The EU Directive on Sharps Safety is mandatory legislation that was adopted in 2010 and transposed into national law by all members by 2013.1


As one of its measures for protecting


workers, the legislation stipulates: “eliminating the unnecessary use of sharps by implementing changes in practice and on the basis of the results of the risk assessment, providing medical devices incorporating safety-engineered protection mechanisms”. The risk assessment is described as a determination of exposure, covering “all situations where there is injury, blood or other potentially infectious material”. Critically, the Directive does not provide any advice on the type of device to be used. Likewise, guidance from the Royal College of Nursing offers an explanation of the difference between the two types of device, noting that “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”,2


but does not give any


recommendation to favour one over the other. In a final example, the standard BS EN ISO 23908:2013, Sharps Injury Prevention – which provides procedural guidance and lists test methods for evaluating the performance of


sharps safety equipment and systems – covers both active and passive devices.3


State of play: a bias towards passive devices in practice Despite the freedom afforded to clinical and care specifiers, there appears to be a widespread preference for passive devices. This is reflected in the individual guidance issued by several governing bodies. One document from NHS Scotland, for example, says: “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”.4 The Irish Health & Safety Executive takes a similar view, stating that, “In general passive devices are preferable”.5


In the field of diabetes


more specifically, best practice groups follow the trend, making statements such as, “Where possible safety-engineered devices with passive activation should be used”.6


The origins of this


bias towards passive devices is unclear and clearly not contained in the legislation, as underlined in some guidance documents from


individual NHS Trusts, such as that from the Swansea Bay University Health Board: “Though passive devices will operate automatically and the sharp is protected even if staff fail to deploy the safety feature, the legislation does not require organisations to specifically provide a passive device rather than an active device.”7 It may be the result of stringent healthcare


worker safety protocols. But the data does not necessarily support this position. 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.”8


Our


research suggests that in some situations, an active device may be preferable and should at least be considered.


The investigation In the context of diabetes administration, MindMetre was made aware of anecdotal evidence of two phenomena resulting in adverse patient outcomes, as reported by diabetes specialist nurses working in NHS Trusts. The first of these was insulin pooling on the skin of patients after using passive injection devices,


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